Analysis of the efficacy and safety of two combination treatment regimens of nivolumab and ipilimumab in patients with dMMR and / or MSI metastatic colorectal cancer: A GERCOR open-label, randomized, non-comparative, two-stage phase II trial (NIPISAFE)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518138-10-00

Acronym

NIPISAFE G-106

Enrollment

Registered

2025-01-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with DMMR and/or MSI metastatic colorectal cancer

Brief summary

The co-primary endpoint of this study is Grade 3 or 4 TRAEs during the first 24 weeks (NCI CTCAE v5.0) and PFS at week 24

Detailed description

AEs (NCI CTCAE v5.0), Treatment and iAEs, Percentage of patients who received immune modulating concomitant medication (e.g., corticosteroids, infliximab, mycophenolate mofetil), Percentage of patients who received hormonal replacement therapy for immune-related endocrine toxicities, Median time to onset, median time to resolution of SAEs and TRAEs (grade 3-4), Score changes in EORTC QLQ-C30 and NCI-PRO-CTCAE scales, ORR at weeks 24 and 48, and at 2 years (RECIST v1.1), PFS at week 48 and at 2 years (RECIST v1.1), PFS and ORR at weeks 24 and 48, and at 2 years (iRECIST), OS at weeks 24 and 48, and at 2 years

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGYERVOY 5 mg/ml concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The co-primary endpoint of this study is Grade 3 or 4 TRAEs during the first 24 weeks (NCI CTCAE v5.0) and PFS at week 24	—

Secondary

Measure	Time frame
AEs (NCI CTCAE v5.0), Treatment and iAEs, Percentage of patients who received immune modulating concomitant medication (e.g., corticosteroids, infliximab, mycophenolate mofetil), Percentage of patients who received hormonal replacement therapy for immune-related endocrine toxicities, Median time to onset, median time to resolution of SAEs and TRAEs (grade 3-4), Score changes in EORTC QLQ-C30 and NCI-PRO-CTCAE scales, ORR at weeks 24 and 48, and at 2 years (RECIST v1.1), PFS at week 48 and at 2 years (RECIST v1.1), PFS and ORR at weeks 24 and 48, and at 2 years (iRECIST), OS at weeks 24 and 48, and at 2 years	—

Measure

Time frame

—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026