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 : October 10, 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|
|Actual Study Start Date :||September 5, 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.
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): 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|