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

  • STATUS
    Recruiting
  • End date
    Mar 12, 2024
  • participants needed
    15
  • sponsor
    Case Comprehensive Cancer Center
Updated on 12 August 2022

Summary

This is a pilot study of combination low dose rate brachytherapy (LDR) added to standard of care (SOC) immunotherapy with Nivolumab in stage III and IV melanoma.

Description

The purpose of this study is to evaluate the effect of combining LDR with immune checkpoint inhibition in stage III and IV melanoma. This involves the addition of a treatment called brachytherapy to planned immunotherapy with nivolumab (also known as Opdivo®). 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, and evaluate response.

Details
Condition Cutaneous Malignant Melanoma
Treatment Nivolumab, Low Dose Rate Brachytherapy (LDR)
Clinical Study IdentifierNCT04620603
SponsorCase Comprehensive Cancer Center
Last Modified on12 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must have histologically confirmed unresectable stage III or stage IV cutaneous melanoma
ECOG performance status 0-2
Have measurable disease per RECIST v1.1. 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 less than 14 days prior to first dose of study drug
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 drug
Other active non-melanoma metastatic cancers requiring systemic treatment
Participants currently receiving systemic corticosteroids doses over 15mg prednisone or equivalent
Participants with uncontrolled HIV or hepatitis
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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