Ovarian Cancer Clinical Trial

Study of REGN5668 Administered in Combination With Cemiplimab or REGN4018 in Adult Women With Recurrent Ovarian Cancer

Summary

The primary objectives of the study are:

In the Dose Escalation Phase:

To assess the safety, tolerability, and pharmacokinetics (PK) of REGN5668 alone and in separate combinations with cemiplimab or REGN4018, in order to determine a maximally tolerated dose(s) (MTD) or recommended phase 2 dose(s) (RP2D) of these combinations

In the Dose Expansion Phase:

To assess the preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018, (separately by cohort and combination) as determined by the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

The secondary objectives of the study are:

In the Dose Escalation Phase:

To assess the preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018 (separately by cohort and combination) 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 REGN5668 in combination with cemiplimab or REGN4018 (separately by cohort and combination)

In both the Dose Escalation and Dose Expansion Phases:

To assess preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018 (separately by cohort and combination) as measured by ORR based on immune based therapy RECIST (iRECIST), best overall response (BOR), duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS) based on RECIST 1.1 and iRECIST
To assess changes in CA-125 levels from baseline after treatment with REGN5668 in combinations with cemiplimab or REGN4018 (separately by cohort and combination)
Immunogenicity of REGN5668, alone and in combinations with cemiplimab or REGN4018

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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
In dose escalation, patients will provide either newly obtained biopsy (newly obtained biopsies at screening are required unless medically inappropriate and discussed with medical monitor. If fresh biopsies are not appropriate, and after sponsor approval, archival tumor tissue in dose escalation is acceptable. In dose expansion, patients will provide a fresh tumor biopsy in screening and on treatment. Hence, in expansion cohorts, only patients who (in the opinion of the investigator) have accessible lesions that can be biopsied without significant risk to the patient are eligible.
Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1. Tumor lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after radiation.
Has a serum CA-125 level ≥2x ULN (in screening)
Has adequate organ and bone marrow function as defined in the protocol
Has a life expectancy of at least 3 months

Key Exclusion Criteria:

Has participated in a study of an investigational agent (except biologics and/or immunotherapy) or an investigational device within 4 weeks of first dose of study drug
Has received treatment with an approved systemic therapy (except biologics and/or immunotherapy) within 3 weeks or has not yet recovered as defined in the protocol
Prior anti-cancer immunotherapy as defined in the protocol
Has received radiation therapy or major surgery within 14 days of first administration of study drug as defined in the protocol
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
Prior treatment with a MUC16-targeted therapy
Expansion cohorts only: More than 3 prior lines of cytotoxic chemotherapy for platinum-experienced and/or intolerant disease
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
Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
Has encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study drug
Has history of clinically significant cardiovascular disease as defined in the protocol

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

326

Study ID:

NCT04590326

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

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There are 8 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
H. Lee Moffitt Cancer Center
Tampa Florida, 33612, United States
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
The Ohio State University Wexner Medical Center
Columbus Ohio, 43210, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

326

Study ID:

NCT04590326

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

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