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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06364631 | CARE1 Pragmatic Clinical Trial | PHASE3 | RECRUITING | 1,250 | — | — | Apr 12, 2024 | May 5, 2032 | Jan 16, 2025 | 46 | Austria, Czechia +2 |
From randomization to time of death
| Arm | Type | Description |
|---|---|---|
| Arm A: ICI - ICI Combination | OTHER | Nivolumab (3 mg/kg infusion, every 3 weeks) x 4 doses + ipilimumab (1 mg/kg infusion, every 3 weeks) x 4 doses. At the end of the 4 injections carried out 21 days apart and in the absence of limiting side effects or progression justifying the cessation of the treatment according to the investigating doctor, maintenance treatment with nivolumab will be continued, at a rate of one injection every 2 weeks at a dose of 240 mg or every 4 weeks at a dose of 480 mg depending on the choice of the investigating doctor. Nivolumab will be administered for a maximum of 2 years. Patients are required to receive all four doses of NIVO+IPI before beginning NIVO monotherapy except for ipilimumab-induced toxicity compatible with nivolumab maintenance. |
| Arm B: VEGFR-TKI- ICI arm (axitinib + pembrolizumab) | OTHER | Investigator's choice between: * Axitinib (5 mg oral twice a day) + pembrolizumab (200 mg flat IV every 3 weeks or 400 mg flat IV every 6 weeks). * Cabozantinib (40 mg oral, once a day away from meals) + nivolumab infusion (480 mg flat dose every 4 weeks) * Lenvatinib (20 mg oral, once a day) + pembrolizumab (200 mg flat IV every 3 weeks or 400 mg flat IV every 6 weeks) |
| Name | Type | Description |
|---|---|---|
| Nivolumab | DRUG | Briefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion. Nivolumab is to be administered first. The nivolumab infusion must be promptly followed by a saline flush to clear the line of nivolumab before starting the ipilimumab infusion. |
| Ipilimumab | DRUG | The second infusion will always be ipilimumab and will start at least 30 minutes after completion of the nivolumab infusion. Ipilimumab is to be administered as an approximately 30-minute IV infusion. When administered together, nivolumab and ipilimumab will be administered on Day 1 of each 21-day cycle. |
| Pembrolizumab | DRUG | Pembrolizumab is to be administered as an approximately 30-minute IV infusion. |
| Cabozantinib | DRUG | Cabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg/day. |
| Axitinib | DRUG | Axitinib is a medication that is taken orally every day, 2 times a day continuously, at the starting dose of 5mg x2/day. |
| Lenvatinib | DRUG | Lenvatinib is a medication that is taken orally every day, once a day at the initial dose of 20mg/day. |
Inclusion Criteria: 1. Histologically confirmed metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component. 2. Intermediate- or poor-risk mRCC as defined by IMDC classification. 3. Adult male or female patients (≥ 18 years of age at inclusion). 4. Karnofsky Performance Status (KPS)...