ClinicalTrials.gg
RecruitingNCT07793942Updated Nov 5, 2026

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

A Phase 2 interventional study of MK-2010 and Pembrolizumab in Malignant Neoplam and Advanced Solid Tumors, sponsored by Merck Sharp & Dohme LLC. Recruiting at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment

Updated Nov 5, 2026Now RecruitingFirst sites in Switzerland, United States and Canada+4 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
480
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Malignant Neoplam
  • Advanced Solid Tumors
03

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.

Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Has radiographically 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 (HIV) on antiretroviral therapy (ART) if diagnosed with HIV
  • Has adequate organ function per protocol

Exclusion criteria

Exclusion Criteria:

  • Has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease if diagnosed with
  • Has a history of posterior reversible encephalopathy syndrome (PRES) or seizure disorder
  • Has hepatic encephalopathy, hepatorenal syndrome, or 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 that is progressing or required active treatment within the past 3 years
  • Has known active central nervous system and/or carcinomatous meningitis
  • Has active disease that required systemic treatment in the past 2 years (hormonal supplementation [eg, thyroxine, insulin, or physiologic ] 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
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
480 participants (estimated)

Study arms

  • Experimental
    MK-2010 + FOLFOX

    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

  • Active comparator
    Pembrolizumab + FOLFOX

    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

  • Experimental
    MK-2010 Monotherapy

    Participants receive MK-2010 intravenously as monotherapy.

    Biological: MK-2010 · Drug: Epinephrine

  • Experimental
    MK-2010 + Belzutifan

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

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

  • Experimental
    MK-2010 + Gemcitabine/Cisplatin

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

    Biological: MK-2010 · Drug: Gemcitabine · Drug: Cisplatin · Drug: Epinephrine

  • Experimental
    MK-2010 + Carboplatin and Paclitaxel/Nab-paclitaxel

    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

  • Experimental
    MK-2010 + Pemetrexed and Cisplatin/Carboplatin

    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

  • BiologicalMK-2010

    Administered as an intravenous (IV) infusion.

    Also known as: LM-299

  • BiologicalPembrolizumab

    Administered intravenously as 400 mg every 6 weeks.

    Also known as: MK-3475, Keytruda

  • Administered intravenously per approved product label.

    Also known as: 5-FU, Fluorouracil

  • DrugLeucovorin or Levoleucovorin

    Administered intravenously per approved product label.

  • Administered intravenously per approved product label.

  • Administered orally as 120 mg daily.

    Also known as: MK-6482, PT2977

  • Administered intravenously per approved product label.

  • Administered intravenously per approved product label.

  • Administered intravenously per approved product label.

  • Administered intravenously per approved product label.

  • Administered intravenously per approved product label.

  • Administered intravenously per approved product label.

  • Administered per approved product label as rescue medication.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to approximately 24 months

  2. 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.

    Time frame: Up to approximately 24 months

  3. 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.

    Time frame: Up to approximately 28 days

  4. 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.

    Time frame: Up to approximately 24 months

Secondary outcomes

  1. 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.

    Time frame: Up to approximately 48 months

  2. 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.

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

  3. 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.

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

  4. Trough Concentration (Ctrough) of MK-2010

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

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

  5. Maximum Concentration (Cmax) of MK-2010

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

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

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

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

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

07

Study locations

7 of 7 sites recruiting
  • New Jersey Cancer Care ( Site 7002)
    Belleville, New Jersey 07109, United States
    Recruiting
    • Study Coordinator · Contact973-751-8880
  • START Astera, LLC ( Site 0220)
    East Brunswick, New Jersey 08816, United States
    Recruiting
    • Study Coordinator · Contact732-426-4750
  • Taylor Cancer Research Center ( Site 9500)
    Maumee, Ohio 43537, United States
    Recruiting
    • Study Coordinator · Contact567-402-4502
  • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8001)
    Eugene, Oregon 97401, United States
    Recruiting
    • Study Coordinator · Contact541-683-5001
  • Princess Margaret Cancer Centre ( Site 1400)
    Toronto, Ontario M5G 2M9, Canada
    Recruiting
    • Study Coordinator · Contact4169464501
  • Cantonal Hospital St.Gallen ( Site 1100)
    Sankt Gallen, Canton of St. Gallen 9007, Switzerland
    Recruiting
    • Study Coordinator · Contact+41714941111
  • CHUV (centre hospitalier universitaire vaudois) ( Site 1101)
    Lausanne, Canton of Vaud 1011, Switzerland
    Recruiting
    • Study Coordinator · Contact+41213140155
08

Updates

3 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 5, 2026
Sites
7 sites added — first sites in Switzerland, United States and Canada. 6 sites changed recruiting status (6 now recruiting)
Show 6 sites
  • New Jersey Cancer Care ( Site 7002) · Belleville, United Statesno status→Recruiting
  • START Astera, LLC ( Site 0220) · East Brunswick, United Statesno status→Recruiting
  • Taylor Cancer Research Center ( Site 9500) · Maumee, United Statesno status→Recruiting
  • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8001) · Eugene, United Statesno status→Recruiting
  • Cantonal Hospital St.Gallen ( Site 1100) · Sankt Gallen, Switzerlandno status→Recruiting
  • CHUV (centre hospitalier universitaire vaudois) ( Site 1101) · Lausanne, Switzerlandno status→Recruiting
Show 7 added (4 United States, 2 Switzerland, 1 Canada)
  • START Astera, LLC ( Site 0220) · East Brunswick, United States
  • Taylor Cancer Research Center ( Site 9500) · Maumee, United States
  • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8001) · Eugene, United States
  • Cantonal Hospital St.Gallen ( Site 1100) · Sankt Gallen, Switzerland
  • New Jersey Cancer Care ( Site 7002) · Belleville, United States
  • CHUV (centre hospitalier universitaire vaudois) ( Site 1101) · Lausanne, Switzerland
  • Princess Margaret Cancer Centre ( Site 1400) · Toronto, Canada
across 3 updates, Oct 5, 2026 – Nov 5, 2026
Start date
Sep 29, 2026→Oct 21, 2026 (actual)
moved 2 times, Oct 5, 2026 – Nov 5, 2026
Contact
Study contact now listed: added T•••@msd.com · •••8839. See the current contact
Oct 5, 2026
Show all 3 updates
  1. Nov 5, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in Canada. 6 sites changed recruiting status (6 now recruiting)
    Show 6 sites
    • New Jersey Cancer Care ( Site 7002) · Belleville, United Statesno status→Recruiting
    • START Astera, LLC ( Site 0220) · East Brunswick, United Statesno status→Recruiting
    • Taylor Cancer Research Center ( Site 9500) · Maumee, United Statesno status→Recruiting
    • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8001) · Eugene, United Statesno status→Recruiting
    • Cantonal Hospital St.Gallen ( Site 1100) · Sankt Gallen, Switzerlandno status→Recruiting
    • CHUV (centre hospitalier universitaire vaudois) ( Site 1101) · Lausanne, Switzerlandno status→Recruiting
    Show site
    • Princess Margaret Cancer Centre ( Site 1400) · Toronto, Canada
    Start date Oct 27, 2026→Oct 21, 2026 (now actual)
    + 1 other change: verification date
  2. Oct 8, 2026
    2 sites added
    Show 2 added (1 United States, 1 Switzerland)
    • New Jersey Cancer Care ( Site 7002) · Belleville, United States
    • CHUV (centre hospitalier universitaire vaudois) ( Site 1101) · Lausanne, Switzerland
    + 1 other change: verification date
  3. Oct 5, 2026
    4 sites added — first sites in Switzerland and United States
    Show 4 added (3 United States, 1 Switzerland)
    • START Astera, LLC ( Site 0220) · East Brunswick, United States
    • Taylor Cancer Research Center ( Site 9500) · Maumee, United States
    • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8001) · Eugene, United States
    • Cantonal Hospital St.Gallen ( Site 1100) · Sankt Gallen, Switzerland
    Start date Sep 29, 2026→Oct 27, 2026
    Contact Study contact now listed: added T•••@msd.com · •••8839. See the current contact
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07793942
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Oct 21, 2026
Primary completion
Sep 26, 2028 (estimated)
Completion
Jul 28, 2030 (estimated)
Last update
Nov 5, 2026

Study contacts

Toll Free Number
Contact
Trialsites@msd.com
1-888-577-8839
Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Anti-PD-1/Anti-VEGF Bispecific Antibody MK-2010

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