Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone

Summary

This phase II trial studies the effects of the combination of olaparib and durvalumab, cediranib and durvalumab, olaparib and capivasertib, and cediranib alone in treating patients with endometrial cancer that has come back (recurrent) or does not respond to treatment (refractory). Olaparib, cediranib, and capivasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Testing the combinations may lower the chance of endometrial cancer growing or spreading compared to usual care.

Timeline

Start

2018-09-27

Primary completion

2024-12-06

Completion

2027-07-01

Outcome

Missed primary endpoint

paper CONCLUSION: The combination of cediranib and olaparib demonstrated modest clinical efficacy; however, the primary end point of the study was not met. PMID 38127487 ↗

registry analysis (superiority test); Arm I (Cediranib maleate_Reference Group 1) vs Arm III (Cediranib Maleate, Olaparib); p = 0.06; Hazard Ratio (HR) 0.7 (95% CI 0.43 to 1.14); Log Rank NCT03660826 ↗

Publications

• Rimel BJ, Enserro D, Bender DP, Jackson CG, Tan A, Alluri N, Borowsky M, Moroney J, Hendrickson AW, Backes F, Swisher E, Powell M, MacKay H. NRG-GY012: Randomized phase 2 study comparing olaparib, cediranib, and the combination of cediranib/olaparib in women with recurrent, persistent, or metastatic endometrial cancer. Cancer. 2024 Apr 15;130(8):1234-1245. doi: 10.1002/cncr.35151. Epub 2023 Dec 21.

Drugs

Indications