Clinical Trials /

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

NCT04154943

Description:

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

Related Conditions:
  • Skin Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
  • Official Title: A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)

Clinical Trial IDs

  • ORG STUDY ID: R2810-ONC-1901
  • SECONDARY ID: 2019-003007-35
  • NCT ID: NCT04154943

Conditions

  • Cutaneous Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
CemiplimabREGN2810, LibtayoCemiplimab

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
CemiplimabExperimentalWill receive IV infusion Q3W
  • Cemiplimab

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathologic complete response (pCR) rate assessed by independent central pathology review
Time Frame:Up to 12 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Major pathologic response (mPR) rate assessed by independent central pathology review
Time Frame:Up to 12 weeks
Safety Issue:
Description:
Measure:pCR rate assessed by local pathology review
Time Frame:Up to 12 weeks
Safety Issue:
Description:
Measure:mPR rate assessed by local pathology review
Time Frame:Up to 12 weeks
Safety Issue:
Description:
Measure:Objective response rate (ORR) prior to surgery, according to investigator assessment using RECIST 1.1
Time Frame:Up to 12 weeks
Safety Issue:
Description:
Measure:Event free survival (EFS)
Time Frame:Up to 50 months
Safety Issue:
Description:
Measure:Disease free survival (DFS)
Time Frame:Up to 47 months
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:Up to 50 months
Safety Issue:
Description:
Measure:Incidence of adverse events (AEs)
Time Frame:Up to 52 months
Safety Issue:
Description:
Measure:Incidence of serious adverse events (SAEs)
Time Frame:Up to 52 months
Safety Issue:
Description:
Measure:Incidence of deaths
Time Frame:Up to 52 months
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities
Time Frame:Up to 52 months
Safety Issue:
Description:
Measure:Change in surgical plan in the screening period versus actual surgery after neoadjuvant cemiplimab
Time Frame:Up to 12 weeks
Safety Issue:
Description:
Measure:Change in post-surgical management plan in the screening period versus actual post-surgical management
Time Frame:Up to 14 weeks
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Regeneron Pharmaceuticals

Trial Keywords

  • CSCC
  • Stage II
  • Stage III
  • Stage IV
  • CSCC of Head/neck
  • CSCC of Extremity
  • CSCC of Trunk

Last Updated

December 2, 2019