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Completed

NCT Number: NCT03005782

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

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).

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Key information

Conditions

Malignancies Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The University of Western Australia - The Queen Elizabeth II Medical Centre (QEIIMC) - Sir Charles Gairdner Hospital (SCGH), Perth, Western Australia, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REGN3767

Drug

Other names: fianlimab

cemiplimab

Drug

Other names: REGN2810

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Dec 29, 2016
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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