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

NCT07793942

Not Yet RecruitingPhase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Malignant Neoplam, Advanced Solid Tumors

Interventions: MK-2010, Pembrolizumab, 5-Fluorouracil, Leucovorin or Levoleucovorin, Oxaliplatin

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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