Clinical Trials /

PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

NCT03132636

Description:

The primary objective is to estimate the objective response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with cemiplimab as a monotherapy

Related Conditions:
  • Basal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
  • Official Title: A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1, in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

Clinical Trial IDs

  • ORG STUDY ID: R2810-ONC-1620
  • SECONDARY ID: 2016-003122-16
  • NCT ID: NCT03132636

Conditions

  • Carcinoma, Basal Cell

Interventions

DrugSynonymsArms
REGN2810Group 1- metastatic BCC

Purpose

The primary objective is to estimate the overall response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with REGN2810 as a monotherapy

Trial Arms

NameTypeDescriptionInterventions
Group 1- metastatic BCCExperimentalAdministration of REGN2810 in accordance with protocol dosing regimen
  • REGN2810
Group 2 - unresectable locally advanced BCCExperimentalAdministration of REGN2810 in accordance with protocol dosing regimen
  • REGN2810

Eligibility Criteria

        Key Inclusion Criteria:

          -  Confirmed diagnosis of invasive BCC

          -  Progression of disease on hedgehog inhibitor (HHI) therapy or intolerance of prior HHI
             therapy

          -  At least 1 measurable lesion

          -  ≥18 years of age

          -  Hepatic function, renal function, bone marrow function in defined lab-value-ranges

          -  Anticipated life expectancy >12 weeks

          -  Consent to provide archived tumor biopsy material (all patients)

          -  Group 2: consent to undergo research biopsies

          -  Group 2: must not be a candidate for radiation therapy or surgery

          -  Comply with study procedures and site visits

          -  Sign Subject Information Sheet and Informed Consent Form

        Key Exclusion Criteria:

          -  Ongoing or recent significant autoimmune disease

          -  Prior treatment with specific pathway-blockers (PD-1/PD-L1)

          -  Prior treatment with immune-modulating agents within 28 days before REGN2810

          -  Untreated brain metastasis that may be considered active

          -  Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to
             treatment with REGN2810

          -  Active infections requiring therapy, including HIV, hepatitis

          -  Pneumonitis within the last 5 years

          -  Cancer treatment other than radiation therapy, including investigational or standard
             of care, within 30 days prior to treatment with REGN2810

          -  Documented allergic reactions or similar to antibody treatments

          -  Concurrent malignancies other than BCC, other than those with negligible risk of
             metastases or death

          -  Any acute or chronic psychiatric problems

          -  Having received a solid organ transplantation

          -  Inability to undergo contrast radiological assessments

          -  Breastfeeding, pregnant, women of childbearing potential not using contraception

        Note: Other protocol-defined inclusion/exclusion criteria apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate (ORR) for metastatic Basal Cell Carcinoma (BCC)
Time Frame:Baseline to 93 weeks
Safety Issue:
Description:ORR for metastatic BCC measured by RECIST version 1.1

Secondary Outcome Measures

Measure:Duration of Response (DOR)
Time Frame:Time from the first observed confirmed response to disease progression or death, up to approximately 121 weeks
Safety Issue:
Description:DOR assessed by time from the first observed confirmed response (CR or PR) to disease progression or death, up to approximately 121 weeks (from first response assessment until end of post-treatment follow up)
Measure:Complete Response (CR) Rate
Time Frame:From date of treatment until best overall response of CR after starting REGN2810, up to approximately 121 weeks
Safety Issue:
Description:CR rate (per central review) assessed from date of treatment until best overall response of CR after starting REGN2810 treatment, up to approximately 121 weeks (from first response assessment until end of post-treatment follow up).
Measure:Progression Free Survival (PFS)
Time Frame:From date of treatment until date of death up to approximately 121 weeks
Safety Issue:
Description:PFS assessed from date of treatment until date of death, up to approximately 121 weeks
Measure:Overall Survival (OS)
Time Frame:From date of treatment until date of death, up to approximately 121 weeks
Safety Issue:
Description:OS assessed from date of treatment until date of death, up to approximately 121 weeks
Measure:Change in scores of patient-reported outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame:From date of treatment until date of first documented progression or date of death, up to approximately 93 weeks
Safety Issue:
Description:Change in scores of patient-reported outcomes in EORTC QLQ-C30 assessed from date of treatment until date of first documented progression or date of death, up to approximately 93 weeks
Measure:Change in scores of patient-reported outcomes in Skindex-16
Time Frame:From date of treatment until date of first documented progression or date of death, up to approximately 93 weeks
Safety Issue:
Description:From date of treatment until date of first documented progression or date of death, assessed up to approximately 93 weeks
Measure:Incidence of treatment emergent adverse events (TEAEs)
Time Frame:Up to week 121
Safety Issue:
Description:
Measure:Concentration at end of infusion (Ceoi)
Time Frame:Up to week 121
Safety Issue:
Description:
Measure:Pre-infusion concentration (Ctrough)
Time Frame:Up to week 121
Safety Issue:
Description:
Measure:Time of end of infusion (teoi)
Time Frame:Up to week 121
Safety Issue:
Description:
Measure:Anti-REGN2810 antibodies
Time Frame:Up to week 121
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Regeneron Pharmaceuticals

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