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

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Endometrial Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: REGN5668; Drug: Cemiplimab; Drug: REGN4018; Drug: Sarilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04590326

R5668-ONC-1938

2022-501904-83-00 (Other Identifier)

Details and patient eligibility

About

This study is researching an investigational drug called REGN5668. Participants will receive additional investigational drugs in combination with REGN5668. These additional drugs include cemiplimab or REGN4018 (with or without sarilumab).

The main purposes of this study are to:

• Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus
• Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus

This study has 2 parts. The purpose of Part 1 (Escalation) to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2.

The study is looking at several other research questions, including:

• Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab or REGN4018
• How REGN5668 works in the body either alone and/or in combination with cemiplimab or REGN4018
• How much of the study drugs (REGN5668, cemiplimab, REGN4018) are in the blood
• To see if REGN5668 in combination with cemiplimab or REGN4018 works to treat cancer
• To find out how safe, tolerable, and effective in mitigating Cytokine Release Syndrome (CRS) sarilumab pretreatment is when given before REGN4018

Enrollment: 612 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Ovarian Cancer Cohorts Only: 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
2. Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol.
3. Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts)
4. Has adequate organ and bone marrow function as defined in the protocol
5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Has a life expectancy of at least 3 months
7. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol

Key Exclusion Criteria:

1. Prior anti-cancer immunotherapy as defined in the protocol
2. Recent treatment with anti-Programmed Cell Death (PD-1)/PDL-1 therapy
3. Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol
4. Prior treatment with a MUC16-targeted therapy
5. Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (including antibody drug conjugates)
6. Has any condition that requires ongoing/continuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug
7. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
8. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
9. Has history of clinically significant cardiovascular disease as defined in the protocol
10. Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s).

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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612 participants in 2 patient groups

Module 1

Experimental group

Description:

REGN5668 and cemiplimab

Treatment:

Drug: Cemiplimab

Drug: REGN5668

Module 2

Experimental group

Description:

REGN5668 and REGN4018

Treatment:

Drug: Sarilumab

Drug: REGN4018

Drug: REGN5668