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Study Investigator/Sponsor decided to end enrollment earlier.
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| NovoCure Ltd. | INDUSTRY |
Not provided
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Phase I/II trial in which participants with recurrent glioblastoma will receive a combination of tumor treating fields(portable device), nivolumab with or without ipilimumab.
Phase I/II trial in which participants with 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab Monotherapy | Experimental | Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months |
|
| Nivolumab+Ipilimumab | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab 240 mg IV | Drug | Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate According to Modified iRANO Criteria | Objective response rate is the proportion of patients whose best overall response per modified immunotherapy response assessment in neuro-oncology (iRANO) criteria is complete (CR) or partial (PR) after at least 6 weeks from start of therapy | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by Standard RANO Criteria | Objective response rate is the proportion of patients whose best overall response per response assessment in neuro-oncology (RANO) criteria is complete (CR) or partial (PR) after at least 6 weeks from start of therapy | 2 years |
| Progression Free Survival (PFS) |
Not provided
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 Response Assessment in Neuro-Oncology (RANO) criteria, or documented recurrent glioblastoma on biopsy.
Measurable disease based on RANO criteria.
Prior therapies including radiation and temozolomide.
Any number of recurrences are allowed. Resection of recurrent glioblastoma is not considered a prior treatment.
From the projected start date of study treatment, the following periods must have elapsed: 4 weeks from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), or 4 weeks from any other antibodies or any other antineoplastic therapies.
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:
Corticosteroid dose must be stable or decreasing for at least 5 days prior to enrollment.
Nivolumab and ipilimumab are potentially teratogenic or abortifacient. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to entry and for the duration of study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Male subjects should agree to use adequate method of contraception starting with the first dose through 7 months after the last dose of therapy.
Brain CT or MRI within 14 days prior to start of study drug.
Archival tissue for evaluation of correlative objectives (if available).
Ability to understand and the willingness to provide written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yazmin Odia | Miami Cancer Institute at Baptist Health, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | 33176 | United States |
Not provided
| Label | URL |
|---|---|
| Miami Cancer Institute website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab Monotherapy | Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2019 |
Not provided
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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 tumor treating field (TTF) therapy plus nivolumab infusions for a maximum of 24 months, plus/minus concurrent ipilimumab for a maximum of 4 doses.
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| Nivolumab 3 mg/kg | Drug | Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months. |
|
|
| Ipilimumab 1 mg/kg | Drug | Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses. |
|
|
| NovoTTF200A (Optune) | Device | 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. |
|
The length of time that a participant lives with the disease but it does not get worse. |
| 2 years |
| Number of Toxicities | Total number of toxicities as defined by AEs that attributed as probable or possibly related to the study drug across all study subjects. | Up to 2 years |
| Rate of Treatment Compliance | Percent of participants who have a compliance rate above the 75% goal for tumor treating fields (TTFields) therapy via the NovoTTF200A (OptuneTM). Daily compliance rates for using the device are averaged (mean ± stdev) over the 28-31 days of the month. | Monthly for up to 2 years |
| Discontinuation Rate of Any Component of Therapy | Proportion of participants who discontinued therapy. Reasons for discontinuation also will be noted. | Up to 2 years |
| Change in Quality of Life From Baseline Using the Functional Assessment of Cancer Therapy-Brain (FACT-Br) | FACT-Br is a validated self-report tool measuring general quality of life (QOL) that assesses symptoms or problems associated with CNS tumors across 5 scales. FACT-Br yields data about total QOL, as well as dimensions of disease specific physical, social/family, emotional, and functional well-being. The tool contains 20 items using a 5-point Likert scale. A higher score indicates better QOL, ranging from 0 (lowest) to 92 (highest). Median percent change between first and last measurement provided, with negative percent change indicating a decline in function. | Up to 2 years |
| Change in Quality of Life From Baseline Using the Functional Assessment of Cancer Therapy-General (FACT-G) | FACT-G is a validated self-report tool measuring general quality of life (QOL) that assesses symptoms or problems associated with any tumors. The tool contains 33 items using a 5-point Likert scale. A higher score indicates better QOL, ranging from 0 (lowest) to 108 (highest). Median percent change between first and last measurement provided, with negative percent change indicating a decline in function. | Up to 2 years |
| FG001 |
| 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 Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months. Nivolumab 3 mg/kg: Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months. Ipilimumab 1 mg/kg: Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses. 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
No participants with prior PD1/PDL1 checkpoint inhibitor were enrolled, thus no participants were assigned to the Nivolumab+Ipilimumab arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab Monotherapy | Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months. 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. |
| BG001 | 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 Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months. Nivolumab 3 mg/kg: Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months. Ipilimumab 1 mg/kg: Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate According to Modified iRANO Criteria | Objective response rate is the proportion of patients whose best overall response per modified immunotherapy response assessment in neuro-oncology (iRANO) criteria is complete (CR) or partial (PR) after at least 6 weeks from start of therapy | No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm. | Posted | Count of Participants | Participants | 2 years |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) by Standard RANO Criteria | Objective response rate is the proportion of patients whose best overall response per response assessment in neuro-oncology (RANO) criteria is complete (CR) or partial (PR) after at least 6 weeks from start of therapy | No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm. | Posted | Count of Participants | Participants | 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | The length of time that a participant lives with the disease but it does not get worse. | No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm. | Posted | Mean | Standard Deviation | days | 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Toxicities | Total number of toxicities as defined by AEs that attributed as probable or possibly related to the study drug across all study subjects. | No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm. | Posted | Number | adverse events | Up to 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | Rate of Treatment Compliance | Percent of participants who have a compliance rate above the 75% goal for tumor treating fields (TTFields) therapy via the NovoTTF200A (OptuneTM). Daily compliance rates for using the device are averaged (mean ± stdev) over the 28-31 days of the month. | No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm. | Posted | Mean | Standard Deviation | percent of participants compliant | Monthly for up to 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Discontinuation Rate of Any Component of Therapy | Proportion of participants who discontinued therapy. Reasons for discontinuation also will be noted. | No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm. | Posted | Count of Participants | Participants | Up to 2 years |
| |||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life From Baseline Using the Functional Assessment of Cancer Therapy-Brain (FACT-Br) | FACT-Br is a validated self-report tool measuring general quality of life (QOL) that assesses symptoms or problems associated with CNS tumors across 5 scales. FACT-Br yields data about total QOL, as well as dimensions of disease specific physical, social/family, emotional, and functional well-being. The tool contains 20 items using a 5-point Likert scale. A higher score indicates better QOL, ranging from 0 (lowest) to 92 (highest). Median percent change between first and last measurement provided, with negative percent change indicating a decline in function. | No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm. | Posted | Median | Full Range | percentage of change | Up to 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life From Baseline Using the Functional Assessment of Cancer Therapy-General (FACT-G) | FACT-G is a validated self-report tool measuring general quality of life (QOL) that assesses symptoms or problems associated with any tumors. The tool contains 33 items using a 5-point Likert scale. A higher score indicates better QOL, ranging from 0 (lowest) to 108 (highest). Median percent change between first and last measurement provided, with negative percent change indicating a decline in function. | No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm. | Posted | Median | Full Range | percentage of change | Up to 2 years |
|
18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nivolumab Monotherapy | Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months. 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. | 2 | 4 | 0 | 4 | 4 | 4 |
| EG001 | 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 Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months. Nivolumab 3 mg/kg: Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months. Ipilimumab 1 mg/kg: Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Scalp rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysarthria | Nervous system disorders | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Hemiplegia | Nervous system disorders | Non-systematic Assessment |
| ||
| Hyperthyroid | Endocrine disorders | Non-systematic Assessment |
| ||
| Pituitary disorder | Endocrine disorders | Non-systematic Assessment |
| ||
| Seizure | Nervous system disorders | Non-systematic Assessment |
| ||
| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Toenail avulsion | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Weakness | General disorders | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Worsening herpes zoster infection | Infections and infestations | Non-systematic Assessment |
|
Did not accrue the target number of participants needed to achieve target power and statistically reliable results.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yazmin Odia | Miami Cancer Institute at Baptist Health, Inc. | 786-596-2000 | YazminO@baptisthealth.net |
| Nov 4, 2022 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|---|
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|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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