Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
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|ClinicalTrials.gov Identifier: NCT03355560|
Recruitment Status : Active, not recruiting
First Posted : November 28, 2017
Last Update Posted : October 4, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Phase 2 Study of Adjuvant Nivolumab After Salvage Resection in Head and Neck Squamous Cell Carcinoma Patients Previously Treated With Definitive Therapy|
|Actual Study Start Date :||December 6, 2017|
|Estimated Primary Completion Date :||September 23, 2023|
|Estimated Study Completion Date :||December 2023|
Nivolumab starting 4-11 weeks after surgery for 6 doses.
Nivolumab 480 mg IV infusion
Other Name: Opdivo
- Percentage of patients with Grade 3 and 4 adverse events of nivolumab [ Time Frame: 28 weeks ]
- Percentage of patients any grade adverse events of nivolumab [ Time Frame: 28 weeks ]
- Disease free survival [ Time Frame: 1 year ]
- Disease free survival [ Time Frame: 2 year ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Prior definitive therapy with radiation (with or without prior surgical resection and/or chemotherapy) who have underwent salvage resection with curative intent and have no other curable options
- Pre-operative scans including chest imaging preferably PET/CT and CT neck w/contrast. MRI neck is acceptable if contrast contraindicated.
- Able to provide archived biopsy or resected tissue.
- Adequate performance status and labs.
- Patients who did not receive at least radiotherapy as prior definitive treatment.
- Patients who have gross measurable residual disease after surgery or those who underwent surgery for palliative purposes i.e. for symptom control.
- Has nasopharyngeal or sinonasal carcinoma.
- Has confirmed metastatic disease.
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): NCT03355560
|United States, Michigan|
|Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45219|
|Principal Investigator:||Trisha Wise-Draper, MD||University of Cincinnati|
|Responsible Party:||Trisha Wise-Draper, Principal Investigator, University of Cincinnati|
|Other Study ID Numbers:||
CA209-997 ( Other Identifier: Bristol Meyers Squibb )
|First Posted:||November 28, 2017 Key Record Dates|
|Last Update Posted:||October 4, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action