| Titre |
A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors |
| Protocole ID |
CA052-002 |
| ClinicalTrials.gov ID |
NCT04895709 |
| Type(s) de cancer |
Tumeurs solides |
| Phase |
Phase I-II |
| Stade |
Maladie avancée ou métastatique |
| Type étude |
Clinique |
| Médicament |
BMS-986340 en monothérapie ou en association avec le nivolumab |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dre Rahima Jamal
|
| Coordonnateur(trice) |
Adeline Hamon
514-890-8000 poste 30737
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- 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
|
| Critètes d'exclusion |
- 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
|
Groupe d'étude en oncologie du Québec