Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer (NCT04620603) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer
United States5 participantsStarted 2021-05-27
Plain-language summary
This is a pilot study of combination low dose rate brachytherapy (LDR) added to standard of care (SOC) immunotherapy in stage III and IV melanoma, stage IV renal call cancer, and stage IV urothelial cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)
Timeframe: 3 months after brachytherapy
2
Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)
Timeframe: 6 months after brachytherapy
3
Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)
Timeframe: 9 months after brachytherapy
4
Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)
Timeframe: 12 months after brachytherapy
5
Number of participants with tumor response assessed by RECIST v1.1
Timeframe: 3 months after brachytherapy
6
Number of participants with tumor response assessed by RECIST v1.1