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

NCT04231864 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-10-26

No results posted yet for this study

Summary

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.

Conditions

  • Epstein-Barr Virus Positive
  • Metastatic Nasopharyngeal Carcinoma
  • Recurrent Nasopharyngeal Carcinoma
  • Stage III Nasopharyngeal Carcinoma
  • Stage IV Nasopharyngeal Carcinoma
  • Stage IVA Nasopharyngeal Carcinoma
  • Stage IVB Nasopharyngeal Carcinoma

Interventions

BIOLOGICAL

Durvalumab

Given intravenously (IV)

DRUG

Epacadostat

Given orally (PO)

Sponsors & Collaborators

Principal Investigators

  • Alain P Algazi, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-04-01
Completion
2024-04-01
FDA Drug
Yes

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04231864 on ClinicalTrials.gov