Study of MK-1248 With and Without Pembrolizumab (MK-3475) for Participants With Advanced Solid Tumors (MK-1248-001)

A Phase 1 study testing MK-1248 and pembrolizumab in people with Advanced Solid Tumor, run by Merck Sharp & Dohme LLC.

Terminated

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

Trial summary

In this study, participants with advanced solid tumors were assigned to receive escalating doses of either MK-1248 alone or MK-1248 in combination with pembrolizumab (MK-3475). This study used the number of dose-limiting toxicities (DLTs) at each dose level to find and confirm the maximum tolerated dose (or maximum… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumor
What is being tested?: MK-1248 and pembrolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: No sites listed yet
Study dates: 12 Nov 2015to 17 Oct 2018
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

Histologically- or cytologically-confirmed metastatic solid tumor for which there is no available therapy that may convey clinical benefit
Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Adequate organ function
Female participants of childbearing potential should be willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication
Male participants should agree to use adequate contraception starting with the first dose of study therapy through 180 days after the last dose of study medication
Can submit a baseline tumor sample

Who cannot join

Has had chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the first dose of study medication, or not recovered from adverse events due to cancer therapeutics administered more than 4 weeks earlier
Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study medication
Previous treatment with another agent targeting the glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR) receptor
Previous treatment with an immunomodulatory therapy and was discontinued from that therapy due to an immune-related adverse event
Expected to require any other form of antineoplastic therapy while on study
On chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication

Show all 20Show fewer

History of a previous, additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years with the exception of successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer or in situ cervical cancer
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Severe hypersensitivity reaction to treatment with another monoclonal antibody
Active autoimmune disease or a documented history of autoimmune disease with the exception of vitiligo or resolved childhood asthma/atopy, or endocrine deficiency following treatment with an immunomodulatory agent
Active infection requiring therapy
Active or a history of non-infectious pneumonitis
Prior stem cell or bone marrow transplant
Known history of human immunodeficiency virus (HIV), active chronic or acute hepatitis B or C
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol), at the time of signing informed consent
Symptomatic ascites or pleural effusion
Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study through 180 days after the last dose of study medication
Major surgery within 16 weeks prior to screening
Live vaccine within 30 days prior to first dose of study medication

About this study

Official title: A Phase 1 Trial of MK-1248 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors.

Conditions: Advanced Solid Tumor
Being tested: MK-1248, pembrolizumab
Keywords: Solid tumor, PD1, PD-L1, PDL1

What participants receive

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

MK-1248Biological
IV infusion
pembrolizumabBiological
Also called KEYTRUDA®, MK-3475
IV infusion

Study groups in NCT02553499
Study group	Role	What they receive
MK-1248	Experimental	Participants received escalating doses of MK-1248 at assigned dose (dose range: 0.12 mg to 170 mg MK-1248) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to ~3 months). Receives: Biological: MK-1248
MK-1248 + Pembrolizumab	Experimental	Participants received escalating doses of MK-1248 at assigned dose (dose range: 0.12 mg to 60 mg MK-1248) via IV infusion on Day 1 of each 21-day cycle for a maximum of 4 cycles (up to ~3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months). Receives: Biological: MK-1248; Biological: pembrolizumab

What is being measured

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

Number of Participants Experiencing a Dose-Limiting Toxicity (DLT)
The occurrence of any of the following toxicities during Cycle 1 (21 days), if possibly, probably or definitely related to study treatment, was considered a DLT: 1. Grade 4 non-hematological toxicity 2. Grade 4 hematological toxicity lasting >7 days, except thrombocytopenia a. Grade 4 thrombocytopenia of any duration b. Grade 3 thrombocytopenia is a DLT if associated with bleeding 3. Any Grade 3 non-hematological toxicity, with the exceptions 4. Any Grade 3 or Grade 4 non-hematological laboratory abnormality, if medical intervention was required, or abnormality led to hospitalization, or abnormality persisted for >1 week 5. Febrile neutropenia Grade 3 or Grade 4 6. Any drug-related AE which caused participant to discontinue study treatment during Cycle 1 7. Grade 5 toxicity 8. Any treatment-related toxicity which caused a >2-week delay in initiation of Cycle 2.
Measured: Cycle 1 (Up to 21 days)

Secondary outcomes (5)

