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PARP Inhibitor
Oregovomab + Niraparib for Ovarian Cancer
Phase 2
Waitlist Available
Research Sponsored by OncoQuest Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have histologically diagnosed high-grade (Grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and experienced a response lasting at least 6 months to first-line platinum-based therapy
Must have an ECOG Performance Status of 0, 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to two years
Awards & highlights
Study Summary
This trial is testing if a new combination of drugs can help people with ovarian cancer that has come back.
Who is the study for?
This trial is for adult women with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back but responded to platinum-based chemotherapy for at least 6 months. Participants must have good organ function, no serious uncontrolled conditions, not be pregnant and agree to contraception. They can't join if they've had certain other cancers recently, major surgery within the last 3 weeks, or been treated with oregovomab before.Check my eligibility
What is being tested?
The study tests a combination of two drugs: Oregovomab and Niraparib in women whose ovarian cancer has returned but was previously sensitive to platinum-based treatments. The goal is to see how safe this combo is and how well it works as an immune-boosting treatment strategy.See study design
What are the potential side effects?
Potential side effects may include allergic reactions due to murine proteins in oregovomab or hypersensitivity issues related to either drug's components. Other common side effects from similar therapies could involve fatigue, nausea, blood cell count changes (like anemia), and possible increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have high-grade ovarian, fallopian tube, or peritoneal cancer that came back after responding to initial chemotherapy for at least 6 months.
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I am able to care for myself and perform daily activities.
Select...
I can take pills by mouth.
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My blood tests show my organs are functioning well.
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I had platinum-based chemo for ovarian cancer and responded well for 6+ months.
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My cancer is ovarian, fallopian tube, or peritoneal and has returned.
Select...
My cancer can be measured and tracked using scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of Disease Control Rate (DCR)
Secondary outcome measures
To Establish the Preliminary Safety and Tolerability of Oregovomab When Added to Niraparib.
Other outcome measures
Overall Response Rate (ORR)
Overall Survival (OS)
Progression-Free Survival (PFS)
Side effects data
From 2018 Phase 2 trial • 11 Patients • NCT0195967255%
Leukopenia
36%
Thrombocytopenia
36%
Lymphopenia
18%
Anemia
18%
Reduced ANC
18%
ALT elevation
18%
AST elevation
9%
Rash
9%
Orthostasis
9%
Pancreatitis
9%
Nausea
9%
Vomiting
9%
Dehydration
9%
Depression
9%
Somnolence
9%
Hypokalemia
9%
Hyperkalemia
9%
Pneumonia
9%
Acidosis
9%
Urinary tract infection
9%
Sepsis
9%
Pleural effusion
9%
Sinusitis
9%
Cardiac disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Combination of Oregovomab and NiraparibExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oregovomab
2013
Completed Phase 2
~20
Niraparib
2018
Completed Phase 4
~1540
Find a Location
Who is running the clinical trial?
OncoQuest Pharmaceuticals Inc.Lead Sponsor
3 Previous Clinical Trials
679 Total Patients Enrolled
2 Trials studying Ovarian Cancer
625 Patients Enrolled for Ovarian Cancer
CanariaBio Inc.Lead Sponsor
5 Previous Clinical Trials
823 Total Patients Enrolled
3 Trials studying Ovarian Cancer
713 Patients Enrolled for Ovarian Cancer
Veristat, LLCUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had up to 3 treatments for my cancer, including a platinum-based one, due to it getting worse or side effects.I am able and willing to sign a consent form for treatment.I have an autoimmune disease and am on immune suppressive therapy.I cannot use certain emergency drugs due to my medication.I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.I am allergic to mouse proteins or have had reactions to specific cancer drugs.I have chronic hepatitis B but it's under control with treatment.I haven't taken any colony-stimulating factors in the last 4 weeks.I have a known immune system condition, but not HIV.I have high-grade ovarian, fallopian tube, or peritoneal cancer that came back after responding to initial chemotherapy for at least 6 months.I have never been diagnosed with MDS or AML.I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.I am able to care for myself and perform daily activities.My doctor believes I can live 6 more months and can pause cancer treatment for 12 weeks.I do not have brain or spinal cord cancer that is causing symptoms.I can take pills by mouth.Your blood test showed high levels of CA125 within the past 28 days.I've had radiation on more than 20% of my bone marrow in the last 2 weeks.My blood tests show my organs are functioning well.I haven't had any cancer besides non-melanoma skin cancer or cervical cancer in situ in the last 5 years.I have been on corticosteroids for more than 5 days, not counting inhalers or planned tapers.I have not had a heart attack in the last year and do not have severe heart or lung conditions.I don't have any serious uncontrolled health issues or infections.I have not had a blood transfusion in the last 2 weeks.I have been treated with oregovomab before.I had platinum-based chemo for ovarian cancer and responded well for 6+ months.I am HIV positive but my viral load is undetectable due to effective treatment.I am on long-term medication to suppress my immune system.My cancer is ovarian, fallopian tube, or peritoneal and has returned.I have hepatitis C that hasn't been treated or is currently being treated with an undetectable viral load.My cancer can be measured and tracked using scans.
Research Study Groups:
This trial has the following groups:- Group 1: Combination of Oregovomab and Niraparib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are enrolled in the experiment?
"CanariaBio Inc., the sponsor, requires 10 eligible participants in order to successfully carry out this trial. These individuals may be recruited from two locations: University of Virginia Health System (Charlottesville, VA) and Stephenson Cancer Center-University of Oklahoma Health Sciences Centre (Oklahoma City)."
Answered by AI
Is this research endeavor still seeking participants?
"This clinical trial is actively seeking participants, as reported on clinicaltrials.gov. The post was initially made on the 25th of July 2022 and has been recently amended on the 26th of July 2022."
Answered by AI
What criteria must a person meet to be eligible for this clinical trial?
"To be eligible for the trial, participants must possess a uterus and reside between 18-99 years old. 10 individuals are being welcomed into this research endeavour."
Answered by AI
Is eligibility for this trial restricted to individuals under the age of 45?
"The eligibility conditions of this medical trial require participants to be between 18 and 99 years old. There are 175 studies for individuals under the age of majority, as well as 1399 research programs available to those over 65."
Answered by AI
Has the regulatory body sanctioned Oregovomab for public use?
"While there is evidence of Oregovomab's safety, a score of 2 was attributed as this Phase 2 trial has yet to demonstrate its efficacy."
Answered by AI
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