Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03350126 | iRECIST Evaluation's Relevance for DCR in MMR/MSI Metastatic Colorectal Cancer Patients on Nivolumab and Ipilimumab | PHASE2 | ACTIVE NOT_RECRUITING | 57 | — | — | Dec 4, 2017 | Dec 1, 2025 | Jul 23, 2025 | 8 | France |
According with RECIST 1.1 and iRECIST
| Arm | Type | Description |
|---|---|---|
| Experimental arm | EXPERIMENTAL | Therapy induction (12 weeks) Nivolumab (IV) and Ipilimumab (IV) - every 21 days - 4 cycles Then Nivolumab (IV) alone every 15 days - 20 cycles - until 12 months |
| Name | Type | Description |
|---|---|---|
| Ipilimumab 200 MG in 40 ML Injection | DRUG | Induction therapy (12 weeks): Nivolumab 3mg/kg intravenously (IV) over 60 minutes and Ipilimumab 1mg/kg (IV) over 90 minutes Q3W |
| Nivolumab 10 MG/ML | DRUG | Induction therapy (12 weeks) : Nivolumab 3mg/kg intravenously (IV) over 60 minutes and Ipilimumab 1mg/kg (IV) over 90 minutes Q3W Maintenance therapy (40 weeks): Nivolumab monotherapy IV over 60 minutes Q2W until iRECIST progression or if no PD for one year. |
Inclusion Criteria: 1. Signed and dated informed consent, 2. For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study drug, 3. Men and women are required to use adequate birth control during the study (when applicable): Within the frame of t...