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 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: R2810-ONC-16202016-003122-16
• Study Type: interventional
• Target: 138
• Locations: 10 countries
• Sites: 71

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

Conditions

Carcinoma, Basal Cell

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) as Assessed by Independent Central Review (ICR)

  ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 assessed as per ICR assessment. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm) (\< 1 centimeter \[cm\]). PR: At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. ORR was determined by Clopper-Pearson method.

  Up to 1422 days (approximately 46 months)

Secondary Outcomes (14)

• Objective Response Rate (ORR) Per Investigator Assessment

  Up to 1422 days (approximately 46 months)

• Duration of Response (DOR) as Assessed by ICR

  Up to 48 months

• Duration of Response (DOR) Per Investigator Assessment

  Up to 48 months

• Complete Response (CR) Rate as Assessed by ICR

  Up to 48 months

• Complete Response (CR) Rate Per Investigator Assessment

  Up to 48 months

Study Arms (2)

Group 1- metastatic BCC

EXPERIMENTAL

Administration of cemiplimab in accordance with protocol dosing regimen

Drug: cemiplimab

Group 2 - unresectable locally advanced BCC

EXPERIMENTAL

Administration of cemiplimab in accordance with protocol dosing regimen

Drug: cemiplimab

Interventions

cemiplimab DRUG

Regimen as per protocol

Also known as: REGN2810, Libtayo

Group 1- metastatic BCC; Group 2 - unresectable locally advanced BCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (71)

The University of Arizona Cancer Centre at Dignity Health

Phoenix, Arizona, 85004, United States

Location

Mayo Clinic Arizona - Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine

Redwood City, California, 94063-3132, United States

Location

UCSF Helen Dillion Family Cancer Care Center

San Francisco, California, 94115, United States

Location

University of Colorado Hospital, Anschutz Outpatient Pavilion

Denver, Colorado, 80045, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami, Florida, 33140, United States

Location

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute (DFCI)

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Atlantic Health System / Morristown Medical Center

Morristown, New Jersey, 07962, United States

Location

Overlook Medical Center

Summit, New Jersey, 07901, United States

Location

New York University School Of Medicine, Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

James Cancer Hospital and Solove Research Institute

Columbus, Ohio, 43210, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

LKH - Universitaetsklinikum Graz

Graz, Styria, 8036, Austria

Location

Medizinische Universitaet Innsbruck, Universitaetsklinik fuer Dermatologie, Venerologie und Allergologie

Innsbruck, 6020, Austria

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Odette Cancer Center-Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

London Regional Cancer Program, London Hsc

Toronto, Ontario, N6A 4L6, Canada

Location

CHU de Dijon - Hopital du Bocage

Dijon, Cedex, 21000, France

Location

Hopital Saint Louis

Paris, Europe, 75010, France

Location

Centre Hospitalier Lyon-Sud -Hospices Civils de Lyon Groupement Hospitalier Sud

Pierre-Bénite, Paris, 69495, France

Location

Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-André - Hôpital Saint-André

Bordeaux, 33000, France

Location

Hopital Ambroise Pare

Boulogne-Billancourt, 92100, France

Location

Centre Hospitalier Universitaire de Grenoble

La Tronche, 38700, France

Location

Hopital Huriez - CHRU de Lille

Lille, 59037, France

Location

Centre Leon-Berard (CLB)

Lyon, 69008, France

Location

CHU Hotel Dieu

Nantes, 44093, France

Location

Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

Rouen, 76031, France

Location

Institut Claudius Regaud

Toulouse, 31059, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

University Hospital Frankfurt

Frankfurt, Hessen/Germany, 60590, Germany

Location

Hauttumorcentrum der Charite (HTCC)-Charite Universitatsmedizin Berlin

Berlin, C-10117, Germany

Location

Elbekliniken Buxtehude

Buxtehude, 21614, Germany

Location

University Hospital Dresden

Dresden, 01307, Germany

Location

Universitaetsklinik Essen

Essen, 45147, Germany

Location

SRH Wald-Kliniken Gera GmbH

Gera, 07548, Germany

Location

Hannover Medical School

Hanover, 30625, Germany

Location

NCT Dermatoonkologie

Heidelberg, 69120, Germany

Location

University of Kiel

Kiel, 24105, Germany

Location

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, 55131, Germany

Location

Klinik Fur Dermatologie Und Allergollogie

Quedlinburg, 06484, Germany

Location

University Hospital Tubingen

Tübingen, 72076, Germany

Location

National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine

Athens, 115 27, Greece

Location

National and Kapodistrian University of Athens - School of Health Sciences

Athens, 11527, Greece

Location

Andreas Sygros Hosptial-University of Athen

Athens, 16121, Greece

Location

University General Hospital of Ioannina - Dermatology and Venereology Department

Ioannina, 45110, Greece

Location

Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna

Bologna, Bo, 40138, Italy

Location

Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

Brescia, Province Of Brescia, 25123, Italy

Location

U.O.Dermatologia Azienda Sanitaria Firenze Universita' Firenze

Florence, 50132, Italy

Location

University L'Aquila

L’Aquila, 67100, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

U.O.S.C Di Oncologia Medica E Terapie Innovative

Napoli, 80131, Italy

Location

Catholic University of the S.Heart

Roma, 168, Italy

Location

Catalan Institute of Oncology Badalona

Badalona, 08916, Spain

Location

Hospital Clinic I Provincialde Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de Torrejon

Madrid, 28850, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

University Hospital Zurich Usz

Zurich, 8091, Switzerland

Location

Related Publications (5)

• Stratigos AJ, Chen CI, Ivanescu C, Lewis KD, Peris K, Bechter O, Harnett J, Mastey V, Reaney M, Daskalopoulou C, LaFontaine PR, Konidaris G, Bury D, Yoo SY, Mohan K, Coates E, Bowler T, Fury MG, Sekulic A. Quality of life in cemiplimab-treated patients with locally advanced basal cell carcinoma in a Phase II clinical trial. Future Oncol. 2024;20(30):2249-2258. doi: 10.1080/14796694.2024.2358670. Epub 2024 Jul 29.

  PMID: 39073799 DERIVED

• Lewis KD, Peris K, Sekulic A, Stratigos AJ, Dunn L, Eroglu Z, Chang ALS, Migden MR, Yoo SY, Mohan K, Coates E, Okoye E, Bowler T, Baurain JF, Bechter O, Hauschild A, Butler MO, Hernandez-Aya L, Licitra L, Neves RI, Ruiz ES, Seebach F, Lowy I, Goncalves P, Fury MG. Final analysis of phase II results with cemiplimab in metastatic basal cell carcinoma after hedgehog pathway inhibitors. Ann Oncol. 2024 Feb;35(2):221-228. doi: 10.1016/j.annonc.2023.10.123. Epub 2023 Dec 9.

  PMID: 38072158 DERIVED

• Stratigos AJ, Sekulic A, Peris K, Bechter O, Prey S, Lewis KD, Basset-Seguin N, Chang ALS, Dalle S, Fernandez Orland A, Licitra L, Robert C, Ulrich C, Hauschild A, Migden MR, Dummer R, Yoo SY, Okoye E, Bassukas I, Loquai C, De Giorgi V, Eroglu Z, Gutzmer R, Ulrich J, Puig S, Inocencio TJ, Chen CI, LaFontaine PR, Seebach F, Lowy I, Fury MG. Phase 2 open-label, multicenter, single-arm study of cemiplimab in patients with locally advanced basal cell carcinoma after hedgehog inhibitor therapy: Extended follow-up. J Am Acad Dermatol. 2024 Feb;90(2):414-418. doi: 10.1016/j.jaad.2023.08.111. Epub 2023 Oct 14. No abstract available.

  PMID: 37839734 DERIVED

• Stratigos AJ, Sekulic A, Peris K, Bechter O, Prey S, Kaatz M, Lewis KD, Basset-Seguin N, Chang ALS, Dalle S, Orland AF, Licitra L, Robert C, Ulrich C, Hauschild A, Migden MR, Dummer R, Li S, Yoo SY, Mohan K, Coates E, Jankovic V, Fiaschi N, Okoye E, Bassukas ID, Loquai C, De Giorgi V, Eroglu Z, Gutzmer R, Ulrich J, Puig S, Seebach F, Thurston G, Weinreich DM, Yancopoulos GD, Lowy I, Bowler T, Fury MG. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):848-857. doi: 10.1016/S1470-2045(21)00126-1. Epub 2021 May 14.

  PMID: 34000246 DERIVED

• Li R, Lee G, Huang M, El-Sherief A. Rare basal cell metastasis of a basal-squamous skin collision tumour to the lung and axillary lymph node. BMJ Case Rep. 2019 Oct 3;12(10):e231487. doi: 10.1136/bcr-2019-231487.

  PMID: 31585957 DERIVED

Related Links

• A Plain Language Summary is available on TrialSummaries.com

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 28, 2017
• Study Start: June 29, 2017
• Primary Completion: May 20, 2021
• Study Completion: April 27, 2023
• Last Updated: April 8, 2025
• Results First Posted: July 26, 2022

Record last verified: 2025-04

Locations

AU (2); GR (4); IT (7); US (23); CA (4); DE (12); ES (4); CH (1); FR (12); BE (2)