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Monoclonal Antibodies

Pembrolizumab + Bevacizumab for Ovarian Cancer

Phase 2

Recruiting

Led By Emese Zsiros

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years of age

Negative pregnancy test for women of childbearing potential

Must not have

Mental impairment that may compromise the ability to give informed consent

Active, untreated central nervous system metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new immunotherapy treatment for ovarian cancer. The treatment includes two monoclonal antibodies and a drug that stimulates the immune system. The goal is to shrink tumors and improve quality of life for patients with ovarian cancer.

Who is the study for?

This trial is for adults over 18 with recurrent ovarian cancer, including serous, endometrioid, or clear cell types. Participants can have had up to three prior treatments and must be expected to live more than six months. They should be relatively active (ECOG status of 0 or 1) and able to undergo a biopsy. Pregnant women are excluded, as well as those with certain medical conditions or severe allergies.

What is being tested?

The study tests pembrolizumab combined with bevacizumab and possibly anti-CD40 CDX-1140 in patients whose ovarian cancer has returned. It aims to see if this combination can shrink tumors by stimulating the immune system and producing antitumor antibodies.

What are the potential side effects?

Potential side effects include reactions related to the immune system's activation such as inflammation in various organs, infusion-related reactions from the drugs being administered into the bloodstream, fatigue, possible allergic responses, and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am not pregnant.

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I am willing to have a biopsy of my tumor.

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My cancer is a recurring ovarian, fallopian tube, or peritoneal type.

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

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Any side effects from my previous cancer treatments are mild.

Exclusion Criteria

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

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I am able to understand and consent to medical procedures.

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I have brain metastases that haven't been treated.

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I have had or currently have lung inflammation.

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I have had certain liver or stomach conditions.

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I have both Hepatitis B and C.

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I have not been treated for an infection within the last week.

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I have not taken certain medications recently.

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I have previously been treated with specific antibodies.

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I might need corticosteroids for more than two weeks.

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I have heart disease, organ transplants, serious gut blockages, or major wounds/fractures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events

Objective response rate (ORR)

Secondary study objectives

Disease control rate (DCR)

Overall survival (OS)

Progression free survival (PFS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (pembrolizumab, bevacizumab, CDX-1140)Experimental Treatment5 Interventions

Patients receive pembrolizumab IV over 30 minutes, bevacizumab IV over 30-90 minutes, and CDX-1140 IV over 90 minutes on day 1. Cycles repeat every 3 weeks until disease progression or development of unacceptable toxicity.

Group II: Arm I (pembrolizumab, bevacizumab)Active Control4 Interventions

Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 3 weeks until disease progression or development of unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Pembrolizumab

2017

Completed Phase 3

~3130