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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Objective response rate (ORR)
Secondary outcome measures
Disease control rate (DCR)
Overall survival (OS)
Progression free survival (PFS)
+1 moreTrial 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
~5280
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,727 Total Patients Enrolled
4 Trials studying Ovarian Cancer
63 Patients Enrolled for Ovarian Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,066 Total Patients Enrolled
42 Trials studying Ovarian Cancer
6,600 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,949 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am able to understand and consent to medical procedures.I have brain metastases that haven't been treated.I have had or currently have lung inflammation.You have had serious allergic reactions to other types of antibodies in the past.I have had certain liver or stomach conditions.I am not pregnant.You have had certain types of cancer or other medical conditions in the past.I have both Hepatitis B and C.I have not been treated for an infection within the last week.I am willing to have a biopsy of my tumor.My cancer is a recurring ovarian, fallopian tube, or peritoneal type.You are expected to live for more than 6 months.I have not taken certain medications recently.You have a current or past autoimmune disease, except for certain specified conditions.You have a measurable tumor according to specific medical guidelines.Your blood and other body chemistry levels need to be within specific ranges.I have previously been treated with specific antibodies.I might need corticosteroids for more than two weeks.You are allergic to certain medications.You have received certain experimental vaccines.I am fully active or restricted in physically strenuous activity but can do light work.I have heart disease, organ transplants, serious gut blockages, or major wounds/fractures.Any side effects from my previous cancer treatments are mild.I have had no more than 3 treatments for my cancer, regardless of my response to platinum-based therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (pembrolizumab, bevacizumab)
- Group 2: Arm II (pembrolizumab, bevacizumab, CDX-1140)
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.
What is the desired outcome of this clinical trial?
"The primary outcome of this clinical trial will be the incidence of adverse events, as measured over a period of up to 2 years. Secondary outcomes include overall survival (OS), quality of life (QoL), and disease control rate (DCR). OS will be summarized by cohort using standard Kaplan-Meier methods, with estimates of the median obtained with 90% confidence intervals. OS will be compared between cohorts using a one-sided log-rank test. QoL will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-30, which consists of 28 questions with answers"
Answered by AI
Could you please elaborate on the safety of CDX-1140 for human patients?
"This clinical trial is only in Phase 2, so while there is data supporting the safety of CDX-1140, its efficacy has yet to be proven."
Answered by AI
Are there any more spots left for participants in this experiment?
"Unfortunately, the trial you're inquiring about is not currently recruiting patients. The study was posted on 11/30/2022 and has not been updated since 9/26/2022. However, there are 4430 other clinical trials that are presently enrolling patients."
Answered by AI
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