Solid TumorPhase 1NCT03249792

Study of MK-2118 Administered as Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab (MK-3475) or by Subcutaneous Injection in Combination With Pembrolizumab in the Treatment of Adults With Advanced/Metastatic Solid Tumors or Lymphomas (MK-2118-001)

A Phase 1 study testing MK-2118 (IT), MK-2118 (SC) and Pembrolizumab in people with Solid Tumor and Lymphoma, run by Merck Sharp & Dohme LLC at 8 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor, Lymphoma
What is being tested?: MK-2118 (IT), MK-2118 (SC) and Pembrolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 8 sitesin 2 countries
Study dates: 20 Sep 2017to 22 Feb 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Arms 1 and 2 Participants:
Has any histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received, or have been intolerant to all treatment known to confer clinical benefit. Solid tumors and lymphomas of any type are eligible for enrollment. For cutaneous T-cell lymphoma (CTCL), histopathological diagnosis should be confirmed in a skin biopsy representative of disease.
Has Stage III or Stage IV disease that is not surgically resectable. Stage IIB (T3N0M0B0-1) CTCL participants are eligible.
Arm 3 Participants:
Has metastatic liver and/or liver lesion involvement that does not exceed one third of the total liver volume in participants to be treated by liver IT injection. Hepatocellular carcinoma participants are excluded from eligibility of IT liver injection.
All Participants:

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Has Stage III or Stage IV disease that is not surgically resectable.
Has ≥1 injectable lesion that is amenable to injection and biopsy via visual inspection for a cutaneous lesion, or via ultrasound guidance for a subcutaneous lesion.
Has ≥1 discrete, distant noninjected lesion that is amenable to biopsy via visual inspection or amenable to biopsy via image guidance.
Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Demonstrates adequate organ function.
A male participant is eligible to participate if he agrees to the following during the intervention period and for at least 120 days after the last dose of study intervetnion:
Refrain from donating sperm.
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Is not a woman of childbearing potential (WOCBP).
Is a WOCBP and using a contraceptive method that is highly effective with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention, AND agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period.
Human Immunodeficiency Virus (HIV)-infected participants must meet these additional criteria:
Has HIV-1 infection documented by laboratory test.
Has well-controlled HIV on antiretroviral therapy (ART), defined as: 1) must have a CD4+ T-cell count >350 cells/mm^3 at time of screening; 2) must have achieved and maintained virologic suppression defined as confirmed HIV ribonucleic acid (RNA) level <50 or below the lower limit of quantification (LLOQ) using the locally available assay at the time of screening and for ≥12 weeks prior to screening; and 3) must have been on a stable regimen, without changes in drugs or dose modification, for ≥4 weeks prior to study entry (Day 1).

Who cannot join

Has history of a second malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 2 years (except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, or in situ cervical cancer).
Has clinically active central nervous system metastases and/or carcinomatous meningitis.
Has severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb).
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Has history of vasculitis.
Has active infection requiring therapy.

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Has history of (noninfectious) pneumonitis that required steroids or current pneumonitis.
Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
Has known Hepatitis B or C infection.
Has known psychiatric or substance abuse disorders that would interfere in cooperation with the requirements of the trial.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
Is not fully recovered from any effects of major surgery, and is free of significant detectable infection.
HIV-infected participants with history of Kaposi's sarcoma and/or multicentric Castleman's disease.
HIV-infected participants who have had an HIV-related opportunistic infection within 6 months.
Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to the first dose of study treatment, or has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from the AEs due to cancer therapeutics administered >4 weeks earlier.
Has been treated within 2 weeks of Cycle 1 Day1 with any of the following: strong/moderate Cytochrome P450 2C9 (CYP2C9) inhibitors, such as: amiodarone, felbamate, fluconazole, miconazole, piperine, oxandrolone, fluorouracil and its derivatives (combination drug tegafur/gimeracil/oteracil [TS-1], Uftoral [UFT], tegafur, carmofur, doxifluridine, capecitabine), sulfaphenazole, cyclosporine, bucurol, tienilic acid; UGT1A3 inhibitors (including ritonavir, quinidine, probenecid, and valproic acid); or strong carbonyl reductase (CBR) inhibitors (including quercetin, menadione, glycyrrhetinic acid, and flufenamic acid).
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and has received study therapy or has used an investigational device within 28 days of administration of MK-2118.
Is expected to require any other form of antineoplastic therapy while on study.
Is on chronic systemic steroid therapy in excess of replacement doses (prednisone ≤10 mg/day is acceptable), or on any other form of immunosuppressive medication. For CTCL, continued use of either prednisone ≤10 mg/day or continued use of topical steroids is acceptable.
Has received a live vaccine within 28 days prior to first dose.
Has been treated with a stimulator of interferon genes (STING) agonist (eg, MK-1454, ADU-S100 [synthetic cyclic dinucleotide (CDN)]).
Has a history of re-irradiation for head and neck squamous cell carcinoma (HNSCC) at the projected injection site.
Has a tumor(s) in direct contact or encases a major blood vessel and has ulceration and/or fungation onto the skin surface at the projected injection site.

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

United States7 sites

University of Chicago ( Site 0002)
Chicago, Illinois, 60637
Mary Crowley Cancer Research Center ( Site 0005)
Dallas, Texas, 75230
MD Anderson Cancer Centr. ( Site 0006)
Houston, Texas, 77030
University of California San Diego Moores Cancer Center ( Site 0004)
La Jolla, California, 92093
UCLA ( Site 0003)
Los Angeles, California, 90095
New York Presbyterian Hospital/Columbia University ( Site 0001)
New York, New York, 10032
UPMC Hillman Cancer Centers ( Site 0007)
Pittsburgh, Pennsylvania, 15232

Other trials in United States

Israel1 site

Sheba Medical Center ( Site 0301)
Ramat Gan, 5265601

Other trials in Israel

About this study

Official title: A Phase 1 Open-label, Multicenter Study of MK-2118 Administered by Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab or by Subcutaneous Injection in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors or Lymphomas

The purposes of this study are to: 1) assess the safety and tolerability and 2) establish a preliminary recommended Phase 2 dose (RP2D) and/or a maximum tolerated dose (MTD) or a maximum administered dose (MAD) of MK-2118 when administered via intratumoral (IT) injection as monotherapy and in combination with pembrolizumab (MK-3475) intravenous (IV) infusion, or via subcutaneous (SC) injection in combination with pembrolizumab IV infusion in the treatment of adult participants with advanced/metastatic solid tumors or lymphomas.

Participants will receive either MK-2118 monotherapy or MK-2118 in combination with pembrolizumab for up to 35 cycles for Arms 1-3 or up to 36 cycles for Arm 4 (up to approximately 2 years).

All participants will undergo at least a 24-hour observation period following the first three administrations of MK-2118 (Arms 1-3: Cycle 1 Days 1, 8, and 15. Arm 4: Cycle 1 Days 1 and 8; and Cycle 2 Day 1).

Qualified participants who experience radiographic or clinical progression in Arm 1 (MK-2118 Intra-tumoral [IT] monotherapy) may switch over to Arm 2 (MK-2118 IT + Pembrolizumab IV Combination Therapy) at an eligible dose.

Pharmacokinetic (PK) outcome measures will not be analyzed separately for the switch-over treatment arms, per protocol.

Read the detailed description

Arm 3 did not enroll any participants.

Data for the pembrolizumab Cmin outcome measure were not collected.

Conditions: Solid Tumor, Lymphoma
Being tested: MK-2118 (IT), MK-2118 (SC), Pembrolizumab
Medical subject headings: Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-2118 (IT)Drug
IT injection
MK-2118 (SC)Drug
SC injection
PembrolizumabBiological
Also called MK-3475
IV infusion

Study groups in NCT03249792
Study group	Role	What they receive
Arm 1 MK-2118 100 µg Intra-tumoral (IT) Monotherapy	Experimental	Participants receive MK-2118 100 µg via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT)
Arm 1 MK-2118 300 µg IT Monotherapy	Experimental	Participants receive MK-2118 300 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT)
Arm 1 MK-2118 900 µg IT Monotherapy	Experimental	Participants receive MK-2118 900 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT)
Arm 1 MK-2118 2700 µg IT Monotherapy	Experimental	Participants receive MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT)
Arm 1 MK-2118 5400 µg IT Monotherapy	Experimental	Participants receive MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT)
Arm 1 MK-2118 7700 µg IT Monotherapy	Experimental	Participants receive MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT)
Arm 1 MK-2118 10000 µg IT Monotherapy	Experimental	Participants receive MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT)
Arm 1 MK-2118 15000 µg IT Monotherapy	Experimental	Participants receive MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT)
Arm 1 MK-2118 20000 µg IT Monotherapy	Experimental	Participants receive MK-2118 20000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT)
Arm 2 MK-2118 2700 µg IT + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT); Biological: Pembrolizumab
Arm 2 MK-2118 5400 µg IT + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT); Biological: Pembrolizumab
Arm 2 MK-2118 7700 µg IT + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT); Biological: Pembrolizumab
Arm 2 MK-2118 10000 µg IT + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT); Biological: Pembrolizumab
Arm 2 MK-2118 15000 µg IT + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT); Biological: Pembrolizumab
(Not Enrolled) Arm 3 MK-2118 Visceral IT + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-2 followed by Q3W on Day 1 of Cycle 3 and beyond, for a total of up to ~35 cycles (up to ~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long. Receives: Drug: MK-2118 (IT); Biological: Pembrolizumab
Arm 4: MK-2118 5000 µg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 5000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long. Receives: Drug: MK-2118 (SC); Biological: Pembrolizumab
Arm 4: MK-2118 10000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 10000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long. Receives: Drug: MK-2118 (SC); Biological: Pembrolizumab
Arm 4: MK-2118 15000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 15000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long. Receives: Drug: MK-2118 (SC); Biological: Pembrolizumab
Arm 4: MK-2118 20000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 20000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long. Receives: Drug: MK-2118 (SC); Biological: Pembrolizumab
Arm 4: MK-2118 30000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 30000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long. Receives: Drug: MK-2118 (SC); Biological: Pembrolizumab
Arm 4: MK-2118 45000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 45000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long. Receives: Drug: MK-2118 (SC); Biological: Pembrolizumab
Arm 4: MK-2118 60000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 60000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long. Receives: Drug: MK-2118 (SC); Biological: Pembrolizumab
Arm 4: MK-2118 90000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 90000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long. Receives: Drug: MK-2118 (SC); Biological: Pembrolizumab
Arm 4: MK-2118 120000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 120000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long. Receives: Drug: MK-2118 (SC); Biological: Pembrolizumab
Arm 4: MK-2118 150000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Participants receive MK-2118 150000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long. Receives: Drug: MK-2118 (SC); Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experience One or More Dose-limiting Toxicities (DLTs)
A DLT is defined as the following toxicities, if related to study treatment: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia (Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with significant bleeding); non-hematologic adverse event (AE) ≥Grade 3 (with exceptions); Grade 3 or Grade 4 nonhematologic abnormality; febrile neutropenia Grade 3 or 4; any toxicity causing treatment discontinuation or missing ≥1 dose; any toxicity causing a >2 week delay initiating pembrolizumab; any elevated aspartate aminotransferase or alanine aminotransferase value that is ≥3× upper limit of normal (ULN) and an elevated total bilirubin value that is ≥2× ULN \& an alkaline phosphatase value that is <2× ULN with no alternative explanation; any ≥Grade 2 immune-mediated uveitis; Grade 5 toxicity. Per protocol, DLTs were analyzed separately for the switch-over treatment arms. The number of participants who experienced one or more DLTs is reported.
Measured: Up to ~35 days
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, safety was analyzed separately for the switch-over treatment arms. The number of participants who experienced one or more AEs is reported.
Measured: Up to ~65 months
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, tolerability was analyzed separately for the switch-over treatment arms. The number of participants who discontinued study treatment due to an AE is reported.
Measured: Up to ~27 months

Secondary outcomes (4)

MK-2118 Minimum Plasma Concentration (Cmin)
Cmin of MK-2118 was defined as the minimum concentration of MK-2118 observed in plasma. Blood samples were collected pre-dose and at specified timepoints post dose for estimation of MK-2118 Cmin. Per protocol, PK outcomes were not analyzed separately for the switch-over treatment arms.
Measured: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours postdose; Cycle 2 Day 1, Cycle 3 Day 1: Predose, 0.5, 1, 2, 4, 6, 8 hours postdose (Arms 1 and 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 and 3= 3 weeks)
MK-2118 Maximum Plasma Concentration (Cmax)
Cmax of MK-2118 was defined as the maximum concentration of MK-2118 observed in plasma. Blood samples were collected pre-dose and at specified timepoints post dose for estimation of MK-2118 Cmax. Per protocol, PK outcomes were not analyzed separately for the switch-over treatment arms.
Measured: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours postdose; Cycle 2 Day 1, Cycle 3 Day 1: Predose, 0.5, 1, 2, 4, 6, 8 hours postdose (Arms 1 and 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 and 3= 3 weeks)
MK-2118 Area Under the Concentration-time Curve From 0 to 24 Hours (AUC 0-24 Hours)
AUC 0-24 hours of MK-2118 was defined as a measure of MK-2118 exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected pre-dose and at specified timepoints post dose for estimation of MK-2118 AUC0-24 hours. Per protocol, PK outcomes were not analyzed separately for the switch-over treatment arms.
Measured: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours postdose; Cycle 2 Day 1, Cycle 3 Day 1: Predose, 0.5, 1, 2, 4, 6, 8 hours postdose (Arms 1 and 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 and 3= 3 weeks)
Pembrolizumab Minimum Plasma Concentration (Cmin)
Cmin of pembrolizumab was defined as the minimum concentration of pembrolizumab observed in plasma. Blood samples were to be collected at specified timepoints for estimation of pembrolizumab Cmin. Per protocol, analysis of pembrolizumab Cmin was not planned in Arm 1 (MK-2118 IT Monotherapy) or for the switch-over treatment arms. For Arm 2 (MK-2118 IT + Pembrolizumab combination) and Arm 4 (MK-2118 SC + Pembrolizumab combination), pembrolizumab Cmin data were not collected.
Measured: Predose on Day 1 of Cycles 1, 2, 3, 4, 5 and every 4 cycles thereafter (up to ~2 years) (Arm 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 to 36= 3 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 201722 Feb 2023

First posted15 Aug 2017
Study start20 Sep 2017
Primary completion22 Feb 2023
Study completion22 Feb 2023

Why it stopped: Business Reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Solid TumorStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03249792
Sponsor's protocol ID: 2118-001
Other IDs: MK-2118-001
Status last verified: Jul 2025
First submitted: 9 Aug 2017
Last updated: 24 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Luke JJ, Sweis RF, Hecht JR, Schneider R, Stein MN, Golan T, Yap TA, Khilnani A, Huang M, Zhao R, Jemielita T, Patel SP. Intratumoral or Subcutaneous MK-2118, a Noncyclic Dinucleotide STING Agonist, with or without Pembrolizumab, for Advanced or Metastatic Solid Tumors or Lymphomas. Clin Cancer Res. 2025 Apr 1;31(7):1233-1242. doi: 10.1158/1078-0432.CCR-24-2824.
PubMed 39846804

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Open-label, Multicenter Study of MK-2118 Administered by Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab or by Subcutaneous Injection in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors or Lymphomas
ClinicalTrials.gov ID: NCT03249792
Acronym / sponsor ID: 2118-001
Conditions: Solid Tumor, Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business Reasons
Enrolment: 140 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 20 Sep 2017 (actual)
Primary completion: 22 Feb 2023 (actual)
Study completion: 22 Feb 2023 (actual)
First posted: 15 Aug 2017 (actual)
Results: Posted 24 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participants will receive either MK-2118 monotherapy or MK-2118 in combination with pembrolizumab for up to 35 cycles for Arms 1-3 or up to 36 cycles for Arm 4 (up to approximately 2 years).

Pharmacokinetic (PK) outcome measures will not be analyzed separately for the switch-over treatment arms, per protocol.

Detailed description

Arm 3 did not enroll any participants.

Data for the pembrolizumab Cmin outcome measure were not collected.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 25

Arm	Type	Receives
Arm 1 MK-2118 100 µg Intra-tumoral (IT) Monotherapy	Experimental	Drug: MK-2118 (IT)Participants receive MK-2118 100 µg via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
Arm 1 MK-2118 300 µg IT Monotherapy	Experimental	Drug: MK-2118 (IT)Participants receive MK-2118 300 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
Arm 1 MK-2118 900 µg IT Monotherapy	Experimental	Drug: MK-2118 (IT)Participants receive MK-2118 900 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
Arm 1 MK-2118 2700 µg IT Monotherapy	Experimental	Drug: MK-2118 (IT)Participants receive MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
Arm 1 MK-2118 5400 µg IT Monotherapy	Experimental	Drug: MK-2118 (IT)Participants receive MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
Arm 1 MK-2118 7700 µg IT Monotherapy	Experimental	Drug: MK-2118 (IT)Participants receive MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
Arm 1 MK-2118 10000 µg IT Monotherapy	Experimental	Drug: MK-2118 (IT)Participants receive MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
Arm 1 MK-2118 15000 µg IT Monotherapy	Experimental	Drug: MK-2118 (IT)Participants receive MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
Arm 1 MK-2118 20000 µg IT Monotherapy	Experimental	Drug: MK-2118 (IT)Participants receive MK-2118 20000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
Arm 2 MK-2118 2700 µg IT + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (IT), Biological: PembrolizumabParticipants receive MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
Arm 2 MK-2118 5400 µg IT + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (IT), Biological: PembrolizumabParticipants receive MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
Arm 2 MK-2118 7700 µg IT + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (IT), Biological: PembrolizumabParticipants receive MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
Arm 2 MK-2118 10000 µg IT + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (IT), Biological: PembrolizumabParticipants receive MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
Arm 2 MK-2118 15000 µg IT + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (IT), Biological: PembrolizumabParticipants receive MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to ~35 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
(Not Enrolled) Arm 3 MK-2118 Visceral IT + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (IT), Biological: PembrolizumabParticipants receive MK-2118 via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-2 followed by Q3W on Day 1 of Cycle 3 and beyond, for a total of up to ~35 cycles (up to ~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to ~35 cycles (up to ~2 years). Each cycle is 3 weeks long.
Arm 4: MK-2118 5000 µg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (SC), Biological: PembrolizumabParticipants receive MK-2118 5000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
Arm 4: MK-2118 10000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (SC), Biological: PembrolizumabParticipants receive MK-2118 10000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
Arm 4: MK-2118 15000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (SC), Biological: PembrolizumabParticipants receive MK-2118 15000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
Arm 4: MK-2118 20000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (SC), Biological: PembrolizumabParticipants receive MK-2118 20000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
Arm 4: MK-2118 30000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (SC), Biological: PembrolizumabParticipants receive MK-2118 30000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
Arm 4: MK-2118 45000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (SC), Biological: PembrolizumabParticipants receive MK-2118 45000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
Arm 4: MK-2118 60000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (SC), Biological: PembrolizumabParticipants receive MK-2118 60000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
Arm 4: MK-2118 90000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (SC), Biological: PembrolizumabParticipants receive MK-2118 90000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
Arm 4: MK-2118 120000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (SC), Biological: PembrolizumabParticipants receive MK-2118 120000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.
Arm 4: MK-2118 150000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	Experimental	Drug: MK-2118 (SC), Biological: PembrolizumabParticipants receive MK-2118 150000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to ~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to ~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

Has any histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received, or have been intolerant to all treatment known to confer clinical benefit. Solid tumors and lymphomas of any type are eligible for enrollment. For cutaneous T-cell lymphoma (CTCL), histopathological diagnosis should be confirmed in a skin biopsy representative of disease.
Has Stage III or Stage IV disease that is not surgically resectable. Stage IIB (T3N0M0B0-1) CTCL participants are eligible.
Has metastatic liver and/or liver lesion involvement that does not exceed one third of the total liver volume in participants to be treated by liver IT injection. Hepatocellular carcinoma participants are excluded from eligibility of IT liver injection.
Has Stage III or Stage IV disease that is not surgically resectable.
Has ≥1 injectable lesion that is amenable to injection and biopsy via visual inspection for a cutaneous lesion, or via ultrasound guidance for a subcutaneous lesion.

Key exclusion criteria (23 listed)

Has history of a second malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 2 years (except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, or in situ cervical cancer).
Has clinically active central nervous system metastases and/or carcinomatous meningitis.
Has severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb).
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Has history of vasculitis.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-2118 (IT)IT injection	Drug	(Not Enrolled) Arm 3 MK-2118 Visceral IT + Pembrolizumab 200 mg IV Combination Therapy, Arm 1 MK-2118 100 µg Intra-tumoral (IT) Monotherapy, Arm 1 MK-2118 10000 µg IT Monotherapy, Arm 1 MK-2118 15000 µg IT Monotherapy, Arm 1 MK-2118 20000 µg IT Monotherapy, Arm 1 MK-2118 2700 µg IT Monotherapy, Arm 1 MK-2118 300 µg IT Monotherapy, Arm 1 MK-2118 5400 µg IT Monotherapy, Arm 1 MK-2118 7700 µg IT Monotherapy, Arm 1 MK-2118 900 µg IT Monotherapy, Arm 2 MK-2118 10000 µg IT + Pembrolizumab 200 mg IV Combination Therapy, Arm 2 MK-2118 15000 µg IT + Pembrolizumab 200 mg IV Combination Therapy, Arm 2 MK-2118 2700 µg IT + Pembrolizumab 200 mg IV Combination Therapy, Arm 2 MK-2118 5400 µg IT + Pembrolizumab 200 mg IV Combination Therapy, Arm 2 MK-2118 7700 µg IT + Pembrolizumab 200 mg IV Combination Therapy
MK-2118 (SC)SC injection	Drug	Arm 4: MK-2118 10000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 120000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 15000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 150000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 20000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 30000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 45000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 5000 µg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 60000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 90000 µg SC + Pembrolizumab 200 mg IV Combination Therapy
PembrolizumabAlso: MK-3475IV infusion	Biological	(Not Enrolled) Arm 3 MK-2118 Visceral IT + Pembrolizumab 200 mg IV Combination Therapy, Arm 2 MK-2118 10000 µg IT + Pembrolizumab 200 mg IV Combination Therapy, Arm 2 MK-2118 15000 µg IT + Pembrolizumab 200 mg IV Combination Therapy, Arm 2 MK-2118 2700 µg IT + Pembrolizumab 200 mg IV Combination Therapy, Arm 2 MK-2118 5400 µg IT + Pembrolizumab 200 mg IV Combination Therapy, Arm 2 MK-2118 7700 µg IT + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 10000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 120000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 15000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 150000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 20000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 30000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 45000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 5000 µg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 60000 µg SC + Pembrolizumab 200 mg IV Combination Therapy, Arm 4: MK-2118 90000 µg SC + Pembrolizumab 200 mg IV Combination Therapy

Primary outcome

Number of Participants Who Experience One or More Dose-limiting Toxicities (DLTs)
Time frame: Up to ~35 days
A DLT is defined as the following toxicities, if related to study treatment: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia (Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with significant bleeding); non-hematologic adverse event (AE) ≥Grade 3 (with exceptions); Grade 3 or Grade 4 nonhematologic abnormality; febrile neutropenia Grade 3 or 4; any toxicity causing treatment discontinuation or missing ≥1 dose; any toxicity causing a >2 week delay initiating pembrolizumab; any elevated aspartate aminotransferase or alanine aminotransferase value that is ≥3× upper limit of normal (ULN) and an elevated total bilirubin value that is ≥2× ULN \& an alkaline phosphatase value that is <2× ULN with no alternative explanation; any ≥Grade 2 immune-mediated uveitis; Grade 5 toxicity. Per protocol, DLTs were analyzed separately for the switch-over treatment arms. The number of participants who experienced one or more DLTs is reported.
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to ~65 months
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, safety was analyzed separately for the switch-over treatment arms. The number of participants who experienced one or more AEs is reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to ~27 months
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, tolerability was analyzed separately for the switch-over treatment arms. The number of participants who discontinued study treatment due to an AE is reported.

4 secondary outcomes

MK-2118 Minimum Plasma Concentration (Cmin)
Time frame: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours postdose; Cycle 2 Day 1, Cycle 3 Day 1: Predose, 0.5, 1, 2, 4, 6, 8 hours postdose (Arms 1 and 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 and 3= 3 weeks)
MK-2118 Maximum Plasma Concentration (Cmax)
Time frame: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours postdose; Cycle 2 Day 1, Cycle 3 Day 1: Predose, 0.5, 1, 2, 4, 6, 8 hours postdose (Arms 1 and 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 and 3= 3 weeks)
MK-2118 Area Under the Concentration-time Curve From 0 to 24 Hours (AUC 0-24 Hours)
Time frame: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours postdose; Cycle 2 Day 1, Cycle 3 Day 1: Predose, 0.5, 1, 2, 4, 6, 8 hours postdose (Arms 1 and 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 and 3= 3 weeks)
Pembrolizumab Minimum Plasma Concentration (Cmin)
Time frame: Predose on Day 1 of Cycles 1, 2, 3, 4, 5 and every 4 cycles thereafter (up to ~2 years) (Arm 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 to 36= 3 weeks)

Results and safety

Results posted to the registry on 24 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1 MK-2118 100 µg Intra-tumoral (IT) Monotherapy	1	0
Arm 1 MK-2118 300 µg IT Monotherapy	1	0
Arm 1 MK-2118 900 µg IT Monotherapy	1	0
Arm 1 MK-2118 2700 µg IT Monotherapy	2	0
Arm 1 MK-2118 5400 µg IT Monotherapy	3	0
Arm 1 MK-2118 7700 µg IT Monotherapy	3	0
Arm 1 MK-2118 10000 µg IT Monotherapy	6	0
Arm 1 MK-2118 15000 µg IT Monotherapy	4	0
Arm 1 MK-2118 20000 µg IT Monotherapy	6	0
Arm 2 MK-2118 2700 µg IT + Pembrolizumab 200 mg IV Combination Therapy	2	0
Arm 2 MK-2118 5400 µg IT + Pembrolizumab 200 mg IV Combination Therapy	13	0
Arm 2 MK-2118 7700 µg IT + Pembrolizumab 200 mg IV Combination Therapy	11	0
Arm 2 MK-2118 10000 µg IT + Pembrolizumab 200 mg IV Combination Therapy	18	0
Arm 2 MK-2118 15000 µg IT + Pembrolizumab 200 mg IV Combination Therapy	13	0
(Not Enrolled) Arm 3 MK-2118 Visceral IT + Pembrolizumab 200 mg IV Combination Therapy	0	0
Arm 4: MK-2118 5000 µg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy	4	0
Arm 4: MK-2118 10000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	8	0
Arm 4: MK-2118 15000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	14	0
Arm 4: MK-2118 20000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	7	0
Arm 4: MK-2118 30000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	6	0
Arm 4: MK-2118 45000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	3	0
Arm 4: MK-2118 60000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	3	0
Arm 4: MK-2118 90000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	3	0
Arm 4: MK-2118 120000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	4	0
Arm 4: MK-2118 150000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	4	0
Switch-over Arm 1 MK-2118 300 µg IT To Arm 2 900 µg IT + Pembrolizumab 200 mg IV	0	0
Switch-over Arm 1 MK-2118 2700 µg IT To Arm 2 2700 µg IT + Pembrolizumab 200 mg IV	0	0
Switch-over Arm 1 MK-2118 15000 µg IT To Arm 2 5400 µg IT + Pembrolizumab 200 mg IV	0	0
Switch-over Arm 1 MK-2118 900 µg IT To Arm 2 7700 µg IT + Pembrolizumab 200 mg IV	0	0
Switch-over Arm 1 MK-2118 7700 µg IT To Arm 2 7700 µg IT + Pembrolizumab 200 mg IV	0	0
Switch-over Arm 1 MK-2118 15000 µg IT To Arm 2 10000 µg IT + Pembrolizumab 200 mg IV	0	0
Switch-over Arm 1 MK-2118 20000 µg IT To Arm 2 10000 µg IT + Pembrolizumab 200 mg IV	0	0
Switch-over Arm 1 MK-2118 20000 µg IT To Arm 2 15000 µg IT + Pembrolizumab 200 mg IV	0	0

Primary outcome: Number of Participants Who Experience One or More Dose-limiting Toxicities (DLTs)

Time frame: Up to ~35 days. Count of participants. Unit: Participants

Measure	Arm 1 MK-2118 100 μg Intra-tumoral (IT) Monotherapy n = 1	Arm 1 MK-2118 300 μg IT Monotherapy n = 1	Arm 1 MK-2118 900 μg IT Monotherapy n = 1	Arm 1 MK-2118 2700 μg IT Monotherapy n = 2	Arm 1 MK-2118 5400 μg IT Monotherapy n = 3	Arm 1 MK-2118 7700 μg IT Monotherapy n = 3	Arm 1 MK-2118 10000 μg IT Monotherapy n = 6	Arm 1 MK-2118 15000 μg IT Monotherapy n = 4	Arm 1 MK-2118 20000 μg IT Monotherapy n = 6	Arm 2 MK-2118 2700 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 2	Arm 2 MK-2118 5400 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 13	Arm 2 MK-2118 7700 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 11	Arm 2 MK-2118 10000 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 15	Arm 2 MK-2118 15000 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 13	Arm 4: MK-2118 5000 μg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy n = 3	Arm 4: MK-2118 10000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 8	Arm 4: MK-2118 15000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 13	Arm 4: MK-2118 20000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 7	Arm 4: MK-2118 30000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 6	Arm 4: MK-2118 45000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 3	Arm 4: MK-2118 60000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 3	Arm 4: MK-2118 90000 μg SC + Pembrolizumab 200 mg IV Combination Therapy

Primary outcome: Number of Participants Who Experience One or More Adverse Events (AEs)

Time frame: Up to ~65 months. Count of participants. Unit: Participants

Measure	Arm 1 MK-2118 100 μg Intra-tumoral (IT) Monotherapy n = 1	Arm 1 MK-2118 300 μg IT Monotherapy n = 1	Arm 1 MK-2118 900 μg IT Monotherapy n = 1	Arm 1 MK-2118 2700 μg IT Monotherapy n = 2	Arm 1 MK-2118 5400 μg IT Monotherapy n = 3	Arm 1 MK-2118 7700 μg IT Monotherapy n = 3	Arm 1 MK-2118 10000 μg IT Monotherapy n = 6	Arm 1 MK-2118 15000 μg IT Monotherapy n = 4	Arm 1 MK-2118 20000 μg IT Monotherapy n = 6	Arm 2 MK-2118 2700 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 2	Arm 2 MK-2118 5400 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 13	Arm 2 MK-2118 7700 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 11	Arm 2 MK-2118 10000 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 16	Arm 2 MK-2118 15000 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 13	Arm 4: MK-2118 5000 μg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy n = 4	Arm 4: MK-2118 10000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 8	Arm 4: MK-2118 15000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 14	Arm 4: MK-2118 20000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 7	Arm 4: MK-2118 30000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 6	Arm 4: MK-2118 45000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 3	Arm 4: MK-2118 60000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 3	Arm 4: MK-2118 90000 μg SC + Pembrolizumab 200 mg IV Combination Therapy

Primary outcome: Number of Participants Who Discontinue Study Treatment Due to an AE

Time frame: Up to ~27 months. Count of participants. Unit: Participants

Measure	Arm 1 MK-2118 100 μg Intra-tumoral (IT) Monotherapy n = 1	Arm 1 MK-2118 300 μg IT Monotherapy n = 1	Arm 1 MK-2118 900 μg IT Monotherapy n = 1	Arm 1 MK-2118 2700 μg IT Monotherapy n = 2	Arm 1 MK-2118 5400 μg IT Monotherapy n = 3	Arm 1 MK-2118 7700 μg IT Monotherapy n = 3	Arm 1 MK-2118 10000 μg IT Monotherapy n = 6	Arm 1 MK-2118 15000 μg IT Monotherapy n = 4	Arm 1 MK-2118 20000 μg IT Monotherapy n = 6	Arm 2 MK-2118 2700 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 2	Arm 2 MK-2118 5400 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 13	Arm 2 MK-2118 7700 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 11	Arm 2 MK-2118 10000 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 16	Arm 2 MK-2118 15000 μg IT + Pembrolizumab 200 mg IV Combination Therapy n = 13	Arm 4: MK-2118 5000 μg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy n = 4	Arm 4: MK-2118 10000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 8	Arm 4: MK-2118 15000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 14	Arm 4: MK-2118 20000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 7	Arm 4: MK-2118 30000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 6	Arm 4: MK-2118 45000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 3	Arm 4: MK-2118 60000 μg SC + Pembrolizumab 200 mg IV Combination Therapy n = 3	Arm 4: MK-2118 90000 μg SC + Pembrolizumab 200 mg IV Combination Therapy

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to ~65 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1 MK-2118 100 µg Intra-tumoral (IT) Monotherapy	1 of 1 (100%)	1 of 1 (100%)	1 of 1
Arm 1 MK-2118 300 µg IT Monotherapy	0 of 1 (0%)	1 of 1 (100%)	1 of 1
Arm 1 MK-2118 900 µg IT Monotherapy	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Arm 1 MK-2118 2700 µg IT Monotherapy	0 of 2 (0%)	2 of 2 (100%)	2 of 2
Arm 1 MK-2118 5400 µg IT Monotherapy	2 of 3 (66.7%)	3 of 3 (100%)	3 of 3
Arm 1 MK-2118 7700 µg IT Monotherapy	0 of 3 (0%)	3 of 3 (100%)	2 of 3
Arm 1 MK-2118 10000 µg IT Monotherapy	3 of 6 (50%)	6 of 6 (100%)	5 of 6
Arm 1 MK-2118 15000 µg IT Monotherapy	1 of 4 (25%)	4 of 4 (100%)	4 of 4
Arm 1 MK-2118 20000 µg IT Monotherapy	1 of 6 (16.7%)	6 of 6 (100%)	4 of 6
Arm 2 MK-2118 2700 µg IT + Pembrolizumab 200 mg IV Combination Therapy	1 of 2 (50%)	2 of 2 (100%)	2 of 2
Arm 2 MK-2118 5400 µg IT + Pembrolizumab 200 mg IV Combination Therapy	4 of 13 (30.8%)	13 of 13 (100%)	8 of 13
Arm 2 MK-2118 7700 µg IT + Pembrolizumab 200 mg IV Combination Therapy	6 of 11 (54.5%)	11 of 11 (100%)	9 of 11
Arm 2 MK-2118 10000 µg IT + Pembrolizumab 200 mg IV Combination Therapy	13 of 16 (81.3%)	16 of 16 (100%)	13 of 18
Arm 2 MK-2118 15000 µg IT + Pembrolizumab 200 mg IV Combination Therapy	6 of 13 (46.2%)	12 of 13 (92.3%)	9 of 13
Arm 4: MK-2118 5000 µg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy	0 of 4 (0%)	4 of 4 (100%)	4 of 4
Arm 4: MK-2118 10000 µg SC + Pembrolizumab 200 mg IV Combination Therapy	2 of 8 (25%)	8 of 8 (100%)	6 of 8
Arm 4: MK-2118 15000 µg SC + Pembrolizumab 200 mg IV Combination Therapy

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 39846804Luke JJ, Sweis RF, Hecht JR, Schneider R, Stein MN, Golan T, Yap TA, Khilnani A, Huang M, Zhao R, Jemielita T, Patel SP. Intratumoral or Subcutaneous MK-2118, a Noncyclic Dinucleotide STING Agonist, with or without Pembrolizumab, for Advanced or Metastatic Solid Tumors or Lymphomas. Clin Cancer Res. 2025 Apr 1;31(7):1233-1242. doi: 10.1158/1078-0432.CCR-24-2824.
Merck Oncology Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

8 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-2118 (IT), MK-2118 (SC) and Pembrolizumab in people with Solid Tumor and Lymphoma, run by Merck Sharp & Dohme LLC at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experience One or More Dose-limiting Toxicities (DLTs) (time frame: Up to ~35 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03249792, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.