Brief Title
Study of REGN5668 Administered in Combination With Cemiplimab or REGN4018 in Adult Women With Recurrent Ovarian Cancer.
Official Title
Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific) Administered in Combination With Cemiplimab or REGN4018 (MUC16xCD3)
Brief 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
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Incidence of dose limiting toxicities (DLT)
Secondary Outcome
Concentration of REGN4018 in serum over time
Condition
Ovarian Cancer
Intervention
REGN5668
Study Arms / Comparison Groups
Module 1
Description: REGN5668 and cemiplimab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
290
Start Date
December 9, 2020
Completion Date
February 11, 2026
Primary Completion Date
February 11, 2026
Eligibility Criteria
Key Inclusion Criteria:
1. 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. 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,
archived 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.
3. 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.
4. Has a serum CA-125 level ≥2x ULN (in screening)
5. Has adequate organ and bone marrow function as defined in the protocol
6. Has a life expectancy of at least 3 months
Key Exclusion Criteria:
1. 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
2. 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
3. Prior anti-cancer immunotherapy as defined in the protocol
4. Has received radiation therapy or major surgery within 14 days of first administration
of study drug as defined in the protocol
5. 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
6. Prior treatment with a MUC16-targeted therapy
7. Expansion cohorts only: More than 3 prior lines of cytotoxic chemotherapy for
platinum-experienced and/or intolerant disease
8. 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
9. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that
required treatment with systemic immunosuppressive treatments as defined in the
protocol
10. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease,
or spinal cord compression as defined in the protocol
11. Has encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or
uncontrolled seizures in the year prior to first dose of study drug
12. Has history of clinically significant cardiovascular disease as defined in the
protocol
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Clinical Trial Management, 844-734-6643, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04590326
Organization ID
R5668-ONC-1938
Secondary IDs
2020-000063-23
Responsible Party
Sponsor
Study Sponsor
Regeneron Pharmaceuticals
Study Sponsor
Clinical Trial Management, Study Director, Regeneron Pharmaceuticals
Verification Date
July 2021