Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Conditions
Keywords
Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma
Brief summary
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
Interventions
DRUGPumitamig
Specified dose on specified days
DRUGFolfox
Specified dose on specified days
DRUGCapox
Specified dose on specified days
DRUGNivolumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
BioNTech SE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. * 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 prophylactic 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment | Up to 2 years after the last participant is randomized | Phase 2 |
| Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR) | Up to approximately 33 months | Phase 3 |
| Overall survival (OS) | Up to approximately 47 months | Phase 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS by RECIST v1.1 per investigator assessment | Up to approximately 33 months | Phase 2 |
| Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment | Up to approximately 33 months | Phase 2 |
| Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment | Up to approximately 33 months | Phase 2 |
| Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment | Up to approximately 33 months | Phase 2 |
| Recommended dose of Pumitamig for Phase 3 | Up to approximately 33 months | Phase 2 |
| Objective response (OR) by RECIST v1.1 per BICR | Up to approximately 33 months | Phase 3 |
| DOR by RECIST v1.1 per BICR | Up to approximately 33 months | Phase 3 |
Countries
Argentina, Australia, Brazil, Canada, Chile, China, Colombia, France, Germany, India, Italy, Japan, Mexico, Poland, Romania, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed