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).
Eligible Conditions
- Recurrent Ovarian Cancer
- Recurrent Primary Peritoneal Cancer
- Recurrent Fallopian Tube Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
7 Primary · 52 Secondary · Reporting Duration: From Cycle 2, Day 1 up to 21 days
Week 62
Change from baseline in QoL as measured by EQ-5D for REGN4018 monotherapy
Change from baseline in QoL as measured by EQ-5D for REGN4018 with cemiplimab
Change from baseline in abdominal symptoms as measured by the Measure of Ovarian Symptoms and Treatment (MOST)-Abdominal index score for REGN4018 monotherapy
Change from baseline in abdominal symptoms as measured by the Measure of Ovarian Symptoms and Treatment (MOST)-Abdominal index score for REGN4018 with cemiplimab
Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for REGN4018 monotherapy
Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for REGN4018 with cemiplimab
Change from baseline in quality of life (QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS/QoL score for REGN4018 monotherapy
Change from baseline in quality of life (QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS/QoL score for REGN4018 with cemiplimab
Day 35
Number of participants with Dose-limiting toxicity (DLTs) for REGN4018 monotherapy
Day 21
Number of participants with DLTs for REGN4018 with cemiplimab
Up to 62 weeks
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
Best overall response (BOR) based on RECIST 1.1 for REGN4018 monotherapy
CA-125 response for REGN4018 with cemiplimab
CR rate based on RECIST 1.1 for REGN4018 with cemiplimab
CR rate based on iRECIST 1.1 for REGN4018 monotherapy
CR rate based on iRECIST 1.1 for REGN4018 with cemiplimab
Cancer antigen-125 (CA-125) response for REGN4018 monotherapy
Complete response (CR) rate based on RECIST 1.1 for REGN4018 monotherapy
Concentration of REGN4018 in serum over time for REGN4018 monotherapy
Concentration of REGN4018 in serum over time for REGN4018 with cemiplimab
DOR based on RECIST 1.1 for REGN4018 with cemiplimab
DOR based on iRECIST for REGN4018 monotherapy
DOR based on iRECIST for REGN4018 with cemiplimab
Disease control rate based on RECIST 1.1 for REGN4018 monotherapy
Disease control rate based on RECIST 1.1 for REGN4018 with cemiplimab
Disease control rate based on iRECIST for REGN4018 monotherapy
Disease control rate based on iRECIST for REGN4018 with cemiplimab
Duration of response (DOR) based on RECIST 1.1 for REGN4018 monotherapy
Number of deaths for REGN4018 monotherapy
Number of deaths for REGN4018 with cemiplimab
Number of participants with SAEs for REGN4018 monotherapy
Number of participants with SAEs for REGN4018 with cemiplimab
Number of participants with TEAEs (including irAEs) for REGN4018 monotherapy
Number of participants with TEAEs (including irAEs) for REGN4018 with cemiplimab
Number of participants with Treatment-emergent adverse event (TEAE)s (including immune-related adverse events (irAEs)) for REGN4018 monotherapy
Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for REGN4018 monotherapy
Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for REGN4018 with cemiplimab
Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) for REGN4018 monotherapy
Number of participants with serious adverse events (SAEs) for REGN4018 monotherapy
ORR based on RECIST 1.1 (Eisenhauer 2009) for REGN4018 monotherapy
ORR based on RECIST 1.1 for REGN4018 with cemiplimab
ORR based on iRECIST (Seymour 2017) for REGN4018 monotherapy
ORR based on iRECIST for REGN4018 with cemiplimab
ORR defined by RECIST 1.1 for REGN4018 with cemiplimab
Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Eisenhauer 2009) for REGN4018 monotherapy
PFS based on RECIST 1.1 for REGN4018 with cemiplimab
PFS based on iRECIST for REGN4018 monotherapy
PFS based on iRECIST for REGN4018 with cemiplimab
Presence or absence of anti-drug antibodies against REGN4018
Presence or absence of anti-drug antibodies against cemiplimab
Progression-free survival (PFS) based on RECIST 1.1 for REGN4018 monotherapy
Time to deterioration in GHS/QoL for REGN4018 monotherapy
Time to deterioration in GHS/QoL for REGN4018 with cemiplimab
Time to deterioration in abdominal symptoms for REGN4018 monotherapy
Time to deterioration in abdominal symptoms for REGN4018 with cemiplimab
Time to deterioration in physical functioning for REGN4018 monotherapy
Time to deterioration in physical functioning for REGN4018 with cemiplimab
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Combination Therapy
1 of 2
Monotherapy
1 of 2
Experimental Treatment
554 Total Participants · 2 Treatment Groups
Primary Treatment: REGN4018 · No Placebo Group · Phase 1 & 2
Combination TherapyExperimental Group · 2 Interventions: REGN4018, cemiplimab · Intervention Types: Drug, Drug
Monotherapy
Drug
Experimental Group · 1 Intervention: REGN4018 · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from cycle 2, day 1 up to 21 days
Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
549 Previous Clinical Trials
199,860 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
229 Previous Clinical Trials
88,336 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Female Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a serum CA-125 level ≥2x ULN.
You have received at least 1 line of platinum-containing therapy.
You have had a relapse or progression on or after the most recent line of therapy.
You have adequate organ and bone marrow function as defined in the protocol.
You have had platinum-based therapy prior to enrollment in this study
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Conditions
Cancer Related
Treatments