MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)

  • STATUS
    Recruiting
  • End date
    Feb 19, 2025
  • participants needed
    610
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 12 August 2022
paclitaxel
cancer
measurable disease
carcinoma
breast cancer
fluorouracil
squamous cell carcinoma
oxaliplatin
carboplatin
capecitabine
adenosquamous carcinoma
adenocarcinoma of the gastroesophageal junction
gemcitabine
pembrolizumab
bevacizumab
docetaxel
gastric cancer
adenocarcinoma
ovarian cancer
mammogram
cancer of the ovary

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.

Details
Condition 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
Treatment Capecitabine, cisplatin, docetaxel, carboplatin, Gemcitabine, Paclitaxel, bevacizumab, Pembrolizumab, Oxaliplatin, 5-fluorouracil, Lenvatinib, Pembrolizumab/Vibostolimab Co-Formulation
Clinical Study IdentifierNCT05007106
SponsorMerck Sharp & Dohme LLC
Last Modified on12 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

One of the following histologically or cytologically confirmed, advanced (locally recurrent 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)
Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator
Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
Adequately controlled blood pressure (BP) with or without antihypertensive medications
Ovarian cancer
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
Gastric cancer
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-programmed cell-death (PD-1), anti-PD-L1, anti-PD-L2, or anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) agent
Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study medication
Active autoimmune disease that has required systemic treatment in past 2 years
Active infection requiring systemic therapy
Concurrent active hepatitis B and hepatitis C virus infection
History of allogenic tissue/solid organ transplant
Previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm)
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
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