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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03005782
Other study ID # R3767-ONC-1613
Secondary ID 2016-002789-30
Status Completed
Phase Phase 1
First received
Last updated
Start date November 7, 2016
Est. completion date April 2, 2024

Study information

Verified date April 2024
Source Regeneron Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objectives in the dose escalation phase are to evaluate safety and pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced malignancies, including lymphoma. The primary objectives in the dose expansion phase are to assess preliminary anti-tumor activity of REGN3767 alone and in combination with cemiplimab (separately by cohort) as measured by objective response rate (ORR).


Recruitment information / eligibility

Status Completed
Enrollment 333
Est. completion date April 2, 2024
Est. primary completion date April 2, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Dose escalation cohorts: Patients with histologically or cytologically confirmed diagnosis of malignancy (including lymphoma) with demonstrated progression of a tumor for whom there is no available therapy likely to convey clinical benefit AND who have not been previously treated with a PD-1/PD-L1 inhibitor. These patients do not require measurable disease - Dose expansion cohorts: Patients with histologically or cytologically confirmed diagnosis of 1 of specified tumors with measurable disease per RECIST 1.1 or Lugano criteria. Some patients may have been previously treated with a PD-1 or PD-L1 inhibitor - Eastern Cooperative Oncology Group performance status of 0 or 1 - Adequate organ and bone marrow function Key Exclusion Criteria: - Prior treatment with any LAG-3 targeting biologic or small molecule - Radiation therapy within 2 weeks prior to randomization and not recovered to baseline from any AE due to radiation - Untreated or active central nervous system metastases - Ongoing or recent (within 5 years) evidence of significant autoimmune disease - Corticosteroid therapy (>10 mg prednisone/day or equivalent) within 1 week prior to the first dose of study drug - Myocardial infarction within 6 months Note: Other protocol defined Inclusion / Exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
REGN3767

