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SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients

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ClinicalTrials.gov Identifier: NCT03126461
Recruitment Status : Withdrawn (the project was never initiated and no participants were enrolled, it was closed permanently)
First Posted : April 24, 2017
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
A one-arm, single center phase 2 trial of SAbR plus ipilimumab plus nivolumab in advanced metastatic melanoma patients

Condition or disease Intervention/treatment Phase
Melanoma Metastatic Melanoma Radiation: SAbR Drug: Ipilimumab Drug: Nivolumab Phase 2

Detailed Description:
SAbR/GRID plus ipilimumab 3mg/kg IV q3wk x 4 plus nivolumab 1 mg/kg IV q3wk x 4, followed by nivolumab 240 mg IV q 2wk until progression or intolerable toxicity

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Trial of SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: SAbR plus ipilimumab plus nivolumab
SAbR/GRID plus ipilimumab 3mg/kg IV q3wk x 4 plus nivolumab 1 mg/kg IV q3wk x 4, followed by nivolumab 240 mg IV q 2wk until progression or intolerable toxicity
Radiation: SAbR
For patients treated on the "GRID A" regimen, a dose of 15-20 Gy will be delivered with the GRID device in either a single field, with prescription to dmax, or with parallel opposed GRID fields (matching beamlets from the opposed directions). For patients treated on the "GRID B" regimen, this same dose will be delivered, with a subsequent regimen of 3 Gy X 10 fractions, with the first of these fractions following the GRID dose.
Other Name: Stereotactic ablative body radiation

Drug: Ipilimumab
ipilimumab 3mg/kg IV q3wk x 4
Other Name: Yervoy®

Drug: Nivolumab
nivolumab 1 mg/kg IV q3wk x 4
Other Name: Opdivo®




Primary Outcome Measures :
  1. Change of tumor size from baseline to follow up [ Time Frame: at 12, 24, 36 weeks ]
    treatment response rate—RR based on RECISTv1.1


Secondary Outcome Measures :
  1. disease control rate [ Time Frame: at 12, 24, 36 weeks ]
    disease control rate defined as response plus stable disease based on RECISTv1.1

  2. Number of treatment-related adverse events [ Time Frame: 2 years ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  3. programmed death ligand-1 (PD-L1) expression [ Time Frame: baseline, cycle 1 Day 1, and week 15 ]
    compare tumor PD-L1 expression at 3 time points



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic diagnosis of metastatic melanoma.
  • Any number of prior systemic therapeutic regimens including chemotherapy, pathway inhibitors, biochemotherapy, investigational agents, and immunotherapies other than ipilimumab, nivolumab or other CTLA-4, PD-1 or PD-L1 inhibitors.
  • Patients must have measurable disease in at least 2 non-radiated sites as defined by RECIST v1.1. All sites must be evaluated within 4 weeks prior to registration.
  • Age ≥ 18 years.
  • Eligible for SABR to 1-5 sites of disease (Refer to 3.2.10)
  • Performance status ECOG 0-2.
  • Adequate organ and marrow function as defined below:

    • leukocytes ≥ 1,000/mcL
    • absolute neutrophil count ≥ 1,000/mcL
    • platelets ≥ 75,000/mcl
    • total bilirubin < 2.5X institutional upper limit of normal or

      • 3 in subjects with Gilbert's Syndrome
    • AST(SGOT)/ALT(SPGT) ≤ 4 X institutional upper limit of normal
    • creatinine < 4X institutional upper limit of normal
    • hemoglobin >7g/dL
  • Ability to understand and the willingness to sign a written informed consent.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of protocol treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

  • No concomitant therapy with any of the following: IL2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; or other investigational therapies; all such therapies must have been discontinued >4weeks prior to registration.
  • No infection with HIV and no known history of hepatitis B or hepatitis C virus indicating acute or chronic infection or active TB.
  • Patients are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated (Surgery or radiation) and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or localized adenocarcinoma of the cervix.
  • 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.
  • Patients must not be pregnant or nursing.
  • Patients are excluded if they have a history of prior treatment with ipilimumab, CTLA-4 inhibitor or agonist, nivolumab, PD-1 or PD-L1 inhibitor.
  • Subjects who have had major surgery within 2 weeks prior to first dose of drug
  • Subjects who have had radiation therapy within 2 weeks prior to first dose of drug
  • Uncontrolled adrenal insufficiency or active chronic liver disease
  • Any history of CNS metastases that is not adequately treated (surgery or radiation ) >14 days prior to registration.
  • Any active known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalent are permitted (although not encouraged) in the absence of active autoimmune disease.
  • Subjects with life expectancy < 6 months
  • Subjects receiving any other investigational or standard antineoplastic agents.

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): NCT03126461


Locations
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United States, Texas
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Kevin Albuquerque, MD University of Texas Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03126461     History of Changes
Other Study ID Numbers: STU 082016-058
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: No
Keywords provided by University of Texas Southwestern Medical Center:
metastatic melanoma
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
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents