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Checkpoint Inhibitor

ONC-392 + Pembrolizumab for Ovarian Cancer (PRESERVE-004 Trial)

Phase 2

Waitlist Available

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

Must not have

Participating in other clinical trials or receiving other anti-cancer therapy

Prior history of symptomatic pulmonary embolism or significant cardiovascular impairment within 12 months of the first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.

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I've had cancer treatment before, but now need a single-agent therapy.

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I have had surgery for my condition, including removal of the uterus and ovaries.

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My cancer did not respond to platinum-based chemotherapy.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I had major surgery more than 4 weeks ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not participating in any other clinical trials or receiving cancer treatments.

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I haven't had a serious lung clot or major heart issues in the last year.

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I am taking more than 10 mg/day of steroids for an autoimmune condition or as immunosuppression.

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I have active inflammatory bowel disease or an intestinal blockage.

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I have never had lung inflammation or scarring that needed steroids.

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I have not had any organ, tissue, or stem cell transplants.

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My cancer did not respond to initial platinum-based chemotherapy.

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My cancer is one of the specified types, including ovarian or carcinosarcoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Treatment Related Adverse Events (TRAEs) and Immune Related Adverse Events (irAEs)

Secondary study objectives

Best Overall Response (BOR)

Disease Control Rate (DCR)

Duration of Response (DoR)

+3 more

Awards & Highlights

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.

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

0 / 14Eligibility criteria met