Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors
Liver Cancer / Hepatoblastoma
Primary Peritoneal Cancer
18 Years and older, Male and Female
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.
- 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
Treatment Sites in Georgia
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