Clinical Trials /

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

NCT04620603

Description:

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.

Related Conditions:
  • Cutaneous Melanoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer
  • Official Title: Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer

Clinical Trial IDs

  • ORG STUDY ID: CASE6620
  • NCT ID: NCT04620603

Conditions

  • Cutaneous Malignant Melanoma

Interventions

DrugSynonymsArms
NivolumabOpdivoLDR + Nivolumab

Purpose

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.

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 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.
    

Trial Arms

NameTypeDescriptionInterventions
LDR + NivolumabExperimentalParticipants 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 Nivolumab at the standard FDA approved dose of 480mg given on the first day of every 28 day cycle. Participants can receive up to 12 doses of Nivolumab.
  • Nivolumab

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description: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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Case Comprehensive Cancer Center

Last Updated

November 4, 2020