Clinical Trials /

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

NCT02383212

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: R2810-ONC-1423
  • NCT ID: NCT02383212

Conditions

  • Advanced Cancer
  • Advanced Malignancies

Interventions

DrugSynonymsArms
REGN2810Monotherapy Cohort
CyclophosphamideDual Combination Cohorts
DocetaxelDual Combination Cohorts
CarboplatinTriple Combination Cohorts
GM-CSFLEUKINE®Triple Combination Cohorts
PaclitaxelTriple Combination Cohorts
PemetrexedTriple Combination Cohorts

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Monotherapy CohortExperimentalREGN2810 will be administered alone
  • REGN2810
Dual Combination CohortsExperimentalDoses 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
  • REGN2810
  • Cyclophosphamide
  • Docetaxel
Triple Combination CohortsExperimentalDoses 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
  • REGN2810
  • Cyclophosphamide
  • Docetaxel
  • Carboplatin
  • GM-CSF
  • Paclitaxel
  • Pemetrexed
Quadruple Combination CohortsExperimentalDoses of REGN2810 will be administered in combination with hypofractionated radiotherapy plus GM-CSF plus Cyclophosphamide
  • REGN2810
  • Cyclophosphamide
  • GM-CSF

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame:Change from baseline to week 48
Safety Issue:
Description:Primary safety variables include incidence and severity of TEAEs, abnormal laboratory findings and number of participants with dose limiting toxicities (DLTs)

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure:Immune-Related Response Criteria (irRC) applied to RECIST measurements
Time Frame:Change from baseline to week 48
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Regeneron Pharmaceuticals

Trial Keywords

  • Advanced cancerous growth

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