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

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study of combination low dose rate brachytherapy (LDR) added to standard of care (SOC) immunotherapy with Nivolumab in stage III and IV melanoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Treatments: Nivolumab

Criteria

Inclusion Criteria:

• Participants must have histologically confirmed unresectable stage III or stage IV cutaneous melanoma.

• ECOG performance status 0-2.

• Have measurable disease per RECIST v1.1. 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.

Exclusion Criteria:

• Participants diagnosed with mucosal or uveal melanoma

• Participants who have been treated with whole head radiation for brain metastases

• Invasive cancers diagnosed < 3 years prior that required systemic treatment.

• 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.

• Prior anti-cancer therapy for melanoma less than 14 days prior to first dose of study drug.

• Pregnant or nursing females

• Unwilling or unable to follow protocol requirements.

• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.

• Other active non-melanoma metastatic cancers requiring systemic treatment.

• Participants currently receiving systemic corticosteroids doses over 15mg prednisone or equivalent.

• Participants with uncontrolled HIV or hepatitis.