Informations générales (source: ClinicalTrials.gov)
A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors
Interventional
Phase 2
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
septembre 2021
août 2025
24 mai 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:12 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Georges François Leclerc ( Site 1155) - 21079 - Dijon - Cote-d Or - France | Contact (sur clinicalTrials) | ||||
| CENTRE LEON BERARD-Medical oncology ( Site 1151) - 69373 Cedex 08 - Lyon - Rhone-Alpes - France | Contact (sur clinicalTrials) | ||||
| Institut Regional du Cancer Montpellier ( Site 1157) - 34298 - Montpellier - Herault - France | Contact (sur clinicalTrials) | ||||
| Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156) - 84000 - Avignon - Vaucluse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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.