A Phase II, Multicenter, Single-Arm Clinical Trial of Radiotherapy and CeMiPlimAb: Rwlc ImmunoTherapy for Locally Advanced, Unresectable Cutaneous Squamous Cell Carcinoma: RAMPART

Memorial Sloan Kettering Cancer Center13 sites in 1 country34 target enrollmentOctober 6, 2022

ConditionsCutaneous Squamous Cell Carcinoma Skin Cancer Squamous Cell Carcinoma Locally Advanced Squamous Cell Carcinoma Locally Advanced Squamous Cell Carcinoma of the Skin Locally Advanced Cutaneous Squamous Cell Carcinoma Locally Advanced Skin Squamous Cell Carcinoma

InterventionsCemiplimab Radiotherapy

DrugsCemiplimab

Overview

Phase: Phase 2
Intervention: Cemiplimab
Conditions: Cutaneous Squamous Cell Carcinoma
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 34
Locations: 13
Primary Endpoint: Disease Free Survival
Status: Active, Not Recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to see if the combination of radiation therapy and cemiplimab immunotherapy is an effective treatment for people with locally advanced, unresectable CSCC.

Registry

clinicaltrials.gov

Start Date

October 6, 2022

End Date

October 6, 2026

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Biopsy proven cutaneous squamous cell carcinoma which is locally advanced
•Mixed histology tumors that are predominantly squamous cell carcinoma are eligible
•Locally advanced primary tumor is T3-T4 and/or N+ by AJCC and/or UICC 8th edition clinical criteria
•T3-T4 primary tumor characteristics noted below:
•Non-eyelid tumor \>4 cm in maximum dimension or with bone erosion or invasion, perineural invasion of nerve 0.1 mm or larger, or invasion beyond subcutaneous fat or \>6 mm from granular layer of adjacent normal epidermis
•Eyelid tumor \>2 cm or invading adjacent ocular, orbital or facial structures
•≥18 years old
•Unresectable or medically inoperable according to local multidisciplinary consensus for reasons such as:
•Tumor or regional lymph node metastases that has recurred despite ≥2 prior surgical procedures, with another curative resection unlikely
•Tumor or nodal disease with significant local invasion that precludes complete resection

Exclusion Criteria

•Primary tumor originating on the mucosal (non-hair bearing) lip or nose, anogenital (penis, scrotum, vulva, perianal) area
•Iatrogenic immunosuppression (\>prednisone 10 mg/day or equivalent within 14 days of initiation of treatment)
•Women of child bearing potential unwilling or unable to use effective contraception while receiving treatment with cemiplimab and for 4 months thereafter
•Distant metastases
•Clinically significant autoimmune disease that requires iatrogenic immunosuppression
•o For example, severe rheumatoid arthritis requiring disease modifying antirheumatic drugs, such as methotrexate
•Current or previous hematopoietic malignancy (leukemia, lymphoma)
•Prior allogeneic transplant of solid organ or bone marrow
•Concurrent malignancies with \>10% risk of metastasis or death within 2 years
•Prior aPD1 immunotherapy or PI3Kδ inhibitor use