Malignant NeoplamPhase 2NCT07793942
A Clinical Trial of MK-2010 Alone and With Other Treatments in Participants With Advanced Solid Tumors (MK-2010-002)
A Phase 2 study testing MK-2010, Pembrolizumab and 5-Fluorouracil in people with Malignant Neoplam and Advanced Solid Tumors, run by Merck Sharp & Dohme LLC at 6 sites in 2 countries.
Trial summary
Researchers are looking for new ways to treat certain types of advanced solid tumors. Solid tumors are cancers mostly in organs and tissues in the body, not in the blood or other fluids. Advanced means the cancer has spread nearby or to other parts in the body and cannot be removed with surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplam, Advanced Solid Tumors
- What is being tested?
- MK-2010, Pembrolizumab and 5-Fluorouracil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 27 Oct 2026to 28 Jul 2030
- Phase
- Phase 2
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
- Has radiographically measurable disease per protocol
- If to receive oral study treatment, has the ability to swallow and retain oral medication and does not have gastrointestinal abnormalities that may alter absorption
- Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) if diagnosed with HIV
- Has adequate organ function per protocol
Who cannot join
- Has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease if diagnosed with HIV
- Has a history of posterior reversible encephalopathy syndrome (PRES) or seizure disorder
- Has hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe liver cirrhosis
- Has a history of confirmed inflammatory bowel disease
- Has a serious active nonhealing wound, ulcer, and/or bone fracture
- Has a history of myocarditis or cardiomyopathy
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- Has a history of or current severe cardiovascular and cerebrovascular diseases
- Is currently receiving any anticoagulants
- Has a diagnosis of immunodeficiency
- Has a known additional malignancy that is progressing or required active treatment within the past 3 years
- Has known active central nervous system metastases and/or carcinomatous meningitis
- Has active autoimmune disease that required systemic treatment in the past 2 years (hormonal supplementation [eg, thyroxine, insulin, or physiologic corticosteroid] is allowed)
- Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
- Has a history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or from central venous access device placement, or has ongoing surgical complications
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States4 sites
New Jersey Cancer Care ( Site 7002)
Belleville, New Jersey, 07109
Study Coordinator, 973-751-8880
START Astera, LLC ( Site 0220)
East Brunswick, New Jersey, 08816
Study Coordinator, 732-426-4750
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8001)
Eugene, Oregon, 97401
Study Coordinator, 541-683-5001
Taylor Cancer Research Center ( Site 9500)
Maumee, Ohio, 43537
Study Coordinator, 567-402-4502
Switzerland2 sites
CHUV (centre hospitalier universitaire vaudois) ( Site 1101)
Lausanne, Canton of Vaud, 1011
Study Coordinator, +41213140155
Cantonal Hospital St.Gallen ( Site 1100)
Sankt Gallen, Canton of St. Gallen, 9007
Study Coordinator, +41714941111
About this study
Official title: A Phase 2, Open-label Clinical Study to Evaluate the Safety and Efficacy of MK-2010 as Monotherapy and in Combination
Researchers are looking for new ways to treat certain types of advanced solid tumors. Solid tumors are cancers mostly in organs and tissues in the body, not in the blood or other fluids. Advanced means the cancer has spread nearby or to other parts in the body and cannot be removed with surgery.
In this trial, researchers want to learn if the trial medicine called MK-2010, given alone or with other treatments, can treat advanced solid tumors. MK-2010 is designed to help the immune system fight cancer.
Read more
The goals of this trial are to learn:
- About the safety of MK-2010 as monotherapy and in combinations and if participants tolerate them. Tolerate means participants will receive trial treatment unless they need to stop it due to health problems.
- How many participants who receive MK-2010 as monotherapy and in combination respond to treatment. Respond means the cancer gets smaller or goes away.
- Conditions
- Malignant Neoplam, Advanced Solid Tumors
- Being tested
- MK-2010, Pembrolizumab, 5-Fluorouracil, Leucovorin or Levoleucovorin, Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-2010Biological
Also called LM-299
Administered as an intravenous (IV) infusion.
PembrolizumabBiological
Also called MK-3475, Keytruda
Administered intravenously as 400 mg every 6 weeks.
5-FluorouracilDrug
Also called 5-FU, Fluorouracil
Administered intravenously per approved product label.
Leucovorin or LevoleucovorinDrug
Administered intravenously per approved product label.
OxaliplatinDrug
Administered intravenously per approved product label.
BelzutifanDrug
Also called MK-6482, PT2977
Administered orally as 120 mg daily.
GemcitabineDrug
Administered intravenously per approved product label.
CisplatinDrug
Administered intravenously per approved product label.
CarboplatinDrug
Administered intravenously per approved product label.
PaclitaxelDrug
Administered intravenously per approved product label.
Nab-paclitaxelDrug
Administered intravenously per approved product label.
PemetrexedDrug
Administered intravenously per approved product label.
EpinephrineDrug
Administered per approved product label as rescue medication.
| Study group | Role | What they receive |
|---|---|---|
| MK-2010 + FOLFOX | Experimental | Participants receive MK-2010 intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin). Receives: Biological: MK-2010; Drug: 5-Fluorouracil; Drug: Leucovorin or Levoleucovorin; Drug: Oxaliplatin; Drug: Epinephrine |
| Pembrolizumab + FOLFOX | Active comparator | Participants receive Pembrolizumab intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin). Receives: Biological: Pembrolizumab; Drug: 5-Fluorouracil; Drug: Leucovorin or Levoleucovorin; Drug: Oxaliplatin; Drug: Epinephrine |
| MK-2010 Monotherapy | Experimental | Participants receive MK-2010 intravenously as monotherapy. Receives: Biological: MK-2010; Drug: Epinephrine |
| MK-2010 + Belzutifan | Experimental | Participants receive MK-2010 intravenously in combination with oral Belzutifan. Receives: Biological: MK-2010; Drug: Belzutifan; Drug: Epinephrine |
| MK-2010 + Gemcitabine/Cisplatin | Experimental | Participants receive MK-2010 intravenously in combination with Gemcitabine and Cisplatin chemotherapy. Receives: Biological: MK-2010; Drug: Gemcitabine; Drug: Cisplatin; Drug: Epinephrine |
| MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxel | Experimental | Participants receive MK-2010 intravenously in combination with Carboplatin and either Paclitaxel or Nab-paclitaxel chemotherapy. Receives: Biological: MK-2010; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Epinephrine |
| MK-2010 + Pemetrexed and Cisplatin/Carboplatin | Experimental | Participants receive MK-2010 intravenously in combination with Pemetrexed and either Cisplatin or Carboplatin chemotherapy. Receives: Biological: MK-2010; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to approximately 24 months
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to approximately 24 months
Number of Participants Who Experience Dose-Limiting Toxicity (DLT)
DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next dose.
Measured: Up to approximately 28 days
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Measured: Up to approximately 24 months
Secondary outcomes (6)
Duration of Response (DOR)
For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Measured: Up to approximately 48 months
Area Under the Curve From Time 0 to Last (AUC0-last) of MK-2010
Blood samples will be collected to determine the AUC0-last of MK-2010.
Measured: Predose and at designated time points up to approximately 24 months
Area Under the Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of MK-2010
Blood samples will be collected to determine the AUC0-tau of MK-2010.
Measured: Predose and at designated time points up to approximately 24 months
Trough Concentration (Ctrough) of MK-2010
Blood samples will be collected to determine Ctrough of MK-2010.
Measured: Predose and at designated time points up to approximately 24 months
Maximum Concentration (Cmax) of MK-2010
Blood samples will be collected to determine Cmax of MK-2010.
Measured: Predose and at designated time points up to approximately 24 months
Incidence of Antidrug Antibodies (ADAs) to MK-2010
Blood samples will be collected to determine ADAs of MK-2010.
Measured: Predose and at designated time points up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start27 Oct 2026 (estimated)
- Primary completion26 Sep 2028 (estimated)
- Study completion28 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplamStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- For the MK-2010 + FOLFOX and Pembrolizumab + FOLFOX treatment arms, participants will be randomized in a 1:1 ratio to either MK-2010 + FOLFOX or Pembrolizumab + FOLFOX. For all other treatment arms, participants will be allocated to their respective treatment arm.
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793942
- Sponsor's protocol ID
- 2010-002
- Other IDs
- MK-2010-002, U1111-1325-1503, 2025-523102-32-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No