A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
1. september 2026 oppdatert av: Regeneron Pharmaceuticals
Phase 2 Platform Trial of Combination Therapies for Participants With Locally Advanced Basal Cell Carcinoma: Master Protocol With Cemiplimab Monotherapy as Comparator Arm
This study will test an experimental Regeneron drug called cemiplimab ("study drug") given alone or in combination with other anti-cancer drugs ("combination treatment") to see if they can help treat laBCC.
The study is looking at:
- What side effects cemiplimab, alone or in a combination treatment, might cause
- How well cemiplimab, alone or in a combination treatment, works
- How cemiplimab, alone or in a combination treatment could affect the immune system, which can help researchers understand why cemiplimab, alone or in a combination treatment, works better in some participants than others
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
135
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Clinical Trials Administrator
- Telefonnummer: 844-734-6643
- E-post: clinicaltrials@regeneron.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Key Inclusion Criteria:
- Histologic confirmation of BCC by local board-certified pathologist, as described in the protocol
- At least one lesion that is measurable by study criteria, defined as ≥ 1cm in at least one dimension, as assessed by radiology and/or digital medical photography, as described in the protocol
- The treating physician must document that the participant is not appropriate for curative-intent surgery or curative-intent radiation
- The treating physician must document that the participant does not wish to receive a hedgehog pathway inhibitor (HHI) or is not a candidate for an HHI
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Subsequent Therapy Arm - specific inclusion criteria:
- Documentation of histopathologic diagnosis of basal cell carcinoma - NOT necessary
- Submission of tumor or blood for exploratory correlative research - NOT necessary
Key Exclusion Criteria:
- Metastatic disease to lymph node(s) or distant site(s) (Note: involvement of lymph node due to direct invasion from overlying cutaneous BCC is still considered laBCC, and is not excluded)
- History or current evidence of significant cardiovascular disease, as described in the protocol
- Exposure to any prior systemic therapy (eg, HHI or an immune checkpoint inhibitor) or locally injectable agent for laBCC, as described in the protocol
- Current participation OR past participation in another investigational trial in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within 4 weeks before planned first dose of study intervention in this clinical trial.
Subsequent Therapy Arm - specific exclusion criteria:
1. Receipt of any anti-cancer therapy (including HHIs, radiation, surgery, or other systemic therapy) for BCC, AFTER treatment on Arms A, B, or C.
NOTE: Other protocol defined inclusion/exclusion criteria apply
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm A
|
Administrert i henhold til protokollen
Andre navn:
|
|
Eksperimentell: Arm B
|
Administrert i henhold til protokollen
Andre navn:
Administered per the protocol
Andre navn:
|
|
Eksperimentell: Arm C
|
Administrert i henhold til protokollen
Andre navn:
Administrert i henhold til protokollen
Andre navn:
|
|
Eksperimentell: Subsequent Therapy Arm
|
Administrert i henhold til protokollen
Andre navn:
Administrert i henhold til protokollen
Andre navn:
Administered per the protocol
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Response Rate (ORR) by blinded independent central review (BICR) per Composite Response Criteria
Tidsramme: Up to approximately 3 years
|
Composite Response Criteria integrates radiology findings [Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] and external lesion assessments from digital photography [modified World Health Organization (WHO) criteria].
|
Up to approximately 3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Duration of Response (DOR) by BICR per Composite Response Criteria
Tidsramme: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Time to Response (TTR) by BICR per Composite Response Criteria
Tidsramme: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Best Overall Response (BOR) of Complete Response (CR) by BICR per composite Response Criteria
Tidsramme: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Progression-Free Survival (PFS) by BICR per Composite Response Criteria
Tidsramme: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Objective Response by investigator review per Composite Response Criteria
Tidsramme: Up to approximately 3 years
|
Up to approximately 3 years
|
|
DOR by investigator review per Composite Response Criteria
Tidsramme: Up to approximately 3 years
|
Up to approximately 3 years
|
|
TTR by investigator review per Composite Response Criteria
Tidsramme: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Complete Response (CR) by investigator review per Composite Response Criteria
Tidsramme: Up to approximately 3 years
|
Up to approximately 3 years
|
|
PFS by investigator review per Composite Response Criteria
Tidsramme: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: Up to approximately 3 years
|
Up to approximately 3 years
|
|
Severity of TEAEs
Tidsramme: Up to approximately 3 years
|
Up to approximately 3 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. oktober 2026
Primær fullføring (Antatt)
13. november 2030
Studiet fullført (Antatt)
13. november 2030
Datoer for studieregistrering
Først innsendt
1. september 2026
Først innsendt som oppfylte QC-kriteriene
1. september 2026
Først lagt ut (Faktiske)
9. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. september 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CMP001-ONC-2607
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD-delingstidsramme
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy.
Tilgangskriterier for IPD-deling
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli.
Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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