MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (M… (NCT05007106) | Clinical Trial Compass
CompletedPhase 2
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
United States, Canada, Chile613 participantsStarted 2021-09-16
Plain-language summary
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* One of the following histologically or cytologically confirmed, advanced (unresectable or metastatic) solid tumors:
* Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
* Endometrial cancer
* Head and neck squamous cell carcinoma (HNSCC)
* Unresectable biliary adenocarcinoma (gallbladder or biliary tree \[intrahepatic or extrahepatic\] cholangiocarcinoma)
* Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ).
* Triple-negative breast cancer (TNBC)
* Hepatocellular carcinoma (HCC)
* Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
* Ovarian cancer
* Gastric cancer
* Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator.
* Adequately controlled blood pressure (BP) with or without antihypertensive medications.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
* Male participants must agree to follow contraceptive guidance.
* Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance.
* Adequate organ function.
Exclusion Criteria:
* History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
* Prior therapy with anti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
Timeframe: Up to approximately 2 years
2
Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Timeframe: Up to approximately 2 years
3
ORR per RECIST 1.1 as Assessed by Investigator in Participants with Selected Solid Tumors
Timeframe: Up to approximately 2 years
4
PFS per RECIST 1.1 as Assessed by Investigator at 9 months
Timeframe: 9 months
5
PFS per RECIST 1.1 as Assessed by Investigator at 12 months