Trial Search Results

Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma

The primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by Pathologic complete response (pCR) rate per independent central pathology review.

The secondary objectives of the study are:

- To evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response, including:

- Major pathologic response (mPR) rate per independent central pathology review

- pCR rate and mPR rate per local pathology review

- ORR prior to surgery, according to local assessment using RECIST 1.1

- To evaluate the efficacy of neoadjuvant cemiplimab on event free survival (EFS), disease free survival (DFS), and overall survival (OS)

- To evaluate the safety profile of neoadjuvant cemiplimab

- To assess change in surgical plan (ablative and reconstructive procedures) from the screening period to definitive surgery, both according to investigator review and independent surgical expert review

- To assess change in post-surgical management plan (radiation, chemoradiation, or observation) from the screening period to post-surgery pathology review, both according to investigator review and independent surgical expert review

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Collaborator: Sanofi

Stanford Investigator(s):

Intervention(s):

  • Drug: Cemiplimab

Phase:

Phase 2

Eligibility


Key Inclusion Criteria

   - Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical
   practice. For stage II patients, lesion must be ≥3 cm at the longest diameter.

   - At least 1 lesion that is measurable by RECIST 1.1

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

   - Adequate organ, bone marrow function, and hepatic function as defined in the protocol

Key Exclusion Criteria

   - Solid malignancy within 5 years of the projected enrollment date, or hematologic
   malignancy (including chronic lymphocytic leukemia [CLL]) at any time

   - Distant metastatic disease (M1), visceral and/or distant nodal

   - Prior radiation therapy for CSCC

   - Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or
   equivalent) within 14 days of the first dose of study drug.

   - Patients with active, known, or suspected autoimmune disease that has required
   systemic therapy within 5 years of the projected enrollment date.

   - History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing
   pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses
   of glucocorticoids to assist with management.

   - Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or
   hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency

   - Active tuberculosis

NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nikita Bedi
650-723-5957
Not Recruiting