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Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT02383212
Recruitment Status : Active, not recruiting
First Posted : March 9, 2015
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 2, 2015
First Posted Date  ICMJE March 9, 2015
Last Update Posted Date November 14, 2017
Actual Study Start Date  ICMJE February 2, 2015
Estimated Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Change from baseline to week 48 ]
    Primary safety variables include incidence and severity of TEAEs, abnormal laboratory findings and number of participants with dose limiting toxicities (DLTs)
  • Incidence of abnormal laboratory findings [ Time Frame: Change from baseline to week 48 ]
  • Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Change from baseline to 28 days after first dose of REGN2810 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Change from baseline to week 48 ]
    Primary safety variables include incidence and seveirty of TEAEs, abnormal laboratory findings and number of participants with dose limiting toxicities (DLTs)
  • Incidence of abnormal laboratory findings [ Time Frame: Change from baseline to week 48 ]
  • Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Change from baseline to 28 days after first dose of REGN2810 ]
Change History Complete list of historical versions of study NCT02383212 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • Response Evaluation Criteria in Solid Tumors (RECIST) as measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) [ Time Frame: Change from baseline to week 48 ]
  • Immune-Related Response Criteria (irRC) applied to RECIST measurements [ Time Frame: Change from baseline to week 48 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies
Official Title  ICMJE A First-in-Human Study of Repeat Dosing With REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death - 1 (PD-1), as Single Therapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies
Brief Summary This is a phase 1, open-label, multicenter, ascending-dose escalation study of REGN2810, alone and in combination with other anti-cancer therapies in patients with advanced malignancies.
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
  • Advanced Cancer
  • Advanced Malignancies
Intervention  ICMJE
  • Drug: REGN2810
  • Radiation: Hypofractionated radiotherapy
  • Drug: Cyclophosphamide
  • Drug: Docetaxel
  • Drug: Carboplatin
  • Drug: GM-CSF
    Other Name: LEUKINE®
  • Drug: Paclitaxel
  • Drug: Pemetrexed
Study Arms  ICMJE
  • Experimental: Monotherapy Cohort
    REGN2810 will be administered alone
    Intervention: Drug: REGN2810
  • Experimental: Dual Combination Cohorts

    Doses of REGN2810 will be administered in combination with hypofractionated radiotherapy

    Doses of REGN2810 will be administered in combination with Cyclophosphamide

    Doses of REGN2810 will be administered in combination with Docetaxel

    Interventions:
    • Drug: REGN2810
    • Radiation: Hypofractionated radiotherapy
    • Drug: Cyclophosphamide
    • Drug: Docetaxel
  • Experimental: Triple Combination Cohorts

    Doses of REGN2810 will be administered in combination with hypofractionated radiotherapy plus Cyclophosphamide

    Doses of REGN2810 will be administered in combination with hypofractionated radiotherapy plus GM-CSF

    Doses of REGN2810 will be administered in combination with Carboplatin plus Paclitaxel

    Doses of REGN2810 will be administered in combination with Carboplatin plus Pemetrexed

    Doses of REGN2810 will be administered in combination with Carboplatin plus Docetaxel

    Interventions:
    • Drug: REGN2810
    • Radiation: Hypofractionated radiotherapy
    • Drug: Cyclophosphamide
    • Drug: Docetaxel
    • Drug: Carboplatin
    • Drug: GM-CSF
    • Drug: Paclitaxel
    • Drug: Pemetrexed
  • Experimental: Quadruple Combination Cohorts
    Doses of REGN2810 will be administered in combination with hypofractionated radiotherapy plus GM-CSF plus Cyclophosphamide
    Interventions:
    • Drug: REGN2810
    • Radiation: Hypofractionated radiotherapy
    • Drug: Cyclophosphamide
    • Drug: GM-CSF
Publications *

*   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
Actual Enrollment  ICMJE
 (submitted: September 14, 2017)
398
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2015)
60
Estimated Study Completion Date  ICMJE December 20, 2019
Estimated Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of malignancy with demonstrated progression of a solid tumor (non-lymphoma) with no alternative standard-of-care therapeutic option (certain exceptions may apply).
  2. At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for response assessment (certain exceptions may apply)
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Key Exclusion Criteria:

  1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.
  2. Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway) (certain exceptions may apply)
  3. Prior treatment with other immune modulating agents within fewer than 4 weeks prior to the first dose of REGN2810. Examples of immune modulating agents include blockers of CTLA-4, 4-1BB (CD137), OX-40, therapeutic vaccines, or cytokine treatments.
  4. Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of progression by imaging for at least 6 weeks prior to the first dose of study treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases, and the patient does not require any systemic corticosteroids for management of brain metastases within 4 weeks prior to the first dose of REGN2810 (certain exceptions may apply).
  5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810

The information provided above is not intended to contain all considerations relevant to potential participation in a clinical trial, therefore not all inclusion/ exclusion criteria are listed.

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 Australia,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02383212
Other Study ID Numbers  ICMJE R2810-ONC-1423
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date November 2017

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