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Monoclonal Antibodies
REGN4018 + Cemiplimab for Ovarian Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer
No standard therapy options
Must not have
Prior treatment with a Mucin 16 (MUC16)-targeted therapy
Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from cycle 2, day 1 up to 21 days
Awards & highlights
Summary
This trial is studying REGN4018, given alone or together with cemiplimab, to see how well it works in treating patients with solid tumors that have spread (metastatic) or cannot be removed by surgery (unresectable).
Who is the study for?
This trial is for adults with recurrent ovarian, fallopian tube, or peritoneal cancer who've had platinum-based therapy or are intolerant to it. They should have no standard treatment options left and a life expectancy of at least 3 months. Those with specific heart conditions, recent anti-PD-1/PD-L1 therapy, MUC16-targeted therapy history, untreated brain tumors or CNS metastases aren't eligible.Check my eligibility
What is being tested?
The study tests REGN4018 alone and combined with cemiplimab in two phases: Dose Escalation to find the safest dose and Dose Expansion to evaluate effectiveness by tumor response rates. It also examines side effects profiles, drug levels in the body (pharmacokinetics), and impacts on quality of life.See study design
What are the potential side effects?
Potential side effects include typical immune-related reactions such as inflammation in various organs due to immune system activation against cancer cells. Other common issues might involve infusion reactions during administration of the drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer.
Select...
I have no standard treatment options left.
Select...
My condition worsened after my last treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with a therapy targeting MUC16 before.
Select...
I have an untreated brain tumor or cancer that has spread to my brain or spinal cord.
Select...
I have recently been treated with PD-1/PD-L1 inhibitors.
Select...
I have undergone more than 4 chemotherapy treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from cycle 2, day 1 up to 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from cycle 2, day 1 up to 21 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with DLTs for REGN4018 with cemiplimab
Number of participants with Dose-limiting toxicity (DLTs) for REGN4018 monotherapy
Number of participants with Treatment-emergent adverse event (TEAE)s (including immune-related adverse events (imAEs)) for REGN4018 monotherapy
+4 moreSecondary outcome measures
BOR based on RECIST 1.1 for REGN4018 with cemiplimab
BOR based on iRECIST for REGN4018 monotherapy
BOR based on iRECIST for REGN4018 with cemiplimab
+49 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: MonotherapyExperimental Treatment2 Interventions
REGN4018 administration
Group II: Combination TherapyExperimental Treatment2 Interventions
REGN4018 and cemiplimab administration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sarilumab
2020
Completed Phase 3
~5980
cemiplimab
2016
Completed Phase 2
~910
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
637 Previous Clinical Trials
381,751 Total Patients Enrolled
3 Trials studying Ovarian Cancer
999 Patients Enrolled for Ovarian Cancer
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
271 Previous Clinical Trials
251,977 Total Patients Enrolled
1 Trials studying Ovarian Cancer
612 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs and bone marrow are working well.I have a history of heart issues as described in the study details.My high blood pressure is under control with stable medication.I have been diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer.I have been treated with a therapy targeting MUC16 before.I have an untreated brain tumor or cancer that has spread to my brain or spinal cord.I have no standard treatment options left.You are expected to live for at least 3 more months.I have ovarian cancer resistant to platinum therapy, treated with 1-4 platinum-based therapies and a PARP inhibitor or bevacizumab.I have recently been treated with PD-1/PD-L1 inhibitors.My condition worsened after my last treatment.I have undergone more than 4 chemotherapy treatments.Your CA-125 blood test shows a level that is at least twice as high as the normal range.I have had platinum-based treatment or cannot tolerate it.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Therapy
- Group 2: Monotherapy
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.
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