A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants With Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Summary
The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.
Arms & interventions
- BiologicalAmivantamab
Amivantamab will be administered.
- BiologicalPembrolizumab
Pembrolizumab will be administered.
- DrugCarboplatin
Carboplatin will be administered.
- Drug5-Flurouracil
5-Flurouracil will be administered for over 4-day infusion period.
- DrugCisplatin
Cisplatin will be administered.
Outcome measures
Primary
Overall Survival (OS)
OS is defined as time from the date of randomization to the date of death due to any cause.
Time frame: Up to approximately 3 years 7 months
Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
ORR is defined as the percentage of randomized participants achieving a confirmed best overall response (BOR) of partial response (PR) or complete response (CR) by BICR using RECIST version 1.1 .
Time frame: Up to approximately 3 years 7 months
Secondary
Progression-Free Survival (PFS) Using RECIST Version 1.1, as Assessed by BICR
Time frame: Up to approximately 3 years 7 months
Duration of Response (DOR) As Assessed by BICR
Time frame: Up to approximately 3 years 7 months
ORR as Assessed by Investigator
Time frame: Up to approximately 3 years 7 months
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 3 years 7 months
Number of Participants with Laboratory Abnormalities
Time frame: Up to approximately 3 years 7 months
Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module 43 (EORTC QLQ-HN43) Symptom Scale Score
Time frame: Baseline, up to approximately 3 years 7 months
Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by EORTC QLQ-Core (C) 30 Symptom Scale Score
Time frame: Baseline, up to approximately 3 years 7 months
Change from Baseline in Functioning HRQoL, as Measured by Functioning Scales of the EORTC QLQ-C30
Time frame: Baseline, up to approximately 3 years 7 months
Change from Baseline in Overall HRQoL, as Measured by Global Health Scales of the EORTC QLQ-C30
Time frame: Baseline, up to approximately 3 years 7 months
Differences Between Treatment Groups (Arms A and B) for EORTC Quality of Life (QLG) Item Library-46 (IL-46) Tolerability Scale Scores
Time frame: Up to approximately 3 years 7 months
Serum Concentration of Amivantamab
Time frame: Up to approximately 3 years 7 months
Number of Participants with Serum Anti-Amivantamab Antibodies
Time frame: Up to approximately 3 years 7 months
Eligibility criteria
Study locations (41)
Ironwood Cancer and Research Center
Chandler, Arizona, 85224
Providence St Jude Medical Center
Fullerton, California, 92835
Valkyrie Clinical Trials
Los Angeles, California, 90067
Valkyrie Clinical Trials Murrieta
Murrieta, California, 92562
Stanford University Medical Center
Stanford, California, 94304
Hartford Hospital
Hartford, Connecticut, 06102
Yale Cancer Center
New Haven, Connecticut, 06510
Florida Cancer Specialists South
Fort Myers, Florida, 33901
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
AdventHealth Medical Group Oncology and Hematology at Orlando
Orlando, Florida, 32804
Florida Cancer Specialists North Region
St. Petersburg, Florida, 33701-4553
Florida Cancer Specialists East
West Palm Beach, Florida, 33401-3406
Emory University
Atlanta, Georgia, 30308
Central Georgia Cancer Care
Macon, Georgia, 31210
Rush University Medical Center Rush University Cancer Center Chicago
Chicago, Illinois, 60607
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, 60637
Cancer Care Specialists of Central Illinois
O'Fallon, Illinois, 62269
University of Kentucky Medical Center
Lexington, Kentucky, 40536
University of Marlyand Baltimore
Baltimore, Maryland, 21201
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Karmanos Cancer Institute
Detroit, Michigan, 48201 2013
Washington University School Of Medicine
St Louis, Missouri, 63108
NHO Revive Research Institute, LLC
Lincoln, Nebraska, 68506
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
Montefiore Medical Center
The Bronx, New York, 10461
Bronx Veterans Affairs Medical Center
The Bronx, New York, 10468
Carolina Cancer Research Center
Wilson, North Carolina, 27893
University of Cincinnati
Cincinnati, Ohio, 45219
Ohio State University
Columbus, Ohio, 43210
Oregon Health And Science University
Portland, Oregon, 97239
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
UT Southwestern Medical Center
Dallas, Texas, 75390
Texas Oncology - San Antonio
Fredericksburg, Texas, 78624
MD Anderson Cancer Center
Houston, Texas, 77030
Texas Oncology-Central South
Waco, Texas, 76712
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of Virginia
Charlottesville, Virginia, 22908
Virginia Cancer Specialists
Fairfax, Virginia, 22031