A Clinical Trial of MK-2010 Alone and With Other Treatments in Participants With Advanced Solid Tumors (MK-2010-002)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07793942
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumors
  • Malignant Neoplam

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MK-2010 — BIOLOGICAL
    Administered as an intravenous (IV) infusion.
  • Pembrolizumab — BIOLOGICAL
    Administered intravenously as 400 mg every 6 weeks.
  • 5-Fluorouracil — DRUG
    Administered intravenously per approved product label.
  • Leucovorin or Levoleucovorin — DRUG
    Administered intravenously per approved product label.
  • Oxaliplatin — DRUG
    Administered intravenously per approved product label.
  • Belzutifan — DRUG
    Administered orally as 120 mg daily.
  • Gemcitabine — DRUG
    Administered intravenously per approved product label.
  • Cisplatin — DRUG
    Administered intravenously per approved product label.
  • Carboplatin — DRUG
    Administered intravenously per approved product label.
  • Paclitaxel — DRUG
    Administered intravenously per approved product label.
  • Nab-paclitaxel — DRUG
    Administered intravenously per approved product label.
  • Pemetrexed — DRUG
    Administered intravenously per approved product label.
  • Epinephrine — DRUG
    Administered per approved product label as rescue medication.

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Sep 29, 2026
Status verified
Aug 2026
Primary completion
Sep 26, 2028
Completion
Jul 28, 2030

Study Design

Enrollment
480 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 24 months ]

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