NCT05310643

Nivolumab and Ipilimumab in Anti-PD1-Resistant dMMR/MSI mCRC

Nivolumab and Ipilimumab in Patients With dMMR and/or MSI Metastatic Colorectal Cancer Resistant to Anti-PD1 Monotherapy: An Open-label Phase II GERCOR Trial (NIPIRESCUE)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

NIPIRESCUE evaluates 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.

Detailed description

NIPIRESCUE is a national, single-arm, open-label phase II study, evaluating nivolumab and ipilimumab in patients with MSI/dMMR mCRC resistant to anti-PD1 monotherapy and previously treated with fluoropyrimidine, oxaliplatine, irinotecan, and VEGF or anti-EGFR therapy. Patients after inclusion will receive: Induction therapy with nivolumab 240 mg and ipilimumab 1 mg/kg every 3 weeks for 4 dosing cycles (4 infusions of nivolumab and ipilimumab) and maintenance therapy with by nivolumab 480 mg every 4 weeks (21 infusions). The primary endpoint is ORR at 24 weeks (6 months) from the beginning of the treatment evaluated by RECIST 1.1.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Induction therapy with nivolumab 240 mg; 4 infusions, every 3 weeks. Maintenance therapy with nivolumab 480 mg; 21 infusions, every 4 weeks.
DRUG	Ipilimumab	Induction therapy with ipilimumab 1 mg/kg; 4 infusions, every 3 weeks.

Timeline

• Start date: 2022-05-05
• Primary completion: 2025-09-01
• Completion: 2027-09-01
• First posted: 2022-04-05
• Last updated: 2025-07-01

Locations

9 sites across 1 country: France