Maximum Concentration (Cmax) of MK-1248 in Serum
Cmax is the maximum (peak) concentration of MK-1248 observed in blood serum. Blood samples were obtained at designated timepoints for the analysis of MK-1248 Cmax. Timepoints: Cycles 1-4 Day 1: Predose, post MK-1248 infusion end (~0.5 hours), 2 hours post MK-1248 infusion start (~2 hours); Cycles 1-4 Days 2, 3, 5, 8 \& 15. Each cycle was 21 days. (Up to ~3 months)
Measured: At designated timepoints (Up to ~3 months)
Trough Concentration (Ctrough) of MK-1248 in Serum
Ctrough is the lowest concentration of MK-1248 in blood serum just before the next dose. Blood samples were obtained at designated timepoints for the analysis of MK-1248 Ctrough, except for during Cycle 1. No blood samples were collected for the analysis of Ctrough in Cycle 1. No samples were collected for the MK-1248 0.6 mg group in Cycles 3 or 4, for the MK-1248 10 mg group in Cycles 1-4, or for the MK-1248 60 mg + Pembrolizumab group in Cycle 4. Timepoints: Cycles 1-4 Day 1: Predose, post MK-1248 infusion end (~0.5 hours), 2 hours post MK-1248 infusion start (~2 hours); Cycles 1-4 Days 2, 3, 5, 8 \& 15. Each cycle was 21 days. (Up to ~3 months)
Measured: At designated timepoints (Up to ~3 months)
Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) of MK-1248 in Serum
AUC0-infinity is the area under the serum concentration-time curve from time zero to infinity. It is a measure of the amount of MK-1248 in blood serum from pre-dose to infinite time. Blood samples were obtained at designated timepoints for the analysis of MK-1248 AUC0-inf. No blood samples were collected for the MK-1248 0.6 mg group in Cycle 4, for the MK-1248 10 mg group in Cycle or for the MK-1248 60 mg + Pembrolizumab group in Cycle 4. Timepoints: Cycles 1-4 Day 1: Predose, post MK-1248 infusion end (~0.5 hours), 2 hours post MK-1248 infusion start (~2 hours); Cycles 1-4 Days 2, 3, 5, 8 \& 15. Each cycle was 21 days. (Up to ~3 months)
Measured: At designated timepoints (Up to ~3 months)
Maximum Concentration (Cmax) of Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) Receptor Target Engagement
GITR protein is internalized upon binding by MK-1248. To evaluate GITR target engagement, a GITR receptor availability assay was developed to assess the availability of surface GITR following administration of MK-1248. GITR is detected on CD4+CD25+ and CD4+CD95+ T-cell sub-populations using flow cytometry and compared to pre-dose baseline. GITR target engagement is calculated as 100% - (%) GITR receptor availability. The Cmax of percent GITR target engagement on CD4+CD25+ T-cells is presented. Timepoints: Arm 1: Screening; Cycles 1-4 Day 1: Predose MK-1248, At end of MK-1248 infusion (0.5 hours), 2 hours after start of MK-1248 infusion (2 hours); Cycles 1-4 Days 2, 8 \& 15. Arm 2: Screening; Cycles 1-4 Day 1: Predose pembrolizumab, At end of MK-1248 infusion (0.5 hours), 2 hours after start of MK-1248 infusion (2 hours): Cycles 1-4 Days 2, 3, 8 \& Day 15: Cycles 5-6: Predose. Each cycle was 21 days.
Measured: At designated timepoints (Up to ~4.5 months)
Trough (Minimum) Concentration (Ctrough) of Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) Receptor Target Engagement
GITR protein is internalized upon binding by MK-1248. To evaluate GITR target engagement, a GITR receptor availability assay was developed to assess the availability of surface GITR following administration of MK-1248. GITR is detected on CD4+CD25+ and CD4+CD95+ T-cell sub-populations using flow cytometry and compared to pre-dose baseline. GITR target engagement is calculated as 100% - (%) GITR receptor availability. The Ctrough of percent GITR target engagement on CD4+CD25+ T-cells is presented. Timepoints: Arm 1: Screening; Cycles 1-4 Day 1: Predose MK-1248, At end of MK-1248 infusion (0.5 hours), 2 hours after start of MK-1248 infusion (2 hours); Cycles 1-4 Days 2, 8 \& 15. Arm 2: Screening; Cycles 1-4 Day 1: Predose pembrolizumab, At end of MK-1248 infusion (0.5 hours), 2 hours after start of MK-1248 infusion (2 hours): Cycles 1-4 Days 2, 3, 8 \& Day 15: Cycles 5-6: Predose. Each cycle was 21 days.
Measured: At designated timepoints (Up to ~4.5 months)

Timeline

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

12 Nov 201517 Oct 2018

First posted17 Sep 2015 (estimated)
Study start12 Nov 2015
Primary completion17 Oct 2018
Study completion17 Oct 2018

Why it stopped: Enrollment prematurely discontinued due to program prioritization \& not due to any safety concerns.

