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Checkpoint Inhibitor
ONC-392 + Pembrolizumab for Ovarian Cancer (PRESERVE-004 Trial)
Phase 2
Recruiting
Led By Joyce Barlin, MD
Research Sponsored by OncoC4, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
Patients must have received 1 or more prior systemic lines of anti-cancer therapy with or without bevacizumab or a PARP inhibitor, and for whom single-agent therapy is appropriate as the next line of treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
PRESERVE-004 Trial Summary
This trialtests if a combination of two drugs can safely and effectively treat ovarian cancer in patients who have not responded to platinum treatments.
Who is the study for?
This trial is for women over 18 with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer that's resistant to platinum-based therapy. They must have had surgery including hysterectomy and be in good health with a life expectancy of at least 12 weeks. Participants need measurable cancer lesions and adequate organ function but can't join if they're on high-dose steroids, have another active cancer, serious infections recently, certain heart issues within the past year, or specific types of ovarian cancers.Check my eligibility
What is being tested?
The study tests ONC-392 (a new anti-CTLA-4 antibody) combined with pembrolizumab (an anti-PD-1 antibody) to see how safe and effective they are together against platinum-resistant ovarian cancer. Patients will receive both drugs to determine their impact on this type of cancer.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions like inflammation in various organs, infusion reactions similar to allergic responses during drug administration, fatigue from treatment exhaustion, digestive problems such as diarrhea or colitis, skin issues like rash or itching.
PRESERVE-004 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
Select...
I've had cancer treatment before, but now need a single-agent therapy.
Select...
I have had surgery for my condition, including removal of the uterus and ovaries.
Select...
My cancer did not respond to platinum-based chemotherapy.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I had major surgery more than 4 weeks ago.
PRESERVE-004 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Treatment Related Adverse Events (TRAEs) and Immune Related Adverse Events (irAEs)
Secondary outcome measures
Best Overall Response (BOR)
Disease Control Rate (DCR)
Duration of Response (DoR)
+3 morePRESERVE-004 Trial Design
2Treatment groups
Experimental Treatment
Group I: 2 mg/kg ONC-392 and 200 mg pembrolizumabExperimental Treatment2 Interventions
Arm B: Pembrolizumab 200 mg will be administered by IV infusion over 30 minutes, followed by ONC-392 at 2.0 mg/kg will be administered by IV infusion over 60 minutes, q3w.
Group II: 1 mg/kg ONC-392 and 200 mg pembrolizumabExperimental Treatment2 Interventions
Arm A: Pembrolizumab 200 mg will be administered by IV infusion over 30 minutes, followed by ONC-392 at 1.0 mg/kg will be administered by IV infusion over 60 minutes, q3w.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
OncoC4, Inc.Lead Sponsor
6 Previous Clinical Trials
1,706 Total Patients Enrolled
1 Trials studying Ovarian Cancer
914 Patients Enrolled for Ovarian Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,999 Total Patients Enrolled
41 Trials studying Ovarian Cancer
6,542 Patients Enrolled for Ovarian Cancer
GOG FoundationNETWORK
42 Previous Clinical Trials
16,683 Total Patients Enrolled
7 Trials studying Ovarian Cancer
3,221 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I finished my targeted radiation therapy at least 2 weeks ago.I needed fluid removed from my abdomen recently due to my condition.I have been diagnosed with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.I am taking more than 10 mg/day of steroids for an autoimmune condition or as immunosuppression.I haven't needed IV antibiotics or been hospitalized for an infection in the last 14 days.I have not been treated for another cancer within the last 2 years.I have had surgery for my condition, including removal of the uterus and ovaries.You have at least one specific area of disease that can be measured to see if the treatment is working.I have brain metastases but have been treated and off steroids for over a week.I am not participating in any other clinical trials or receiving cancer treatments.I've had cancer treatment before, but now need a single-agent therapy.I haven't had a serious lung clot or major heart issues in the last year.It's been over 4 weeks since my last cancer drug treatment.I have active inflammatory bowel disease or an intestinal blockage.I have not received a live vaccine in the last 30 days.My cancer did not respond to platinum-based chemotherapy.My doctor believes I can live for at least 3 more months and am fit for experimental treatment.I have never had lung inflammation or scarring that needed steroids.I have not had any organ, tissue, or stem cell transplants.I have recovered from major surgery or previous cancer treatments without severe side effects.My recent lab tests show my organs are working well.I am fully active or restricted in physically strenuous activity but can do light work.My cancer did not respond to initial platinum-based chemotherapy.I am a woman over 18 and agree to participate in the study.I had major surgery more than 4 weeks ago.My cancer is one of the specified types, including ovarian or carcinosarcoma.
Research Study Groups:
This trial has the following groups:- Group 1: 2 mg/kg ONC-392 and 200 mg pembrolizumab
- Group 2: 1 mg/kg ONC-392 and 200 mg pembrolizumab
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Has the Food and Drug Administration greenlit usage of 3 mg/kg ONC-392 and 200 mg pembrolizumab?
"Based on the available data, we have assigned a score of 2 to 3 mg/kg ONC-392 and 200 mg pembrolizumab. This is due to this being classified as a Phase 2 trial, meaning that while there are some safety studies conducted there has yet been no evidence suggesting efficacy."
Answered by AI
What aims are this research endeavor attempting to accomplish?
"The primary endpoint of this two-year trial is Objective Response Rate (ORR), while secondary endpoints include Overall Survival (OS), Disease Control Rate (DCR), and Progression Free Survival (PFS). OS will be measured from randomization to death, DCR through the efficacy of ONC-392 and pembrolizumab combination therapy, and PFS according to RECIST 1.1 and iRECIST criteria."
Answered by AI
Has enrollment in this clinical trial commenced?
"According to information found on clinicaltrials.gov, this medical study is no longer recruiting participants; the trial was originally published on December 30th 2022 and updated for the final time at November 26th 2022. Despite currently being inactive, there are 738 other trials that require patients right now."
Answered by AI
How many locations are currently hosting this clinical experiment?
"The clinical trial is now enrolling patients from various sites, with Dr. Sudarshan Sharma's LTD. 414 Hinsdale clinic, Baptist Health Lexington 407 in Lexington, and Nuvance Health System 401 in Danbury being prominent among them along with other 17 medical centers."
Answered by AI
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