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Purpose

The purpose of this study is to evaluate the safety and efficacy of Pumitamig in combination with chemotherapy versus Nivolumab in combination with chemotherapy in participants with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants must be previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC) or distal esophageal adenocarcinoma (EAC). GEJ involvement can be confirmed via biopsy, endoscopy, or imaging. - Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1 or < 1 status for Phase 2, and document PD-L1 ≥ 1 status for the Phase 3 part of the study. - Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines. - Participants must have measurable disease as defined by RECIST v1.1.

Exclusion Criteria

  • Participants must not have untreated known central nervous system (CNS) metastases. - Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome. - Participants must not have evidence of major coagulation disorders (eg, hemophilia). - Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (eg, inferior vena cava filter placed) and/or adequately anticoagulated on a stable dose. - Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization. - Participants must not have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A1
  • Drug: Pumitamig
    Specified dose on specified days
    Other names:
    • BMS-986545
    • BNT327
    • PM8002
  • Drug: Folfox
    Specified dose on specified days
  • Drug: Capox
    Specified dose on specified days
Experimental
Arm A2
  • Drug: Pumitamig
    Specified dose on specified days
    Other names:
    • BMS-986545
    • BNT327
    • PM8002
  • Drug: Folfox
    Specified dose on specified days
  • Drug: Capox
    Specified dose on specified days
Experimental
Arm C
  • Drug: Pumitamig
    Specified dose on specified days
    Other names:
    • BMS-986545
    • BNT327
    • PM8002
  • Drug: Folfox
    Specified dose on specified days
  • Drug: Capox
    Specified dose on specified days
Experimental
Arm D
  • Drug: Folfox
    Specified dose on specified days
  • Drug: Capox
    Specified dose on specified days
  • Drug: Nivolumab
    Specified dose on specified days

Recruiting Locations

Florida Cancer Specialists - South
Fort Myers, Florida 33901
Contact:
Fadi Kayali, Site 0429
239-274-9930

Florida Cancer Specialists - North
St. Petersburg, Florida 33701
Contact:
Muhammad Imam, Site 0430
000-000-0000

Missouri Cancer Associates
Columbia, Missouri 65201
Contact:
Caleb Smith, Site 0426
573-874-7800

Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York 11042
Contact:
Nicholas Hornstein, Site 0386
323-533-7275

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Yelena Janjigian, Site 0242
646-888-4186

Oncology Associates Of Oregon, Pc
Eugene, Oregon 97401
Contact:
Marc Uemura, Site 0432
541-214-8284

Northwest Cancer Specialists, P.C.
Portland, Oregon 97213-2982
Contact:
Spencer Shao, Site 0419
503-528-5005

SCRI Oncology Partners
Nashville, Tennessee 37203
Contact:
Meredith Pelster, Site 0417
615-986-4366

Texas Oncology - Amarillo Cancer Center
Amarillo, Texas 79124
Contact:
Anton Melnyk, Site 0423
325-692-0188

Texas Oncology-Austin Central
Austin, Texas 78731
Contact:
Vivian Cline, Site 0416
512-427-9400

Texas Oncology
Beaumont, Texas 77702
Contact:
Pavel Levin, Site 0424

Texas Oncology - Northeast Texas
Denison, Texas 75020
Contact:
Amir Faridi, Site 0415
000-000-0000

Texas Oncology - DFW
Grapevine, Texas 76051
Contact:
Ravi Patel, Site 0421

Texas Oncology - San Antonio
San Antonio, Texas 78240
Contact:
John R. Ogden, Site 0427

Oncology and Hematology Associates of Southwest Virginia, Inc. - Salem
Salem, Virginia 24153
Contact:
Mark Kochenderfer, Site 0413
540-982-0237

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.