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Trial record 3 of 54 for:    regeneron | Open Studies

Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Regeneron Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03005782
First received: November 18, 2016
Last updated: February 9, 2017
Last verified: February 2017
  Purpose
In dose escalation: safety and PK In dose expansion: response rate

Condition Intervention Phase
Malignancies
Drug: REGN3767
Drug: REGN2810
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Rate of dose limiting toxicities (Dose Escalation Phase) [ Time Frame: Baseline to 28 days ]
  • Rate of adverse events (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  • Rate of serious adverse events (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  • Occurrence of death (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  • 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 ]
  • Maximum Plasma Concentration [Cmax] (Dose Escalation Phase) [ Time Frame: Baseline to week 51 ]
  • Area Under the Curve [AUC] (Dose Escalation Phase) [ Time Frame: Baseline to week 51 ]
  • Objective response rate based on RECIST 1.1 for Solid Tumors (Dose Expansion phase) [ Time Frame: Baseline to 51 weeks ]
  • Objective response rate by Lugano criteria for Lymphoma (Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]

Secondary Outcome Measures:
  • Objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (solid tumors) (Dose Escalation Phase) [ Time Frame: Baseline to week 51 ]
  • Objective response rate per Lugano criteria (lymphomas) (Dose Escalation Phase) [ Time Frame: Baseline to week 51 ]
  • Best overall response based on RECIST 1.1 criteria (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  • Best overall response based on irRECIST criteria (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  • Best overall response based on Lugano criteria (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  • Duration of response based on RECIST criteria (Dose Escalation Phase) [ Time Frame: Baseline to week 51 ]
  • Duration of response based on irRECIST criteria (Dose Escalation Phase) [ Time Frame: Baseline to week 51 ]
  • Duration of response based on Lugano criteria (Dose Escalation Phase) [ Time Frame: Baseline to week 51 ]
  • Disease control rate based on RECIST criteria (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  • Disease control rate based on irRECIST criteria (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  • Disease control rate based on Lugano criteria (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  • Progression free survival based on RECIST (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  • Progression free survival based on irRECIST (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  • Progression free survival based on Lugano criteria (Dose Escalation Phase) [ Time Frame: Baseline to 51 weeks ]
  • Incidence of adverse events (Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  • Incidence of serious adverse events (Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  • 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 ]
  • 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 ]
  • Maximum Plasma Concentration [Cmax] (Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  • Area Under the Curve [AUC] (Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]
  • Incidence of anti-drug antibodies (Dose Escalation Phase and Dose Expansion Phase) [ Time Frame: Baseline to 51 weeks ]

Estimated Enrollment: 283
Study Start Date: November 2016
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: REGN3767
Group A will consist of up to 3 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition one tumor-specific cohort will be treated at the recommended phase 2 dose (RP2D) during dose expansion.
Drug: REGN3767
Experimental: REGN3767 + REGN2810
Group B will consist of up to 3 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: REGN2810

  Eligibility

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

Inclusion Criteria:

  • Men and women ≥18 years of age
  • 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03005782

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, Michigan
Recruiting
Grand Rapids, Michigan, United States
United States, Texas
Recruiting
San Antonio, Texas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03005782     History of Changes
Other Study ID Numbers: R3767-ONC-1613
2016-002789-30 ( EudraCT Number )
Study First Received: November 18, 2016
Last Updated: February 9, 2017

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on March 22, 2017