Clinical trial NCT05574101: A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer
Official title: A Phase II, Multicenter, Single-Arm Clinical Trial of Radiotherapy and CeMiPlimAb: Rwlc ImmunoTherapy for Locally Advanced, Unresectable Cutaneous Squamous Cell Carcinoma: RAMPART
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cutaneous 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
Keywords: Skin cancer
squamous cell carcinoma
locally advanced squamous cell carcinoma
Cutaneous Squamous Cell Carcinoma
Locally Advanced Squamous Cell Carcinoma of the Skin
Locally Advanced Cutaneous Squamous Cell Carcinoma
Locally Advanced Skin Squamous Cell Carcinoma
cemiplimab
RAMPART
22-090
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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
  * Tumor or nodal disease in anatomically challenging area where surgery may result in significant disfigurement or dysfunction (amputation of nose, ear, eye, digit, limb, etc)
  * Medical contraindication to surgery
  * Patient refusal of surgery due to anticipate morbidity
* ECOG ≤2
* Adequate bone marrow and metabolic function (by blood tests)

  * Total bilirubin ≤1.5 x upper limit of normal
  * Aspirate aminotransferase (AST) ≤3 x upper limit of normal
  * Alanine aminotransferase (ALT) ≤3 x upper limit of normal
  * Alkaline phosphatase ≤2.5 x upper limit of normal
  * Serum creatinine ≤1.5 x upper limit of normal or estimated creatinine clearance \>30 mL/min according to Cockcroft-Gault formula
  * Hemoglobin \>9 g/dL
  * Absolute neutrophil count ≥1.5 x10\^9/L
  * Platelet count ≥75 x10\^9/L
* Able to provide informed consent
* Acceptable candidate for curative intent radiotherapy and Cemiplimab immunotherapy, in opinion of radiation and medical oncologist, respectively
* Life expectancy \>18 months

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
* Prior radiotherapy for the cutaneous squamous cell carcinoma requiring treatment
* Other ongoing cancer therapy

  o Adjuvant endocrine therapy is permitted for patients with prostate or breast cancer
* Uncontrolled HIV or infectious hepatitis (viral load detectable in patient with known infection)
* Pregnancy or breastfeeding
* Comorbid or diagnostic abnormalities within the last year that would interfere with interpretation of study results

Primary outcomes:
measure: Disease Free Survival
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado (Data Collection Only)
state: Colorado
city: Tampa
country: United States
facility: Moffitt Cancer Center (Data Collection Only)
state: Florida
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center at Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All protocol activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (All protocol activities)
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic (Data Collection Only)
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center (Data Collection Only)
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Seattle
country: United States
facility: University of Washington (Data Collection Only)
state: Washington
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christopher Barker, MD
role: PRINCIPAL_INVESTIGATOR
References: