Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
Eligible participants will be assigned to one of two experimental treatment arms.
In Arm 1, participants will receive escalating doses of MK-6837 via intravenous (IV) infusion once every 3 weeks.
In Arm 2, participants will receive escalating doses of MK-6837 via IV infusion once every 3 weeks plus pembrolizumab immunotherapy via IV infusion every 3 weeks.
Conditions
This trial is treating people with advanced or metastatic solid cancers
Eligibility
Inclusion
The main inclusion criteria include but are not limited to the following:
- Histologically or cytologically confirmed solid tumor by pathology report that is advanced or metastatic
- Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on Antiretroviral Therapy (ART)
- Participants who are Hepatitis B Surface Antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before allocation
- Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Exclusion
The main exclusion criteria include but are not limited to the following:
- Has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any Adverse Events (AEs) that were due to cancer therapeutics administered more than 4 weeks earlier
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
- Has clinically significant cardiovascular disease
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related AE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention
- Known additional malignancy that is progressing or has required active treatment within the past 2 years
- Known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis
- Active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy
- History of allogeneic tissue/solid organ transplant
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Merck Sharp & Dohme LLC
Scientific Title
A Phase 1 Open-label, Multicenter Study of MK-6837 as Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors
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