NCT04231864

Durvalumab and Epacadostat for Treatment of Unresectable, Recurrent, or Metastatic Epstein-Barr Virus Positive Nasopharyngeal Cancer

Withdrawn Phase 2 Last updated 26 October 2020

What this trial tests

Phase 2 trial testing Durvalumab in Epstein-Barr Virus Positive. Withdrawn.

Timeline

1 December 2020

Primary endpoint
1 April 2022

1 April 2024

Quick facts

Lead sponsor	Alain Algazi
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 December 2020
Primary completion	1 April 2022
Estimated completion	1 April 2024

Drugs / interventions tested

• Durvalumab — full drug profile →
• Epacadostat — full drug profile →

Conditions studied

• Epstein-Barr Virus Positive — all drugs for Epstein-Barr Virus Positive →
• Metastatic Nasopharyngeal Carcinoma — all drugs for Metastatic Nasopharyngeal Carcinoma →
• Recurrent Nasopharyngeal Carcinoma — all drugs for Recurrent Nasopharyngeal Carcinoma →
• Stage III Nasopharyngeal Carcinoma — all drugs for Stage III Nasopharyngeal Carcinoma →

Sponsor

Alain Algazi

Who can join

18 and older, any sex, with Epstein-Barr Virus Positive or Metastatic Nasopharyngeal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well durvalumab and epacadostat work in treating patients with Epstein-Barr virus positive nasopharyngeal cancer that cannot be removed by surgery (unresectable), has come back (recurrent), or has spread to other places in the body (metastatic). Epacadostat blocks the enzyme, IDO1, from working. Blocking this enzyme may allow for a stronger immune response against cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving durvalumab and epacadostat may work better in treating patients with nasopharyngeal cancer compared to durvalumab alone.

Publications & conference data

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

1. Indoleamine 2,3-dioxygenase 1 (IDO1) inhibitors in clinical trials for cancer immunotherapy.
   Tang K, Wu YH, Song Y, Yu B. · · 2021 · cited 276× · PMID 33883013 · DOI 10.1186/s13045-021-01080-8
2. Immuno-Metabolism and Microenvironment in Cancer: Key Players for Immunotherapy.
   Giannone G, Ghisoni E, Genta S, Scotto G, et al · · 2020 · cited 119× · PMID 32575899 · DOI 10.3390/ijms21124414
3. Cancer cell metabolic reprogramming: a keystone for the response to immunotherapy.
   Cerezo M, Rocchi S. · · 2020 · cited 87× · PMID 33177494 · DOI 10.1038/s41419-020-03175-5
4. Targeting Indoleamine Dioxygenase and Tryptophan Dioxygenase in Cancer Immunotherapy: Clinical Progress and Challenges.
   Peng X, Zhao Z, Liu L, Bai L, et al · · 2022 · cited 38× · PMID 35965963 · DOI 10.2147/dddt.s373780
5. What is the prospect of indoleamine 2,3-dioxygenase 1 inhibition in cancer? Extrapolation from the past.
   Yao Y, Liang H, Fang X, Zhang S, et al · · 2021 · cited 33× · PMID 33557876 · DOI 10.1186/s13046-021-01847-4
6. New Immunometabolic Strategy Based on Cell Type-Specific Metabolic Reprogramming in the Tumor Immune Microenvironment.
   Sung JY, Cheong JH. · · 2022 · cited 27× · PMID 35269390 · DOI 10.3390/cells11050768
7. Tryptophan Metabolism Disorder-Triggered Diseases, Mechanisms, and Therapeutic Strategies: A Scientometric Review.
   Chen X, Xu D, Yu J, Song XJ, et al · · 2024 · cited 26× · PMID 39408347 · DOI 10.3390/nu16193380
8. The role of tumor metabolism in modulating T-Cell activity and in optimizing immunotherapy.
   Ganjoo S, Gupta P, Corbali HI, Nanez S, et al · · 2023 · cited 16× · PMID 37180129 · DOI 10.3389/fimmu.2023.1172931