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

Sponsor
Gruppo Oncologico del Nord-Ovest
Study ID
NCT04817826
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    durvalumab 1500 mg Q4W for 3 cycles (day 1, 29 and 57).
  • Tremelimumab — DRUG
    tremelimumab 300 mg single administration (day 1)

Study Details

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.

Key Dates

Start date
Apr 1, 2021
Status verified
Feb 2025
Primary completion
Apr 30, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
31 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Pre-operative treatment with tremelimumab 300 mg single administration (day 1) and durvalumab 1500 mg Q4W for 3 cycles (day 1, 29 and 57). Patients in Cohort 1 will undergo standard gastrectomy with D2 lymphadenectomy and then they will be followed by an active follow-up every 12 weeks for two years and then a standard follow-up every six months until the end of the fifth year from surgery.
  • Experimental: Cohort 2
    Pre-operative treatment with tremelimumab 300 mg single administration (day 1) and durvalumab 1500 mg Q4W for 3 cycles (day 1, 29 and 57). In Cohort 2, patients with no evidence of complete clinical response will undergo standard gastrectomy with D2 lymphadenectomy and then they will be followed up. Patients with complete clinical response will undergo a non-operative management (NOM) with an active follow-up phase every 12 weeks for two years, followed by standard follow-up every six months until the end of the fifth year. At any time during follow-up, in case of clinical suspicion or confirmation of residual gastric cancer, patients will undergo standard surgery according to the clinical practice at their Centre.

Primary Outcome Measure

Primary outcome of Cohort 1: Pathological complete response (ypT0N0) and negative ctDNA status [ Time Frame: From the enrollment of the first patient in Cohort 1 up to 4 months from the enrollment of the last patient in Cohort 1 ]

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