Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT06981325
Phase
PHASE2
Status
Recruiting
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Conditions

  • Basal Cell Carcinoma (BCC)
  • First Line Treatment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for up to 12 months (max. 17 cycles).

Study Details

The study is an open-label, singel arm, prospective, multicenter phase II trial evaluating the efficacy and safety of Cemiplimab when applied as first-line therapy in patients with locally advanced basal cell carcinoma (BCC), which were not pretreated with hedgehog inhibitors (HHI).

Key Dates

Start date
Aug 7, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab - Single Arm
    Single Arm with Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for up to 12 months (max. 17 cycles).

Primary Outcome Measure

Objective Response Rate (ORR) at six months [ Time Frame: 24 months ]

Central Contacts

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