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Trial record 1 of 1 for:    R3767-ONC-1613
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Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers

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ClinicalTrials.gov Identifier: NCT03005782
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief 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).


Condition or disease Intervention/treatment Phase
Malignancies Drug: REGN3767 Drug: cemiplimab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 589 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (Anti-LAG-3 mAb) Administered Alone or in Combination With REGN2810 (Anti-PD-1 mAb) in Patients With Advanced Malignancies
Actual Study Start Date : November 7, 2016
Estimated Primary Completion Date : March 26, 2021
Estimated Study Completion Date : October 4, 2021

Arm Intervention/treatment
Experimental: Monotherapy (REGN3767)
Group A will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition 1 tumor-specific cohort will be treated at the recommended phase 2 dose (RP2D) during dose expansion.
Drug: REGN3767
Experimental: Combination Therapy (REGN3767+cemiplimab)
Group B will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition, 9 tumor-specific cohorts will be treated at the RP2D during dose expansion
Drug: REGN3767
Drug: cemiplimab
Other Name: REGN2810




Primary Outcome Measures :
  1. Rate of dose limiting toxicities (Dose Escalation Phase) [ Time Frame: Baseline to 28 days ]
  2. Rate of adverse events (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  3. Rate of serious adverse events (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  4. Occurrence of death (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  5. Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  6. 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) [ Time Frame: Baseline to 51 weeks ]
  7. AUCall-to-dose ratio [AUCall/Dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  8. AUC from time zero extrapolated to infinity [AUCinf] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  9. AUCinf-to-dose ratio [AUCinf/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  10. AUC computed from time zero to the time of the last positive concentration [AUClast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  11. AUClast-to-dose ratio [AUClast/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  12. Clearance [CL] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  13. Maximum Plasma Concentration [Cmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to week 51 ]
  14. Cmax-to-dose ratio [Cmax/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  15. Last positive (quantifiable) concentration [Clast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  16. Mean residence time extrapolated to infinity [MRTinf] (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  17. 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) [ Time Frame: Baseline to 51 weeks ]
  18. Observed terminal half-life [t1/2] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  19. t1/2 beta (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  20. Time of the last positive (quantifiable) concentration [tlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  21. Time to Cmax [tmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  22. Volume of distribution at steady state [Vss] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  23. Volume of distribution of the terminal phase [Vz] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  24. Objective response rate based on RECIST 1.1 for Solid Tumors (Dose Expansion phase) [ Time Frame: Baseline to 51 weeks ]
  25. Objective response rate by Lugano criteria for Lymphoma (Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]

Secondary Outcome Measures :
  1. Objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (solid tumors) (Dose Escalation Phase) [ Time Frame: Baseline to week 51 ]
  2. Objective response rate per Lugano criteria (lymphomas) (Dose Escalation Phase) [ Time Frame: Baseline to week 51 ]
  3. Best overall response based on RECIST 1.1 criteria (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  4. Best overall response based on irRECIST criteria (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  5. Best overall response based on Lugano criteria (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  6. Duration of response based on RECIST criteria (Dose Escalation Phase) [ Time Frame: Baseline to week 51 ]
  7. Duration of response based on irRECIST criteria (Dose Escalation Phase) [ Time Frame: Baseline to week 51 ]
  8. Duration of response based on Lugano criteria (Dose Escalation Phase) [ Time Frame: Baseline to week 51 ]
  9. Disease control rate based on RECIST criteria (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  10. Disease control rate based on irRECIST criteria (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  11. Disease control rate based on Lugano criteria (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  12. Progression free survival based on RECIST (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  13. Progression free survival based on irRECIST (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  14. Progression free survival based on Lugano criteria (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  15. Incidence of adverse events (Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  16. Incidence of serious adverse events (Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  17. Incidence of death (Dose Expansion Phase) [ Time Frame: From Baseline to the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 42 months ]
  18. Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  19. Incidence of anti-drug antibodies (Dose Escalation Phase and Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Documented allergic or acute hypersensitivity reaction attributed to antibody treatments

Note: Other protocol defined Inclusion / Exclusion criteria apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005782


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

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Locations
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United States, California
California Cancer Associates for Research and Excellence Recruiting
Encinitas, California, United States, 92024
California Cancer Associates For Research And Excellence Recruiting
Fresno, California, United States, 93720
University of California San Diego (UCSD) Recruiting
La Jolla, California, United States, 92093-0698
The Angeles Clinic Recruiting
Los Angeles, California, United States, 90025
University of California Davis Health Systems Recruiting
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
Lombardi Comprehensive Cancer Center - MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
United States, Kansas
University of Kansas Clinical Research Center Recruiting
Fairway, Kansas, United States, 66205
United States, Michigan
Henry Ford Health Hospital Recruiting
Detroit, Michigan, United States, 48202
Cancer and Hematology Centers of Western Michigan Recruiting
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Washington University in Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
John Theurer Cancer Center, Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
New Mexico Cancer Care Alliance-UNM Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Northwell Health-Monter Cancer Center Recruiting
Lake Success, New York, United States, 11042
Laura & Isaac Perlmutter Cancer Center Recruiting
New York, New York, United States, 10016
Columbia University Recruiting
New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
United States, Ohio
University Hospitals Seidman Cancer Center and Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44087
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
UPMC- Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
Hollings Cancer Center - Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
South Texas Oncology and Hematology Recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Cancer Care Specialist, PC Recruiting
Fairfax, Virginia, United States, 22031
Ireland
St. Vincents University Hospital Recruiting
Dublin, Ireland, D04 T6F4
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
United Kingdom
Guy's Hospital Recruiting
London, Europe, United Kingdom, SE19RT
University Of Oxford - Churchill Hospital Recruiting
Headington, Oxford, United Kingdom, OX37LJ
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03005782     History of Changes
Other Study ID Numbers: R3767-ONC-1613
2016-002789-30 ( EudraCT Number )
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Neoplasms
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents