Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT04620603
Eligibility Criteria:
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 uveal melanoma
* 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.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04620603
Study Brief:
Protocol Section:
NCT04620603