Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer
Status:
Recruiting
Trial end date:
2024-06-05
Target enrollment:
Participant gender:
Summary
Primary Objectives
In the Dose Escalation Phase:
• To assess the safety and pharmacokinetics (PK) in order to determine a maximally tolerated
dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination
with cemiplimab.
In the Dose Expansion Phase:
• To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with
cemiplimab, (separately by cohort) as determined by the objective response rate (ORR) by
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Secondary Objectives
In the Dose Escalation Phase:
• To assess the preliminary efficacy of REGN4018 as monotherapy and in combination with
cemiplimab (separately by cohort) as determined by ORR by RECIST 1.1
In the Dose Expansion Phase:
- To characterize the safety profile in each expansion cohort
- To characterize the PK of REGN4018 as monotherapy and in combination with cemiplimab.
- To assess the effects of REGN4018 as monotherapy and in combination with cemiplimab on
patient-reported outcomes (PROs), including health-related quality of life (HRQoL),
functioning, and symptoms
In both the Dose Escalation and Dose Expansion Phases:
- To assess preliminary efficacy of REGN4018 as monotherapy and in combination with
cemiplimab (separately by cohort) as measured by ORR based on iRECIST, best overall
response (BOR), duration of response (DOR), disease control rate, complete response (CR)
rate and progression-free survival (PFS) based on RECIST 1.1 and iRECIST
- To assess efficacy of REGN4018 as monotherapy and in combination with cemiplimab as
measured by CA-125 level.
- Immunogenicity of REGN4018 and cemiplimab