| Titre |
Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma |
| Protocole ID |
MK-3475-C11 (KEYNOTE-C11) |
| ClinicalTrials.gov ID |
NCT05008224 |
| Type(s) de cancer |
Hodgkin (Maladie de) |
| Phase |
Phase II |
| Type étude |
Clinique |
| Médicament |
Pembrolizumab avec chimiothérapie |
| Institution |
CIUSSS DU NORD-DE-L'ILE-DE-MONTREAL
 HOPITAL DU SACRE-COEUR-DE-MONTREAL
5400 boul. Gouin Ouest, Montréal, QC, H4J1C5
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dre Inès Chamakhi
|
| Coordonnateur(trice) |
Caroline Chagnon
514-338-2222 poste 2818
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
The main inclusion criteria include, but are not limited to the following:
- Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV classical Hodgkin Lymphoma (cHL). Stage I and II participants may be enrolled, but must have at least one National Comprehensive Cancer Network (NCCN) unfavorable risk factor per protocol
- Has measurable 2-fluorodeoxyglucose (FDG)-avid disease based on investigator assessment according to Lugano 2014 response criteria
- Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy for the treatment of cHL before the first dose of study intervention
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before the start of study intervention
|
| Critètes d'exclusion |
The main exclusion criteria include, but are not limited to the following:
- Has confirmed nodular lymphocyte-predominant Hodgkin Lymphoma (HL)
- Has an uncontrolled intercurrent cardiovascular illness
- Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 protein (PD-L1), or anti- programmed cell death ligand 2 protein (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Has received or is expected to receive a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has a history or current evidence of pulmonary fibrosis
- Has had an allogenic tissue/solid organ transplant
|
Groupe d'étude en oncologie du Québec