Titre A Phase 2, Open-label, Multicenter, Study of an Immunotherapeutic Treatment, DPX-Survivac in Combination With Low Dose Cyclophosphamide and Pembrolizumab, in Subjects With Selected Advanced and Recurrent Solid Tumours.
Protocole ID P1719-SUR-Z11 / KEYNOTE 903
ClinicalTrials.gov ID NCT03836352
Type(s) de cancer Tumeurs solides
Phase Phase II
Stade Maladie avancée ou métastatique
Type étude Traitement
Médicament DPX-Survivac avec Low Dose Cyclophosphamide et Pembrolizumab
      11 Côte du Palais, Québec, QC, G1R 2J6
Ville Québec
Investigateur(trice) principal(e) Dr Vincent Castonguay
Coordonnateur(trice) Maryse Gingras
Statut Actif en recrutement
Critètes d'éligibilité
  • Subjects with advanced or metastatic solid tumours who have disease progression
  • Epithelial ovarian, fallopian tube, or peritoneal cancer
  • Hepatocellular carcinoma
  • Non-small cell lung cancer
  • Urothelial cancer
  • Microsatellite instability high solid tumours, other than the above indications
  • Radiologic and/or biochemical evidence of disease progression
  • Completion of pre-treatment tumour biopsy
  • Subjects with HCC, NSCLC, BlCa, or MSI-H subjects other than those with gastric or colorectal cancer must have evidence of survivin expression in their pre-treatment biopsy sample
  • Must have measurable disease by RECIST v1.1
  • Ambulatory with an ECOG 0-1
  • Life expectancy ≥ 6 months
  • Meet protocol-specified laboratory requirements
Critètes d'exclusion
  • Eligible for otherwise curative treatment or undergoing concurrent therapy
  • Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor where subject was discontinued from that treatment due to a Grade 3 or higher immune-related toxicity
  • Prior receipt of survivin-based vaccine(s) and/or immunotherapies
  • Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
  • Clinical ascites or metastatic pleural fluid
  • Malignant bowel obstruction or recent history of bowel obstruction
  • For OvCa, subjects with any single lesion greater than 5 cm
  • Autoimmune disease requiring treatment within the last two years (except replacement therapy)
  • Recent history of thyroiditis
  • Any history of (non-infectious) pneumonitis that required steroid therapy or current pneumonitis
  • Presence of a serious acute or chronic infection
  • Active CNS metastases and/or carcinomatous meningitis
  • GI condition that might limit absorption of oral agents
  • Allogenic tissue/solid organ transplant
  • Other serious intercurrent chronic or acute illness, including myocardial infarction or cerebrovascular event within 6 months
  • Ongoing treatment with steroid therapy or other immunosuppressive
  • Receipt of live attenuated vaccines
  • Acute or chronic skin and/or microvascular disorders
  • Edema or lymphedema in the lower limbs > grade 2
  • Severe hypersensitivity (≥ Grade 3) to pembrolizumab