A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and Amivantamab in Addition to Standard of Care Therapeutic Agents in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
Primary:
- To assess anti-tumor activity of amivantamab monotherapy in participants with R/M HNSCC who have received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor.
Secondary:
- To further assess anti-tumor activity of amivantamab monotherapy in participants with R/M HNSCC who have received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor
- To characterize safety and tolerability of amivantamab monotherapy in participants with R/M HNSCC who have received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor.
- To characterize PK of amivantamab monotherapy in participants with R/M HNSCC who have received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor.
PACLITAXEL
Pembrolizumab (MK-3475)
Chemotherapy single agent systemic
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
- Rutgers University
Inclusion Criteria: - Have histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies. Acceptable prior lines of therapy will be determined according to specific cohort 1, 2, 3A and 3B: (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) Any known p16 status of tumor must be negative (Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing); (c) Participants must provide local testing results of programmed cell death ligand 1 (PD-L1) status, if available; Cohort 4: (a) Patients must have primary tumor location in oropharynx. Unknown primary tumors are not included (b) Primary tumor must be HPV-positive, confirmed by positive p16 test or high-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue (current or archival) (c) Participants must provide local testing results of PD-L1 status, if available - Participants in Cohorts 1, 2, and 3B and 4 must have measurable disease according to RECIST version 1.1. Participants in Cohort 3A must have evaluable disease (defined as having at least 1 non-target lesion according to RECIST version 1.1 - Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less prior to the first dose of study treatment (except for alopecia or post-radiation skin changes [any grade], Grade less than or equal to [<=]2 peripheral neuropathy and Grade <=2 hypothyroidism stable on hormone replacement) - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 - Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or use of granulocyte colony-stimulating factor within 7 days prior to the date of the laboratory test. Participants should have: a) Hemoglobin >=9 grams per deciliter (g/dL); b) Neutrophils >=1.5 x 10^3/mcg; c) Platelets >=100 x 10^3/mcg Exclusion Criteria: - Uncontrolled illness including any medical history or current (non-infectious) interstitial lung disease (ILD)/ pneumonitis/ pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening - Participant with untreated brain metastases leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation - Participant with a history of clinically significant cardiovascular disease - Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days - Received radiotherapy for palliative purposes within 7 days of the first administration of study treatment
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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