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

ConditionsNeoplasm Malignant Gastric Neoplasms Gastroesophageal Junction Adenocarcinoma Biliary Tract Carcinoma Uterine Cervical Neoplasms

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorMerck Sharp & Dohme LLC

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Has high-risk locally advanced cervical cancer.

Has histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Pembrolizumab
Biological/Vaccine
Administered as an IV infusion
Cisplatin
Drug
Administered as an IV infusion
5-Fluorouracil
Drug
Administered as an IV infusion
Oxaliplatin
Drug
Administered as an IV infusion
Capecitabine
Drug
Administered as an oral tablet
Gemcitabine
Drug
Administered as an IV infusion
External Beam Radiotherapy
Radiation
External beam radiation per the Radiation Manual
Brachytherapy
Radiation
Internal radiation - brachytherapy per the Radiation Manual

Treatment groups

150 Participants

are divided into 3 treatment groups

Group A: Cohort 1 (Gastric)Experimental treatment 5 interventions

Group B: Cohort 2 (Biliary)Experimental treatment 3 interventions

Group C: Cohort 3 (Cervical)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

Number of Participants Who Experienced One or More Adverse Events (AEs)

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.

Time frame

Up to approximately 27 months

Number of Participants Who Discontinued Study Intervention Due to an AE

Time frame

Up to approximately 24 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Merck Sharp & Dohme LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: