Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer

Korábbi kezelés

• Participants who have been treated with whole head radiation for brain metastases
• Invasive cancers not being treated on this trial (i.e. lymphoma that received systemic therapy) diagnosed < 3 years prior that required systemic treatment. This is intended to include a patient with melanoma who was diagnosed < 3 years prior to screening for this trial that has received antecedent systemic therapy.
• Prior anti-cancer therapy for melanoma, renal cell cancer, or urothelial cancer less than 14 days prior to first dose of study treatment.
• Participants currently receiving systemic corticosteroids doses over 15mg prednisone or equivalent.

Más betegség

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study treatment.
• Other active non-melanoma, non-renal cell, or non-urothelial metastatic cancers requiring systemic treatment.
• Participants with uncontrolled HIV or hepatitis.

Egyéb

• Participants diagnosed with uveal melanoma
• Pregnant or nursing females
• Unwilling or unable to follow protocol requirements.

• Participants must have histologically confirmed unresectable stage III or stage IV cutaneous melanoma, stage IV renal cell cancer, and stage IV urothelial cancer.
• ECOG performance status 0-2.
• Have measurable disease per RECIST v1.1 or iRECIST. Refer to Appendix B
• Have the following clinical laboratory values:
  • Absolute neutrophil count (ANC) ≥ 1500/ μL
  • Hgb ≥ 9 g/dL
  • Platelet count ≥ 75, 000/ μL
  • Total bilirubin ≤ 1.5 x ULN (upper limit of normal)
  • AST and ALT ≤ 2x ULN
  • Serum Creatinine < 2x ULN
• Female participants who:
  • Are postmenopausal for at least 1 year before entering the screening visit, OR
  • Are surgically sterile, OR
  • Agree to practice true abstinence from heterosexual contact or agree to use effective contraception without interruption during the study therapy and 90 days after the last dose.
• Male participants who:
  • Are surgically sterile, OR
  • Agree to practice true abstinence from heterosexual contact or agree to use effective contraception without interruption during the study therapy and 90 days after the last dose.