| 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 |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 L'HOTEL-DIEU DE QUEBEC ET CRCEO
11 Côte du Palais, Québec, QC, G1R 2J6
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dr Vincent Castonguay
|
| Coordonnateur(trice) |
Maryse Gingras
418-691-5781
|
| 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
|
Groupe d'étude en oncologie du Québec