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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

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ClinicalTrials.gov Identifier: NCT03132636
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 24, 2017
First Posted Date  ICMJE April 28, 2017
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE June 29, 2017
Estimated Primary Completion Date October 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • Overall Response Rate (ORR) for metastatic Basal Cell Carcinoma (BCC) [ Time Frame: Baseline to 93 weeks ]
    ORR for metastatic BCC measured by RECIST version 1.1
  • ORR for unresectable locally advanced BCC [ Time Frame: Baseline to 93 weeks ]
    ORR for unresectable locally advanced BCC measured by Composite Response Criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03132636 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • Duration of Response (DOR) [ Time Frame: Time from the first observed confirmed response to disease progression or death, up to approximately 121 weeks ]
    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)
  • Complete Response (CR) Rate [ Time Frame: From date of treatment until best overall response of CR after starting REGN2810, up to approximately 121 weeks ]
    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).
  • Progression Free Survival (PFS) [ Time Frame: From date of treatment until date of death up to approximately 121 weeks ]
    PFS assessed from date of treatment until date of death, up to approximately 121 weeks
  • Overall Survival (OS) [ Time Frame: From date of treatment until date of death, up to approximately 121 weeks ]
    OS assessed from date of treatment until date of death, up to approximately 121 weeks
  • 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 ]
    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
  • 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 ]
    From date of treatment until date of first documented progression or date of death, assessed up to approximately 93 weeks
  • Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Up to week 121 ]
  • Concentration at end of infusion (Ceoi) [ Time Frame: Up to week 121 ]
  • Pre-infusion concentration (Ctrough) [ Time Frame: Up to week 121 ]
  • Time of end of infusion (teoi) [ Time Frame: Up to week 121 ]
  • Anti-REGN2810 antibodies [ Time Frame: Up to week 121 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • Duration of Response (DOR) [ Time Frame: Time from the first observed confirmed response to disease progression or death, up to approximately 119 weeks ]
    DOR assessed by time from the first observed confirmed response (CR or PR) to disease progression or death, up to approximately 119 weeks (from first response assessment until end of post-treatment follow up)
  • Complete Response (CR) Rate [ Time Frame: From date of treatment until best overall response of CR after starting REGN2810, up to approximately 119 weeks ]
    CR rate (per central review) assessed from date of treatment until best overall response of CR after starting REGN2810 treatment, up to approximately 119 weeks (from first response assessment until end of post-treatment follow up).
  • Progression Free Survival (PFS) [ Time Frame: From date of treatment until date of death up to approximately 119 weeks ]
    PFS assessed from date of treatment until date of death, up to approximately 119 weeks
  • Overall Survival (OS) [ Time Frame: From date of treatment until date of death, up to approximately 119 weeks ]
    OS assessed from date of treatment until date of death, up to approximately 119 weeks
  • 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 ]
    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
  • 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 ]
    From date of treatment until date of first documented progression or date of death, assessed up to approximately 93 weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Basal Cell
Intervention  ICMJE Drug: REGN2810
Regimen as per protocol
Study Arms  ICMJE
  • Experimental: Group 1- metastatic BCC
    Administration of REGN2810 in accordance with protocol dosing regimen
    Intervention: Drug: REGN2810
  • Experimental: Group 2 - unresectable locally advanced BCC
    Administration of REGN2810 in accordance with protocol dosing regimen
    Intervention: Drug: REGN2810
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2017)
137
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 9, 2022
Estimated Primary Completion Date October 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   France,   Germany,   Greece,   Italy,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03132636
Other Study ID Numbers  ICMJE R2810-ONC-1620
2016-003122-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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 April 2019

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