Spots Global Cancer Trial Database for Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors
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Trial Identification
Brief Title: Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors
Official Title: 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.
Study ID: NCT03836352
Study Description
Brief 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint 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
Montefiore Medical Center, Bronx, New York, United States
NYU Winthrop Hospital, Mineola, New York, United States
University of Toledo, Toledo, Ohio, United States
Mary Crowley Cancer Research Center, Dallas, Texas, United States
MD Anderson, Houston, Texas, United States
William Osler Health System, Brampton, Ontario, Canada
Juravinski Cancer Center, Hamilton, Ontario, Canada
Southlake Regional Health Center, Newmarket, Ontario, Canada
The Ottawa Hospital, Ottawa, Ontario, Canada
Sunnybrook Research Institute, Toronto, Ontario, Canada
Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada
McGill University Health Center, Montreal, Quebec, Canada
CHU de Québec-Université Laval, Québec, Quebec, Canada
Contact Details
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