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A Trial of Pembrolizumab With Chemotherapy or Chemoradiotherapy in Participants From India With Different Types of Cancer (MK-3475-G44/KEYNOTE-G44)

28 août 2026 mis à jour par: Merck Sharp & Dohme LLC

A Prospective, Open-label, Phase 4 Study to Evaluate the Safety of Pembrolizumab (KEYTRUDA®) in Combination With Indication-specific Chemotherapy or Chemoradiotherapy in Participants Across Multiple Indications in India (KEYNOTE-G44)

The goal of this study is to assess the safety of pembrolizumab with chemotherapy or chemoradiotherapy in participants in India for:

  • Advanced gastric or gastroesophageal junction [GEJ] cancer that is (human epidermal growth factor receptor 2 [HER2]-negative and has a programmed death-ligand 1 [PD-L1] combined positive score [CPS] ≥1
  • Advanced and/or unresectable biliary tract cancer [BTC], and
  • High-risk, locally advanced cervical cancer

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Estimé)

150

Phase

  • Phase 4

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

Cohort 1:

  • The participant must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, with locally confirmed programmed death-ligand 1 (PD-L1) CPS ≥1.
  • Has locally confirmed human epidermal growth factor receptor 2 (HER2) negative cancer.

Cohort 2:

- Has a histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (BTC) (intra or extrahepatic cholangiocarcinoma or gallbladder cancer).

Cohort 3:

  • Has high-risk locally advanced cervical cancer.
  • Has histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.

All Cohorts:

  • If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.
  • If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.

Exclusion Criteria:

Cohort 1:

  • Has squamous cell or undifferentiated gastric cancer.
  • Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to first dose of study.
  • Had active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks or tumor bleeding within 2 weeks prior to the first dose of study intervention.

Cohort 2:

  • Has ampullary cancer.
  • Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and/or mucinous cystic neoplasms.
  • Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) BTC (intra or extrahepatic cholangiocarcinoma or gallbladder cancer), with the exception of neoadjuvant/adjuvant therapy, which is allowed.
  • Has known active CNS metastases and/or carcinomatous meningitis.
  • Had active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks or tumor bleeding within 2 weeks prior to the first dose of study intervention.

Cohort 3:

- Has undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy.

All Cohorts:

  • Has hypokalemia.
  • Has hypomagnesemia.
  • Has hypocalcemia.
  • Received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-PD-L1, or anti-programmed death-ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years.
  • Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.
  • Has a known additional invasive malignancy that is progressing or has required active treatment within the past 3 years.
  • Has history of human immunodeficiency virus (HIV) infection.
  • Has known active tuberculosis.
  • Has not adequately recovered from major surgery or is having ongoing surgical complications.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Cohort 1 (Gastric)
Participants with human epidermal growth factor receptor 2 (HER2)-negative advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 will receive 200 mg of pembrolizumab intravenously (IV) every 3 weeks (Q3W) for maximum of 35 cycles plus either 800mg/m^2/day of 5-fluorouracil (5-FU) IV on Days 1 through 5, Q3W and 80mg/m^2 of cisplatin IV on Day 1, Q3W OR 1000mg/m^2 of capecitabine orally twice daily on Days 1 through 14, Q3W and 130mg/m^2 oxaliplatin IV on Day 1, Q3W. A cycle is 21 days.
Administré en perfusion IV
Autres noms:
  • Platinol-AQ
Administré en perfusion IV
Autres noms:
  • 5-FU
  • ADRICIL
Administered as an IV infusion
Autres noms:
  • MK-3475
  • KEYTRUDA®
Administered as an IV infusion
Autres noms:
  • ELOXATIN
Administered as an oral tablet
Autres noms:
  • XELODA
Expérimental: Cohort 2 (Biliary)
Participants with advanced/unresectable biliary tract cancer (BTC) will receive 200 mg pembrolizumab IV Q3W for a maximum of 35 cycles plus 1000 mg/m^2 of gemcitabine IV on Days 1 and 8, Q3W and 25 mg/m^2 of cisplatin IV on Days 1 and 8, Q3W for a maximum of 8 cycles. A cycle is 21 days.
Administré en perfusion IV
Autres noms:
  • Platinol-AQ
Administered as an IV infusion
Autres noms:
  • MK-3475
  • KEYTRUDA®
Administered as an IV infusion
Autres noms:
  • GEMZAR
Expérimental: Cohort 3 (Cervical)
Participants with high-risk locally advanced cervical cancer will receive 200 mg pembrolizumab IV Q3W for a maximum of 35 cycles plus 40 mg/m^2 of cisplatin IV weekly for up to 5 infusions concurrent with radiotherapy (RT) and external beam RT and brachytherapy (BT). A cycle is 21 days.
Administré en perfusion IV
Autres noms:
  • Platinol-AQ
Administered as an IV infusion
Autres noms:
  • MK-3475
  • KEYTRUDA®
External beam radiation per the Radiation Manual
Internal radiation - brachytherapy per the Radiation Manual

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants Who Experienced One or More Adverse Events (AEs)
Délai: Up to approximately 27 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported.
Up to approximately 27 months
Number of Participants Who Discontinued Study Intervention Due to an AE
Délai: Up to approximately 24 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to AEs will be reported.
Up to approximately 24 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Directeur d'études: Medical Director, Merck Sharp & Dohme LLC

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

6 novembre 2026

Achèvement primaire (Estimé)

31 janvier 2030

Achèvement de l'étude (Estimé)

31 janvier 2030

Dates d'inscription aux études

Première soumission

28 août 2026

Première soumission répondant aux critères de contrôle qualité

28 août 2026

Première publication (Réel)

3 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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