TremelImumab aNd Durvalumab For the Non-operatIve Management (NOM) of MSI-high Resectable GC/GEJC. (NCT04817826) | Clinical Trial Compass
Active — Not RecruitingPhase 2
TremelImumab aNd Durvalumab For the Non-operatIve Management (NOM) of MSI-high Resectable GC/GEJC.
Italy31 participantsStarted 2021-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent and any locally required authorization (such as the European Union \[EU\] Data Privacy Directive) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
✓. Age ≥ 18 years old.
✓. ECOG Performance Status 0-1.
✓. Body weight \>30 kg.
✓. Diagnosis of resectable gastric or gastroesophageal junction (Siewert II-III) cancer, categorized according to TNM classification 8th edition:
✓. Absence of distant metastases as defined by negativity of computed tomography (CT) and 18-fluorodeoxyglucose positron-emission tomography (18-FDG PET).
✓. Life expectancy of at least 12 weeks
✓. MSI-high status confirmed by IHC and multiplex PCR, and EBV-negative status by ISH, as determined centrally at the Co-ordinating Centre. Lack of heterogeneity of dMMR status as showed by lack of tumor cells showing concomitant expression of all 4 protein markers.
Exclusion criteria
✕. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
✕. Previous enrolment in the present study
✕. Participation in another clinical study with an investigational product during the last 12 months
What they're measuring
1
Primary outcome of Cohort 1: Pathological complete response (ypT0N0) and negative ctDNA status
Timeframe: From the enrollment of the first patient in Cohort 1 up to 4 months from the enrollment of the last patient in Cohort 1
2
Primary outcome of Cohort 2: 2-year complete response rate
Timeframe: From the enrollment of the first patient in Cohort 2 up to 2 years from the end of pre-operative treatment of the last patient enrolled in Cohort 2
✕. Prior medical treatments or irradiation for gastric cancer.
✕. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
✕. Previous treatments with immune checkpoint inhibitors targeting CTLA4, including tremelimumab, PD-1 or PD-L1, including durvalumab.
✕. History of allergy or severe hypersensitivity reaction to monoclonal antibodies.