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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Cutaneous Malignant Melanoma
• Renal Cell Cancer
• Urothelial Cancer of Renal Pelvis

ELIGIBILITY

Inclusion Criteria:
* 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.
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, renal cell cancer, or urothelial cancer less than 14 days prior to first dose of study treatment. - * 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 treatment. - * Other active non-melanoma, non-renal cell, or non-urothelial metastatic cancers requiring systemic treatment. - * Participants currently receiving systemic corticosteroids doses over 15mg prednisone or equivalent. - * Participants with uncontrolled HIV or hepatitis.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Jay Ciezki, MD

Role: Principal Investigator

Affiliation: Cleveland Clinic, Case Comprehensive Cancer Center

Overall Contact

Name: Jay Ciezki, MD

Phone: 1-866-223-8100

Email: TaussigResearch@ccf.org

LOCATION