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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
Adequate organ and bone marrow function as defined in the protocol
Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from cycle 2, day 1 up to 21 days
Awards & highlights

Study 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 below
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My organs and bone marrow are working well.
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I have been diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer.
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I have no standard treatment options left.
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I have ovarian cancer resistant to platinum therapy, treated with 1-4 platinum-based therapies and a PARP inhibitor or bevacizumab.
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My condition worsened after my last treatment.
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I have had platinum-based treatment or cannot tolerate it.

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

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 more
Secondary 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 more

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
~570

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
615 Previous Clinical Trials
379,157 Total Patients Enrolled
3 Trials studying Ovarian Cancer
999 Patients Enrolled for Ovarian Cancer
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
259 Previous Clinical Trials
250,354 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the most frequent purpose for taking REGN4018?

"REGN4018 is an effective treatment for the alk gene mutation, as well as advance directives and malignant neoplasms."

Answered by AI

What goals does this experiment seek to achieve?

"The main objective of this study, which will last for around 62 weeks, is to assess the number of patients that experience laboratory abnormalities (grade 3 or worse according to CTCAE) as a result of REGN4018 monotherapy. Additionally, the study hopes to gain information on secondary objectives such as DOR based on iRECIST for REGN4018 with cemiplimab in the Dose Escalation and Dose Expansion Phases, the presence or absence of anti-drug antibodies against REGN4018 in the same phases, and changes from baseline in physical functioning as measured by EORTC QLQ"

Answered by AI

Are there any patients still needed for this research?

"Yes, this study is still looking for participants. The listing on clinicaltrials.gov says that the trial was originally posted on 5/21/2018 and was edited as recently as 10/11/2022. Up to 554 people will be accepted at 13 different locations."

Answered by AI

Are there any other research centers conducting this experiment?

"There are 13 hospitals enrolling patients for this study, which include locations in Nashville, Hilliard and Oklahoma City. The other 10 sites are located throughout the country. If you choose to enroll in this study, try to select a hospital near you to limit travel demands."

Answered by AI

How many individuals are participating in this clinical trial?

"In order to carry out this clinical trial, we need 554 patients that fit the bill in terms of our specified inclusion criteria. If you're interested, you may be able to participate from locations such as Sarah Cannon Research Institute in Nashville, Tennessee or The General Hospital Corporation d/b/a Massachusetts General Hospital in Hilliard, Ohio."

Answered by AI

What other scientific papers have been published that mention REGN4018?

"City of Hope first researched REGN4018 in 2010 and, since then, 6 studies have completed. Of the 59 ongoing trials, a considerable number are based in Nashville, Tennessee."

Answered by AI
~185 spots leftby Jun 2026