| Titre |
An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Advanced Malignancies |
| Protocole ID |
SGNS40-002 (KEYNOTE-C86) |
| ClinicalTrials.gov ID |
NCT04993677 |
| Type(s) de cancer |
Mélanome
Poumon non à petites cellules |
| Phase |
Phase II |
| Stade |
Maladie avancée ou métastatique |
| Type étude |
Clinique |
| Médicament |
SEA-CD40 |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 L'HOTEL-DIEU DE QUEBEC ET CRCEO
11 Côte du Palais, Québec, QC, G1R 2J6
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dr Olivier Dumas
|
| Coordonnateur(trice) |
Mélanie Croussette
418-525-4444 poste 22637
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
-
Histologically or cytologically confirmed unresectable malignancy defined as one of the following:
-
Cohort 1: Relapsed and/or refractory metastatic melanoma
- Uveal/ocular melanoma is excluded
-
Must have progressed on treatment with an anti-PD-(L)1 mAb. PD-(L)1 treatment progression is defined as meeting all of the following criteria:
- Has received at least 2 doses of an approved anti-PD-(L)1 mAb
- Has demonstrated disease progression after PD-(L)1 as defined by RECIST v1.1.
- Progressive disease has been documented within 12 weeks from the last dose of anti- PD-(L)1 mAb
- Last dose of anti-PD-(L)1 must have been within 90 days prior to enrollment
- Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or declined treatment with BRAF/MEK targeted therapy prior to study entry
-
Cohort 2: Metastatic uveal melanoma
- Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy
- No prior liver-directed therapy
-
Cohort 3: Metastatic PD-(L)1-naive melanoma
- Uveal/ocular melanoma is excluded
- Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy.
- For participants with a targetable BRAF mutation, prior BRAF/MEK targeted therapy is allowed if completed 4 weeks prior to first dose of study treatment.
-
Cohorts 4 and 5: Non-squamous NSCLC
- Participants must have stage IV disease per AJCC 8th edition
- No known driver mutations/alterations mutation for which targeted therapy is available
- Must have non-squamous histology.
- No prior therapy for metastatic disease
- No prior treatment with anti-PD-(L)1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms
- Able to provide archival tumor tissue from locations not radiated prior to biopsy. If archival tumor sample is not available a fresh baseline biopsy is required.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Measurable disease per RECIST v1.1 at baseline
|
| Critètes d'exclusion |
- History of another malignancy within 3 years of first dose of study drug
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Previous exposure to CD40-targeted therapy
- Currently on chronic systemic steroids in excess of physiologic replacement
- Has had an allogeneic tissue/solid organ transplant.
- History of autoimmune disease that has required systemic treatment in the past 2 years
|
Groupe d'étude en oncologie du Québec