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NCT Number: NCT07793942

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-2010

Biological

Administered as an intravenous (IV) infusion.

Other names: LM-299

Pembrolizumab

Biological

Administered intravenously as 400 mg every 6 weeks.

Other names: MK-3475, Keytruda

5-fluorouracil

Drug

Administered intravenously per approved product label.

Other names: 5-FU, Fluorouracil

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.

Other names: MK-6482, PT2977

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.

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 24 months

    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.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 24 months

    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.

  3. Number of Participants Who Experience Dose-Limiting Toxicity (DLT)

    Time frame: Up to approximately 28 days

    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.

  4. Objective Response Rate (ORR)

    Time frame: Up to approximately 24 months

    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.

Secondary outcomes

  1. Duration of Response (DOR)

    Time frame: Up to approximately 48 months

    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.

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

    Time frame: Predose and at designated time points up to approximately 24 months

    Blood samples will be collected to determine the AUC0-last of MK-2010.

  3. Area Under the Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) of MK-2010

    Time frame: Predose and at designated time points up to approximately 24 months

    Blood samples will be collected to determine the AUC0-tau of MK-2010.

  4. Trough Concentration (Ctrough) of MK-2010

    Time frame: Predose and at designated time points up to approximately 24 months

    Blood samples will be collected to determine Ctrough of MK-2010.

  5. Maximum Concentration (Cmax) of MK-2010

    Time frame: Predose and at designated time points up to approximately 24 months

    Blood samples will be collected to determine Cmax of MK-2010.

  6. Incidence of Antidrug Antibodies (ADAs) to MK-2010

    Time frame: Predose and at designated time points up to approximately 24 months

    Blood samples will be collected to determine ADAs of MK-2010.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 2, Open-label Clinical Study to Evaluate the Safety and Efficacy of MK-2010 as Monotherapy and in Combination

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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