Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants that have benefited from prior treatment with immunotherapy. Defined as response to prior treatment and/or stable disease lasting at least 5 months and disease worsening seen on most recent imaging.

Participants will receive Pembrolizumab and Epacadostat.

Participants that have not benefited from prior treatment with immunotherapy. Defined as stable disease lasting at least 5 months or suboptimal response (11-49% shrinkage of tumors). Disease continues to be stable on most recent imaging.

Participants will receive Pembrolizumab and Epacadostat.

Pembrolizumab (200mg/kg) given by intravenous infusion every 3 weeks.

Epacadostat (100mg) taken by mouth twice a day.

Epacadostat

Tanguy Seiwert, MD

Study to determine response rate of the combination of pembrolizumab plus epacadostat in patients with head and neck cancers that have received prior immunotherapy.

Participants will be assigned to one of 2 study groups based on response to prior therapy.

Epacadostat and Pembrolizumab in Patients With Head and Neck Cancer That Have Failed Prior Immunotherapy

A Phase II Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy

Rate of clinical disease response (tumor shrinkage) as seen on imaging.

Number of patients that have not had disease worsening across both study groups.

Number of patients surviving across both study groups.

Number of patients with side effect. Summary of side effects by type is provided in adverse events section below.

University of Chicago

Participants that have or have not benefited from prior treatment with immunotherapy.

Acquired Resistance or Suboptimal Benefit Group

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Theodore Karrison, PhD

Response Rate

Study terminated after two patients were enrolled due to conflict of interest with no further patient follow-up.

Spots Global Cancer Trial Database for Epacadostat and Pembrolizumab in Patients With Head and Neck Cancer That Have Failed Prior Immunotherapy

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial