Tiny study tests radiation boost to immunotherapy in Hard-to-Treat cancers
NCT ID NCT04620603
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tested whether adding low-dose radiation (brachytherapy) to standard immunotherapy could help shrink tumors in people with advanced melanoma, kidney cancer, or urothelial cancer. Only 5 participants were enrolled, and the main goal was to see how many responded to treatment. Because it is so small, the results are very preliminary and cannot yet guide treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Low-dose brachytherapy (radiation) plus standard immunotherapy (immune checkpoint inhibitor)
- What this could lead to
- If it works, this could point toward a way to make immunotherapy more effective by adding targeted radiation directly to tumors.
- What could go wrong
- This is a very early, tiny pilot study with only 5 people. It is too small to draw firm conclusions, and the combination may not improve outcomes or could increase side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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5 people
The number who actually took part.
- Started
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May 2021
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44122, United States
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