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)
|
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
|