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.

Who is this study for? Adults with Solid Tumors
What treatments are being studied? DPX-Survivac, Pembrolizumab
Status: Active_not_recruiting
Location: See all (23) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will assess the safety and efficacy of DPX-Survivac and low dose cyclophosphamide with pembrolizumab in subjects with selected advanced and recurrent solid tumours.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subjects with advanced or metastatic solid tumours who have completed treatment with first line therapy:

‣ 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

• Must have measurable disease by RECIST v1.1

• Ambulatory with an ECOG 0-1

• Life expectancy ≥ 6 months

• Meet protocol-specified laboratory requirements

Locations
United States
Arizona
The University of Arizona Cancer Center
Tucson
California
Cedars Sinai Medical Center: Samuel Oschin Comprehensive Cancer Center
Los Angeles
Florida
Boca Raton Regional Hospital, Lynn Cancer Institute
Boca Raton
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie
Comprehensive Hematology and Oncology
Saint Petersburg
Georgia
Winship Cancer Institute: The Emory Clinic
Atlanta
Kentucky
James Brown Graham Cancer Center:University of Louisville Hospital
Louisville
Louisiana
Ochsner Cancer Institute
New Orleans
Minnesota
Allina Health, Virginia Piper Cancer Institute
Minneapolis
New Mexico
Christus St. Vincent Regional Cancer Center
Santa Fe
New York
Montefiore Medical Center
Bronx
NYU Winthrop Hospital
Mineola
Ohio
University of Toledo
Toledo
Texas
Mary Crowley Cancer Research Center
Dallas
MD Anderson
Houston
Other Locations
Canada
William Osler Health System
Brampton
Juravinski Cancer Center
Hamilton
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal
McGill University Health Center
Montreal
Southlake Regional Health Center
Newmarket
The Ottawa Hospital
Ottawa
CHU de Québec-Université Laval
Québec
Sunnybrook Research Institute
Toronto
Time Frame
Start Date: 2018-12-21
Completion Date: 2023-12-31
Participants
Target number of participants: 184
Treatments
Experimental: Arm 1 (All cohorts)
DPX-Survivac, Cyclophosphamide, Pembrolizumab
Experimental: Arm 2 (Ovarian cohort only)
DPX-Survivac, Pembrolizumab
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: ImmunoVaccine Technologies, Inc. (IMV Inc.)

This content was sourced from clinicaltrials.gov

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