NCT04231864

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

A Multi-Center, Phase II, Open Label, Single-Arm Trial of Durvalumab and Epacadostat in Patients With Unresectable, Recurrent, and Metastatic EBV+ NPC

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Alain Algazi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Determine whether adding an IDO inhibitor to PD-L1 antibody therapy improves the probability of remission in nasopharyngeal carcinoma (NPC). SECONDARY OBJECTIVES: I. Determine whether adding an IDO inhibitor to PD-L1 antibody therapy improves long-term clinical outcomes in NPC. II. Determine whether the combination of durvalumab and epacadostat in recurrent and metastatic NPC patients is safe and well tolerated. EXPLORATORY OBJECTIVES: I. Identify potential associations between pre-treatment and on-treatment regulatory and effector immune cell populations and clinical outcomes in NPC patients treated with durvalumab and epacadostat. II. Characterize the oral and fecal microbiome in responding and non-responding patients. OUTLINE: Patients receive durvalumab intravenously (IV) over 1 hour on day 1 and epacadostat orally (PO) twice daily (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. After completion of study treatment, patients are followed up every 3 months until start of a new anti-cancer treatment, until 30 days after documented disease progression, until death, or until 36 months from the initiation of treatment on study, whichever comes first.

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

Type	Name	Description
BIOLOGICAL	Durvalumab	Given intravenously (IV)
DRUG	Epacadostat	Given orally (PO)

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-04-01
• Completion: 2024-04-01
• First posted: 2020-01-18
• Last updated: 2020-10-26

Regulatory

• FDA-regulated drug study