Clinical trial • Phase II/III • Oncology

PUMITAMIG for Gastric cancer | Gastroesophageal junction cancer | Esophageal adenocarcinoma

Phase II/III trial of PUMITAMIG for Gastric cancer | Gastroesophageal junction cancer | Esophageal adenocarcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Gastric cancer | Gastroesophageal junction cancer | Esophageal adenocarcinoma
Trial Stage
Phase II/III
Drug Modality
Other antibody|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
07-11-2025
First CTIS Authorization Date
10-03-2026

Trial design

Randomised, nivolumab (opdivo 10 mg/ml concentrate for solution for infusion) in combination with chemotherapy (agents listed include oxaliplatin, fluorouracil, capecitabine, calcium folinate); specific dose/schedule not specified in available data.-controlled, adaptive Phase II/III trial in Spain, Germany, Poland and others.

Randomised
Yes
Comparator
Nivolumab (OPDIVO 10 mg/mL concentrate for solution for infusion) in combination with chemotherapy (agents listed include oxaliplatin, fluorouracil, capecitabine, calcium folinate); specific dose/schedule not specified in available data.
Adaptive
True, dose-selection adaptive design: Phase 2 compares two doses of pumitamig to select a recommended dose which will be carried forward to the Phase 3 comparison versus standard treatment.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
506

Eligibility

Recruits 506 No vulnerable population selected (isVulnerablePopulationSelected: false). Standard informed consent via subject information and informed consent form (L1_SIS and ICF) is used; no assent or parental consent for minors is mentioned in the available documents..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Standard informed consent via subject information and informed consent form (L1_SIS and ICF) is used; no assent or parental consent for minors is mentioned in the available documents.

Inclusion criteria

  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Documented PD-L1 ≥ 1"}
  • {"criterion_text":"- Documented HER2-negative cancer, as determined according to local guidelines."}
  • {"criterion_text":"- Measurable disease as defined by RECIST v1.1."}

Exclusion criteria

  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Evidence of major coagulation disorders (eg, hemophilia)."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- History of abdominal fistula or GI perforation within 6 months of randomization."}
  • {"criterion_text":"- 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 endpoints

  • {"endpoint_text":"- (Phase 2): ORR, to compare how two different doses of the study drug affect tumor growth to help select the better dose.","definition_or_measurement_approach":"Objective Response Rate (ORR) measured per RECIST v1.1 (phase 2)."}
  • {"endpoint_text":"- (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).","definition_or_measurement_approach":"Progression-free survival assessed by blinded independent central review (BICR) using radiographic imaging techniques (e.g., CT scans)."}
  • {"endpoint_text":"- (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\".","definition_or_measurement_approach":"Overall Survival measured as time from randomization to death from any cause."}

Secondary endpoints

  • {"endpoint_text":"- (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)","definition_or_measurement_approach":"Progression-free survival per RECIST v1.1 by investigator assessment; time between randomization and first documented progression or death."}
  • {"endpoint_text":"- (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)","definition_or_measurement_approach":"Duration of response per RECIST v1.1 by investigator assessment; time between first documentation of objective response and progression or death."}
  • {"endpoint_text":"- (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","definition_or_measurement_approach":"Time to response per RECIST v1.1 by investigator assessment; time from randomization to first documentation of objective tumor response."}
  • {"endpoint_text":"- (Phase 2): Disease control (Best overall response of confirmed Complete Response, confirmed Partial Response, or Stable Disease) by RECIST v1.1 per investigator assessment","definition_or_measurement_approach":"Disease control per RECIST v1.1 by investigator assessment (best overall response: CR, PR, or SD)."}
  • {"endpoint_text":"- (Phase 2): Recommended dose of pumitamig for Phase 3","definition_or_measurement_approach":"Dose selection based on Phase 2 efficacy and safety comparisons between the two tested doses."}
  • {"endpoint_text":"- (Phase 3): Objective Response by RECIST v1.1 per BICR","definition_or_measurement_approach":"Objective response assessed by RECIST v1.1 by blinded independent central review (BICR)."}
  • {"endpoint_text":"- (Phase 3): Duration of response by RECIST v1.1 per BICR","definition_or_measurement_approach":"Duration of response per RECIST v1.1 as assessed by BICR."}

Recruitment

Planned Sample Size
506
Recruitment Window Months
78
Consent Approach
Informed consent is obtained using Subject Information Sheet and Informed Consent Form (L1_SIS and ICF) documents; multiple country-specific and language versions are provided (documents listed per country). Participants are adults (no parental consent/assent described).

