A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

Part of paid clinical trials in Durham, North Carolina.

Sponsor
CanariaBio Inc.
Study ID
NCT05335993
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Adenocarcinoma of Ovary
  • Peritoneal Cancer
  • Recurrent Carcinoma of Ovary
  • Recurrent Epithelial Cancer of Ovary
  • Recurrent Epithelial Ovarian Cancer
  • Recurrent Fallopian Tube Cancer
  • Recurrent Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Oregovomab — BIOLOGICAL
    2 mg, added to 50 mL of Sodium Chloride infused over 20 ± 5 minutes.
  • Niraparib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 25, 2022
Status verified
Mar 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination of Oregovomab and Niraparib
    * Niraparib (300/200 mg) will be administered orally once daily. * Oregovomab (2 mg) will be administered via IV infusion on Day 1 of Week 1, Week 4, Week 7, Week 12, and Week 20.

Primary Outcome Measure

Assessment of Disease Control Rate (DCR) [ Time Frame: At 12 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Duke Cancer CenterDurhamNorth Carolina27710-
Stephenson Cancer Center- University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
University of Virginia Health SystemCharlottesvilleVirginia22903-

Find similar trials in Durham, NC

By research site
Duke Cancer Center· Durham, NCStephenson Cancer Center- University of Oklahoma Health Sciences Center· Oklahoma City, OKUniversity of Virginia Health System· Charlottesville, VA

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