Status:
TERMINATED
A Study of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-1088-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 resp...
Eligibility Criteria
Inclusion
- The main inclusion and exclusion criteria include but are not limited to the following:
- 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 before screening, as determined by the investigator
- If human immunodeficiency virus (HIV) positive, has well-controlled HIV on anti-retroviral therapy (ART)
Exclusion
- 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 clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Health Association (NYHA) Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
- Has a corrected QT interval using Fridericia's Correction Formula (QTcF) \>470 msec
- Has history of an allogeneic stem cell transplant or a solid organ transplant.
- 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 had radiation-related toxicities requiring corticosteroids
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has a "superscan" bone scan
Key Trial Info
Start Date :
July 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05394350
Start Date
July 7 2022
End Date
September 7 2023
Last Update
November 8 2024
Active Locations (13)
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1
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0103)
Miami, Florida, United States, 33136
2
Laura and Isaac Perlmutter Cancer Center ( Site 0102)
New York, New York, United States, 10016
3
South Texas Accelerated Research Therapeutics (START) ( Site 0101)
San Antonio, Texas, United States, 78229
4
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0201)
Toronto, Ontario, Canada, M5G 2M9