Clinical trial NCT06384820: 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)
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cutaneous Squamous Cell Carcinoma
Keywords: Neoadjuvant
Adjuvant
Surgery
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-04-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Pathological complete response (pCR) rate by blinded independent pathological review (BIPR)
timeFrame: Up to 100 days
Secondary outcomes:
measure: pCR rate by local pathological review
timeFrame: Up to 100 days
measure: Major pathological response (MPR)
timeFrame: Up to 100 days
measure: Event-free survival (EFS)
timeFrame: Up to 3 years
measure: Disease free survival (DFS)
timeFrame: Up to 3 years
measure: Objective response rate (ORR) prior to surgery
timeFrame: Up to 100 days
measure: Overall survival (OS)
timeFrame: Up to 3 years
measure: Occurrence of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 3 years
measure: Occurrence of immune-mediated adverse events (imAEs)
timeFrame: Up to 3 years
measure: Occurrence of treatment-related TEAEs
timeFrame: Up to 3 years
measure: Occurrence of adverse event of special interest (AESI)
timeFrame: Up to 3 years
measure: Occurrence of treatment-emergent serious adverse events (SAEs)
timeFrame: Up to 3 years
measure: Occurrence of laboratory abnormalities
timeFrame: Up to 3 years
measure: Occurrence of death due to TEAE
timeFrame: Up to 3 years
measure: Occurrence of interruption of study drug(s) due to TEAEs
timeFrame: Up to 3 years
measure: Occurrence of discontinuation of study drug(s) due to TEAEs
timeFrame: Up to 3 years
measure: Occurrence of cancellation of surgery due to TEAE
timeFrame: Up to 100 days
measure: Occurrence of delay to surgery due to TEAE
timeFrame: Up to 100 days
measure: Concentrations of cemiplimab in serum
timeFrame: Up to 3 years
measure: Concentrations of fianlimab in serum
timeFrame: Up to 3 years
measure: Concentrations of other experimental agents (as applicable) in serum
timeFrame: Up to 3 years
measure: Incidence of anti-drug antibodies (ADA) to cemiplimab
timeFrame: Up to 3 years
measure: Incidence of ADA to fianlimab
timeFrame: Up to 3 years
measure: Incidence of ADA to other experimental agents (as applicable)
timeFrame: Up to 3 years
measure: Titer of ADA to cemiplimab
timeFrame: Up to 3 years
measure: Titer of ADA to fianlimab
timeFrame: Up to 3 years
measure: Titer of ADA to other experimental agents (as applicable)
timeFrame: Up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: