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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04620603
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Cutaneous Malignant Melanoma Radiation: Low Dose Rate Brachytherapy (LDR) Drug: Standard-of-Care Immunotherapy Phase 1 Phase 2

Detailed 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
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. SOC immunotherapy will be given on the first day of every 28-day cycle. Participants can receive up to 12 doses of SOC immunotherapy.
Radiation: Low Dose Rate Brachytherapy (LDR)
LDR on treatment day 1

Drug: Standard-of-Care Immunotherapy
Every 28 days, 12 cycles total




Primary Outcome Measures :
  1. Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) [ Time Frame: Cycle 3 day 1 (C3D1) of immunotherapy treatment (28-Day cycle) ]

    iRECIST was developed by the RECIST working group for the use of RECIST version 1.1 in cancer immunotherapy trials, to ensure consistent design and data collection.

    ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans


  2. Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) [ Time Frame: Cycle 6 day 1 (C6D1) of immunotherapy treatment (28-Day cycle) ]

    iRECIST was developed by the RECIST working group for the use of RECIST version 1.1 in cancer immunotherapy trials, to ensure consistent design and data collection.

    ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans


  3. Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) [ Time Frame: Cycle 9 day 1 (C9D1) of immunotherapy treatment (28-Day cycle) ]

    iRECIST was developed by the RECIST working group for the use of RECIST version 1.1 in cancer immunotherapy trials, to ensure consistent design and data collection.

    ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans


  4. Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) [ Time Frame: Cycle 12 day 1 (C12D1) of immunotherapy treatment (28-Day cycle) ]

    iRECIST was developed by the RECIST working group for the use of RECIST version 1.1 in cancer immunotherapy trials, to ensure consistent design and data collection.

    ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans


  5. Number of participants with tumor response assessed by RECIST v1.1 [ Time Frame: Cycle 3 day 1 (C3D1) of immunotherapy treatment (28-Day cycle) ]
    ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans

  6. Number of participants with tumor response assessed by RECIST v1.1 [ Time Frame: Cycle 6 day 1 (C6D1) of immunotherapy treatment (28-Day cycle) ]
    ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans

  7. Number of participants with tumor response assessed by RECIST v1.1 [ Time Frame: Cycle 9 day 1 (C9D1) of immunotherapy treatment (28-Day cycle) ]
    ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans

  8. Number of participants with tumor response assessed by RECIST v1.1 [ Time Frame: Cycle 12 day 1 (C12D1) of immunotherapy treatment (28-Day cycle) ]
    ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620603


Contacts
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Contact: Jay Ciezki, MD 1-866-223-8100 TaussigResearch@ccf.org

Locations
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United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44122
Contact: Jay Ciezki, MD    866-223-8100    TaussigResearch@ccf.org   
Principal Investigator: Jay Ciezki         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Jay Ciezki, MD Cleveland Clinic, Case Comprehensive Cancer Center
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04620603    
Other Study ID Numbers: CASE6620
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared but the study team is expecting to publish the data

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas