Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)

Cutaneous Squamous Cell Carcinoma Clinical Trial

Official title:

A Phase 2 Peri-Operative Study of Treatment With Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Patients With Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384820
• Other study ID #: R3767-ONC-2330
• Secondary ID: 2023-510514-38-0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 14, 2024
• Est. completion date: May 6, 2030

Study information

• Verified date: April 2024
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is researching an investigational drug called REGN2810, also known as cemiplimab, when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC).

The aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery.

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

• Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery

• Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery

• What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab

• How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times

• Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: May 6, 2030
• Est. primary completion date: June 8, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Stage III/IV (M0) CSCC, for which surgery would be recommended in routine clinical practice

2. Tumor biopsy is required during screening period as described in the protocol

3. Participant is willing to undergo delayed surgery

4. At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

6. Adequate organ and bone marrow function as described in the protocol

Key Exclusion Criteria:

1. Stage I or II CSCC

2. Anogenital, penile, vermilion lip CSCC

3. CSCC bone invasion

4. Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy as described in the protocol

5. Prior radiation therapy for CSCC

6. Myocardial infarction within 6 months of enrollment, or history of myocarditis.

7. Prior treatment with anti-cancer systemic therapy within the last 3 years prior to projected enrollment date as described in the protocol

Note: Other protocol-defined Inclusion/Exclusion Criteria apply

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Cutaneous Squamous Cell Carcinoma

Intervention

Drug:
• cemiplimab
Administered Intravenous (IV) infusion every three weeks (Q3W)
• fianlimab
IV infusion Q3W

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response (pCR) rate by blinded independent pathological review (BIPR)		Up to 100 days
Secondary	pCR rate by local pathological review		Up to 100 days
Secondary	Major pathological response (MPR)		Up to 100 days
Secondary	Event-free survival (EFS)		Up to 3 years
Secondary	Disease free survival (DFS)		Up to 3 years
Secondary	Objective response rate (ORR) prior to surgery		Up to 100 days
Secondary	Overall survival (OS)		Up to 3 years
Secondary	Occurrence of treatment-emergent adverse events (TEAEs)		Up to 3 years
Secondary	Occurrence of immune-mediated adverse events (imAEs)		Up to 3 years
Secondary	Occurrence of treatment-related TEAEs		Up to 3 years
Secondary	Occurrence of adverse event of special interest (AESI)		Up to 3 years
Secondary	Occurrence of treatment-emergent serious adverse events (SAEs)		Up to 3 years
Secondary	Occurrence of laboratory abnormalities	Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0	Up to 3 years
Secondary	Occurrence of death due to TEAE		Up to 3 years
Secondary	Occurrence of interruption of study drug(s) due to TEAEs		Up to 3 years
Secondary	Occurrence of discontinuation of study drug(s) due to TEAEs		Up to 3 years
Secondary	Occurrence of cancellation of surgery due to TEAE		Up to 100 days
Secondary	Occurrence of delay to surgery due to TEAE		Up to 100 days
Secondary	Concentrations of cemiplimab in serum		Up to 3 years
Secondary	Concentrations of fianlimab in serum		Up to 3 years
Secondary	Concentrations of other experimental agents (as applicable) in serum		Up to 3 years
Secondary	Incidence of anti-drug antibodies (ADA) to cemiplimab		Up to 3 years
Secondary	Incidence of ADA to fianlimab		Up to 3 years
Secondary	Incidence of ADA to other experimental agents (as applicable)		Up to 3 years
Secondary	Titer of ADA to cemiplimab		Up to 3 years
Secondary	Titer of ADA to fianlimab		Up to 3 years
Secondary	Titer of ADA to other experimental agents (as applicable)		Up to 3 years