“A phase II, single arm study investigating neoadjuvant plus adjuvant treatment with Cemiplimab in surgically resectable, high risk stage III/IV (M0) Cutaneaous Squamous Cell Carcinoma”

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fondazione Melanoma Onlus

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

10 Feb 2021 → ongoing

Decision date (initial)

2024-11-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Regeneron

External identifiers

EU CT number

2024-515204-39-00

EudraCT number

2019-001469-34

ClinicalTrials.gov

NCT04632433

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

neoadjuvant plus adjuvant treatment with immunotherapy may have an anti-tumor activity and reduce the risk of relapse in patients with surgically resectable, high risk stage III/IV (M0)squamous cell carcinoma.

Conditions and MedDRA coding

surgically resectable, high risk stage III/IV (M0) Cutaneaous Squamous Cell Carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Patients of either sex aged ≥18 years.
2. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
3. Patients must have histologically or cytologically surgically resectable, high risk stage III/IV (M0) cutaneous squamous cell carcinoma. 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.
4. Patients must be medically fit enough to undergo surgery as determined by the surgical oncology team.
5. Patients must have measurable disease, defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
7. Patients must have organ and marrow function as defined below: absolute neutrophil count (ANC) ≥1.5 X 10^9/L; hemoglobin ≥9-5 g/dL; platelets ≥100 X 10^9/L; prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤1.5 X upper limit of normal (ULN); total bilirubin ≤1.5 X ULN (isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X ULN ^1; albumin ≥2.5 g/dL; creatinine ≤1.5 X ULN 2 OR calculated creatinine clearance ≥50 mL/min OR 24-hour urine creatinine clearance ≥50 mL/min
8. 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 6 months after the last dose of cemiplimab
9. Men who are sexually active with women of childbearing potential must practice a reliable method of contraception for the total study duration plus 6 months after the last dose of cemiplimab

Exclusion criteria 8

1. Evidence of metastatic disease extra limphnodal
2. Currently or previous cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug
3. 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
4. Any major surgery within the last 3 weeks
5. Unwillingness or inability to follow the procedures required in the protocol
6. Uncontrolled diabetes, hypertension, pneumonitis and abnormal thyroid function or other medical conditions that may interfere with assessment of toxicity
7. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
8. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. major pathological response rate (<10% remaining viable tumour cells in resected primary tumor).
2. Recurrence-free survival (RFS - the time from start of treatment until disease recurrence (local, regional or distant) or death from any cause)
3. Overall Survival (OS - the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive)
4. Safety
5. To determine molecular and immunophenotypic changes in tumor and peripheral blood evaluating several biomarkers. Since the identification of new markers for immunotherapy is rapidly evolving, the definitive list of analyses remains to be determined

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondazione Melanoma Onlus

Sponsor organisation

Fondazione Melanoma Onlus

Address

Via Mariano Semmola

City

Naples

Postcode

80131

Country

Italy

Scientific contact point

Organisation

Fondazione Melanoma Onlus

Contact name

Paolo Antonio Ascierto

Public contact point

Organisation

Fondazione Melanoma Onlus

Contact name

Paolo Antonio Ascierto

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications