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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 : Active, not recruiting
First Posted : April 28, 2017
Last Update Posted : March 23, 2022
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 March 23, 2022
Actual Study Start Date  ICMJE June 29, 2017
Actual Primary Completion Date May 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2019)
  • Objective 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
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2019)
  • 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 objective response of CR after starting cemiplimab, up to approximately 121 weeks ]
    CR rate (per central review) assessed from date of treatment until best objective response of CR after starting cemiplimab 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-cemiplimab 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 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
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: cemiplimab
Regimen as per protocol
Other Names:
  • REGN2810
  • Libtayo
Study Arms  ICMJE
  • Experimental: Group 1- metastatic BCC
    Administration of cemiplimab in accordance with protocol dosing regimen
    Intervention: Drug: cemiplimab
  • Experimental: Group 2 - unresectable locally advanced BCC
    Administration of cemiplimab in accordance with protocol dosing regimen
    Intervention: Drug: cemiplimab
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: April 24, 2017)
137
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 29, 2023
Actual Primary Completion Date May 20, 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 cemiplimab
  • Untreated brain metastasis that may be considered active
  • Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to treatment with cemiplimab
  • 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 cemiplimab
  • 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 information is only displayed when the study is recruiting subjects
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
Current Responsible Party Regeneron Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Regeneron Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date March 2022

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