A Study of MK-6598 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-6598-001)

• Status: Not yet recruiting
• Trial end date: 2027-12-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety and establish a preliminary recommended Phase 2 dose (RP2D) of MK-6598 administered as monotherapy and in combination with pembrolizumab (MK-3475) in adult participants with advanced or metastatic solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme LLC
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• Has a histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and has received, or been intolerant to, all treatment known to confer clinical benefit.

• Has measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the local site investigator/radiology.

• Has one or more discrete malignant lesions that are amenable to a minimum of 2 separate biopsies.

• Has a baseline tumor sample that can be submitted for analysis.

• Human immunodeficiency virus (HIV)-positive participants may be enrolled if the HIV is well controlled HIV on antiretroviral therapy (ART).

• A male participant who receives MK-6598 must agree to use contraception and should refrain from donating sperm during the specified period(s) of at least 102 days after study interventions.

• A female participant is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following: not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for up to 120 days after study intervention.

Exclusion Criteria:

• Chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention or has not recovered to CTCAE Version 5.0 Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier (this includes participants with previous immunomodulatory therapy with residual immune-related AEs).

• History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.

• Clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis.

• A severe hypersensitivity (≥Grade 3) reaction to treatment with a monoclonal antibody/components of the study intervention.

• Active infection requiring therapy.

• History of interstitial lung disease.

• History of (noninfectious) pneumonitis that required steroids or current pneumonitis.

• Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.

• Has known hepatitis B or C infections or known to be positive for hepatitis B surface antigen (HBsAg)/hepatitis B virus (HBV) deoxyribonucleic acid (DNA) or hepatitis C antibody or ribonucleic acid (RNA).

• Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.

• Received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis.

• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.

• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137), and was discontinued from that treatment due to a ≥Grade 3 immune-related AE (irAE).

• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the start of study treatment.

• Has had an allogeneic tissue/solid organ transplant in the last 5 years or has evidence of graft-versus-host disease.