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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04730544 | Two Combination Treatment Regimens of Nivolumab and Ipilimumab in Patients With dMMR and / or MSI mCRC. | PHASE2 | ACTIVE NOT_RECRUITING | 96 | — | — | May 21, 2021 | Apr 1, 2028 | Jun 13, 2025 | 19 | France |
According to NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
PFS is defined as time from inclusion to the first documented PD determined by the Investigator assessment in accordance to RECIST v1.1 or death due to any cause, whichever occurs first. Alive patients without progression will be censored at the last tumor assessment, either during study treatment period or during follow-up period.
| Arm | Type | Description |
|---|---|---|
| Experimental Arm A | EXPERIMENTAL | Treatment for 108 weeks (one cycle = 12 weeks; 9 cycles): Nivolumab 480 mg every 4 weeks (27 infusions) and ipilimumab 1 mg/kg every 6 weeks (18 infusions) for a total of 24 months of treatment (or less in case of RECIST progression (PD) or limiting toxicity, whichever occurs first). |
| Control Arm B | ACTIVE_COMPARATOR | Induction of 12 weeks (one cycle = 3 weeks; 4 cycles): Nivolumab 240 mg and ipilimumab 1 mg/kg every 3 weeks for 4 dosing cycles (4 infusions of nivolumab and ipilimumab), Maintenance of 96 weeks (one cycle = 4 weeks; 24 cycles): Nivolumab 480 mg every 4 weeks for 24 dosing cycles (24 infusions) for a total of 24 months of treatment (or less in case of RECIST progression (PD) or limiting toxicity, whichever occurs first). |
| Name | Type | Description |
|---|---|---|
| Nivolumab 480mg + Ipilimumab | DRUG | Nivolumab 480 mg q4w + Ipilimumab 1 mg/kg q6w |
| Nivolumab 240 mg + Ipilimumab | DRUG | induction phase : Nivolumab 240 mg q3w + Ipilimumab 1 mg/kg q3w and then maintenance : Nivolumab 480 mg q4w |
Inclusion Criteria: 1. Signed and dated patient informed consent form and willingness to comply with all study procedures and availability for the study duration, 2. Age ≥ 18 years, 3. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, or 2, 4. Histologically or cytologically ...