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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 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
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
628 Previous Clinical Trials
381,143 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
266 Previous Clinical Trials
251,700 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
~274 spots leftby Apr 2027
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