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TITRE (EN) 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)
CLINICAL TRIAL.gov ID NCT04609566
TYPE(S) DE CANCER Mélanome
PHASE Phase II
TYPE D'ÉTUDE Clinique
INSTITUTION CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
3755 rue de la Côte Ste. Catherine
(514) 340-8222
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Wilson Miller
COORDONATEUR(RICE) Daria Krutauz
daria.krutauz.ccomtl@ssss.gouv.qc.ca
514-340-8222 poste 24301 Rim Hojeij
rim.hojeij.ccomtl@ssss.gouv.qc.ca
514-340-8222 poste 26187
STATUT  Fermé
DATE D'ACTIVATION 2023-01-19
CRITÈRES D'ÉLIGIBILITÉ (EN)

  • 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
CRITÈRES D'EXCLUSION (EN)
  • 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.