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ACTIVE NOT RECRUITING
NCT04817826
PHASE2

TremelImumab aNd Durvalumab For the Non-operatIve Management (NOM) of MSI-high Resectable GC/GEJC.

Sponsor: Gruppo Oncologico del Nord-Ovest

View on ClinicalTrials.gov

Summary

INFINITY is a Phase II, multicentre, single-arm, multi-cohort trial aimed at evaluating the activity and safety of the combination of tremelimumab and durvalumab as neoadjuvant (Cohort 1) and definitive (Cohort 2) treatment for MSI-high gastric/gastroesophageal juction cancer patients eligible for radical surgery.

Official title: TremelImumab aNd Durvalumab Combination For the Non-operatIve Management (NOM) of Microsatellite InstabiliTY (MSI)-High Resectable Gastric or Gastroesophageal Junction Cancer: The Multicentre, Single-arm, Multi-cohort, Phase II INFINITY Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2021-04-01

Completion Date

2026-04-30

Last Updated

2025-06-10

Healthy Volunteers

No

Interventions

DRUG

Durvalumab

durvalumab 1500 mg Q4W for 3 cycles (day 1, 29 and 57).

DRUG

Tremelimumab

tremelimumab 300 mg single administration (day 1)

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, Italy