Methods

  • Country-specific recruitment materials (Doctor-to-patient letters and patient recruitment brochures) provided as K2/K1 documents in multiple languages (EN, DE, PL, IT, FR, RO) as listed in recruitment documents.
  • Investigator/site-based recruitment supported by third parties (e.g., Massive Bio Inc. listed with role: Investigator recruitment, Patient recruitment materials).

Geography

Total Number Of Sites
42
Total Number Of Participants
184

Spain

Earliest CTIS Part Ii Submission Date
23-12-2025
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
79
Number Of Sites
8
Number Of Participants
32

Sites

Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Contact Person Name
Inmaculada Ales
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Pilar Aitana Calvo
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Contact Person Name
Ana Custodio
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Tania Fleitas
Contact Person Email
tfleitas@incliva.es
Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Contact Person Name
María Alsina
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Javier Sastre
Contact Person Email
jsastrev@salud.madrid.org
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Contact Person Name
Fernando Rivera
Contact Person Email
fernando.rivera@scsalud.es
Site Name
Hospital Clinico San Carlos (duplicate entry context) or other listed Spanish site
Department Name
Oncology

Germany

Earliest CTIS Part Ii Submission Date
24-02-2026
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
14
Number Of Sites
8
Number Of Participants
40

Sites

Site Name
Heidelberg University
Department Name
III. Medizinische Klinik - Hämatologie und Internistische Onkologie
Contact Person Name
Ralf-Dieter Hofheinz
Site Name
Haematologisch Onkologische Praxis Eppendorf
Department Name
Studienzentrum
Contact Person Name
Alexander Stein
Contact Person Email
stein@hope-hamburg.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie
Contact Person Name
Annika Kurreck
Contact Person Email
annika.kurreck@charite.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie
Contact Person Name
Gertraud Stocker
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch-Onkologische Forschung (IKF)
Contact Person Name
Thorsten Götze
Contact Person Email
goetze.thorsten@khnw.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
I. Medizinische Klinik und Poliklinik
Contact Person Name
Markus Möhler
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Innere Medizin I
Contact Person Name
Thomas Seufferlein
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
NCT - Klinik für Medizinische Onkologie
Contact Person Name
Georg Haag

Poland

Earliest CTIS Part Ii Submission Date
17-02-2026
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
34
Number Of Sites
5
Number Of Participants
23

Sites

Site Name
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
Department Name
Oddział Onkologii Klinicznej i Chemioterapii
Contact Person Name
Katarzyna Woźniak
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
lucjan.wyrwicz@nio.gov.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
Department Name
Oddział Chemioterapii Dziennej
Contact Person Name
Wiesław Bal
Contact Person Email
wieslaw.bal@gliwice.nio.gov.pl
Site Name
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu
Department Name
Klinika Onkologii z Odcinkiem Dziennym
Contact Person Name
Barbara Radecka
Contact Person Email
brad@onkologia.opole.pl
Site Name
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Department Name
Poradnia Onkologiczna
Contact Person Name
Joanna Omyła-Staszewska
Contact Person Email
joannaomyla@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
06-02-2026
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
46
Number Of Sites
7
Number Of Participants
24

Sites

Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncology
Contact Person Name
Filippo Pietrantonio
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Oncology
Contact Person Name
Ferdinando De Vita
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncology
Contact Person Name
Silvia Foti
Contact Person Email
Foti.silvia@hsr.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Oncology
Contact Person Name
Massimo Di Maio
Contact Person Email
massimo.dimaio@unito.it
Site Name
Istituto Oncologico Veneto
Department Name
Oncology
Contact Person Name
Sara Lonardi
Contact Person Email
sara.lonardi@iov.veneto.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oncology
Contact Person Name
Giampaolo Tortora
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute (other listed Italian site)
Department Name
Oncology

