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

Sponsor
Alain Algazi
Study ID
NCT04231864
Phase
PHASE2
Status
Withdrawn

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — BIOLOGICAL
    Given intravenously (IV)
  • Epacadostat — DRUG
    Given orally (PO)

Study Details

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.

Key Dates

Start date
Dec 1, 2020
Status verified
Oct 2020
Primary completion
Apr 1, 2022
Completion
Apr 1, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (durvalumab, epacadostat)
    Patients receive durvalumab intravenously (IV) over 1 hour on day 1 and epacadostat orally (PO) twice a day (BID) on days 1-28. Cycles repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity. Patients with disease progression who are benefiting from treatment in the opinion of the principal investigator may continue durvalumab and epacadostat for up to an additional 12 months from the initiation (or re-initiation) of treatment on study.

Primary Outcome Measure

Best overall response rate (BORR) [ Time Frame: Up to 2 years ]

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