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
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Missak Haigentz MD
- Principal Investigator
- Rutgers Cancer Institute of New Jersey-University Hospital
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:
(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
- Participants in Cohorts 1, 2, and 3B 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.
For further information about clinical trials, please contact us at 732-235-7356.