Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Partic… (NCT03631407) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC) (MK-7690-046)
United States41 participantsStarted 2018-09-24
Plain-language summary
This trial will evaluate the safety and efficacy of vicriviroc (MK-7690) at 2 dose levels in combination with pembrolizumab (MK-3475) in participants with advanced/metastatic microsatellite stable (MSS) colorectal cancer (CRC).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Have a histologically proven locally advanced unresectable or metastatic CRC.
* Have locally confirmed MSS CRC.
* Have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan, and have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit.
* Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
* Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study intervention.
* Male participants must agree to use contraception and refrain from donating sperm for at least 120 days after the last dose of study intervention.
* Female participants must be not pregnant and not breastfeeding. Further, a female participant must either not be a woman of childbearing potential (WOCBP) or, if a WOCBP, agree to use contraception during the treatment period and for at least 120 days after the last dose of study intervention.
* Have adequate organ function.
Exclusion Criteria:
* Have a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) th…
What they're measuring
1
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)
Timeframe: Up to ~32 months
2
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Timeframe: Up to Day 21 of Cycle 1 (each cycle is 21 days)
3
Number of Participants Who Experienced an Adverse Event (AE)
Timeframe: Up to ~28 months
4
Number of Participants Who Discontinued Study Treatment Due to an AE