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

NCT ID: NCT05394350

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-07
• Study Completion Date: 2023-09-07

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 responded to conventional therapy. The effect of MK-1088 on tumor size will also be examined.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK-1088 100 mg

Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months).

Group Type: EXPERIMENTAL

MK-1088

Intervention Type: DRUG

Oral Tablet

MK-1088 200 mg

Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)

Group Type: EXPERIMENTAL

MK-1088

Intervention Type: DRUG

Oral Tablet

MK-1088 400 mg

Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)

Group Type: EXPERIMENTAL

MK-1088

Intervention Type: DRUG

Oral Tablet

MK-1088 600 mg

Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)

Group Type: EXPERIMENTAL

MK-1088

Intervention Type: DRUG

Oral Tablet

MK-1088 100 mg + Pembrolizumab

Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)

Group Type: EXPERIMENTAL

MK-1088

Intervention Type: DRUG

Oral Tablet

Pembrolizumab

Intervention Type: BIOLOGICAL

IV Infusion

MK-1088 200 mg + Pembrolizumab

Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)

Group Type: EXPERIMENTAL

MK-1088

Intervention Type: DRUG

Oral Tablet

Pembrolizumab

Intervention Type: BIOLOGICAL

IV Infusion

Interventions

MK-1088

Oral Tablet

Intervention Type: DRUG

Pembrolizumab

IV Infusion

Intervention Type: BIOLOGICAL

Other Intervention Names

MK-3475; KEYTRUDA®

Eligibility Criteria

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 before 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0103)

Miami, Florida, United States

Laura and Isaac Perlmutter Cancer Center ( Site 0102)

New York, New York, United States

South Texas Accelerated Research Therapeutics (START) ( Site 0101)

San Antonio, Texas, United States

Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0201)

Toronto, Ontario, Canada

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

Québec, Quebec, Canada

Rigshospitalet ( Site 0500)

Copenhagen, Capital Region, Denmark

Herlev and Gentofte Hospital ( Site 0501)

Copenhagen, Capital Region, Denmark

Odense Universitetshospital ( Site 0502)

Odense, Region Syddanmark, Denmark

Rambam Health Care Campus-Oncology Division ( Site 0300)

Haifa, , Israel

Hadassah Medical Center ( Site 0302)

Jerusalem, , Israel

Cantonal Hospital St.Gallen ( Site 0403)

Sankt Gallen, Canton of St. Gallen, Switzerland

Ospedale Regionale Bellinzona e Valli ( Site 0400)

Bellinzona, Canton Ticino, Switzerland

Kantonsspital Graubünden-Medizin ( Site 0402)

Chur, Kanton Graubünden, Switzerland

Countries

United States; Canada; Denmark; Israel; Switzerland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26166&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

MK-1088-002

Identifier Type: OTHER

Identifier Source: secondary_id

2022-502288-40-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-006712-93

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1088-002

Identifier Type: -

Identifier Source: org_study_id