Clinical Trial 21965

• Overview

  Study Title:

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

  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.

  Objective:

  Primary Objective * To determine the efficacy of radiotherapy and cemiplimab immunotherapy for locally advanced unresectable cutaneous squamous cell carcinoma as measured by disease free survival 78 weeks (18 months) after the start of therapy. Secondary objectives * To estimate the overall response rate after neoadjuvant cemiplimab immunotherapy and again after concurrent radiotherapy and cemiplimab, according to the response evaluation criteria for solid tumors (RECIST), version 1.1. * To estimate the cause-specific, progression-free and overall survival after radiotherapy and cemiplimab. * To assess the frequency and severity of adverse events associated with radiotherapy and cemiplimab according to the CTCAE, version 5.0. * To assess the impact of radiotherapy and cemiplimab on quality of life according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). CRA: raadn@mskcc.org - Noor Raad

• Treatments

  Therapies:

  Immunotherapy; Radiotherapy

  Medications:

  Cemiplimab (); REGN2810 (Cemiplimab); Radiotherapy ()

• Inclusion 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: (a) Tumor or regional lymph node metastases that has recurred despite ≥2 prior surgical procedures, with another curative resection unlikely (b) Tumor or nodal disease with significant local invasion that precludes complete resection (c) 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) (d) Medical contraindication to surgery (e) Patient refusal of surgery due to anticipate morbidity
  • ECOG ≤2
  • Adequate bone marrow and metabolic function (by blood tests), as defined in protocol.
  • Acceptable candidate for curative intent radiotherapy and cemiplimab immunotherapy, in opinion of radiation and medical oncologist, respectively.
  • Life expectancy >18 months

• Exclusion Criteria

  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. 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. 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

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