A Study of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-1088-002)

• Status: Not yet recruiting
• Trial end date: 2025-09-17
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the safety, tolerability, and pharmacokinetics (PK) of MK-1088 in monotherapy and in combination with pembrolizumab in participants with advanced solid tumors who have not responded to conventional therapy. The effect of MK-1088 on tumor size will also be examined.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

• Has a histologically- or cytologically-confirmed diagnosis of advanced/metastatic solid tumor by pathology report and have received, have been intolerant to, or have been ineligible for treatment known to confer clinical benefit

• For metastatic castrate-resistant prostate cancer (mCRPC) only: (1) Must have previously received docetaxel, prior treatment with one other chemotherapy is allowed as well as up to 2 second-generation hormonal manipulations and (2) have prostate cancer progression within 6 months prior to screening, as determined by the investigator

• If human immunodeficiency virus (HIV) positive, has well-controlled HIV on anti-retroviral therapy (ART)

Exclusion Criteria:

• Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention

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

• Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis

• Has an active infection requiring therapy

• Has a history of interstitial lung disease

• Has a 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

• Has concurrent active Hepatitis B and Hepatitis C virus infection

• Has HIV with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

• Has not fully recovered from any effects of major surgery without significant detectable infection

• Has a history or current evidence of a gastrointestinal (GI) condition or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications

• Has uncontrolled hypertension or a cardiovascular event within 3 months prior to start of study therapy

• Has received prior systemic anticancer therapy including investigational agents within 4 weeks before allocation

• Has 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

• Has a "superscan" bone scan