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Study of Cemiplimab and REGN1979 in Patients With Lymphoma

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02651662
Recruitment Status : Active, not recruiting
First Posted : January 11, 2016
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 5, 2016
First Posted Date  ICMJE January 11, 2016
Last Update Posted Date August 4, 2020
Actual Study Start Date  ICMJE January 11, 2016
Estimated Primary Completion Date October 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Up to 18 months ]
TEAEs include abnormal laboratory findings and dose limiting toxicities (DLTs)
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Baseline to Week 72 (End of study) ]
TEAEs include abnormal laboratory findings and dose limiting toxicities (DLTs)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2019)
  • Pharmacokinetics (PK) of cemiplimab when given alone, and of cemiplimab and REGN1979 when given in combination [ Time Frame: Up to 18 months ]
    PK variables of cemiplimab may include, but are not limited to, the following: Area under the concentration-time curve (AUC) over a dosing interval, the peak concentration and last positive (quantifiable) concentration
  • Antitumor activity (includes response evaluation per Cheson and Lugano criteria) [ Time Frame: Up to 18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
  • Pharmacokinetics (PK) of REGN2810 [ Time Frame: Baseline to Week 72 (End of study) ]
    PK variables of REGN2810 may include, but are not limited to, the following: Area under the concentration-time curve (AUC) over a dosing interval, the peak concentration and last positive (quantifiable) concentration
  • Immunogenicity (anti-REGN2810 antibodies) [ Time Frame: Baseline to Week 72 ]
  • Antitumor activity (includes response evaluation per Cheson criteria) [ Time Frame: Baseline to Week 72 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Cemiplimab and REGN1979 in Patients With Lymphoma
Official Title  ICMJE A Phase 1 Study to Assess Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, and REGN2810, an Anti-Programmed Death-1 Monoclonal Antibody, in Patients With B-Cell Malignancies
Brief Summary

This is an open-label, multicenter, dose escalation study of cemiplimab and REGN1979 in patients with lymphoma. The study treatment period will be from 6 to 12 months, depending on how an individual patient responds to treatment. The follow-up period will be 6 months for all patients.

The primary objective of the study is to assess safety, tolerability and dose-limiting toxicity (DLT) of:

  • Single-agent cemiplimab in patients with lymphoma (B-NHL and HL)
  • Combination REGN1979 and cemiplimab in patients with B-NHL

The secondary objectives of the study are:

  • To determine a recommended dose for:
  • Cemiplimab as a single-agent in patients with lymphoma (B-NHL and HL)
  • REGN1979 and cemiplimab administered in combination in patients with B-NHL
  • To characterize the pharmacokinetic (PK) profile of cemiplimab when administered as a single agent and of cemiplimab and REGN1979 when administered in combination
  • To assess the immunogenicity of cemiplimab when administered alone and the immunogenicity of cemiplimab and REGN1979 when administered in combination
  • To study the preliminary antitumor activity of cemiplimab as a single agent and of the combination of cemiplimab and REGN1979 in specific indications, as measured by overall response rate, MRD in patients with bone marrow disease at baseline, duration of response, and median progression-free survival and rates at 6 and 12 months
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Drug: cemiplimab
    Multiple dose levels administered IV Q2W
    Other Names:
    • REGN2810
    • Libtayo
  • Drug: REGN1979
    Single dose level of cemiplimab and multiple dose levels of REGN1979 administered IV
Study Arms  ICMJE
  • Experimental: Open label (cemiplimab)
    Experimental cohorts will consist of multiple dose levels of cemiplimab administered intravenously (IV) every 2 weeks (Q2W)
    Intervention: Drug: cemiplimab
  • Experimental: Open label (cemiplimab and REGN1979)
    Experimental cohorts will consist of a single dose level of cemiplimab administered intravenously (IV) and multiple dose levels of REGN1979 administered intravenously (IV)
    Interventions:
    • Drug: cemiplimab
    • Drug: REGN1979
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2018)
172
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2016)
72
Estimated Study Completion Date  ICMJE October 11, 2021
Estimated Primary Completion Date October 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria [(Non-Hodgkin Lymphoma (NHL) and Hodgkin Lymphoma (HL)]:

  1. Have documented CD20+ B-cell NHL or documented HL, with active disease that is either not responsive to or relapsed after prior therapy, for whom no standard of care options exists.
  2. Must have at least 1 bi-dimensionally measurable lesion (≥1.5 cm) documented by diagnostic imaging (CT, PET-CT or MRI).
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  4. Life expectancy of at least 6 months
  5. Adequate bone marrow function
  6. Adequate organ function
  7. Willing and able to comply with clinic visits and study-related procedures
  8. Provide signed informed consent

Key Exclusion Criteria (NHL and HL):

  1. Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement by nonprimary CNS NHL
  2. History of or current relevant CNS pathology
  3. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for iAEs
  4. Prior allogeneic stem cell transplantation
  5. Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway), unless benefit was demonstrated
  6. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or other uncontrolled infection
  7. History of hypersensitivity to any compound in the tetracycline antibiotics group
  8. Known hypersensitivity to both allopurinol and rasburicase
  9. Pregnant or breastfeeding women
  10. Continued sexual activity in men or women of childbearing potential who are unwilling to practice adequate contraception during the study
  11. Prior treatment with idelalisib

Note: Other protocol Inclusion/Exclusion criteria apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02651662
Other Study ID Numbers  ICMJE R1979-ONC-1504
2015-001697-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 May 2020

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