Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy

• ClinicalTrials.gov Identifier: NCT03355560
• Recruitment Status: Active, not recruiting
• First Posted: November 28, 2017
• Last Update Posted: October 4, 2022
• Sponsor: Trisha Wise-Draper
• Collaborator: Bristol-Myers Squibb
• Information provided by (Responsible Party): Trisha Wise-Draper, University of Cincinnati

Tracking Information

• First Submitted Date: November 22, 2017
• First Posted Date: November 28, 2017
• Last Update Posted Date: October 4, 2022
• Actual Study Start Date: December 6, 2017
• Estimated Primary Completion Date: September 23, 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 22, 2017): Percentage of patients with Grade 3 and 4 adverse events of nivolumab [ Time Frame: 28 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 22, 2017)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
• 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
• Brief Summary: The purpose of this research study is to test the safety and efficacy of nivolumab after salvage resection in head and neck cancer in patients that have previously received definitive radiation with or without chemotherapy.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Head and Neck Cancer

Intervention

Drug: Nivolumab

Nivolumab 480 mg IV infusion

Other Name: Opdivo

Study Arms

Experimental: Nivolumab

Nivolumab starting 4-11 weeks after surgery for 6 doses.

Intervention: Drug: Nivolumab

• Publications *: Leddon JL, Gulati S, Haque S, Allen C, Palackdharry S, Mathews M, Kurtzweil N, Riaz MK, Takiar V, Nagasaka M, Patil Y, Zender C, Tang A, Cervenka B, McGrath J, Korn WM, Hinrichs BH, Jandarov R, Harun N, Sukari A, Wise-Draper TM. Phase II Trial of Adjuvant Nivolumab Following Salvage Resection in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck. Clin Cancer Res. 2022 Aug 15;28(16):3464-3472. doi: 10.1158/1078-0432.CCR-21-4554.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 25, 2019): 39
• Original Estimated Enrollment (submitted: November 22, 2017): 24
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: September 23, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03355560
• Other Study ID Numbers: UCCI-HN-17-01; CA209-997 ( Other Identifier: Bristol Meyers Squibb )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Trisha Wise-Draper, University of Cincinnati
• Original Responsible Party: Sulsau-Ul Haque, University of Cincinnati, Principal Investigator
• Current Study Sponsor: Trisha Wise-Draper
• Original Study Sponsor: Sulsau-Ul Haque
• Collaborators: Bristol-Myers Squibb

Investigators

• Principal Investigator: Trisha Wise-Draper, MD; University of Cincinnati

• PRS Account: University of Cincinnati
• Verification Date: October 2022