Informations générales (source: ClinicalTrials.gov)
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 (OrigAMI-4)
Interventional
Phase 1/Phase 2
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
avril 2024
avril 2028
04 avril 2025
The purpose of this study is to determine safety and preliminary efficacy of amivantamab
monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to
paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants
with recurrent/metastatic head and neck cancer. The study will also confirm the
recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:06 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Oscar Lambret - 59020 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU Nantes - 44000 - Nantes Cedex 1 - France | Contact (sur clinicalTrials) | ||||
| Institut Sainte Catherine - 84918 - Avignon Cedex 9 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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; Cohort 5 (a) The eligible primary tumor locations are the oropharynx,
oral cavity, hypopharynx, or larynx; (b) HPV status must be known (either positive
or negative) for patients with primary tumor location in oropharynx with p16 test or
high-risk HPV ISH in tissue; (c) Participants must provide local testing results of
PD-L1 status
- Participants in Cohorts 1, 2, 3B, 4 and 5 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
- 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; Cohort 5 (a) The eligible primary tumor locations are the oropharynx,
oral cavity, hypopharynx, or larynx; (b) HPV status must be known (either positive
or negative) for patients with primary tumor location in oropharynx with p16 test or
high-risk HPV ISH in tissue; (c) Participants must provide local testing results of
PD-L1 status
- Participants in Cohorts 1, 2, 3B, 4 and 5 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
- 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