Table 3.
Ongoing Clinical Trials Investigating Novel Combination Treatment Regimens for RCC
| Trial Name | Phase | Target Population | Treatment Arms | Primary Endpoint | Secondary Endpoint | Estimated Study Completion Date |
|---|---|---|---|---|---|---|
| NCT03149822 | I/II | Metastatic RCC | Phase 1: Pembrolizumab (200 mg) + Cabozantinib (40 mg) | ORR | Maximum Tolerated Dose (MTD), toxicities, PFS, progression of overall disease, clinical benefit rate, recommended phase 2 dose, duration on treatment beyond treatment progression | June 2020 |
| Phase 1: Pembrolizumab (200 mg) + Cabozantinib (60 mg) | ||||||
| Phase 2: Pembrolizumab (200 mg) + Cabozantinib (recommender phase 2 dose) | ||||||
| NCT03200587 | Ib | Metastatic RCC | Avelumab + Cabozantinib (20, 40, or 60 mg) | Recommended phase II dose | PFS | September 2022 |
| COSMIC-313 (NCT03937219) | III | Previously untreated intermediate- or poor-risk advanced or metastatic RCC | Cabozantinib + Nivolumab + Ipilimumab | PFS | OS | June 2024 |
| Placebo + Nivolumab + Ipilimumab | ||||||
| NCT 03428217 | II | Advanced or metastatic RCC | CB-839 + Cabozantinib | PFS (per IRC) | OS, PFS (per investigator) | September 2022 |
| Placebo + Cabozantinib | ||||||
| CheckMate 9ER (NCT03141177) | III | Locally advanced or metastatic RCC with a clear-cell component with no prior systemic therapy for RCC. | Nivolumab + Cabozantinib | PFS | OS, ORR, AE, Serious AE | May 2024 |
| Nivolumab + Ipilimumab + Cabozantinib | ||||||
| Sunitinib |