Health Condition 1: C069- Malignant neoplasm of mouth, unspecified Health Condition 2: C109- Malignant neoplasm of oropharynx,unspecified Health Condition 3: C139- Malignant neoplasm of hypopharynx,unspecified
Conditions
Interventions
Intervention1: Amivantamab: Participants will receive amivantamab as a subcutaneous (SC) injection at a dose based on body weight (1,600 mg (2,240 mg for greater than equal to 80 kg) on C1D1
and 2,400/3,360 mg on C1D8 and C1D15 and Q3W from Cycle 2 onwards) for up to 24 months.
Control Intervention1: Pembrolizumab: Participants will receive pembrolizumab 200 mg infusion (IV) at Q3W for up
Sponsors
Johnson and Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Be more than or equal to 18 years of age 2. Have histologically or cytologically confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies a. eligible primary tumor locations are the oral cavity, oropharynx, hypopharynx, or larynx b. Must not have a primary tumor site of nasopharynx or primary tumor of unknown location c. Must have documented local testing results per local regulations d. Human papillomavirus status must be known for participants with primary tumor location in oropharynx via p16 test, HPV DNA test, or high-risk HPV in situ hybridization. Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative 3. Be treatment-naive for systemic therapy in the recurrent or metastatic setting 4. Have an ECOG performance status of 0 or 1 5. Have measurable disease according to Response Evaluation Criteria in Solid Tumors, RECIST version 1.1
Exclusion criteria
Exclusion criteria: 1. Have an uncontrolled illness 2. Have untreated brain metastases or history of known presence of leptomeningeal disease 3. Have a history of clinically significant cardiovascular disease 4. Inadequate organ or bone marrow function 5. Known allergies, hypersensitivity, contraindications, or intolerance to excipients of Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) and Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)Timepoint: Up to approximately 3 years 7 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS)Timepoint: Up to approximately 3 years 7 months;Duration of Response (DOR)Timepoint: Up to approximately 3 years 7 months;ORR as Assessed by InvestigatorTimepoint: Up to approximately 3 years 7 months;Number of Participants with Treatment-Emergent Adverse EventsTimepoint: Up to approximately 3 years 7 months;Number of Participants with Laboratory AbnormalitiesTimepoint: 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 ScoreTimepoint: Up to approximately 3 years 7 months;Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by EORTC QLQCore (C) 30 Symptom Scale ScoreTimepoint: Up to approximately 3 years 7 months;Change from Baseline in Functioning HRQoL, as Measured by Functioning Scales of the EORTC QLQ-C30 EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer.Timepoint: Up to approximately 3 years 7 months;Change from Baseline in Overall HRQoL, as Measured by Global Health Scales of the EORTC QLQ-C30 EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer.Timepoint: 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 ScoresTimepoint: Up to approximately 3 years 7 months;Serum Concentration of AmivantamabTimepoint: Up to approximately 3 years 7 months;Number of Participants with Serum Anti-Amivantamab AntibodiesTimepoint: Up to approximately 3 years 7 months | — |
Countries
Australia, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Republic of Korea, Romania, Spain, Taiwan, United Kingdom, United States of America
Contacts
Public ContactDr Sanish Davis
Johnson and Johnson Private Limited
Outcome results
None listed