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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05310643
Other study ID # NIPIRESCUE G-113
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 5, 2022
Est. completion date September 30, 2027

Study information

Verified date January 2023
Source GERCOR - Multidisciplinary Oncology Cooperative Group
Contact Romain COHEN, MD
Phone 01 40 29 85 00
Email romain.cohen@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

NIPIRESCUE is a national, single-arm, open-label phase II study. The study aims to evaluate the clinical activity of nivolumab and ipilimumab in patients with MSI/dMMR mCRC resistant to anti-PD1 monotherapy and previously treated with fluoropyrimidine, oxaliplatine, irinotecan, and anti- vascular endothelial growth factor (VEGF) or anti- epidermal growth factor receptor (EGFR) therapy.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nivolumab
Induction therapy with nivolumab 240 mg; 4 infusions, every 3 weeks. Maintenance therapy with nivolumab 480 mg; 21 infusions, every 4 weeks.
Ipilimumab
Induction therapy with ipilimumab 1 mg/kg; 4 infusions, every 3 weeks.

Locations

Country Name City State
France CHU Jean Minjoz Besançon
France CHRU Lille Lille
France Centre Léon Bérard Lyon
France ICM Val d'Aurelle Montpellier
France Hôpital Saint Antoine Paris
France CHU Poitiers Poitiers

Sponsors (1)

Lead Sponsor Collaborator
GERCOR - Multidisciplinary Oncology Cooperative Group

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rate (ORR) by RECIST 1.1 ORR defined as the number of patients with partial or complete response from the beginning of the treatment divided by the total of number of patients evaluable for the primary endpoint analysis. At week 24 (6 months)
Secondary Number of participants with treatment-related adverse events All grade and severe toxicities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Assessed up 60 months
Secondary Disease control rate (DCR) by RECIST 1.1 DCR is defined as the percentage of patients who achieve complete response, partial response, or stable disease after study treatment. At 12 week and 24 week
Secondary Duration of response Duration of response is measured from the time of the first response observed (partial or complete) until documented tumor progression or death At 5 years
Secondary Progression-free survival (PFS) by RECIST 1.1 PFS is defined as time from beginning of treatment to progression or death due to any cause, whichever occurs first. At 5 years
Secondary Overall survival (OS) OS is defined as the time between beginning of treatment and death from any cause. At 5 years
Secondary Antigen-specific CD4+ T cell immunity Assessment of antigen-specific CD4+ T cell immunity response as a biomarker of immunotherapy in dMMR/or MSI mCRC At Baseline, at week 3 and week 6
Secondary Circulating tumoral DNA (ctDNA) changes during treatment Evaluation of circulating tumoral DNA (ctDNA) changes during treatment as marker of treatment response At Baseline, at week 3 and week 6
Secondary Gut microbiota composition Analysis of gut microbiota composition changes and their association with clinical activity of study treatment At baseline and at 6 weeks
Secondary MSI/MMR status Tumor will be tested for MSI/MMR status using immunohistochemistry (anti-MLH1, PMS2, MSH2, MSH6) and PCR (pentaplex panel). At baseline
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