a study of mk-6837 as a monotherapy and combination therapy in participants with advanced/metastatic solid tumors (mk-6837-001)

Conditions: Neoplasm Metastasis

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (pk), and preliminary efficacy of mk-6837, administered as a monotherapy and in combination with pembrolizumab (mk-3475), in participants with histologically or cytologically confirmed advanced/metastatic solid tumors that have not responded to conventional therapy. there will not be any hypothesis testing in the study.


Eligibility criteria:
inclusion criteria: 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 criteria: 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

Keywords: programmed cell death-1 (pd1, pd-1) programmed cell death 1 ligand 1 (pdl1, pd-l1) programmed cell death 1 ligand 2 (pdl2, pd-l2)