Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT03829722|
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Oropharynx Squamous Cell Carcinoma||Drug: Nivolumab Drug: Carboplatin Drug: Paclitaxel Radiation: Radiation Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-Related Oropharynx Cancer|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||September 2024|
Experimental: Nivolumab, Carboplatin/Paclitaxel, Radiotherapy
Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
Given IV once per week during radiation therapy (AUC=1).
Other Name: Paraplatin
Given IV once per week during radiation therapy (30mg/m^2)
Other Name: Taxol
Radiation: Radiation Therapy
Given 5 days/week for a total of 35 doses (70 gray total).
- Progression-free survival (PFS) [ Time Frame: Up to 2 years after completion of study treatment ]Estimated using the Kaplan-Meier method. Evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Proportion of patients who progressed in any location [ Time Frame: Up to 2 years after completion of study treatment ]To characterize patterns of failure, investigators will summarize the proportion of patients who progressed in any location and whether the first progression was local, regional, distant or in multiple locations.
- Overall survival (OS) [ Time Frame: Up to 2 years after completion of study treatment ]Estimated using the Kaplan-Meier method
- Incidence of acute toxicity [ Time Frame: Up to 6 months after completion of study treatment ]Toxicity evaluation per CTCAE v 5.0
- Incidence of late toxicity [ Time Frame: Up to 2 years after completion of study treatment ]Toxicity evaluation per CTCAE v 5.0
- Correlation of mid-treatment FDG-PET scans with post-treatment PET-CT. [ Time Frame: 12 weeks after completion of study treatment ]Correlation of metabolic image uptake data on mid-treatment FDG-PET scans performed between fractions 8-12 with standard 12 week post-treatment PET-CT.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829722
|United States, Michigan|
|University of Michigan Rogel Cancer Center||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Michelle Mierzwa, M.D. 734-936-7810 firstname.lastname@example.org|
|Principal Investigator:||Michelle Mierzwa, M.D.||University of Michigan Rogel Cancer Center|