Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Patients With Platinum-Resistant Ovarian Cancer



Status:Recruiting
Conditions:Ovarian Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/11/2018
Start Date:May 21, 2018
End Date:May 5, 2022
Contact:Clinical Trails Administrator
Email:clinicaltrials@regeneron.com
Phone:844-734-6643

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A Phase 1/2 Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Patients With Platinum-Resistant Ovarian Cancer

The primary objectives of the Dose Escalation Phase are 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, the primary objectives are 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). The secondary objectives of the Dose
Escalation Phase are to assess the preliminary efficacy of REGN4018 as monotherapy and in
combination with cemiplimab (separately by cohort) as determined by ORR.

In the Dose Expansion Phase, the secondary objectives are to characterize the safety profile
in each expansion cohort and characterize the PK of REGN4018 as monotherapy and in
combination with cemiplimab.

In both the Dose Escalation and Dose Expansion Phases, secondary objectives are 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, and progression-free survival (PFS) and to
assess efficacy of REGN4018 as monotherapy and in combination with cemiplimab as measured by
CA-125 level.


Key Inclusion Criteria:

1. Patients with histologically or cytologically confirmed diagnosis of advanced,
epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian
tube cancer who have all of the following:

1. serum CA-125 level ≥2x upper limit of normal (ULN) (in screening)

2. progression or relapse during or within 6 months of the most recent treatment
with a platinum-containing chemotherapy regimen

3. documented progression on the most recent line of therapy

4. no standard therapy options

2. Adequate organ and bone marrow function

3. Adequately controlled blood pressure

4. Life expectancy of at least 3 months

Key Exclusion Criteria:

1. Recent treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy

2. No more than 3 prior lines of cytotoxic chemotherapy for platinum-resistant disease

3. Prior treatment with idelalisib (excluded from cemiplimab combination cohorts only)

4. Prior treatment with a Mucin 16 (MUC16)-targeted therapy (excluded from expansion
cohorts only)

5. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or
spinal cord compression

6. History of clinically significant cardiac disease

Note: Other protocol Inclusion/Exclusion Criteria apply
We found this trial at
6
sites
Oklahoma City, Oklahoma
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Oklahoma City, OK
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Boston, Massachusetts
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Boston, MA
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Buffalo, New York 14263
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Buffalo, NY
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Columbus, Ohio
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Columbus, OH
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Nashville, Tennessee
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Nashville, TN
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New York, New York
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New York, NY
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