Tumeurs solides

TITRE	Étude de phase II ouverte et multicentrique évaluant un traitement immunothérapeutique, DPX-Survivac, en association avec le cyclophosphamide à faible dose et le pembrolizumab, chez des sujets présentant certaines tumeurs solides avancées et récurrentes.
PROTOCOLE ID	P1719-SUR-Z11 / KEYNOTE 903
CLINICAL TRIAL.gov ID	NCT03836352
TYPE(S) DE CANCER	Tumeurs solides
PHASE	Phase II
TYPE D'ÉTUDE	Traitement
INSTITUTION	CHU DE QUEBEC – UNIVERSITE LAVAL 11 Côte du Palais (418) 525-4444
VILLE	Québec
INVESTIGATEUR(RICE) PRINCIPAL(E)	Vincent Castonguay
COORDONATEUR(RICE)	Maryse Gingras maryse.gringras@chudequebec.ca 418-691-5781
STATUT	Fermé
CRITÈRES D'ÉLIGIBILITÉ	(EN) 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
CRITÈRES D'EXCLUSION	(EN) 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