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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

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Le Collectif Canadien pour le cholangiocarcinome (C3) est financé par une subvention d'équipe révolutionnaire de la Société Canadienne du cancer en partenariat avec les Instituts de recherche en santé du Canada. Les fonds de la subvention pour le C3 sont gérés par l'Institut de recherche de l'Hôpital d'Ottawa, qui sert d'institut principal pour toutes les opérations collaboratives.

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