Durvalumab and Tremelimumab in Treating Participants With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Summary

This phase II trial studies how well durvalumab and tremelimumab work in treating participants with ovarian, primary peritoneal, or fallopian tube cancer that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether give durvalumab and tremelimumab in combination or sequential administration works better in treating participants with ovarian, primary peritoneal, or fallopian tube cancer.

Timeline

Start

2017-05-18

Primary completion

2025-09-11

Completion

2025-09-11

Outcome

Missed primary endpoint

paper There was no difference in irPFS for combination tremelimumab plus durvalumab compared to tremelimumab alone PMID 38009662 ↗

paper combination arm (1.87 months; 95% CI, 1.77-2.43 months) (p = .402). PMID 38009662 ↗

Publications

• Hinchcliff EM, Knisely A, Adjei N, Fellman B, Yuan Y, Patel A, Xu C, Westin SN, Sood AK, Soliman PT, Shafer A, Fleming ND, Gershenson DM, Vikram R, Bathala T, Vining D, Ganeshan DM, Lu KH, Sun CC, Meyer LA, Jazaeri AA. Randomized phase 2 trial of tremelimumab and durvalumab in combination versus sequentially in recurrent platinum-resistant ovarian cancer. Cancer. 2024 Apr 1;130(7):1061-1071. doi: 10.1002/cncr.35126. Epub 2023 Nov 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	—	Intravenous
Subject	Tremelimumab	Monoclonal antibody	—	Intravenous

Indications