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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
No Placebo-Only Group

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.
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.
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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~from cycle 2, day 1 up to 21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from cycle 2, day 1 up to 21 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 more
Secondary study objectives
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 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
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
671 Previous Clinical Trials
385,134 Total Patients Enrolled
3 Trials studying Ovarian Cancer
928 Patients Enrolled for Ovarian Cancer
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
284 Previous Clinical Trials
254,227 Total Patients Enrolled
1 Trials studying Ovarian Cancer
612 Patients Enrolled for Ovarian Cancer

Media Library

Cemiplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03564340 — Phase 1 & 2
Ovarian Cancer Research Study Groups: Combination Therapy, Monotherapy
Ovarian Cancer Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT03564340 — Phase 1 & 2
Cemiplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03564340 — Phase 1 & 2
~128 spots leftby Jun 2026
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