NRG-BN002
Terminated
Protocol Information
Tab containing protocol details, study design, and eligibility criteria
Tab containing study documents, informed consent forms, and study materials
Tab containing information for potential study participants
Phase I Study of Ipilimumab, Nivolumab, and the Combination in Patients with Newly Diagnosed Glioblastoma
Principal Investigator
Status
Terminated
Open to Accrual
July 13, 2015
Temporarily Closed to Accrual
December 2, 2015
Open to Accrual
December 9, 2015
Temporarily Closed to Accrual
February 10, 2016
Open to Accrual
February 17, 2016
Temporarily Closed to Accrual
May 10, 2016
Open to Accrual
July 15, 2016
Temporarily Closed to Accrual
August 9, 2016
Open to Accrual
August 16, 2016
Temporarily Closed to Accrual
August 24, 2016
Open to Accrual
August 31, 2016
Temporarily Closed to Accrual
November 1, 2016
Open to Accrual
February 23, 2017
Closed to Accrual
August 16, 2017
Closed to Accrual & Treatment
November 5, 2018
Terminated
December 22, 2022
Disease Site
Brain [BN] Malignant Glioma
Phase
I
Developmental Therapeutics
Yes
Primary Objective
Determine the maximum safe dose of single-agent treatment with ipilimumab, nivolumab and the combination when given with temozolomide during maintenance treatment for newly diagnosed glioblastoma.
Patient Population
Histopathologically proven diagnosis of glioblastoma or gliosarcoma prior to registration by pathology report. The tumor must be unifocal, confined to the supratentorial compartment and have undergone a gross total or near gross total resection.
Please note
This is a limited-institution study with pre-selected sites.
Target Accrual
42
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.
Protocol Document
Informed Consent
Tracked Amendments
- NRG-BN002-Amendment-12-protocol-and-consent-tracked.pdf
- NRG-BN002-Amendment-3-protocol-and-consent-tracked.pdf
- NRG-BN002-Amendment-4-protocol-and-consent-tracked.pdf
- NRG-BN002-Amendment-6-protocol-tracked.pdf
- NRG-BN002-Amendment-7-protocol-tracked.pdf
- NRG-BN002-Amendment-8-protocol-and-consent-tracked.pdf
- NRG-BN002-Amendment-8-protocol-tracked.pdf
- NRG-BN002-Amendment-9-protocol-tracked.pdf
- NRG-BN002-Amendment-10-protocol-tracked.pdf
Previous Protocol Versions
Previous Informed Consents
Summary of Changes
Forms
Study Memos
- NRG-BN002-Study-Memorandum-Amendment-10-January-29-2019.pdf
- NRG-BN002-Study-Memorandum-Closure-August-16-2017.pdf
- NRG-BN002-Study-Memorandum-Closure-Notice-August-2-2017.pdf
- NRG-BN002-Study-Memorandum-Amendment-8-April-7-2017.pdf
- NRG-BN002-Study-Memorandum-Amendments-76Reopening-February-23-2017.pdf
- NRG-BN002-Study-Memorandum-Temporary-Closure-November-1-2016.pdf
- NRG-BN002-Study-Memorandum-Reopening-of-DL-3.3a-August-31-2016.pdf
- BN001-BN002-and-CC003-Study-Memorandum-April-8-2016.pdf
- NRG-BN002-Study-Memorandum-Amendment-5-March-18-2016.pdf
- CTEP-Action-Letter-for-Studies-Using-Ipilimumab-March-17-2016.pdf
- CTEP-Action-Letter-for-Studies-Using-Nivolumab-March-17-2016.pdf
- NRG-BN002-Study-Memorandum-Amendment-4-December-28-2015.pdf
- NRG-BN002-Study-Memorandum-Amendment-3-September-29-2015.pdf
- NRG-BN002-Study-Memorandum-Reactivation_Amendments-1-2-July-13-2015.pdf
- NRG-BN002-Study-Memorandum-Activation-April-13-2015.pdf
Safety Reports
- Ipilimumab-Nivolumab-AE-2101848_-10-15-21_ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2724667_11-8-21-ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2812676_9-16-21_ISR.pdf
- Nivolumab-AE-2387700_1-19-2022-FU-2.pdf
- Nivolumab-and-Ipilimumab-AE-2656714_1-22-22_FU1.pdf
- Ipilimumab-Nivolumab_AE-2764709_11-12-21-FU1.pdf
- Nivolumab-AE-2410214_11-16-2021-FU-1.pdf
- Mar.3.2022.Ipilimumab-and-Nivolumab-AE-2337769_-12-15-2021-ISR.pdf
- Mar.3.2022.Ipilimumab-and-Nivolumab-AE-2884258_-12-16-2021_ISR.pdf
- Mar.3.2022.Nivolumab-AE-2594900_12-22-2021-ISR.pdf
- Mar.3.2022.Nivolumab-AE-2606703_11-23-2021-ISR.pdf
- Mar.3.2022.Nivolumab-AE-2600198_-11-18-2021_SR.pdf
- Ipilimumab-and-Nivolumab-AE-2884258-Protocol-EA6141-FU-1.pdf
- Ipilimumab-and-Nivolumab-AE-2427414-Protocol-NRG-BN007-ISR.pdf
- Nivolumab-AE-2808782_-4-1-2022_-ISR.pdf
- Nivolumab-AE-2121446_4-21-22-ISR.pdf
- Ipilimumab-Nivolumab-XL184-AE-2528098_4-18-22-FU-1.pdf
- Ipilimumab-and-Nivolumab-AE-2001839-Protocol-EA2174-ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2733334_-6-30-2022_-ISR.pdf
- Nivolumab-and-Ipilimumab-AE-2217814-and-AE-2240757_july-8-2022-ISR.pdf
- Nivolumab-and-Talimogene-laherparepvec-AE-2149339_-6-28-2022_-FU-1.pdf
- Nivolumab-and-XL184-Cabozantinib-AE-2431301-Protocol-A031704-FU-2.pdf
- Nivolumab-and-Ipilimumab-AE-2537691_7-25-2022_ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2858701_7-11-2022-ISR.pdf
- Nivolumab-and-Talimogene-laherparepvec-AE-2149339_7.6.FU-2.pdf
- Ipilimumab-and-Nivolumab-AE-2386542_9-26-22-ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2225591-Oct-28-2022-ISR.pdf
- Ipilimumab-and-Nivolumab-Nov-8-2022-FU-1.pdf
- Ipilimumab-and-Nivolumab-AE-2474947_1-31-2023_ISR.pdf
- Ipilimumab-and-Nivolumab-AE-2114316_-1-23-2023_ISR.pdf
- Ipilimumab-Nivolumab-and-XL184-AE-2884721_3-20-2023_-FU-2.pdf
- Ipilimumab-Nivolumab-and-XL184-AE-2884721_3-8-2023_FU-1.pdf
- Nivolumab-AE-2255992_4-19-2023_FU-1.pdf
- Nivolumab-AE-2255992_3-28-2023-ISR.pdf
- Ipilimumab-Nivolumab-and-XL184-AE-2864407_3-29-23_.pdf
- Ipilimumab-and-Nivolumab-AE-2970751-4.21.23_ISR.pdf
- Ipilimumab-Nivolumab-and-XL184-AE-2121179-6.5.2023-ISR.pdf
- Nivolumab-AE-2255992_5.9.2023-FU-2.pdf
- Nivolumab-AE-2562894_5.11.2023-ISR.pdf
- BMS_109136-Posted-7-1-19.pdf
- BMS_112286-Posted-7-1-19.pdf
- BMS-2018-119416-Posted-4-15-19.pdf
- Ipilimumab-Posted-12-23-19-1.pdf
- Ipilimumab-Bevacizumab-Posted-7-15-19.pdf
- Ipilimumab-Posted-8-26-19.pdf
- Nivolumab-Ipilimumab-Posted-5-28-19.pdf
- Nivolumab-Ipilimumab-Posted-5-28-192.pdf
- Nivolumab-Ipilimumab-Posted-5-28-193.pdf
- Nivolumab-Ipilimumab-Posted-5-28-19-1.pdf
- Nivolumab-Ipilimumab-Posted-6-10-19.pdf
- Nivolumab-Ipilimumab-Posted-8-5-19.pdf
- Nivolumab-Ipillimumab-Posted-7-22-19.pdf
- Nivolumab-and-Ipilimumab-Posted-11-4-19.pdf
- Nivolumab-and-Ipilimumab-Posted-11-11-19.pdf
- Nivolumab-3-25-19.pdf
- Nivolumab-and-Ipilimumab-Posted-9-2-19.pdf
- Varlilumab-Nivolumab-Posted-5-28-19.pdf
- Varlilumab-Nivolumab-Posted-5-28-192.pdf
- Varlilumab-Nivolumab-Posted-5-6-19.pdf
- 1.6.22-Ipilimumab-and-Nivolumab-AE-2731178_12-14-2021.ISR_.pdf
- 12.3.21-Ipilimumab-and-Nivolumab-AE-2956220_10-29-2021-ISR.pdf
- 12.3.21-Nivolumab-Ipilimumab-AE-2928511_10-1-2021-ISR.pdf
- Copanlisib-dihydrochloride-and-Nivolumab-AE-2410214_10-19-2021_ISR-POSTED-11.11.21.pdf
- 9.17.21-Nivolumab-AE-2859502_8-13-2021-ISR.pdf
- Copanlisib-Ipilimumab-Nivolumab-Posted-1.11.21.pdf
- Ipilimumab-Posted-1-6-2020.pdf
- Ipilimumab-Posted-8-10-2020.pdf
- Ipilimumab-Nivolumab-and-Recombinant-Human-IL-15-Posted-12.14.20.pdf
- Ipilimumab-and-Nivolumab-AE-2956220_10-29-2021-ISR-POSTED-11.11.21.pdf
- Ipilimumab-and-Nivolumab-Posted-4.5.21.pdf
- Ipilimumab-Nivolumab-and-Recombinant-Human-IL-15-Posted-1.11.21.pdf
- Nivolumab-Posted-1.19.21-2.pdf
- Nivolumab-Posted-1.19.21.pdf
- Nivolumab-Posted-12.14.20.pdf
- Nivolumab-Posted-11.30.20.pdf
- Nivolumab-Posted-11.12.20.pdf
- Nivolumab-Posted-12.21.20.pdf
- Nivolumab-Posted-2.15.21.pdf
- Nivolumab-Posted-2.29.21.pdf
- Nivolumab-Posted-2-17-20.pdf
- Nivolumab-Posted-2-17-20-2.pdf
- Nivolumab-Posted-3-9-20.pdf
- Nivolumab-Posted-5-4-20.pdf
- Nivolumab-Posted-5-26-20-2.pdf
- Nivolumab-Posted-4.6.2020.pdf
- Nivolumab-Posted-6-8-20.pdf
- Nivolumab-Posted-8.17.20.pdf
- Nivolumab-Posted-9.21.20.pdf
