A Phase II Trial of Stereotactic Body Radiotherapy With Concurrent Anti-PD1 Treatment in Metastatic Melanoma.

This is an interventional treatment trial for Melanoma Read More

Inclusion Criteria:

• Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
• Histologically confirmed diagnosis of melanoma
• At least 3 extracranial measurable metastatic lesions per RECIST v1.1. All radiology studies must be performed within 28 days prior to registration
• First line anti-PD1 treatment.
• Karnofsky Performance status > 60
• Age 18 years or older
• Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment
• Female participants who are breastfeeding or plan to breastfeed should be instructed to discontinue nursing during treatment.
• Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study treatment

• Demonstrate adequate organ function defined as the following:

  • AST and ALT ≤2.5 X ULN or ≤5 X ULN with liver metastases
  • Serum total bilirubin ≤1.5 X ULN or direct bilirubin ≤ULN for patient with total bilirubin level >1.5 ULN
  • Serum creatinine ≤1.5 X ULN
  • Absolute neutrophil count >1,000 /mcL
  • Platelets >75,000 /mcL
  • Hemoglobin >9 g/dL or > 5.6 mmol/L
• No history of active autoimmune disease requiring systemic treatment within the past 3 months or documented history of clinically severe autoimmune disease, or syndrome that requires systemic steroids or immunosuppressive agents
• Prior malignancy: Subjects who have had another malignancy should be disease-free for 5 years, or should have a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma
• No evidence of interstitial lung disease
• No uncontrolled central nervous metastases and/or carcinomatous meningitis.
• No prior radiotherapy interfering with SBRT.
• No concomitant therapy with IL-2, interferon, other immunotherapy regimens, chemotherapy, immunosuppressive agent or chronic use of systemic corticosteroids.
• No active infection requiring systemic therapy
• No known history of human immunodeficiency virus (HIV)
• No known active Hepatitis B or Hepatitis C
• Did not receive a live vaccine within 30 days prior to start of study treatment
• No mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
• Patient not unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study