NCT03026062

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

Completed Phase 2 Last updated 19 September 2025

What this trial tests

Phase 2 trial testing Durvalumab in Platinum-Resistant Fallopian Tube Carcinoma in 100 participants. Completed in 11 September 2025.

Timeline

18 May 2017

Primary endpoint
11 September 2025

11 September 2025

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	18 May 2017
Primary completion	11 September 2025
Estimated completion	11 September 2025
Sites	1 location across United States

Drugs / interventions tested

• Durvalumab — full drug profile →
• Tremelimumab (TREMELIMUMAB) — full drug profile →

Conditions studied

• Platinum-Resistant Fallopian Tube Carcinoma — all drugs for Platinum-Resistant Fallopian Tube Carcinoma →
• Platinum-Resistant Ovarian Carcinoma — all drugs for Platinum-Resistant Ovarian Carcinoma →
• Platinum-Resistant Primary Peritoneal Carcinoma — all drugs for Platinum-Resistant Primary Peritoneal Carcinoma →
• Recurrent Fallopian Tube Carcinoma — all drugs for Recurrent Fallopian Tube Carcinoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, female only, with Platinum-Resistant Fallopian Tube Carcinoma or Platinum-Resistant Ovarian Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tumor Microenvironment in Ovarian Cancer: Function and Therapeutic Strategy.
   Yang Y, Yang Y, Yang J, Zhao X, et al · · 2020 · cited 168× · PMID 32850861 · DOI 10.3389/fcell.2020.00758
2. Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
   Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6
3. Paradigm Shift: A Comprehensive Review of Ovarian Cancer Management in an Era of Advancements.
   Tavares V, Marques IS, Melo IG, Assis J, et al · · 2024 · cited 85× · PMID 38339123 · DOI 10.3390/ijms25031845
4. Ovarian Cancer in the Era of Immune Checkpoint Inhibitors: State of the Art and Future Perspectives.
   Maiorano BA, Maiorano MFP, Lorusso D, Maiello E. · · 2021 · cited 60× · PMID 34503248 · DOI 10.3390/cancers13174438
5. Current Understanding on Why Ovarian Cancer Is Resistant to Immune Checkpoint Inhibitors.
   Pawłowska A, Rekowska A, Kuryło W, Pańczyszyn A, et al · · 2023 · cited 41× · PMID 37446039 · DOI 10.3390/ijms241310859
6. Immunotherapy in Gynecologic Cancers: Are We There Yet?
   Pakish JB, Jazaeri AA. · · 2017 · cited 39× · PMID 28840453 · DOI 10.1007/s11864-017-0504-y
7. Driving Immune Responses in the Ovarian Tumor Microenvironment.
   Ning F, Cole CB, Annunziata CM. · · 2020 · cited 36× · PMID 33520713 · DOI 10.3389/fonc.2020.604084
8. Current Possibilities of Gynecologic Cancer Treatment with the Use of Immune Checkpoint Inhibitors.
   Grywalska E, Sobstyl M, Putowski L, Roliński J. · · 2019 · cited 35× · PMID 31547532 · DOI 10.3390/ijms20194705