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Trial record 17 of 1109 for:    Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation, Approved for marketing Studies | glioblastoma

Trial of Combination TTF(Optune), Nivolumab Plus/Minus Ipilimumab for Bevacizumab-naïve, Recurrent Glioblastoma

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ClinicalTrials.gov Identifier: NCT03430791
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : June 11, 2019
Sponsor:
Collaborators:
Bristol-Myers Squibb
NovoCure Ltd.
Information provided by (Responsible Party):
Baptist Health South Florida

Brief Summary:
Phase II trial in which participants with bevacizumab-naïve, recurrent glioblastoma will receive a combination of tumor treating fields(portable device), nivolumab with or without ipilimumab.

Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Drug: Nivolumab 240 mg IV Drug: Nivolumab 3 mg/kg Drug: Ipilimumab 1 mg/kg Device: NovoTTF200A (Optune) Phase 2

Detailed Description:

Phase II trial in which participants with bevacizumab-naïve, recurrent glioblastoma will receive a combination of tumor treating fields(portable device), nivolumab with or without ipilimumab.

The NovoTTF200A (OptuneTM) device is worn continuously for a goal of 75% or more of the time, ranging from at least 18 hours daily uninterrupted or 22 hours daily with 2-3 days off monthly. Therapy is planned for approximately 24 months.

Infusions with nivolumab will start within 1 week of study start. Ipilimumab will either start with the second nivolumab infusion or at after tumor progression. Nivolumab is infused intravenously at 240 mg once every 2 weeks with or without ipilimumab for a maximum of 24 months. Ipilimumab is dosed at 1 mg/kg once every 6 weeks for a maximum of 4 doses (24 weeks). Infusions will continue until maximum doses are completed or there is confirmed tumor progression, intolerable adverse effects or withdrawal of consent.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an open-label, phase II trial with two parallel arms, two-stage design and appropriate stopping rules for poor efficacy. Arm A will enroll participants without prior PD1/PDL1 checkpoint inhibitor, while Arm B will enroll participants with prior PD1/PDL1 checkpoint inhibitor. The investigator expect to enroll at least 30 (15 in each Arm) and a maximum of 60 (30 in each Arm) evaluable subjects. All subjects will receive TTFields therapy plus nivolumab infusions for a maximum of 24 months, plus/minus concurrent ipilimumab for a maximum of 4 doses.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Combination Tumor Treating Fields, Nivolumab Plus/Minus Ipilimumab for Bevacizumab-naïve, Recurrent Glioblastoma
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nivolumab Monotherapy
Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months
Drug: Nivolumab 240 mg IV
Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
Other Name: Nivolumab Monotheraphy

Device: NovoTTF200A (Optune)
A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.

Experimental: Nivolumab+Ipilimumab

Nivolumab 3 mg/kg IV with ipilimumab then 240 mg every 2 weeks for maximum of 24 months.

Ipilimumab 1 mg/kg IV every 6 weeks maximum of 4 times. NovoTTF200A (Optune) TTF for maximum 24 months

Drug: Nivolumab 240 mg IV
Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
Other Name: Nivolumab Monotheraphy

Drug: Nivolumab 3 mg/kg
Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
Other Name: Nivolumab+Ipilimumab

Drug: Ipilimumab 1 mg/kg
Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
Other Name: Nivolumab+Ipilimumab

Device: NovoTTF200A (Optune)
A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.




Primary Outcome Measures :
  1. Objective response rate according to modified iRANO criteria [ Time Frame: Analyses will occur 4 months after accrual of 15 patients for each arm. ]
    Overall response rate is the proportion of patients whose best overall response per modified iRANO criteria is complete (CR) or partial (PR) after at least 6 weeks from start of therapy



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:

  • Histologically confirmed World Health Organization Grade IV glioblastoma with supratentorial distribution.
  • Unequivocal evidence of progressive disease on contrast-enhanced brain CT or MRI as defined by RANO criteria, or documented recurrent glioblastoma on biopsy.
  • Prior therapies including radiation and temozolomide.
  • Only 1-2 prior treatments for recurrences are allowed. Resection of recurrent glioblastoma is not considered a prior treatment.
  • Must be at least 12 weeks from radiotherapy or progression outside of the high-dose radiation target volume or unequivocal evidence of progressive tumor on biopsy.
  • All adverse events Grade > 1 related to prior therapies (chemotherapy, radiotherapy, and/or surgery) must be resolved, except for alopecia.
  • Karnofsky Performance Status (KPS) ≥ 60
  • Adequate organ and marrow function as defined below, all screening labs should be performed within 14 days of treatment initiation:

    • absolute neutrophil count ≥ 1,000/mcL
    • platelets ≥ 100,000/mcL
    • hemoglobin > 8.0 mg/dL
    • total bilirubin ≤ 2.0 x upper limit of normal
    • AST (SGOT)/ALT (SGPT) ≤2.5 × upper limit of normal
    • creatinine or creatinine clearance ≥60 mL/min/1.73 m2 for creatinine >ULN
  • Corticosteroid dose must be stable or decreasing for at least 5 days prior to enrollment.
  • Ability to understand and the willingness to provide written informed consent.

Exclusion Criteria:

  • Infratentorial disease.
  • Prior use of bevacizumab, ipilimumab or other CTLA-4 inhibitor, or TTFields.
  • Tumors with known IDH1 or IDH2 mutations.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab or ipilimumab or their excipients.
  • Current or planned participation in a study of an investigational agent or using an investigational device.
  • Uncontrolled intercurrent illness that would limit compliance with study requirements.
  • Active or life-threatening infection requiring intravenous or >2 weeks of systemic therapy.
  • Prior stereotactic radiotherapy, convection enhanced delivery (CED) or brachytherapy requires a biopsy to confirm radiographic progression is consistent with progressive tumor and not treatment-related necrosis unless the recurrent lesion is outside of any prior high-dose radiation target volume or distant from the prior CED or brachytherapy site.
  • breastfeeding must be discontinued by enrollment on study.
  • Uncontrolled HIV or AIDS is not allowed. Patients with known history of HIV but with undetectable viral load on antiretroviral therapy are allowed.
  • CHF, or MI or hemorrhagic/ischemic stroke in the last 3 months.
  • Active illicit drug use or diagnosis of alcoholism
  • Known additional malignancy that is progressing or requires active treatment within 3 years of start of study drug.
  • Any surgery (not including minor diagnostic procedures such as lymph node biopsy) within 2 weeks of start of treatment.
  • Any significant autoimmune disorders expected to impact multiple or internal organs, excluding mild eczema or autoimmune thyroiditis treated with thyroidectomy and requiring systemic immunosuppressive or immunomodulatory therapy.
  • Any implanted programmable cranial device, including reprogrammable ventriculoperitoneal shunt (VPS) or cochlear implants, that precludes use of TTFields (Optune) therapy.

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): NCT03430791


Contacts
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Contact: Yazmin Odia, MD 786-527-8082 yazmino@baptisthealth.net

Locations
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United States, Florida
Miami Cancer Institute at Baptist Health, Inc. Recruiting
Miami, Florida, United States, 33176
Contact: Yazmin Odia, MD    786-527-8082    yazmino@baptisthealth.net   
Principal Investigator: Yazmin Odia, MD         
Sponsors and Collaborators
Baptist Health South Florida
Bristol-Myers Squibb
NovoCure Ltd.
Investigators
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Principal Investigator: Yazmin Odia Miami Cancer Institute at Baptist Health, Inc.

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Responsible Party: Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT03430791     History of Changes
Other Study ID Numbers: 2017-ODI-002
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: May 2019
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Baptist Health South Florida:
bevacizumab-naïve
recurrent glioblastoma
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors