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.
This study is a Phase 2 with safety lead-in study to assess the safety and efficacy of DPX-Survivac, low dose cyclophosphamide, and pembrolizumab combination therapy in subjects with selected advanced and recurrent solid tumours. Two ovarian cancer arms will be recruited and randomized in this study, one with and one without cyclophosphamide. All other cohorts will be single arm, receiving treatment with the triple combination. Up to 20 subjects, from any cohort, will be enrolled to assess the safety of study treatments before the study moves to the expansion phase. Once the safety lead-in is completed, the five cohorts will be expanded to recruit additional subjects following a Simon two stage design. Enrollment in the ovarian cancer cohort will be randomized 1:1 into two arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
The University of Arizona Cancer Center
Tucson, Arizona, United States
Cedars Sinai Medical Center: Samuel Oschin Comprehensive Cancer Center
Los Angeles, California, United States
Boca Raton Regional Hospital, Lynn Cancer Institute
Boca Raton, Florida, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
Comprehensive Hematology and Oncology
St. Petersburg, Florida, United States
Winship Cancer Institute: The Emory Clinic
Atlanta, Georgia, United States
James Brown Graham Cancer Center:University of Louisville Hospital
Louisville, Kentucky, United States
Ochsner Cancer Institute
New Orleans, Louisiana, United States
Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, United States
...and 13 more locations
Efficacy as measured by objective response rate
Centrally evaluated using RECIST v1.1
Time frame: Approximately 24 months
Safety as measured by the rate of adverse events
Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Approximately 24 months
Objective response rate
Centrally evaluated using iRECIST
Time frame: Approximately 24 months
Duration of response
Time frame: Approximately 24 months
Disease control rate
Time frame: Approximately 24 months
Progression Free Survival
Time frame: Approximately 24 months
Overall survival
Time frame: Approximately 24 months
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