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

Phase 2Not Yet RecruitingNCT07793942

Merck Sharp & Dohme LLC480 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

480

Conditions

Malignant Neoplam Advanced Solid Tumors

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Number of Participants Who Discontinue Study Treatment Due to an AE

Time frame: 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.

Time frame: 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.

Time frame: Up to approximately 24 months

Secondary Outcomes

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

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.