Study of Pumitamig in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy in Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

8 Apr 2026 → ongoing

Decision date (initial)

2026-03-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-523263-37-00

WHO UTN

U1111-1325-8116

ClinicalTrials.gov

NCT07221149

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Dose response, Safety

To compare 2 different doses of the new
medicine combined with chemotherapy to assess which of the 2 doses is better in
controlling the cancer and/or has less side effects. The second stage, the dose which is
found to be better will be compared against current licensed treatment to see if
Pumitamig plus chemotherapy controls cancer growth better than the current standard
treatment.

Secondary objectives 1

1. Comparing how well Pumitamig helps patient survive compared to standard treatment, and how safe it is, and how well people tolerate it compared to the other standard treatment. The study also wants to see if the quality of life of people taking Pumitamig is better than those taking the other treatment.

Conditions and MedDRA coding

Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic GC, GEJC or distal EAC. GEJ involvement can be confirmed via biopsy, endoscopy, or imaging.
2. Documented PD-L1 ≥ 1
3. Documented HER2-negative cancer, as determined according to local guidelines.
4. Measurable disease as defined by RECIST v1.1.

Exclusion criteria 6

1. Untreated known CNS metastases. Note: Participants are eligible if CNS metastases are adequately treated, and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. Note: Participants must have either discontinued corticosteroids or be on a stable or decreasing dose of ≤ 10 mg prednisone (or equivalent) daily for at least 2 weeks prior to randomization. Note: Baseline imaging required at screening must be performed 28 days after treatment for CNS metastases is completed. CNS metastases must be radiographically stable.
2. 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.
3. Evidence of major coagulation disorders (eg, hemophilia).
4. 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.
5. History of abdominal fistula or GI perforation within 6 months of randomization.
6. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. (Phase 2): ORR, to compare how two different doses of the study drug affect tumor growth to help select the better dose.
2. (Phase 3): PFS (progression-free survival) by BICR (Blinded Independent Central Review) The ability of Pumitamig to work better than current standard treatment by assessing how long it takes before the cancer starts growing again by radiographic imaging techniques (like CT scans).
3. (Phase 3): OS (Overall Survival) This study will assess if people live longer when they take Pumitamig compared to other standard treatment. This is what is called "Overall Survival".

Secondary endpoints 7

1. (Phase 2): PFS (progression-free survival) by RECIST v1.1 per investigator assessment, defined as the time between the randomization date and the date of first documented tumor progression or death from any cause (whichever occurs first)
2. (Phase 3): Duration of response (Partial Response or Complete Response) by RECIST v1.1 per investigator assessment, defined as the time between the date of the first documentation of objective tumor response (Complete Response or Partial Response) and the date of disease progression or to death from any cause (whichever occurs first)
3. (Phase 2): Time to response (Complete Response or Partial Response) by RECIST v1.1 per investigator assessment, defined as the time between randomization to the date of the first documentation of objective tumor response
4. (Phase 2): Disease control (Best overall response of confirmed Complete Response, confirmed Partial Response, or Stable Disease) by RECIST v1.1 per investigator assessment
5. (Phase 2): Recommended dose of pumitamig for Phase 3
6. (Phase 3): Objective Response by RECIST v1.1 per BICR
7. (Phase 3): Duration of response by RECIST v1.1 per BICR

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 7

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Third parties 8

Locations

6 EU/EEA countries · 39 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 65 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications