MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
Clinicaltrials.gov ID
NCT05007106
Status
Recruiting
Study Type
Interventional, Phase 2
Sponsor
Merck Sharp & Dohme LLC
Start Date
September 15, 2021
Anticipated End Date
February 21, 2027
Study Contact
Phone Number:1-888-577-8839
Email: Trialsites@merck.com
Kingston, Ontario, Canada, K7L 2V7
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)
Contact: Study Coordinator 613-549-6666 Ext 6641
Toronto, Ontario, Canada, M5G 2M9
Princess Margaret Cancer Centre (Site 1056)
Contact: Study Coordinator 416-946-4575
About the Study
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.
Conditions
Uterine Cervical Neoplasms
Endometrial Neoplasms
Squamous Cell Carcinoma of Head and Neck
Gallbladder Neoplasms
Cholangiocarcinoma
Esophageal Neoplasms
Triple Negative Breast Neoplasms
Hepatocellular Carcinoma
Urinary Bladder Neoplasms
Ovarian Neoplasms
Stomach Neoplasms
Inclusion/Exclusion Criteria?
Primary, Secondary, Other Outcome Measures??
Locations in Canada
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051), Kingston, Ontario, K7L 2V7, Canada
Princess Margaret Cancer Centre ( Site 1056), Toronto, Ontario, M5G 2M9, Canada
About the Study
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.
Conditions
Uterine Cervical Neoplasms
Endometrial Neoplasms
Squamous Cell Carcinoma of Head and Neck
Gallbladder Neoplasms
Cholangiocarcinoma
Esophageal Neoplasms
Triple Negative Breast Neoplasms
Hepatocellular Carcinoma
Urinary Bladder Neoplasms
Ovarian Neoplasms
Stomach Neoplasms
Interventions
BIOLOGICAL:
Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab
DRUG:
Lenvatinib
5-Fluorouracil
Cisplatin
Paclitaxel
Gemcitabine
Carboplatin
Docetaxel
Bevacizumab
Capecitabine
Oxaliplatin
Locations in Canada
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051), Kingston, Ontario, K7L 2V7, Canada
Princess Margaret Cancer Centre ( Site 1056), Toronto, Ontario, M5G 2M9, Canada