Description:
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus
epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or
carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and
neck squamous cell carcinoma (HNSCC).
Title
- Brief Title: Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
- Official Title: A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First Line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)
Clinical Trial IDs
- ORG STUDY ID:
KEYNOTE-669/ECHO 304
- NCT ID:
NCT03358472
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Pembrolizumab | MK-3475 | Pembrolizumab |
Epacadostat | INCB024360 | Pembrolizumab + Epacadostat |
Cetuximab | | EXTREME |
Cisplatin | | EXTREME |
Carboplatin | | EXTREME |
5-Fluorouracil | | EXTREME |
Purpose
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus
epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab + cisplatin or
carboplatin + 5-fluorouracil) as first-line treatment for recurrent or metastatic head and
neck squamous cell carcinoma (HNSCC).
Trial Arms
Name | Type | Description | Interventions |
---|
Pembrolizumab + Epacadostat | Experimental | | |
Pembrolizumab | Experimental | | |
EXTREME | Active Comparator | EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil. | - Cetuximab
- Cisplatin
- Carboplatin
- 5-Fluorouracil
|
Eligibility Criteria
Inclusion Criteria:
- Measurable disease based on RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function per protocol-defined criteria.
- Documentation of results from testing of human papilloma virus (HPV) status for
oropharyngeal cancer.
- Baseline archival tumor specimen available or willing to undergo a prestudy treatment
tumor core or excisional biopsy of a tumor lesion not previously irradiated, to obtain
the specimen.
Exclusion Criteria:
- Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous
histologies as primary tumors.
- Disease progression within 6 months of completion of curatively intended systemic
treatment for locoregionally advanced HNSCC.
- Use of protocol-defined prior/concomitant therapy.
- Known additional malignancy that is progressing or has required active treatment
within the past 3 years.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Active autoimmune disease that has required systemic treatment in past 2 years.
- Known history of human immunodeficiency virus (HIV) infection. HIV testing is not
required unless mandated by local health authority.
- Known history of or is positive for active hepatitis B (defined as hepatitis B surface
antigen [HBsAg] reactive) or hepatitis C (defined as HCV RNA [qualitative] is
detected).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen |
Time Frame: | Minimum Week 9 |
Safety Issue: | |
Description: | ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination.
Responses are based on investigator assessments per RECIST 1.1 without confirmation using all available scans. |
Secondary Outcome Measures
Measure: | Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs) |
Time Frame: | Up to 14 months |
Safety Issue: | |
Description: | AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Data reported from start of study to data cutoff 17 Jan 2019, up to 14 months. |
Measure: | Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs |
Time Frame: | Up to 14 months |
Safety Issue: | |
Description: | AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Data reported from start of study to data cutoff 17 Jan 2019, up to 14 months. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Head and neck squamous cell carcinoma
- programmed cell death 1 (PD-1) inhibitor
- indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor
Last Updated
April 2, 2021