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NCT Number: NCT03889912

Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma

This study is researching an experimental drug called cemiplimab. The study is focused on Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC).

The aim of the study is to evaluate the safety and tolerability (how your body reacts to the drug) of cemiplimab (also known as REGN2810).

The first part of the study tested several different doses of cemiplimab given weekly for 12 weeks.

The study is also looking at several other research questions, including:

* What side effects may happen from taking the study drug * To see effect of cemiplimab on the tumor * How much study drug is in the blood at different times

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Key information

Conditions

Cutaneous Squamous Cell Carcinoma Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Princess Alexandra Hospital, Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria

  • Dose Escalation: History of recurrent resectable CSCC or BCC (Cohort C and I only) that satisfies conditions as defined in the protocol
  • Patients must have measurable disease in the index lesion, defined as 1-2 cm in the longest diameter
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Key Exclusion Criteria

  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs)
  • Prior treatment with an agent that blocks the programmed cell death 1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway.
  • Prior treatment with other systemic immune modulating agent as defined in the protocol
  • M1 or N1, N2 (a, b, or c), or N3 CSCC or BCC. Patients with history of metastatic CSCC (distant or nodal), or metastatic BCC (distant or nodal) are excluded unless the disease-free interval is at least 3 years
  • Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded.
  • Patients with a history of solid organ transplant
  • Has received a Coronavirus induced disease of 2019 (COVID-19) vaccination (initial series and booster) within 1 week of planned start of study medication

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Treatment and study plan

cemiplimab

Drug

Each patient will receive intralesional injections of cemiplimab every week (QW), or at less frequent dosing into the lesion at the assigned dose level for 3-12 weeks prior to scheduled surgery

Other names: REGN2810, Libtayo

Primary outcomes

  1. Incidence, nature, and severity of dose limiting toxicities (DLTs) (if any) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5

    Time frame: From the first dose through day 28

    Dose levels 1-3

  2. Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5

    Time frame: From the first dose to 90 days after the last dose

    Dose levels 1-3

  3. Incidence and severity of TEAEs graded according to the NCI CTCAE v5

    Time frame: From the first dose up to 90 days after the last dose

  4. The incidence and severity of injection site reactions (ISRs)

    Time frame: From the first dose to 90 days after the last dose

Secondary outcomes

  1. Objective response rate (ORR) of index lesion

    Time frame: At baseline and at Week 13

    Determined by the investigator using the modified World Health Organization (WHO) criteria

  2. Pathologic complete response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion

    Time frame: At time of surgery

  3. Major pathologic response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion

    Time frame: At time of surgery

  4. Cemiplimab concentration in serum over time

    Time frame: From the first dose up to 90 days after the last dose

  5. Incidence of anti-drug antibody (ADA) titers for cemiplimab

    Time frame: Up to 90 days after last dose

  6. Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations

    Time frame: Up to 90 days after last dose

    The determination of the phase 2 recommended dose will be based primarily on clinical safety observations, according to the dose escalation scheme.

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC)

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2019
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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