Master protocol of novel combinations in participants with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

Phase 2

Recruiting

• Conditions: Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
• Interventions: Drug: volrustomig

• Registration Number: 2024-510977-27-00
• Lead Sponsor: AstraZeneca AB

Brief Summary

To assess the efficacy of novel agent plus chemotherapy by evaluation of ORR (objective response rate) and PFS6 (proportion of participants alive and progression-free at 6 months)

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-04-04
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

18 years or older at the time of signing the ICF.

Body weight > 35 kg.

Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Has measurable target disease assessed by the Investigator based on RECIST 1.1.

ECOG PS 0 or 1.

Life expectancy of at least 12 weeks.

Adequate organ and bone marrow function.

Exclusion Criteria

Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by ISH) or indeterminate gastric or GEJ carcinoma.

Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression.

Participants with ascites which cannot be controlled with appropriate interventions.

Uncontrolled intercurrent illness.

Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.

History of another primary malignancy.

Previous treatment with an immune-oncology agent.

Active infectious diseases, including tuberculosis, HIV infection, or hepatitis A/B/C.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
volrustomig	volrustomig	Participants receiving volrustomig

Primary Outcome Measures

Name	Time	Method
ORR in response evaluable set		ORR in response evaluable set
PFS6 in full analysis set		PFS6 in full analysis set

Secondary Outcome Measures

Name	Time	Method
DoR per RECIST 1.1 based on Investigator assessment.		DoR per RECIST 1.1 based on Investigator assessment.
PFS per RECIST 1.1 as assessed by the Investigator.		PFS per RECIST 1.1 as assessed by the Investigator.
OS.		OS.
Incidence of AEs, AESIs, and SAEs; physical examination; Laboratory findings; vital signs; 12-lead ECG.		Incidence of AEs, AESIs, and SAEs; physical examination; Laboratory findings; vital signs; 12-lead ECG.
Incidences of ADAs against novel agent in serum.		Incidences of ADAs against novel agent in serum.
Serum concentrations of novel agent and derived PK parameters.		Serum concentrations of novel agent and derived PK parameters.

Trial Locations

Locations (6)

Institut Catala D'oncologia; 🇪🇸 L'hospitalet De Llobregat, Spain

Hospital General Universitario De Elche; 🇪🇸 Elche, Spain

Hospital Universitari Vall D Hebron; 🇪🇸 Barcelona, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Marques De Valdecilla; 🇪🇸 Santander, Spain

Hospital General Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain

Institut Catala D'oncologia

🇪🇸L'hospitalet De Llobregat, Spain

Mariona Calvo Campos

Site contact

934170400

mcalvo@iconcologia.net