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)

NCT06384820 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: R3767-ONC-23302023-510514-38-00
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is researching an investigational drug called REGN2810, also known as cemiplimab, and 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)

Conditions

Cutaneous Squamous Cell Carcinoma

Keywords

Neoadjuvant; Adjuvant; Surgery

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate by blinded independent pathological review (BIPR)

  Up to 100 days

Secondary Outcomes (26)

• pCR rate by local pathological review

  Up to 100 days

• Major pathological response (MPR)

  Up to 100 days

• Event-free survival (EFS)

  Up to 3 years

• Disease free survival (DFS)

  Up to 3 years

• Objective response rate (ORR) prior to surgery

  Up to 100 days

Study Arms (2)

cemiplimab

EXPERIMENTAL

Drug: cemiplimab

fianlimab+cemiplimab

EXPERIMENTAL

Drug: cemiplimab; Drug: fianlimab

Interventions

cemiplimab DRUG

Administered Intravenous (IV) infusion every three weeks (Q3W)

Also known as: REGN2810, Libtayo

cemiplimab; fianlimab+cemiplimab

fianlimab DRUG

IV infusion Q3W

Also known as: REGN3767

fianlimab+cemiplimab

Eligibility Criteria

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

You may qualify if:

• Stage III/IV (M0) CSCC, for which surgery would be recommended in routine clinical practice
• Tumor biopsy is required during screening period as described in the protocol
• Participant is willing to undergo delayed surgery
• At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ and bone marrow function as described in the protocol

You may not qualify if:

• Stage I or II CSCC
• Anogenital, penile, vermilion lip CSCC
• CSCC bone invasion
• Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy as described in the protocol
• Prior radiation therapy for CSCC
• Myocardial infarction within 6 months of enrollment, or history of myocarditis.
• Prior treatment with anti-cancer systemic therapy within the last 3 years prior to projected enrollment date as described in the protocol

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Interventions

cemiplimab

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: November 14, 2024
• Primary Completion: June 8, 2026
• Study Completion (Estimated): May 6, 2030
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf