Combination of Oregovomab and Niraparib for Recurrent Epithelial Cancer of Ovary

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Duke Cancer Center, Durham, NC
Recurrent Epithelial Cancer of Ovary+10 More
Oregovomab - Biological
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

1 of 3

Other trials for Recurrent Epithelial Cancer of Ovary

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

2 of 3
This is further along than 68% of similar trials

Other trials for Recurrent Epithelial Cancer of Ovary

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
Photo of durham  1Photo of durham  2Photo of durham  3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.