Squamous Cell Carcinoma of Head and Neck
Conditions
Brief 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.
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.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be more than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) * Have histologically or cytologically confirmed recurrent/metastatic (R/M) 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 (HPV) 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 (ISH). Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative * Be treatment-naive for systemic therapy in the R/M setting * Have an ECOG performance status of 0 or 1 * Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1
Exclusion criteria
* Have an uncontrolled illness * Have untreated brain metastases or history of known presence of leptomeningeal disease * Have a history of clinically significant cardiovascular disease * Inadequate organ or bone marrow function * Known allergies, hypersensitivity, contraindications, or intolerance to excipients of: Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 3 years 7 months | OS is defined as time from the date of randomization to the date of death due to any cause. |
| Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) | Up to approximately 3 years 7 months | 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 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) Using RECIST Version 1.1, as Assessed by BICR | Up to approximately 3 years 7 months | PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, based on BICR assessment using RECIST v1.1, regardless of treatment discontinuation or start of subsequent anticancer therapy. |
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Up to approximately 3 years 7 months | TEAE is defined as any new or worsening adverse event (AE) occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy or any AE that is considered treatment-related regardless of the start date of the event. |
| Number of Participants with Laboratory Abnormalities | Up to approximately 3 years 7 months | Blood samples will be collected to determine the laboratory (serum chemistry and hematology) abnormalities. |
| 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 | Baseline, up to approximately 3 years 7 months | EORTC QLQ-HN43, is a self-administered, 43-item questionnaire measuring the health-related quality of life (HRQoL) of participants with head and neck cancer. EORTC QLQ-HN43 includes 19 scales (anxiety, body image, coughing, dry mouth and sticky saliva, neurological problems, opening mouth, pain in the mouth, social contact, problems with senses, shoulder problems, skin problems, swelling in the neck, social eating, speech, swallowing, sexuality, problems with teeth, weight loss, and problems with wound healing). Responses to items are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". Higher scores indicate worse health outcomes. |
| Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by EORTC QLQ-Core (C) 30 Symptom Scale Score | Baseline, up to approximately 3 years 7 months | EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 3 symptom scales (fatigue, pain, and nausea and vomiting), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, or more severe symptoms. |
| Change from Baseline in Functioning HRQoL, as Measured by Functioning Scales of the EORTC QLQ-C30 | Baseline, up to approximately 3 years 7 months | EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status / quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, or more severe symptoms. |
| Change from Baseline in Overall HRQoL, as Measured by Global Health Scales of the EORTC QLQ-C30 | Baseline, up to approximately 3 years 7 months | EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status / quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, or more severe symptoms. |
| Differences Between Treatment Groups (Arms A and B) for EORTC Quality of Life (QLG) Item Library-46 (IL-46) Tolerability Scale Scores | Up to approximately 3 years 7 months | EORTC IL46 is a single item used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Higher score indicates more impact of treatment side-effects. |
| Serum Concentration of Amivantamab | Up to approximately 3 years 7 months | Serum concentrations of amivantamab will be analyzed. |
| Duration of Response (DOR) As Assessed by BICR | Up to approximately 3 years 7 months | DOR as assessed by BICR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR as best response. |
| Number of Participants with Serum Anti-Amivantamab Antibodies | Up to approximately 3 years 7 months | Participants who are positive to serum anti-amivantamab antibodies will be reported. |
| ORR as Assessed by Investigator | Up to approximately 3 years 7 months | ORR as assessed by the investigator is defined as the percentage of randomized participants achieving CR or PR, as defined by investigator assessment using RECIST v1.1 criteria. |
Countries
Australia, Austria, Belgium, Brazil, China, Czechia, France, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Romania, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed