| Titre |
A Randomized, Open-label, Phase II Open Platform Study Evaluating the Efficacy and Safety of Novel Spartalizumab (PDR001) Combinations in Previously Treated Unresectable or Metastatic Melanoma |
| Protocole ID |
PLATforM |
| ClinicalTrials.gov ID |
NCT03484923 |
| Type(s) de cancer |
Mélanome |
| Phase |
Phase II |
| Stade |
Métastatique |
| Type étude |
Traitement |
| Médicament |
Spartalizumab avec LAG525 vs avec Capmatinib vs avec Canakinumab |
| 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) |
Amine Saad
514-340-8222 poste 24599
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- Histologically confirmed unresectable or metastatic stage IIIB/C/D or IV melanoma using AJCC edition 8
- Previously treated for unresectable or metastatic melanoma:
-
Subjects with V600BRAF wild-type disease must have received prior therapy with checkpoint inhibitor therapy (i.e. anti-PD-1/PD-L1 single-agent, or in combination with anti-CTLA-4) and must have had objective evidence of disease progression (i.e. RECIST v1.1) while on or after this therapy.
- Disease progression on or after prior therapy must have occurred within 12 weeks prior to randomization in the study.
- The last dose of prior therapy (anti-PD-1, anti-PD-L1 or anti-CTLA-4) must have been received more than 4 weeks prior to randomization.
-
Subjects with V600BRAF mutant disease must have received prior therapy with checkpoint inhibitor therapy (i.e. anti-PD-1/PD-L1 single-agent, or in combination with anti-CTLA-4) and must have had objective evidence of disease progression (i.e. RECIST v1.1) while on or after this therapy. Subjects must also have received prior therapy with a V600BRAF inhibitor, either as a single-agent or in combination with a MEK inhibitor.
- Disease progression on or after prior therapy must have occurred within 12 weeks prior to randomization in the study.
- The last dose of prior therapy must have been received more than 4 weeks (for anti-PD-1, anti-PD-L1 or anti-CTLA-4) or more than 2 weeks (for V600BRAF or MEK inhibitor) prior to randomization.
- ECOG performance status 0-2
- At least one measurable lesion per RECIST v1.1
- At least one lesion, suitable for sequential mandatory tumor biopsies (screening and on-treatment) in accordance with the biopsy guidelines specified in protocol. The same lesion must be biopsied sequentially.
- Screening tumor biopsy must fulfill the tissue quality criteria outlined in the protocol, as assessed by a local pathologist
|
| Critètes d'exclusion |
- Subjects with uveal or mucosal melanoma
-
Presence of clinically active or unstable brain metastasis. Note: Subjects with unstable brain lesions who have been definitively treated with stereotactic radiation therapy, surgery or gamma knife therapy are eligible.
- Subjects with brain lesions who are untreated (i.e. newly discovered brain lesions during screening) or received whole brain radiation must have documented stable disease as assessed by two consecutive assessments ≥ 4 weeks apart and have not required steroids for at least ≥ 4 weeks prior to randomization.
- Use of any live vaccines against infectious diseases within 3 months before randomization.
- Active infection requiring systemic antibiotic therapy at time of randomization.
- Systemic chronic steroid therapy (? 10mg/day prednisone or equivalent) or any other immunosuppressive therapy administered within 7 days prior to randomization. Note: Local steroids such as topical, inhaled, nasal and ophthalmic steroids are allowed.
- Active, known or suspected autoimmune disease or a documented history of autoimmune disease. Note: Subjects with vitiligo, controlled type I diabetes mellitus on stable insulin dose, residual autoimmune-related hypothyroidism only requiring hormone replacement or psoriasis not requiring systemic treatment are permitted.
- Prior allogenic bone marrow or solid organ transplant
- History of known hypersensitivity to any of the investigational drugs used in this study
- Prior systemic therapy for unresectable or metastatic melanoma except anti-PD-1/PD-L1 single-agent or in combination with anti-CTLA-4, or V600BRAF and MEK inhibitors.
- Medical history or current diagnosis of myocarditis
- Cardiac Troponin T (TnT) level > 2 x ULN at screening
|
Groupe d'étude en oncologie du Québec