Combination of Oregovomab and Niraparib for Recurrent Epithelial Cancer of Ovary
Phase-Based Progress Estimates
Effectiveness
Safety
Duke Cancer Center, Durham, NC
Recurrent Epithelial Cancer of Ovary+10 More
Oregovomab - BiologicalEligibility
18+
Female
What conditions do you have?
Select
Eligibility
18+
Female
What conditions do you have?
Select
Study 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.
Eligible Conditions
- Recurrent Epithelial Cancer of Ovary
- Adenocarcinoma of Ovary
- Recurrent Carcinoma of Ovary
- Malignant Peritoneal Neoplasm
- Recurrent Ovarian Cancer
- Recurrent Fallopian Tube Cancer
- Recurrent, Epithelial Ovarian Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: Baseline up to two years
At 24 weeks
Assessment of Disease Control Rate (DCR)
At week 7
To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.
Baseline up to two years
Overall Survival (OS)
Progression-Free Survival (PFS)
Week 24
Overall Response Rate (ORR)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
Combination of Oregovomab and Niraparib
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: Combination of Oregovomab and Niraparib · No Placebo Group · Phase 2
Combination of Oregovomab and NiraparibExperimental Group · 2 Interventions: Oregovomab, Niraparib · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oregovomab
2013
Completed Phase 2
~20
Niraparib
2017
Completed Phase 2
~790
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to two years
Closest Location: Duke Cancer Center · Durham, NC
2013First Recorded Clinical Trial
1 TrialsResearching Recurrent Epithelial Cancer of Ovary
34 CompletedClinical Trials
Eligibility Criteria
Age 18+ · Female Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have recurrent epithelial adenocarcinoma of the ovary, fallopian tube or peritoneum.
You have a performance status of 0, 1 or 2.
You have previously received up to 3 prior lines of therapy, including at least one platinum-based therapy
You have had an elevated serum CA125 level measured at screening within 28 days of start of study treatment.
You have measurable disease, including identification of marker lesions, by radiographic or physical criteria suitable for evaluation according to RECIST v1.1 for documentation of disease response or progression.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments