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Monoclonal Antibodies

REGN5668 + Cemiplimab/REGN4018 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

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 5 years

Awards & highlights

Study Summary

This trial is testing the safety and efficacy of two drugs, REGN5668 and cemiplimab, in combination with each other or with another drug, REGN4018. The primary objective is to assess the safety and tolerability of the combinations and to determine the maximally tolerated dose. The secondary objectives are to assess the preliminary efficacy of the combinations and to characterize the safety profile and pharmacokinetics of the combinations.

Who is the study for?

This trial is for adult women with advanced ovarian, fallopian tube, or peritoneal cancer who've had at least one platinum-based therapy. They should have a life expectancy of over 3 months, good organ and bone marrow function, and higher than normal CA-125 levels. Exclusions include ongoing steroid use, recent anti-cancer immunotherapy or MUC16-targeted therapy, more than three prior chemo treatments for certain conditions (expansion phase), significant autoimmune disease requiring treatment within the last 5 years, active brain tumors/CNS metastases/spinal cord compression, or serious heart disease.Check my eligibility

What is being tested?

The study tests REGN5668 alone and in combination with either cemiplimab or REGN4018 to find safe dosages (Dose Escalation Phase) and to evaluate preliminary effectiveness based on tumor response rates (Dose Expansion Phase). It also examines safety profiles, pharmacokinetics (how the body processes the drugs), changes in CA-125 levels after treatment with these combinations.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones associated with cancer immunotherapies like those being tested may include fatigue; reactions at injection site; flu-like symptoms such as fever and chills; nausea; diarrhea; skin rash; potential risk of immune-related adverse events due to activation of the body's immune system which can affect organs.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I have ovarian, peritoneal, or fallopian tube cancer and have been treated with platinum-based therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Concentrations of REGN5668 in serum when dosed alone and in combination with cemiplimab or REGN4018

Incidence of DLTs

Incidence of deaths

+5 more

Secondary outcome measures

BOR based on RECIST 1.1 and iRECIST

CA-125 change from baseline after treatment with REGN5668 in combinations with cemiplimab or REGN4018 (separately by cohort and combination)

Concentration of REGN4018 in serum over time

+8 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Anaemia

20%

Nausea

17%

Fatigue

16%

Vomiting

15%

Decreased appetite

15%

Constipation

11%

Asthenia

11%

Back pain

11%

Pyrexia

11%

Diarrhoea

10%

Arthralgia

Urinary tract infection

Dyspnoea

Abdominal pain

Cough

Oedema peripheral

Hypoalbuminaemia

Headache

Pain in extremity

Rash

Blood creatinine increased

Insomnia

Hypokalaemia

Hypothyroidism

Pruritus

Vaginal haemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Pelvic pain

Stomatitis

Neutropenia

Acute kidney injury

Immune-mediated hepatitis

Autoimmune hepatitis

Febrile neutropenia

Pneumonia

Pyelonephritis

Thrombocytopenia

Neutrophil count decreased

Pyelonephritis acute

White blood cell count decreased

Sepsis

Duodenal ulcer

Haematuria

Hydronephrosis

Hyperpyrexia

Kidney infection

Pneumonitis

Hyperglycaemia

100%

80%

60%

40%

20%

Study treatment Arm

Cemiplimab

Investigator Choice (IC) Chemotherapy

Trial Design

2Treatment groups

Experimental Treatment

Group I: Module 2Experimental Treatment3 Interventions

REGN5668 and REGN4018

Group II: Module 1Experimental Treatment2 Interventions

REGN5668 and cemiplimab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

Sarilumab

2020

Completed Phase 3

~5980

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

619 Previous Clinical Trials

379,643 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

261 Previous Clinical Trials

250,452 Total Patients Enrolled

Media Library

Cemiplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04590326 — Phase 1 & 2

Endometrial Cancer Research Study Groups: Module 1, Module 2

Endometrial Cancer Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT04590326 — Phase 1 & 2

Cemiplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04590326 — 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 are the most important goals of this research?

"As specified by the trial's sponsor, Regeneron Pharmaceuticals, the primary outcome will be monitored over a maximum of 62 weeks and is defined as the Incidence of deaths. Additionally, this clinical study will track ORR, DCR, and PFS as secondary outcomes. These latter metrics are based on iRECIST and RECIST 1.1 respectively; both measurements will occur during the Dose escalation and expansion phases."

Answered by AI

Could you please list other studies that have used REGN5668?

"At present, there are fifty-six ongoing investigations into REGN5668 with 4 trials in the third stage. The majority of clinical research for REGN5668 is taking place in Barcelona and California; however, there are 1,738 sites running studies related to REGN5668."

Answered by AI

For what purpose is REGN5668 most commonly prescribed?

"The alk gene mutation is most commonly treated with REGN5668. However, this medication is also useful for other conditions such as advance directives, malignant neoplasms, and metastatic cutaneous squamous cell carcinoma."

Answered by AI

How many people are qualifying for this research project?

"A total of 326 volunteers are needed to complete this clinical trial. If you meet the specified inclusion criteria, you may be able to participate at locations such as the Regeneron Research Site in Chicago, Illinois or Northwestern Memorial Hospital in Columbus, Ohio."

Answered by AI

Are there any slots left for new participants in this experiment?

"That is accurate, the information available on clinicaltrials.gov does show that this trial is still recruiting patients. This specific trial was posted on December 9th 2020 and edited September 26th 2022. They are looking for a total of 326 participants at 15 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial to Find Out How Safe REGN5668 is and How Well it Works When Given With Either Cemiplimab or REGN4018

2020. "A Trial to Find Out How Safe REGN5668 is and How Well it Works When Given With Either Cemiplimab or REGN4018". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04590326.

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