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 Advanced 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: Parallel groups
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02553499
Sponsor's protocol ID: 1248-001
Other IDs: MK-1248-001
Status last verified: Oct 2019
First submitted: 16 Sep 2015
Last updated: 4 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Geva R, Voskoboynik M, Dobrenkov K, Mayawala K, Gwo J, Wnek R, Chartash E, Long GV. First-in-human phase 1 study of MK-1248, an anti-glucocorticoid-induced tumor necrosis factor receptor agonist monoclonal antibody, as monotherapy or with pembrolizumab in patients with advanced solid tumors. Cancer. 2020 Nov 15;126(22):4926-4935. doi: 10.1002/cncr.33133. Epub 2020 Aug 18.
PubMed 32809217

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?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Trial of MK-1248 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors.
ClinicalTrials.gov ID: NCT02553499
Acronym / sponsor ID: 1248-001
Conditions: Advanced Solid Tumor
Keywords: Solid tumor, PD1, PD-L1, PDL1
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Enrollment prematurely discontinued due to program prioritization \& not due to any safety concerns.
Enrolment: 37 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 12 Nov 2015 (actual)
Primary completion: 17 Oct 2018 (actual)
Study completion: 17 Oct 2018 (actual)
First posted: 17 Sep 2015 (estimated)
Results: Posted 4 Nov 2019

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MK-1248	Experimental	Biological: MK-1248Participants received escalating doses of MK-1248 at assigned dose (dose range: 0.12 mg to 170 mg MK-1248) via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 4 cycles (up to ~3 months).
MK-1248 + Pembrolizumab	Experimental	Biological: MK-1248, Biological: pembrolizumabParticipants received escalating doses of MK-1248 at assigned dose (dose range: 0.12 mg to 60 mg MK-1248) via IV infusion on Day 1 of each 21-day cycle for a maximum of 4 cycles (up to ~3 months) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to ~24 months).

Who may qualify

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

Key inclusion criteria (7 listed)

Histologically- or cytologically-confirmed metastatic solid tumor for which there is no available therapy that may convey clinical benefit
Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Adequate organ function
Female participants of childbearing potential should be willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication

Key exclusion criteria (20 listed)

Has had chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the first dose of study medication, or not recovered from adverse events due to cancer therapeutics administered more than 4 weeks earlier
Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study medication
Previous treatment with another agent targeting the glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR) receptor
Previous treatment with an immunomodulatory therapy and was discontinued from that therapy due to an immune-related adverse event
Expected to require any other form of antineoplastic therapy while on study

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-1248IV infusion	Biological	MK-1248, MK-1248 + Pembrolizumab
pembrolizumabAlso: KEYTRUDA®, MK-3475IV infusion	Biological	MK-1248 + Pembrolizumab

Primary outcome

Number of Participants Experiencing a Dose-Limiting Toxicity (DLT)
Time frame: Cycle 1 (Up to 21 days)
The occurrence of any of the following toxicities during Cycle 1 (21 days), if possibly, probably or definitely related to study treatment, was considered a DLT: 1. Grade 4 non-hematological toxicity 2. Grade 4 hematological toxicity lasting >7 days, except thrombocytopenia a. Grade 4 thrombocytopenia of any duration b. Grade 3 thrombocytopenia is a DLT if associated with bleeding 3. Any Grade 3 non-hematological toxicity, with the exceptions 4. Any Grade 3 or Grade 4 non-hematological laboratory abnormality, if medical intervention was required, or abnormality led to hospitalization, or abnormality persisted for >1 week 5. Febrile neutropenia Grade 3 or Grade 4 6. Any drug-related AE which caused participant to discontinue study treatment during Cycle 1 7. Grade 5 toxicity 8. Any treatment-related toxicity which caused a >2-week delay in initiation of Cycle 2.

