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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03949153 | Cryotherapy With in Situ Immunotherapy in Melanoma Metastasis | PHASE1 | COMPLETED | 19 | — | — | Aug 16, 2019 | Mar 18, 2022 | Jun 5, 2026 | 1 | France |
Number of failures linked to the procedure, from all causes (unless the patient changes his/her mind = withdrawal from the study). In the context of this study, failure is defined as follows: * Technically impossible to perform the cryoablation procedure, or * Impossible to inject at least 2 ml of ipilimumab into the treated lymphadenopathy.
| Arm | Type | Description |
|---|---|---|
| Experimental arm | EXPERIMENTAL | Single Nivolumab 240 mg infusion at D0, followed by cryotherapy using interventional radiology of metastatic lymphadenopathy at D1 and in situ injection with ipilimumab at D2. |
| Name | Type | Description |
|---|---|---|
| Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] | DRUG | Single Nivolumab 240 mg infusion at D0 |
| Cryotherapy | PROCEDURE | Cryotherapy using interventional radiology of metastatic lymphadenopathy at D1 |
| Ipilimumab Injection | DRUG | In situ injection with ipilimumab at D2. |
Inclusion Criteria: 1. Subject with previously treated (or unknown) primary stage IIIB/IIIC melanoma with lymph node metastases, with at least one ≥1 cm3 that is accessible to cryotherapy under interventional radiology (IR), assessed at the inclusion visit (V1). 2. ECOG performance status (0 to 2) ...