A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.
NCT05335993 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-04-03
Summary
Study to evaluate the safety and activity of oregovomab and niraparib as a combinatorial immune priming strategy in subjects with platinum sensitive recurrent ovarian cancer.
Conditions
- Recurrent Ovarian Cancer
- Recurrent Epithelial Cancer of Ovary
- Recurrent Epithelial Ovarian Cancer
- Recurrent Fallopian Tube Cancer
- Peritoneal Cancer
- Recurrent Carcinoma of Ovary
- Adenocarcinoma of Ovary
Interventions
- BIOLOGICAL
-
Oregovomab
2 mg, added to 50 mL of Sodium Chloride infused over 20 ± 5 minutes.
- DRUG
-
Niraparib
300mg administered orally once daily starting at the first day of treatment (Day 1 Week 1) to the end of Week 12. Subjects whose baseline weight is \<77 kg or platelet count is \<150,000 μL, the daily dosing will be 200mg.
Sponsors & Collaborators
-
Veristat, LLC
collaborator UNKNOWN -
Raptim Research
collaborator OTHER -
CanariaBio Inc.
lead INDUSTRY
Principal Investigators
-
Sunil Gupta, MD, FRCPC · CanariaBio Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-25
- Primary Completion
- 2026-12-30
- Completion
- 2027-12-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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