Cabometyx and Avelumab in Patients With Metastatic Renal Cell Carcinoma (mRCC)

Summary

This is an open-label, non-controlled, non-randomized, phase I dose-finding, of Cabometyx + Avelumab, to establish safety, feasibility, and the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D) of Cabometyx in combination with Avelumab, and to investigate preliminary efficacy. The MTD or RP2D determined in this study will be used for a future study to formally test efficacy. The MTD determined by dose escalation will be the recommended Phase 2 dose.

Timeline

Start

2018-06-21

Primary completion

2020-04-14

Completion

2021-11-25

Publications

• Li H, Sahu KK, Brundage J, Benson M, Swami U, Boucher KM, Gupta S, Hawks J, Sirohi D, Agarwal N, Maughan BL. Phase I Trial of Combination Therapy With Avelumab and Cabozantinib in Patients With Newly Diagnosed Metastatic Clear Cell Renal Cell Carcinoma. Oncologist. 2023 Aug 3;28(8):737-e693. doi: 10.1093/oncolo/oyad019.

Drugs

Indications