Head and Neck CancerPhase 2NCT03355560
Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
A Phase 2 study testing Nivolumab in people with Head and Neck Cancer, run by Trisha Wise-Draper at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Dec 2017to 15 Apr 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UC Health
Cincinnati, Ohio, 45219
Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
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
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Nivolumab
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
Nivolumab 480 mg IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Experimental | Nivolumab starting 4-11 weeks after surgery for 6 doses. Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Grade 3 and 4 Adverse Events of Nivolumab
As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one Grade 3 or Grade 4 adverse while on treatment of nivolumab.
Measured: AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Secondary outcomes (3)
Percentage of Patients With Any Grade Adverse Events of During Treatment of Nivolumab
As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one adverse while on treatment of nivolumab for a minimum of 30 days following the last dose of study treatment. Adverse Events were not collected beyond the 30 days following the last dose.
Measured: AE collection occurs during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Disease Free Survival
The primary endpoint of this study was disease free survival (DFS) at 2-years as measured from the time of treatment allocation to the first evidence of any tumor or death from any cause.
The "median follow-up of 22.1 months" reflects the actual duration of follow-up across participants at the time of data analysis. While the outcome measure was designed to be assessed at the 2-year mark, not all participants had reached exactly 24 months of follow-up when the data were analyzed. Therefore, the median follow-up time represents the central tendency of the follow-up duration for the cohort.
Measured: Median follow up was 22.1 months
Disease Free Survival
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start6 Dec 2017
- Primary completion1 Jan 2024
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trisha Wise-Draper
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Trisha Wise-Draper, University of Cincinnati
- Investigators
- Trisha Wise-Draper, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355560
- Sponsor's protocol ID
- UCCI-HN-17-01
- Other IDs
- CA209-997
- Status last verified
- Apr 2026
- First submitted
- 22 Nov 2017
- Last updated
- 6 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35653116
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03355560
- Acronym / sponsor ID
- UCCI-HN-17-01
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Trisha Wise-DraperUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Posted 6 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab | Experimental | Drug: NivolumabNivolumab starting 4-11 weeks after surgery for 6 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: OpdivoNivolumab 480 mg IV infusion | Drug | Nivolumab |
Primary outcome
Percentage of Patients With Grade 3 and 4 Adverse Events of Nivolumab
Time frame: AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one Grade 3 or Grade 4 adverse while on treatment of nivolumab.
3 secondary outcomes
Percentage of Patients With Any Grade Adverse Events of During Treatment of Nivolumab
Time frame: AE collection occurs during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Disease Free Survival
Time frame: Median follow up was 22.1 months
Disease Free Survival
Time frame: 2 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35653116Leddon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trisha Wise-Draper, MD principal investigator
University of Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab in people with Head and Neck Cancer, run by Trisha Wise-Draper at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Grade 3 and 4 Adverse Events of Nivolumab (time frame: AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03355560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.