MEDI4736 Combinations in Metastatic Renal Cell Carcinoma

Summary

This study is being carried out to see if the drugs MEDI4736, Savolitinib and Tremelimumab can be used alone or in combination to reduce the size of tumours in patients with kidney cancer. The drugs being tested in this study have an anti-tumour effect and have been tested in pre-clinical and human studies before. MEDI4736 and tremelimumab work with the immune system to help the body fight against tumour cells with immune cells. Savolitinib works to correct a faulty signal which causes tumour growth. If a patient is eligible for the study and decides to take part, they will be enrolled into one of 3 stages of the study. * First stage \[CLOSED TO RECRUITMENT\]: aims to find the optimal dose of MEDI4736+savolitinib. * Second stage \[CLOSED TO RECRUITMENT\]: patients with papillary cell cancer will be treated with MEDI4736+savolitinib. Patients with clear cell cancer will be randomised to one of four treatment arms and receive MEDI4736, savolitinib, MEDI4736+savolitinib, or MEDI4736+tremelimumab. * Third stage \[NOT YET OPEN TO RECRUITMENT\]: patients will be tested for biomarkers before enrolment, and depending on the results will be allocated to one of 2 treatments (MEDI4736 alone or MEDI4736+tremelimumab) to see if certain biomarkers are linked to drug efficacy.

Timeline

Start

2016-05-03

Primary completion

2024-07-17

Completion

2024-07-17

Publications

• Results Powles T et al. CALYPSO: A three-arm randomized phase II study of durvalumab alone or with savolitinib or tremelimumab in previously treated advanced clear cell renal cancer. Journal of Clinical Oncology 40, no. 17_suppl (June 10, 2022) LBA4503-LBA4503
• Results Suarez C, Larkin JMG, Patel P, Valderrama BP, Rodriguez-Vida A, Glen H, Thistlethwaite F, Ralph C, Srinivasan G, Mendez-Vidal MJ, Hartmaier R, Markovets A, Prendergast A, Szabados B, Mousa K, Powles T. Phase II Study Investigating the Safety and Efficacy of Savolitinib and Durvalumab in Metastatic Papillary Renal Cancer (CALYPSO). J Clin Oncol. 2023 May 10;41(14):2493-2502. doi: 10.1200/JCO.22.01414. Epub 2023 Feb 21.
• Results Suarez Rodriguez et al. Overall survival results for durvalumab and savolitinib in metastatic papillary renal cancer. Journal of Clinical Oncology 2020 38:6_suppl, 619-619.
• Results Suarez Rodriguez et al Clinical activity of durvalumab and savolitinib in MET-driven, metastatic papillary renal cancer. J Clin Oncol 39, 2021 (suppl 15; abstr 4511).
• Jackson-Spence F, Larkin J, Patel P, Valderrama BP, Rodriguez-Vida A, Glen H, Thistlethwaite FC, Ralph C, Srinivasan G, Mendez-Vidal MJ, Childress M, Li W, Boyle P, Gasco A, Markovets A, Hartmaier R, Ackerman C, Szabados BE, Priyadarshini G, Jamal F, Powles T, Suarez C. CALYPSO: Final Results of Savolitinib and Durvalumab Combination in Metastatic Papillary Renal Cancer. J Clin Oncol. 2026 Apr 20;44(12):1076-1082. doi: 10.1200/JCO-25-01840. Epub 2026 Mar 20.

Drugs

Indications