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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04590326
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 9, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date January 22, 2021
Actual Study Start Date  ICMJE December 9, 2020
Estimated Primary Completion Date February 26, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2020)
  • Incidence of dose limiting toxicities (DLT) [ Time Frame: 42 days ]
    Dose escalation phase, Module 1
  • Incidence of DLTs [ Time Frame: 21 days post combination administration ]
    Dose escalation phase, Module 2
  • Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Through study completion, up to 5 years ]
    Primary: Dose escalation phase Secondary: Dose expansion phase
  • Incidence of serious adverse events (SAEs) [ Time Frame: Through study completion, up to 5 years ]
    Primary: Dose escalation phase Secondary: Dose expansion phase
  • Incidence of deaths [ Time Frame: Through study completion, up to 5 years ]
    Primary: Dose escalation phase Secondary: Dose expansion phase
  • Incidence of laboratory abnormalities (Grade 3 or higher per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0 [v5.0]) [ Time Frame: Through study completion, up to 5 years ]
    Primary: Dose escalation phase Secondary: Dose expansion phase
  • Concentrations of REGN5668 in serum when dosed alone and in combinations with cemiplimab or REGN4018 [ Time Frame: Up to 62 weeks ]
    Primary: Dose escalation phase Secondary: Dose expansion phase
  • ORR defined by RECIST 1.1 (Eisenhauer, 2009) in combination with cemiplimab or REGN4018 (separately by cohort and combination) [ Time Frame: Up to 62 weeks ]
    Primary: Dose expansion phase Secondary: Dose escalation phase
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2020)
  • Concentration of REGN4018 in serum over time [ Time Frame: Up to 62 weeks ]
    Dose expansion phase
  • Concentration of cemiplimab in serum over time [ Time Frame: Up to 62 weeks ]
    Dose expansion phase
  • ORR based on iRECIST [ Time Frame: Up to 62 weeks ]
    Dose escalation and expansion phases
  • BOR based on RECIST 1.1 and iRECIST [ Time Frame: Up to 62 weeks ]
    Dose escalation and expansion phases
  • DOR based on RECIST 1.1 and iRECIST [ Time Frame: Up to 62 weeks ]
    Dose escalation and expansion phases
  • DCR based on RECIST 1.1 and iRECIST [ Time Frame: Up to 62 weeks ]
    Dose escalation and expansion phases
  • PFS based on RECIST 1.1 and iRECIST [ Time Frame: Up to 62 weeks ]
    Dose escalation and expansion phases
  • CA-125 change from baseline after treatment with REGN5668 in combinations with cemiplimab or REGN4018 (separately by cohort and combination) [ Time Frame: Up to 62 weeks ]
    Dose escalation and expansion phases
  • Presence or absence of anti-drug antibodies against REGN5668 [ Time Frame: Up to 62 weeks ]
    Dose escalation and expansion phases
  • Presence or absence of anti-drug antibodies against REGN4018 [ Time Frame: Up to 62 weeks ]
    Dose escalation and expansion phases
  • Presence or absence of anti-drug antibodies against cemiplimab [ Time Frame: Up to 62 weeks ]
    Dose escalation and expansion phases
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of REGN5668 Administered in Combination With Cemiplimab or REGN4018 in Adult Women With Recurrent Ovarian Cancer.
Official Title  ICMJE 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
Intervention  ICMJE
  • Drug: REGN5668
    REGN5668 will be administered by once weekly intravenous (IV) infusion.
  • Drug: Cemiplimab
    For Module 1, after a minimum of a 3-week monotherapy lead-in of REGN5668, cemiplimab will be administered concomitantly every 3 weeks (Q3W) by IV infusion.
    Other Names:
    • REGN2810
    • Libtayo
  • Drug: REGN4018
    For Module 2, a 4-week monotherapy lead-in of REGN4018 will be administered by once weekly IV infusion. After lead-in, REGN5668 and REGN4018 will be administered concomitantly.
Study Arms  ICMJE
  • Experimental: Module 1
    REGN5668 and cemiplimab
    Interventions:
    • Drug: REGN5668
    • Drug: Cemiplimab
  • Experimental: Module 2
    REGN5668 and REGN4018
    Interventions:
    • Drug: REGN5668
    • Drug: REGN4018
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2020)
290
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 26, 2026
Estimated Primary Completion Date February 26, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) or archived tumor tissue. In 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. Expansion cohorts only: 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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04590326
Other Study ID Numbers  ICMJE R5668-ONC-1938
2020-000063-23 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
URL: https://vivli.org/
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP