Trial Outcomes & Findings for Epacadostat and Pembrolizumab in Patients With Head and Neck Cancer That Have Failed Prior Immunotherapy (NCT NCT03463161)

NCT ID: NCT03463161

Last Updated: 2020-01-27

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: up to 18 months
• Results posted on: 2020-01-27

Participant Flow

Participant milestones

Measure	Acquired Resistance or Suboptimal Benefit Group Participants that have or have not benefited from prior treatment with immunotherapy.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Acquired Resistance or Suboptimal Benefit Group n=2 Participants Participants that have or have not benefited from prior treatment with immunotherapy.
Age, Continuous	55.5 years n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	2 participants n=93 Participants

PRIMARY outcome

Timeframe: up to 18 months

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

Outcome measures

Measure	Acquired Resistance or Suboptimal Benefit Group n=2 Participants Participants that have or have not benefited from prior treatment with immunotherapy.
Response Rate	0 Participants

SECONDARY outcome

Timeframe: 1 year

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

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

Number of patients surviving across both study groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Acquired Resistance or Suboptimal Benefit Group n=2 Participants Participants that have or have not benefited from prior treatment with immunotherapy.
Side Effects	2 Participants

Adverse Events

Acquired Resistance or Suboptimal Benefit Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acquired Resistance or Suboptimal Benefit Group n=2 participants at risk Participants that have or have not benefited from prior treatment with immunotherapy.
Musculoskeletal and connective tissue disorders Chest wall pain	100.0% 2/2 • 8 months
Respiratory, thoracic and mediastinal disorders Cough	50.0% 1/2 • 8 months
Gastrointestinal disorders Constipation	50.0% 1/2 • 8 months
Investigations Neutrophil count decreased	50.0% 1/2 • 8 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	50.0% 1/2 • 8 months
Gastrointestinal disorders GastGastrointestinal disorders - Other, specifyrointestinal disorders - Other, specify	50.0% 1/2 • 8 months

Additional Information

Theodore Karrison, PhD

University of Chicago

Phone: (773) 702-9326

Email: tkarrison@health.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place