Recruiting
Phase 2

MK-2010

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07793942

Conditions

Malignant Neoplam

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MK-2010

Pembrolizumab

5-Fluorouracil

Leucovorin or Levoleucovorin

Oxaliplatin

Study Details

Brief 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.

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.

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

Study ID

NCT07793942

Start date

Oct 21, 2026

Status verified date

Nov, 2026

Completion date

Jul 28, 2030

Anticipated

Primary completion date

Sep 26, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Design

Enrollment

480 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MK-2010 + FOLFOX

Participants receive MK-2010 intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin).

active comparator: Pembrolizumab + FOLFOX

Participants receive Pembrolizumab intravenously in combination with FOLFOX chemotherapy (comprising Leucovorin or Levoleucovorin, 5-Fluorouracil, and Oxaliplatin).

experimental: MK-2010 Monotherapy

Participants receive MK-2010 intravenously as monotherapy.

experimental: MK-2010 + Belzutifan

Participants receive MK-2010 intravenously in combination with oral Belzutifan.

experimental: MK-2010 + Gemcitabine/Cisplatin

Participants receive MK-2010 intravenously in combination with Gemcitabine and Cisplatin chemotherapy.

experimental: MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxel

Participants receive MK-2010 intravenously in combination with Carboplatin and either Paclitaxel or Nab-paclitaxel chemotherapy.

experimental: MK-2010 + Pemetrexed and Cisplatin/Carboplatin

Participants receive MK-2010 intravenously in combination with Pemetrexed and either Cisplatin or Carboplatin chemotherapy.

Interventions

MK-2010

Administered as an intravenous (IV) infusion.

Pembrolizumab

Administered intravenously as 400 mg every 6 weeks.

5-Fluorouracil

Administered intravenously per approved product label.

Leucovorin or Levoleucovorin

Administered intravenously per approved product label.

Oxaliplatin

Administered intravenously per approved product label.

Belzutifan

Administered orally as 120 mg daily.

Gemcitabine

Administered intravenously per approved product label.

Cisplatin

Administered intravenously per approved product label.

Carboplatin

Administered intravenously per approved product label.

Paclitaxel

Administered intravenously per approved product label.

Nab-paclitaxel

Administered intravenously per approved product label.

Pemetrexed

Administered intravenously per approved product label.

Epinephrine

Administered per approved product label as rescue medication.

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 24 months ]
  • Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 24 months ]
  • Number of Participants Who Experience Dose-Limiting Toxicity (DLT) [ Time Frame: Up to approximately 28 days ]
  • Objective Response Rate (ORR) [ Time Frame: Up to approximately 24 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

New Jersey Cancer Care ( Site 7002)

Recruiting

Belleville, New Jersey, United States, 07109

Contacts

Study Coordinator

973-751-8880

START Astera, LLC ( Site 0220)

Recruiting

East Brunswick, New Jersey, United States, 08816

Contacts

Study Coordinator

732-426-4750

Taylor Cancer Research Center ( Site 9500)

Recruiting

Maumee, Ohio, United States, 43537

Contacts

Study Coordinator

567-402-4502

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8001)

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Study Coordinator

541-683-5001

Princess Margaret Cancer Centre ( Site 1400)

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Study Coordinator

4169464501

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Nov 5, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.