- Nivolumab-2-Posted-11.30.20.pdf
- Nivolumab-2-Posted-11.12.20.pdf
- Nivolumab-1-Posted-6-8-20.pdf
- Nivolumab-2-Posted-5-4-20.pdf
- Nivolumab-2-Posted-8.17.20.pdf
- Nivolumab-3-Posted-11.12.20.pdf
- Nivolumab-5-Posted-11.12.20.pdf
- Nivolumab-4-Posted-11.12.20.pdf
- Nivolumab-3-Posted-5-4-20.pdf
- Nivolumab-and-Copanlisib-Posted-3.22.21.pdf
- Nivolumab-and-Ipilimumab-1.25.21.pdf
- Nivolumab-and-Ipilimumab-Posted-1.11.21.pdf
- Nivolumab-and-Ipilimumab-Posted-11.12.20.pdf
- Nivolumab-and-Ipilimumab-Posted-10.19.20.pdf
- Nivolumab-and-Ipilimumab-Posted-1.4.21.pdf
- Nivolumab-and-Ipilimumab-Posted-11.30.20.pdf
- Nivolumab-and-Ipilimumab-Posted-1-6-2020.pdf
- Nivolumab-and-Ipilimumab-Posted-2.15.21.pdf
- Nivolumab-and-Ipilimumab-Posted-2-17-20-3.pdf
- Nivolumab-and-Ipilimumab-Posted-2-17-20-2.pdf
- Nivolumab-and-Ipilimumab-Posted-2.29.21.pdf
- Nivolumab-and-Ipilimumab-Posted-2-17-20-4.pdf
- Nivolumab-and-Ipilimumab-Posted-2-17-20.pdf
- Nivolumab-and-Ipilimumab-Posted-3.2.2020.pdf
- Nivolumab-and-Ipilimumab-Posted-4.6.2020.pdf
- Nivolumab-and-Ipilimumab-Posted-4.6.2020-2.pdf
- Nivolumab-and-Ipilimumab-Posted-3.22.21.pdf
- Nivolumab-and-Ipilimumab-Posted-4-20-20.pdf
- Nivolumab-and-Ipilimumab-Posted-8-10-2020.pdf
- Nivolumab-and-Ipilimumab-2-Posted-11.12.20.pdf
- Nivolumab-and-Ipilimumab-2-Posted-2.29.21.pdf
- Nivolumab-and-Ipilimumab-2-Posted-1-6-2020.pdf
- Nivolumab-and-Ipilimumab-2-Posted-11.30.20.pdf
- Nivolumab-and-Ipilimumab-2-Posted-8-10-20.pdf
- Nivolumab-and-Ipilimumab-3-Posted-8-10-2020.pdf
- Nivolumab-and-Ipilimumab-AE-2429564_Feb-12-2020_-ISR.pdf
- Nivolumab-Posted-5-26-20-1.pdf
- Nivolumab-and-XL184-Cabozantinib-AE-2431301-7-6-2021-FU-1.pdf
- Nivolumab-and-Ipillimumab-Posted-7-7-2020.pdf
- Nivolumab-Posted-5-26-20.pdf
- Nivolumab-AE-2372628_7-8-2021_FU-1.pdf
- Nivolumab-AE-2451406-7-22-2021_3-ISR.pdf
- Nivolumab_Ipilimumab-Posted-9.28.20.pdf
- Nivolumab-Ipilimumab-and-Cabozatinib-Posted-8-10-2020.pdf
- Nivolumab-Ipilimumab-and-Cabozantinib-Posted-10.5.20.pdf
- Posted-1.14.22-Ipilimumab-Nivolumab-Cabozantinib-AE-2124027_12-Dec-16-2021-FU1.pdf
- Posted-8.12.21-Ipilimumab-and-Nivolumab-AE-2116361-7-26-21ISR.pdf
- Posted-8.12.21-Ipilimumab-and-Nivolumab-AE-2195772-and-AE-2857228-7-21-21-FU-1.pdf
- Posted-8.6.21-Nivolumab-and-XL184-Cabozantinib-AE-2431301-7-6-2021-FU-1.pdf
- Posted-8.6.21-Nivolumab-AE-2372628_7-8-2021_FU-1.pdf
- Posted-8.6.21-Nivolumab-AE-2451406-7-22-2021_3-ISR.pdf
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.
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