| TITRE |
Étude de phase I/II sur le BMS-986340 administré en monothérapie et en association avec le nivolumab à des participants atteints de tumeurs solides à un stade avancé |
| PROTOCOLE ID |
CA052-002 |
| CLINICAL TRIAL.gov ID |
NCT04895709 |
| TYPE(S) DE CANCER |
Tumeurs solides |
| PHASE |
Phase I-II |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CHUM
1051 rue Sanguinet
(514) 890-8000
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Rahima Jamal
|
| COORDONATEUR(RICE) |
Adeline Hamon
parc.eligibilite.chum@ssss.gouv.qc.ca
514-890-8000 poste 30737
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Radiographically documented progressive disease on or after the most recent therapy
- Received standard-of-care therapies, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
- Parts 1A, 1B, and 2A: Advanced or metastatic non-small cell lung cancer, squamous cell carcinoma of head and neck, microsatellite stable colorectal cancer, gastric/ gastroesophageal junction adenocarcinoma, or cervical cancer, and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant
|
| CRITÈRES D'EXCLUSION |
(EN)
- Women who are pregnant or breastfeeding
- Primary central nervous system (CNS) malignancy
- Untreated CNS metastases
- Leptomeningeal metastases
- Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment
- Active, known, or suspected autoimmune disease
- Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
- Prior organ or tissue allograft
- Uncontrolled or significant cardiovascular disease
- Major surgery within 4 weeks of study drug administration
- History of or with active interstitial lung disease or pulmonary fibrosis
Other protocol-defined inclusion/exclusion criteria apply
|
