A Phase 1/Phase 2 Study to Evaluate the Safety and Tolerability of MK-1088 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors

Merck Sharp & Dohme LLC0 sites80 target enrollmentApril 22, 2022

DrugsKEYTRUDA® (Pembrolizumab, MK-3475)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 80
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 22, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Eligibility Criteria

Inclusion Criteria

•1\.The participant must have 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 only:
•Must have previously received docetaxel, prior treatment with one other chemotherapy is allowed as well as up to 2 second\-generation hormonal manipulations
•Have prostate cancer progression within 6 months before to screening, as determined by the investigator:
•a.PSA progression using local laboratory values as defined by a minimum of 2 rising PSA levels with an interval of \=1 week between each assessment where the PSA value at screening should be \=2 ng/mL
•b.Radiographic disease progression in soft tissue based on PCWG\-modified RECIST 1\.1 or RECIST 1\.1 criteria with or without PSA progression
•c.Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression
•2\.Disease per PCWG\-modified RECIST 1\.1 for mCRPC or measurable disease per RECIST 1\.1 as assessed by the local site investigator/radiology. Target lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
•For participants with metastatic castrate\-resistant prostate cancer:
•a.Have PCWG\-modified RECIST 1\.1 measurable prostate cancer on CT or MRI scans as assessed by the local site/investigator/radiology

Exclusion Criteria

•1\.Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks before the first dose of study intervention, or has not recovered to CTCAE Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier
•2\.Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
•3\.Has clinically active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain or meningeal metastases may participate and be eligible for treatment provided they are stable and asymptomatic, have no evidence of new or enlarging brain metastases, are evaluated within 4 weeks before first study intervention administration, and are off immunosuppressive doses of systemic steroids at least 2 weeks before enrollment
•4\.Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody/components of the study intervention
•5\.Has an active infection requiring therapy
•6\.Has a history of interstitial lung disease
•7\.Has a history of pneumonitis that required steroids or current pneumonitis
•8\.Has an active autoimmune disease that has required systemic treatment in the past 2 years
•9\.Has concurrent active Hepatitis B and Hepatitis C virus infection
•10\.HIV\-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease