NRG-HN003
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
A Phase I and Expansion Cohort Study of Adjuvant Cisplatin, Intensity-Modulated Radiotherapy, and MK-3475 (Pembrolizumab) in High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC)
Status
Terminated
Open to Accrual
November 28, 2016
Temporarily Closed to Accrual
March 29, 2017
Open to Accrual
April 19, 2017
Temporarily Closed to Accrual
June 2, 2017
Open to Accrual
October 9, 2017
Temporarily Closed to Accrual
April 6, 2018
Closed to Accrual
October 4, 2018
Closed to Accrual & Treatment
October 4, 2018
Terminated
May 20, 2022
Disease Site
Head and Neck [HN] Head and Neck
Phase
I
Developmental Therapeutics
Yes
Primary Objective
To determine the recommended phase II schedule for the combination of MK-3475 (pembrolizumab) and standard, adjuvant cisplatin-radiotherapy in patients with high-risk, HPV-negative head and neck squamous cell carcinoma, based upon dose-limiting toxicity.
Patient Population
Patients with stage III-IVb, high-risk squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx; patients with oropharyngeal cancer must be p16-negative.
Target Accrual
56
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.
Open Registration Checklist
Blank CRFs
Forms
Regulatory Resources
Study Memos
- NRG-HN003-Study-Memorandum-Permanent-Closure-October-4-2018.pdf
- NRG-HN003-Study-Memorandum-Temporary-Closure-April-6-2018.pdf
- NRG-HN003-Study-Memorandum-Reopening-October-9-2017.pdf
- NRG-HN003-Study-Memorandum-June-5-2017.pdf
- NRG-HN003-Study-Memorandum-Temporary-Closure-June-2-2017.pdf
- CTEP-Action-Letter-for-Studies-Using-Pembrolizumab-June-1-2017-2.pdf
- NRG-HN003-Study-Memorandum-May-12-2017.pdf
- NRG-HN003-Study-Memorandum-Amendment-1_Reopening-April-19-2017.pdf
- NRG-HN003-Study-Memorandum-Temporary-Closure-March-29-2017.pdf
- NRG-HN003-Pathology-Correlative-Instructions-November-28-2016.pdf
- NRG-HN003-Study-Memorandum-Activation-November-28-2016.pdf
- NRG-HN003-Study-Memorandum-Amendments-2-3-July-3-2017.pdf
- NRG-HN003-Study-Memorandum-Amendment-4-September-24-2018.pdf
Safety Reports
- Nivolumab-Blinatumomab-Posted-12-2-19.pdf
- Pembrolizumab-Posted-11-18-19.pdf
- Pembrolizumab-Posted-10-21-19.pdf
- Pembrolizumab-Posted-10-7-19.pdf
- Mogamulizumab-Pembrolizumab-Posted-9-9-19.pdf
- Pembrolizumab-Entinostat-Posted-9-9-19.pdf
- Pembrolizumab-Psoted-9-2-19.pdf
- Pembrolizumab-Ziv-aflibercept-Posted-7-29-19.pdf
- Mogamulizumab-Pembrolizumab-Posted-7-8-19.pdf
- Pembrolizumab-Posted-7-1-19.pdf
- Pembrolizumab-Posted-7-1-19-1.pdf
- Ipilimumab-Bevacizumab-Posted-7-1-19.pdf
- Pembrolizumab-Epacadostat-Posted-6-10-19.pdf
- Pembrolizumab-Posted-6-10-19.pdf
- Pembrolizumab-Posted-4-8-19.pdf
- Pembrolizumab-Posted-3-25-19.pdf
- 1811USA003686-Posted-2-11-19.pdf
- Pembrolizumab-Posted-2-4-19.pdf
- Pembrolizumab-Posted-1-21-19.pdf
- Pembrolizumab-1-21-192.pdf
- Pembrolizumab-Posted-1-14-19.pdf
- Durvalumab-Posted-2-3-20.pdf
- Pembrolizumab-posted-2-10-20-1.pdf
- Pembrolizumab-Posted-2-17-20.pdf
- Pembrolizumab-Posted-3-9-20.pdf
- Pembrolizum-Posted-3-16-20.pdf
- Pembrolizumab-Posted-3-16-20.pdf
- Pembrolizumab-Posted-3_23_2020.pdf
- Pembrolizumab-2-Posted-3_23_2020.pdf
- Pembrolizumab-2-Posted-6.15.20.pdf
- Pembrolizumab-Posted-6.15.20.pdf
- Pembrolizumab-Posted-6-29-20.pdf
- Pembrolizumab-Posted-7-7-2020.pdf
- Pembrolizumab-2-Posted-7-7-2020.pdf
- Mogamulizumab-and-Pembrolizumab-Posted-8.31.20.pdf
- Pembrolizumab-Posted-8.31.20.pdf
- Pembrolizumab-2-Posted-8.31.20.pdf
- Pembrolizumab-Posted-9.28.20.pdf
- Pembrolizumab-Posted-10.5.20.pdf
- Pembrolizumab-Posted-10.26.20.pdf
- Pembrolizumab-Posted-11.30.20.pdf
- Pembrolizumab-3-Posted-11.30.20.pdf
- Pembrolizumab-2-Posted-11.30.20.pdf
- Anetumab-ravtansine-and-Pembrolizumab-Posted-1.19.21.pdf
- Pembrolizumab-Posted-1.25.21.pdf
- Pembrolizumab-1-Posted-1.25.21.pdf
- Pembrolizumab-Posted-1.28.21.pdf
- Pembrolizumab-Posted-2.8.21.pdf
- Pembrolizumab-MK-3475-AE-2446105_3-24-2021_ISR-posted-4-12-2021.pdf
- Pembrolizumab-MK-3475-AE-2496602-posted-4-19-2021.pdf
- 9.17.21-Pembrolizumab-AE-2055713_8-27-2021-FU-1.pdf
- 9.17.21-Pembrolizumab-AE-2475131_8-20-2021_IS.pdf
- 9.17.21-Pembrolizumab-AE-2476748_8-19-2021_ISR.pdf
- 9.17.21-Pembrolizumab-AE-2679951_9-1-2021_FU-1.pdf
- Mar.3.2022.Pembrolizumab-AE-2611854_-1-6-2022-FU1.pdf
- Mar.3.2022.Pembrolizumab-AE-2103744_1-11-2022_ISR.pdf
- Mar.3.2022.Pembrolizumab-AE-2043241_-8-27-21-FU1.pdf
- Pembrolizumab-AE-2076125_1-11-2022-ISR.pdf
- Pembrolizumab-AE-2566800_5-19-2022-FU-1.pdf
- Pembrolizumab-AE-2103744-Protocol-EA5163-FU-1.pdf
- Pembrolizumab-AE-2076125-Protocol-EA5163-FU-1.pdf
- Pembrolizumab-AE-2126277_-6-1-2022_1.pdf
- Pembrolizumab-AE-2251128_5-27-2022_ISR.pdf
- Pembrolizumab-AE-2701398_-6-3-2022_1.pdf
- Pembrolizumab-AE-2402811_7-14-2022-ISR.pdf
- Pembrolizumab-AE-2932187_6-29-2022_FU-1.pdf
- Pembrolizumab-AE-2999624_9-6-22_-FU-1.pdf
- Pembrolizumab-AE-2263995-Dec-5-2022-FU-1.pdf
- Pembrolizumab-AE-2683099_Dec-2-2022_FU-1.pdf
- Pembrolizumab-AE-2689369-Nove-30-2022-FU-1.pdf
- Pembrolizumab-AE-2802843-Dec-8-2022-FU-1.pdf
- Pembrolizumab-AE-2832577_-Dec-7-2022-FU-1.pdf
- Pembrolizumab-AE-2877167_12-14-2022_-FU-1.pdf
- Interleukin-12-and-Pembrolizumab-AE-2198993_-8.31.23_-ISR.pdf
- Pembrolizumab-AE-2024637_8.31.23_FU-1.pdf
- Pembrolizumab-AE-2462200-Protocol-NRG-GY018-FU-1.pdf
- Pembrolizumab-AE-2622147_9.7.23_FU-1.pdf
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.
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