Melanoma Clinical Trial

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

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.

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Full 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 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, and evaluate response.

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Eligibility Criteria

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.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

15

Study ID:

NCT04620603

Recruitment Status:

Recruiting

Sponsor:

Case Comprehensive Cancer Center

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There is 1 Location for this study

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Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland Ohio, 44122, United States More Info
Jay Ciezki, MD
Contact
866-223-8100
[email protected]
Jay Ciezki
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

15

Study ID:

NCT04620603

Recruitment Status:

Recruiting

Sponsor:


Case Comprehensive Cancer Center

How clear is this clinincal trial information?

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