| Titre |
A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Subjects With Metastatic Solid Malignancies After Progression on Prior PD-1 Inhibitor Treatment |
| Protocole ID |
SGN35-033 (KEYNOTE B81) |
| ClinicalTrials.gov ID |
NCT04609566 |
| Type(s) de cancer |
Mélanome
ORL
Poumon non à petites cellules |
| Phase |
Phase II |
| Stade |
Métastatique |
| Type étude |
Clinique |
| Médicament |
Brentuximab védotine avec pembrolizumab |
| Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
 HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Wilson Miller
|
| Coordonnateur(trice) |
Daria Krutauz
514-340-8222 poste 24301
Rim Hojeij
514-340-8222 poste 26187
|
| Statut |
 Actif en recrutement |
| Date d'activation |
19-01-2023 |
| Critètes d'éligibilité |
-
Participants must have
-
Metastatic squamous or nonsquamous non-small cell lung cancer (NSCLC) (without known targetable EGFR, ALK, ROS1, or BRAF mutations) who either
- a) have not yet received frontline therapy for metastatic disease and without prior exposure to anti PD-1/PD-L1 or
- b) are relapsed/refractory with progression on anti PD-1/PD therapy.
- Relapsed/refractory metastatic cutaneous melanoma (regardless of mutation status) with progression on a PD-1 inhibitor
- Metastatic head and neck squamous cell carcinoma (HNSCC) who have not yet received frontline therapy for metastatic disease and without prior exposure to a PD-1/PD-L1 inhibitor.
- Cohorts 1-4 only: Melanoma participants must be currently on PD-1 checkpoint inhibitor (CPI) therapy (e.g. nivolumab or pembrolizumab) or had their last dose of PD-1 CPI containing therapy as the last previous line of therapy within 90 days prior to enrollment; PD-1 CPI therapy must be the immediate prior line of treatment.
-
Cohorts 1-4 only: Participants must have progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other CPIs or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria.
- Have received at least 2 doses of an approved PD-1 inhibitor.
-
Have demonstrated disease progression (PD) after a PD-1 inhibitor as defined by RECIST v1.1.
- Progressive disease has been documented within 90 days from the last dose of PD-1 inhibitor.
- Participants with melanoma will need iRECIST confirmation of progression with a second assessment at least four weeks after the initial date of progressive disease
- NSCLC participants on PD-1 inhibitor containing therapy for less than 90 days will need iRECIST confirmation of progression at least 4 weeks after the initial date of progressive disease
- Tumor tissue sample obtained within 3 months prior to enrollment is required, and no systemic anticancer therapy given after the sample was obtained.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of equal or less than 1
|
| Critètes d'exclusion |
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Prior immunosuppressive chemotherapy, any immunotherapy other than a PD-1 inhibitor within 4 weeks of first study drug dose.
- History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy.
|
Groupe d'étude en oncologie du Québec