Neoadjuvant Plus Adjuvant Treatment With Cemiplimab in Cutaneaous Squamous Cell Carcinoma

NCT04632433 | Active Not Recruiting Phase 2

• 1 other identifier: NEO-CESQ
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 7

Brief Summary

Neoadjuvant plus adjuvant treatment with immunotherapy may have an anti-tumor activity and reduce the risk of relapse in patients with high risk surgically resectable stage III cutaneous squamous cell carcinoma.

Conditions

Cutaneous Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Major pathological response rate

  \<10% remaining viable tumour cells in resected primary tumor

  43-71 days

Secondary Outcomes (4)

• Recurrence-free survival

  At 6 and 12 months postoperative

• Overall Survival

  Until three years from last infusion

• Prevalence of related AEs

  Through study treatment completion, an average of 17 months

• Use of selected biomarkers to detect molecular and immunophenotypic changes

  At screening 1 and 2, at surgery, every 12 weeks during adjuvant and at recurrence of disease untill an average of 1 year from surgery

Study Arms (1)

single arm

EXPERIMENTAL

Patients will receive cemiplimab at a dosage of 350 mg every 3 weeks for two cycles prior surgery. Stage III stage must be documented at screening and re-assessed prior surgery by spiral or multidetector computed tomography (CT) scan (if clinically indicated) and Positron emission tomography (PET). Postoperatively, adjuvant immunotherapy with cemiplimab will be administered at a dosage of 350 mg every 3 weeks for one year.

Drug: Cemiplimab

Interventions

Cemiplimab DRUG

350 mg every 3 weeks

single arm

Eligibility Criteria

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

You may qualify if:

• Patients of either sex aged ≥18 years.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Patients must have histologically or cytologically confrimed stage III cutaneous squamous cell carcinomas. The definition of resectability can be determined by the patient's surgical oncologist and verified via discussion at Multidisciplinary Tumor Conference attended by CSCC medical and surgical oncology staff. Resectable tumors are defined as having no significant vascular, neural or bony involvement.
• Patients must be medically fit enough to undergo surgery as determined by the surgical oncology team.
• Patients must have measurable disease, defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Patients must have organ and marrow function
• Female subjects of childbearing potential must have a negative pregnancy test result at baseline and must practice a reliable method of contraception for the total study duration plus 16 weeks (i.e., 30 days plus the time required for cemiplimab to undergo five half lives) after the last dose of cemiplimab.
• Men who are sexually active with women of childbearing potential must practice a reliable method of contraception for the total study duration plus 16 weeks (i.e., 80 days plus the time required for cemiplimab to undergo five half-lives) after the last dose of cemiplimab.

You may not qualify if:

• Evidence of metastatic disease extra lymphnodal.
• Currently and previous cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug.
• Prior malignancy within the prior 5 years, except for the following: in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 years.
• Any major surgery within the last 3 weeks.
• Unwillingness or inability to follow the procedures required in the protocol.
• Uncontrolled diabetes, hypertension, pneumonitis and abnormal thyroid function or other medical conditions that may interfere with assessment of toxicity.
• Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment.
• Female subjects who are pregnant (positive pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
• Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection;
• Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

Sponsors & Collaborators

• Fondazione Melanoma Onlus: lead

Study Sites (7)

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Bergamo, 24127, Italy

Location

Ospedale S.M. Annunziata - Azienda USL Toscana Centro

Bagno a Ripoli, Firenze, 50012, Italy

Location

IRCCS - Istituto Scientifico Romagnolo per la Cura e lo Studio dei Tumori (I.R.S.T) S.r.l.

Meldola, Forlì-Cesena, 47014, Italy

Location

Fondazione I.R.C.C.S. Istituto Nazionale dei Tumori

Milan, Milano, 20133, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"

Naples, Naples, 80131, Italy

Location

Istituto Oncologico Veneto

Padua, Padova, 35128, Italy

Location

ASST Spedali Civili Brescia

Brescia, Italy

Location

MeSH Terms

Interventions

cemiplimab

Study Officials

• Paolo Ascierto, MD

  Fondazione Melanoma Onlus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will receive cemiplimab at a dosage of 350 mg every 3 weeks for two cycles prior surgery. Stage III stage must be documented at screening and re-assessed prior surgery by spiral or multidetector computed tomography (CT) scan (if clinically indicated) and Positron emission tomography (PET). Postoperatively, adjuvant immunotherapy with cemiplimab will be administered at a dosage of 350 mg every 3 weeks for one year.

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 17, 2020
• Study Start: February 10, 2021
• Primary Completion: February 6, 2023
• Study Completion: February 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7)