A randomized, placebo-controlled, double-blind study of adjuvant cemiplimab versus placebo after surgery and radiation therapy in patients with high risk cutaneous squamous cell carcinoma

Phase 1

• Conditions: Patients with features associated with high-risk of recurrent CSCC disease, who have completed surgery and post-operative RT radiation therapy; MedDRA version: 21.0Level: PTClassification code 10041823Term: Squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-000566-38-IT
• Lead Sponsor: REGENERON PHARMACEUTICALS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

-Men and women =18 years old
- For Japan only, men and women =21 years old
- Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease - High risk CSCC, as defined in the protocol
- Completion of curative intent post-operative radiation therapy (RT) within 2 to 6 weeks of randomization
- Eastern Cooperative Oncology Group performance status (ECOG PS) =1
- Adequate hepatic, renal, and bone marrow function as defined in the
protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112

Exclusion Criteria

- Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
- Concurrent malignancy other than localized CSCC and/or history of malignancy other than localized CSCC within 3 years of date of randomization as defined in the protocol
- Patients with hematologic malignancies
- Patients with hematologic malignancies (eg, chronic lymphocytic leukemia (CLL))
- Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless the disease-free interval is at least 3 years (regional nodal involvement of disease in draining lymph node basin that was nodal involvement of disease in draining lymph node basin that was resected and radiated prior to enrollment will not be exclusionary
- Ongoing or recent (within 5 years of randomization date) evidence of immunosuppressive treatments, which may suggest risk for immune related adverse events (irAEs). The following are not exclusionary:
vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
- Has had prior systemic anti-cancer immunotherapy for CSCC

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified