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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04620603
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Case Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jay Ciezki, MD
Principal Investigator Affiliation Cleveland Clinic, Case Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Cutaneous Malignant Melanoma, Renal Cell Cancer, Urothelial Cancer of Renal Pelvis
Additional Details

The purpose of this study is to evaluate the effect of combining LDR with immune checkpoint inhibition in stage III and IV melanoma, stage IV renal call cancer, and stage IV urothelial cancer. This involves the addition of a treatment called brachytherapy to SOC immunotherapy. Brachytherapy is a form of radiation therapy where radioactive pellets are placed within a tumor to temporarily irradiate the tumor at a low level. This is the first time that this combination (immunotherapy and brachytherapy) has been used in humans. The objectives of this study are to evaluate the effect of combining LDR with immunotherapy, determine safety and feasibility, generate a toxicity profile, evaluate response, and overall survival.

Arms & Interventions

Arms

Experimental: LDR + SOC Immunotherapy

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.

Interventions

Radiation: - Low Dose Rate Brachytherapy (LDR)

LDR on treatment day 1

Drug: - Standard-of-Care Immunotherapy

Standard or care immunotherapy will be administered at the FDA approved dose via IV infusion.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44122

Site Contact

Jay Ciezki, MD

[email protected]

866-223-8100

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