cemiplimab


Locations

Country Name City State
Australia Royal Brisbane and Women's Hospital Brisbane
Australia Peter Maccallum Cancer Centre (PMCC) Melbourne
Australia The University of Western Australia - The Queen Elizabeth II Medical Centre (QEIIMC) - Sir Charles Gairdner Hospital (SCGH) Perth Western Australia
Ireland St. Vincents University Hospital Dublin
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
United Kingdom University Of Oxford - Churchill Hospital Headington Oxford
United Kingdom Guy's Hospital London Europe
United States New Mexico Cancer Care Alliance-UNM Cancer Center Albuquerque New Mexico
United States Winship Cancer Institute at Emory University Atlanta Georgia
United States University of Colorado Cancer Center Aurora Colorado
United States Roswell Park Cancer Institute Buffalo New York
United States Hollings Cancer Center - Medical University of South Carolina Charleston South Carolina
United States Levine Cancer Institute Charlotte North Carolina
United States University Hospitals Seidman Cancer Center and Case Western Reserve University Cleveland Ohio
United States Henry Ford Health Hospital Detroit Michigan
United States California Cancer Associates for Research and Excellence Encinitas California
United States Virginia Cancer Care Specialist, PC Fairfax Virginia
United States University of Kansas Clinical Research Center Fairway Kansas
United States California Cancer Associates For Research And Excellence Fresno California
United States Cancer and Hematology Centers of Western Michigan Grand Rapids Michigan
United States John Theurer Cancer Center, Hackensack University Medical Center Hackensack New Jersey
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Dana Farber Cancer Institute Jamaica Plain Massachusetts
United States University of California San Diego (UCSD) La Jolla California
United States Northwell Health-Monter Cancer Center Lake Success New York
United States The Angeles Clinic Los Angeles California
United States Miami Cancer Institute Miami Florida
United States Sarah Cannon Research Institute Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Columbia University New York New York
United States Laura & Isaac Perlmutter Cancer Center New York New York
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Stephenson Cancer Center Oklahoma City Oklahoma
United States Orlando Health, Inc Orlando Florida
United States Rhode Island Hospital Providence Rhode Island
United States University of California Davis Health Systems Sacramento California
United States Washington University in Saint Louis Saint Louis Missouri
United States South Texas Oncology and Hematology San Antonio Texas
United States California Pacific Medical Center (CPMC) San Francisco California
United States Lombardi Comprehensive Cancer Center - MedStar Georgetown University Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Ireland,  Korea, Republic of,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of dose limiting toxicities (Dose Escalation Phase) Baseline to 28 days
Primary Rate of adverse events (Dose Escalation Phase) Baseline to 51 weeks
Primary Rate of serious adverse events (Dose Escalation Phase) Baseline to 51 weeks
Primary Occurrence of death (Dose Escalation Phase) Baseline to 51 weeks
Primary Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Escalation Phase) Baseline to 51 weeks
Primary Area under the curve (AUC) computed from time zero to the time of the last concentration [AUCall] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary AUCall-to-dose ratio [AUCall/Dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary AUC from time zero extrapolated to infinity [AUCinf] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary AUCinf-to-dose ratio [AUCinf/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary AUC computed from time zero to the time of the last positive concentration [AUClast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary AUClast-to-dose ratio [AUClast/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary Clearance [CL] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary Maximum Plasma Concentration [Cmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to week 51
Primary Cmax-to-dose ratio [Cmax/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary Last positive (quantifiable) concentration [Clast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary Mean residence time extrapolated to infinity [MRTinf] (Dose Escalation Phase) Baseline to 51 weeks
Primary Mean residence time when the drug concentration profile is based on values up to and including the last positive concentration [MRTlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary Observed terminal half-life [t1/2] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary t1/2 beta (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary Time of the last positive (quantifiable) concentration [tlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary Time to Cmax [tmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary Volume of distribution at steady state [Vss] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary Volume of distribution of the terminal phase [Vz] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) Baseline to 51 weeks
Primary Objective response rate based on RECIST 1.1 for Solid Tumors (Dose Expansion phase) Baseline to 51 weeks
Primary Objective response rate by Lugano criteria for Lymphoma (Dose Expansion Phase) Baseline to 51 weeks
Secondary Objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (solid tumors) (Dose Escalation Phase) Baseline to week 51
Secondary Objective response rate per Lugano criteria (lymphomas) (Dose Escalation Phase) Baseline to week 51
Secondary Best overall response based on RECIST 1.1 criteria (Dose Escalation Phase) Baseline to 51 weeks
Secondary Best overall response based on irRECIST criteria (Dose Escalation Phase) Baseline to 51 weeks
Secondary Best overall response based on Lugano criteria (Dose Escalation Phase) Baseline to 51 weeks
Secondary Duration of response based on RECIST criteria (Dose Escalation Phase) Baseline to week 51
Secondary Duration of response based on irRECIST criteria (Dose Escalation Phase) Baseline to week 51
Secondary Duration of response based on Lugano criteria (Dose Escalation Phase) Baseline to week 51
Secondary Disease control rate based on RECIST criteria (Dose Escalation Phase) Baseline to 51 weeks
Secondary Disease control rate based on irRECIST criteria (Dose Escalation Phase) Baseline to 51 weeks
Secondary Disease control rate based on Lugano criteria (Dose Escalation Phase) Baseline to 51 weeks
Secondary Progression free survival based on RECIST (Dose Escalation Phase) Baseline to 51 weeks
Secondary Progression free survival based on irRECIST (Dose Escalation Phase) Baseline to 51 weeks
Secondary Progression free survival based on Lugano criteria (Dose Escalation Phase) Baseline to 51 weeks
Secondary Incidence of adverse events (Dose Expansion Phase) Baseline to 51 weeks
Secondary Incidence of serious adverse events (Dose Expansion Phase) Baseline to 51 weeks
Secondary Incidence of death (Dose Expansion Phase) From Baseline to the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 42 months
Secondary Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Expansion Phase) Baseline to 51 weeks
Secondary Incidence of anti-drug antibodies (Dose Escalation Phase and Dose Expansion Phase) Baseline to 51 weeks
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