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

NCT07793942 | Not Yet Recruiting Phase 2 FDA Drug

• 5 other identifiers: 2010-002MK-2010-002U1111-1325-15032025-523102-32-002025
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Up to approximately 24 months

Secondary Outcomes (6)

• Duration of Response (DOR)

  Up to approximately 48 months

• Area Under the Curve From Time 0 to Last (AUC0-last) of MK-2010

  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

  Predose and at designated time points up to approximately 24 months

• Trough Concentration (Ctrough) of MK-2010

  Predose and at designated time points up to approximately 24 months

• Maximum Concentration (Cmax) of MK-2010

  Predose and at designated time points up to approximately 24 months

Study Arms (7)

MK-2010 + FOLFOX

EXPERIMENTAL

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

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).

Biological: Pembrolizumab; Drug: 5-Fluorouracil; Drug: Leucovorin or Levoleucovorin; Drug: Oxaliplatin; Drug: Epinephrine

MK-2010 Monotherapy

EXPERIMENTAL

Participants receive MK-2010 intravenously as monotherapy.

Biological: MK-2010; Drug: Epinephrine

MK-2010 + Belzutifan

EXPERIMENTAL

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

Biological: MK-2010; Drug: Belzutifan; Drug: Epinephrine

MK-2010 + Gemcitabine/Cisplatin

EXPERIMENTAL

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

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.

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.

Biological: MK-2010; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Epinephrine

Interventions

MK-2010 BIOLOGICAL

Administered as an intravenous (IV) infusion.

Also known as: LM-299

MK-2010 + Belzutifan; MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxel; MK-2010 + FOLFOX; MK-2010 + Gemcitabine/Cisplatin; MK-2010 + Pemetrexed and Cisplatin/Carboplatin; MK-2010 Monotherapy

Pembrolizumab BIOLOGICAL

Administered intravenously as 400 mg every 6 weeks.

Also known as: MK-3475, Keytruda

Pembrolizumab + FOLFOX

5-Fluorouracil DRUG

Administered intravenously per approved product label.

Also known as: 5-FU, Fluorouracil

MK-2010 + FOLFOX; Pembrolizumab + FOLFOX

Leucovorin or Levoleucovorin DRUG

Administered intravenously per approved product label.

MK-2010 + FOLFOX; Pembrolizumab + FOLFOX

Oxaliplatin DRUG

Administered intravenously per approved product label.

MK-2010 + FOLFOX; Pembrolizumab + FOLFOX

Belzutifan DRUG

Administered orally as 120 mg daily.

Also known as: MK-6482, PT2977

MK-2010 + Belzutifan

Gemcitabine DRUG

Administered intravenously per approved product label.

MK-2010 + Gemcitabine/Cisplatin

Cisplatin DRUG

Administered intravenously per approved product label.

MK-2010 + Gemcitabine/Cisplatin; MK-2010 + Pemetrexed and Cisplatin/Carboplatin

Carboplatin DRUG

Administered intravenously per approved product label.

MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxel; MK-2010 + Pemetrexed and Cisplatin/Carboplatin

Paclitaxel DRUG

Administered intravenously per approved product label.

MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxel

Nab-paclitaxel DRUG

Administered intravenously per approved product label.

MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxel

Pemetrexed DRUG

Administered intravenously per approved product label.

MK-2010 + Pemetrexed and Cisplatin/Carboplatin

Epinephrine DRUG

Administered per approved product label as rescue medication.

MK-2010 + Belzutifan; MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxel; MK-2010 + FOLFOX; MK-2010 + Gemcitabine/Cisplatin; MK-2010 + Pemetrexed and Cisplatin/Carboplatin; MK-2010 Monotherapy; Pembrolizumab + FOLFOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Interventions

pembrolizumab; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin; belzutifan; Gemcitabine; Cisplatin; Carboplatin; Paclitaxel; 130-nm albumin-bound paclitaxel; Pemetrexed; Epinephrine

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 31, 2026
• Study Start: September 29, 2026
• Primary Completion (Estimated): September 26, 2028
• Study Completion (Estimated): July 28, 2030
• Last Updated: August 31, 2026

Record last verified: 2026-08