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Checkpoint Inhibitor
LDR Brachytherapy + Immunotherapy for Melanoma
Phase 1 & 2
Recruiting
Led By Jay Ciezki, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have histologically confirmed unresectable stage III or stage IV cutaneous melanoma, stage IV renal cell cancer, and stage IV urothelial cancer
Female participants who meet specific criteria for postmenopausal status, surgical sterility, or contraception use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after brachytherapy
Awards & highlights
Study Summary
This trial is testing a new combination treatment for stage III and IV melanoma that includes low dose rate brachytherapy along with standard immunotherapy.
Who is the study for?
This trial is for adults with certain advanced cancers (stage III/IV melanoma, stage IV kidney or urothelial cancer) who are in fair to good health and not pregnant. They must have measurable disease, meet specific lab value criteria, and agree to use contraception if applicable. It's not for those with other active metastatic cancers needing treatment, recent anti-cancer therapy, high-dose steroid use, uncontrolled HIV/hepatitis, certain types of melanoma or brain radiation history.Check my eligibility
What is being tested?
The study tests adding low dose rate brachytherapy (LDR), a type of internal radiation therapy, to the standard immune checkpoint inhibitors used in treating advanced skin cancer (melanoma), kidney cancer (renal cell carcinoma), and bladder cancer (urothelial). The goal is to see how well they work together.See study design
What are the potential side effects?
Possible side effects include typical reactions from immunotherapy like fatigue, skin reactions or autoimmune conditions where the body attacks its own cells. Brachytherapy may cause localized pain or discomfort at the site of treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced and cannot be removed by surgery.
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I am a woman who is either postmenopausal, surgically sterile, or using contraception.
Select...
I am a man who is either surgically sterile or using contraception.
Select...
I am able to get out of my bed or chair and move around.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months after brachytherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after brachytherapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)
Number of participants with tumor response assessed by RECIST v1.1
Trial Design
1Treatment groups
Experimental Treatment
Group I: LDR + SOC ImmunotherapyExperimental Treatment2 Interventions
Participants will receive one treatment of brachytherapy on treatment day 1 (LDRD1). After a minimum of 7 days but no more than 30 days to allow antigenic release, participants will then begin immunotherapy treatment with SOC immunotherapy at the standard FDA-approved dose. Standard immunotherapy will be administered on D1 of every standard of care cycle (either 14, 21, 28, or 42 day cycle) at the standard dose. Participants can receive up to 1 year of SOC immunotherapy.
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,895 Total Patients Enrolled
Jay Ciezki, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active cancer needing treatment, except for skin, kidney, or bladder cancer.My cancer was diagnosed less than 3 years ago and needed treatment that affects my whole body.Your blood test results need to be within certain ranges.My cancer is advanced and cannot be removed by surgery.I am a woman who is either postmenopausal, surgically sterile, or using contraception.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.You have a disease that can be measured using specific guidelines.My HIV or hepatitis is not under control.I am a man who is either surgically sterile or using contraception.I haven't had cancer treatment for melanoma, kidney, or bladder cancer in the last 2 weeks.I am able to get out of my bed or chair and move around.I am taking more than 15mg of prednisone or its equivalent daily.I have been diagnosed with melanoma of the mucosal or uveal type.I have received whole head radiation for brain metastases.
Research Study Groups:
This trial has the following groups:- Group 1: LDR + SOC Immunotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for individuals to join this research trial?
"Clinicaltrials.gov confirms that this research endeavour is still currently recruiting patients, having been initially posted on May 27th 2021 and recently renewed on August 10th 2022."
Answered by AI
What type of illnesses can Low Dose Rate Brachytherapy (LDR) be utilized to remediate?
"Low Dose Rate Brachytherapy (LDR) is a viable treatment option for patients suffering from malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
Are there any documented instances of Low Dose Rate Brachytherapy (LDR) being studied previously?
"Currently, there are 718 clinical trials globally researching Low Dose Rate Brachytherapy (LDR), with 82 of them in the advanced Phase 3. Of those, many originate in Basel BE but can be found at 40283 different locations worldwide."
Answered by AI
Has a clinical trial of this kind ever been attempted before?
"Since 2012, Low Dose Rate Brachytherapy (LDR) research has been conducted. The inaugural study was funded by Ono Pharmaceutical Co. Ltd and included 659 participants before it received Phase 1 & 2 approval. Currently, 718 trials are actively testing this treatment option in 2355 cities across 49 nations around the world."
Answered by AI
What is the uppermost limit of individuals taking part in this clinical experiment?
"Indeed, clinicaltrials.gov confirms that this trial is still seeking enrolment, with the initial posting having been made on May 27th 2021 and last updated August 10th 2022. In total 15 volunteers are being recruited from a single site."
Answered by AI
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