NCT05335993

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

Phase 2, Single Arm Clinical Trial to Evaluate the Safety and Activity of Oregovomab and Niraparib as a Combinatorial Immune Priming Strategy in Subjects With Platinum Sensitive Recurrent Ovarian Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: CanariaBio Inc. · Industry
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase 2 single arm open label study to evaluate the combination of oregovomab and niraparib as a combinatorial immune priming strategy in subjects with platinum sensitive recurrent ovarian cancer. Approximately 15 subjects will be screened to enroll approximately 10 evaluable subjects. The study will include: * Screening period up to 28 days prior to start of study treatment. * Treatment period up to 24 weeks. * Post-treatment follow-up period: * Safety Follow-up: all subjects will be followed at least 30 days after end of treatment for safety. * Long Term Follow-up: all subjects will be followed for survival approximately every 3 months for 1 year, until death, withdrawal of consent, lost to follow-up, or sponsor decision to close the study; or whichever comes first.

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

Type	Name	Description
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.

Timeline

• Start date: 2022-07-25
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2022-04-20
• Last updated: 2026-04-03

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study