MK-7684A avec ou sans autres thérapies anticancéreuses chez les participants atteints de tumeurs solides sélectionnées

Essai clinique

Type : Industriel
Statut : Ouvert
Phase : II
Étape du traitement : Traitements combinés
Date d'ouverture : 16/09/2021
Date clôture : 19/02/2025
Promoteur : Merck Sharp & Dohme LLC
Progression du cancer: Loco-régional
Résumé :

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.

Domaines/spécialités :
  • Cancers digestifs
    • Œsophage
    • Estomac
    • Foie –Voie biliaire
  • Cancers gynécologiques
    • Ovaire
    • Endomètre
    • Col de l’utérus
  • Cancers uro-génitaux
    • Vessie
    • Autres cancers uro-génitaux
  • Cancer du sein
  • Cancer de la tête et du cou
Pathologies :
  • Tumeur maligne de l'oesophage - Cim10 : C15
  • Tumeur maligne de l'estomac - Cim10 : C16
  • Tumeur maligne du foie et des voies biliaires intrahépatiques - Cim10 : C22
  • Tumeur maligne du sein - Cim10 : C50
  • Tumeur maligne de l'ovaire - Cim10 : C56
  • Tumeur maligne de la vessie - Cim10 : C67
  • Carcinome in situ du col de l'utérus - Cim10 : D06
  • Tumeur maligne de l'endomètre - Cim10 : C541
  • Tumeur maligne de siège mal défini de la tête, de la face et du cou - Cim10 : C760
  • Carcinome in situ du foie, de la vésicule et des voies biliaires - Cim10 : D015
Liens externes :

Critères de population

Sexe : Homme et femme
Age minimum : 18 ans
Critères d’inclusion :

  • 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)
    • 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.
Critères d’exclusion :
  • 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.

Centre d'investigation

En cours
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Nom : Pr GHIRINGHELLI
Prénom : François
Téléphone : Non disponible
Email : fghiringhelli@cgfl.fr
CONTACT TECHNIQUE
Nom : ARNAUD
Prénom : Magali
Téléphone : 03 80 73 75 00
Email : marnaud@cgfl.fr

Référentiels Oncologik

  • Vessie