France

Earliest CTIS Part Ii Submission Date
05-02-2026
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
48
Number Of Sites
7
Number Of Participants
35

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service oncologie digestive
Contact Person Name
Aziz ZAANAN
Contact Person Email
aziz.zaanan@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service hépatogastroentérologie
Contact Person Name
Yann TOUCHEFEU
Contact Person Email
yann.touchefeu@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service d'oncologie médicale
Contact Person Name
David TOUGERON
Contact Person Email
david.tougeron@chu-poitiers.fr
Site Name
Centre Leon Berard
Department Name
Service oncologie médicale
Contact Person Name
Clelia COUTZAC
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service oncologie médicale
Contact Person Name
Anthony TURPIN
Contact Person Email
anthony.turpin@chru-lille.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service d'oncologie digestive et hepato-gastro-enterologie
Contact Person Name
Laetitia DAHAN
Contact Person Email
laetitia.dahan@ap-hm.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Service de cancérologie et d'hématologie
Contact Person Name
Jean-Philippe METGES

Romania

Earliest CTIS Part Ii Submission Date
14-01-2026
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
93
Number Of Sites
7
Number Of Participants
30

Sites

Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncology
Contact Person Name
Tudor Eliade Ciuleanu
Contact Person Email
office@iocn.ro
Site Name
Institutul Regional De Oncologie Iasi
Department Name
Oncology
Contact Person Name
Bogdan Gafton
Contact Person Email
manager@iroiasi.ro
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncology
Contact Person Name
Andrei Ungureanu
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncology
Contact Person Name
Michael Schenker
Contact Person Email
office@centruldeoncologie.ro
Site Name
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
Department Name
Oncology
Contact Person Name
Adrian Radu Vidra
Contact Person Email
raduvidra@gmail.com
Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Oncology
Contact Person Name
Constantin Volovat
Contact Person Email
cvolovat@yahoo.com
Site Name
Additional listed Romanian oncology site
Department Name
Oncology

Sponsor

Primary sponsor

Full Name
Bristol-Myers Squibb Services Unlimited Company
Organisation Type
Pharmaceutical company
Country Of Registered Address
Ireland

Contract research organisations

Name
Iqvia Inc.
Responsibilities
Site payments

Third parties

  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Site payments","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Routine clinical pathology testing, Primary/ surrogate endpoint test, Central Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"ePRO Licensing and translation services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"ePRO/eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long term sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Massive Bio Inc.","duties_or_roles":"Investigator recruitment, Patient recruitment materials","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"PDL-1 Samples analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Mural Health Technologies Inc.","duties_or_roles":"Clinical Trial Payment - Subject Reimbursement and Financial Services","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
BNT327 20 mg ml
Active Substance
PUMITAMIG
Modality
Other antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
Intravenous
Authorisation Status
Investigational
Investigational Product Name
BNT327 50 mg ml
Active Substance
PUMITAMIG
Modality
Other antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
Intravenous
Authorisation Status
Investigational
Investigational Product Name
OPDIVO 10 mg/mL concentrate for solution for infusion.
Active Substance
NIVOLUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation EU/1/15/1014/002)
Investigational Product Name
OXALIPLATIN
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
CONCENTRATE FOR SOLUTION FOR INFUSION
Route
Intravenous/infusion
Investigational Product Name
FLUOROURACIL
Active Substance
FLUOROURACIL
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INJECTION
Route
Injection/Intravenous
Investigational Product Name
CAPECITABINE
Active Substance
CAPECITABINE
Modality
Small molecule
Routes Of Administration
ORAL USE (FILM COATED TABLETS)
Route
Oral
Investigational Product Name
CALCIUM FOLINATE
Active Substance
CALCIUM FOLINATE
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INJECTION
Route
Injection
Combination Treatment
Yes

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