5 secondary outcomes

Maximum Concentration (Cmax) of MK-1248 in Serum
Time frame: At designated timepoints (Up to ~3 months)
Trough Concentration (Ctrough) of MK-1248 in Serum
Time frame: At designated timepoints (Up to ~3 months)
Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) of MK-1248 in Serum
Time frame: At designated timepoints (Up to ~3 months)
Maximum Concentration (Cmax) of Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) Receptor Target Engagement
Time frame: At designated timepoints (Up to ~4.5 months)
Trough (Minimum) Concentration (Ctrough) of Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) Receptor Target Engagement
Time frame: At designated timepoints (Up to ~4.5 months)

Results and safety

Results posted to the registry on 4 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-1248 0.12 mg	2	0
MK-1248 0.6 mg	2	0
MK-1248 3 mg	2	0
MK-1248 10 mg	2	0
MK-1248 30 mg	3	0
MK-1248 60 mg	3	0
MK-1248 120 mg	3	0
MK-1248 170 mg	3	0
MK-1248 0.12 mg + Pembrolizumab	3	0
MK-1248 0.6 mg + Pembrolizumab	3	0
MK-1248 3 mg + Pembrolizumab	3	0
MK-1248 10 mg + Pembrolizumab	3	0
MK-1248 30 mg + Pembrolizumab	3	0
MK-1248 60 mg + Pembrolizumab	2	0

Primary outcome: Number of Participants Experiencing a Dose-Limiting Toxicity (DLT)

Time frame: Cycle 1 (Up to 21 days). Count of participants. Unit: Participants

Measure	MK-1248 0.12 mg n = 2	MK-1248 0.6 mg n = 2	MK-1248 3 mg n = 2	MK-1248 10 mg n = 2	MK-1248 30 mg n = 3	MK-1248 60 mg n = 3	MK-1248 120 mg n = 3	MK-1248 170 mg n = 3	MK-1248 0.12 mg + Pembrolizumab n = 3	MK-1248 0.6 mg + Pembrolizumab n = 3	MK-1248 3 mg + Pembrolizumab n = 3	MK-1248 10 mg + Pembrolizumab n = 3	MK-1248 30 mg + Pembrolizumab n = 3	MK-1248 60 mg + Pembrolizumab n = 2
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: The DLT analysis population consisted of all participants who received MK-1248 and were observed for safety for 21 days after the first dose of MK-1248 or experienced a DLT prior to 21 days after the first dose of MK-1248.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to ~27 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-1248 0.12 mg	0 of 2 (0%)	2 of 2 (100%)	0 of 2
MK-1248 0.6 mg	2 of 2 (100%)	2 of 2 (100%)	2 of 2
MK-1248 3 mg	0 of 2 (0%)	2 of 2 (100%)	2 of 2
MK-1248 10 mg	0 of 2 (0%)	2 of 2 (100%)	0 of 2
MK-1248 30 mg	0 of 3 (0%)	3 of 3 (100%)	3 of 3
MK-1248 60 mg	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
MK-1248 120 mg	2 of 3 (66.7%)	2 of 3 (66.7%)	1 of 3
MK-1248 170 mg	1 of 3 (33.3%)	3 of 3 (100%)	3 of 3
MK-1248 0.12 mg + Pembrolizumab	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
MK-1248 0.6 mg + Pembrolizumab	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
MK-1248 3 mg + Pembrolizumab	0 of 3 (0%)	2 of 3 (66.7%)	1 of 3
MK-1248 10 mg + Pembrolizumab	2 of 3 (66.7%)	3 of 3 (100%)	2 of 3
MK-1248 30 mg + Pembrolizumab	0 of 3 (0%)	3 of 3 (100%)	1 of 3
MK-1248 60 mg + Pembrolizumab	0 of 2 (0%)	2 of 2 (100%)	2 of 2

Limitations and caveats (from the sponsor): Enrollment into this study was prematurely discontinued due to program prioritization and not related to any safety concerns.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32809217Geva R, Voskoboynik M, Dobrenkov K, Mayawala K, Gwo J, Wnek R, Chartash E, Long GV. First-in-human phase 1 study of MK-1248, an anti-glucocorticoid-induced tumor necrosis factor receptor agonist monoclonal antibody, as monotherapy or with pembrolizumab in patients with advanced solid tumors. Cancer. 2020 Nov 15;126(22):4926-4935. doi: 10.1002/cncr.33133. Epub 2020 Aug 18.

Related trials for Advanced Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-1248 and pembrolizumab in people with Advanced Solid Tumor, run by Merck Sharp & Dohme LLC.

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 7 inclusion and 20 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 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

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 4 Nov 2019). 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 Experiencing a Dose-Limiting Toxicity (DLT) (time frame: Cycle 1 (Up to 21 days)). 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 NCT02553499, 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 4 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.