Trial · NCT02684253

Screening Trial of Nivolumab With Image Guided, Stereotactic Body Radiotherapy (SBRT) Versus Nivolumab Alone in Patients With Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

NCT02684253, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2022-03-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Screening Trial of Nivolumab With Image Guided, Stereotactic Body Radiotherapy (SBRT) Versus Nivolumab Alone in Patients With Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). Trials, record NCT02684253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02684253

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Screening Trial of Nivolumab With Image Guided, Stereotactic Body Radiotherapy (SBRT) Versus Nivolumab Alone in Patients With Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT number: NCT02684253
Status: Completed
Phases: Phase 2
Enrollment: 65 participants, actual
Lead sponsor: Memorial Sloan Kettering Cancer Center
Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)
Interventions: Nivolumab, Stereotactic Body Radiation Therapy (SBRT)
First posted: 2016-02-17
Last updated: 2022-03-10
Results first posted: 2022-03-10

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Overall Response Rate	96 weeks	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Overall Response Rate	96 weeks		percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants With Overall Response Rate	Nivolumab 3mg/kg IV Every 2 Weeks		34.5	95% Confidence Interval 19.9 to 52.7	percentage of participants
Percentage of Participants With Overall Response Rate	Stereotactic Body Radiotherapy & Nivolumab		29	95% Confidence Interval 16.1 to 46.6	percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Nivolumab 3mg/kg IV Every 2 Weeks	32
Overall Study	STARTED	Stereotactic Body Radiotherapy & Nivolumab	33
Overall Study	COMPLETED	Nivolumab 3mg/kg IV Every 2 Weeks	32
Overall Study	COMPLETED	Stereotactic Body Radiotherapy & Nivolumab	33
Overall Study	NOT COMPLETED	Nivolumab 3mg/kg IV Every 2 Weeks	0
Overall Study	NOT COMPLETED	Stereotactic Body Radiotherapy & Nivolumab	0

Source ClinicalTrials.gov

Adverse events116

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Activated partial thromboplastin time prolonged	Investigations	Nivolumab 3mg/kg IV Every 2 Weeks	2	32
other	Activated partial thromboplastin time prolonged	Investigations	Stereotactic Body Radiotherapy & Nivolumab	0	33
other	Alanine aminotransferase increased	Investigations	Nivolumab 3mg/kg IV Every 2 Weeks	2	32
other	Alanine aminotransferase increased	Investigations	Stereotactic Body Radiotherapy & Nivolumab	3	33
other	Alkaline phosphatase increased	Investigations	Nivolumab 3mg/kg IV Every 2 Weeks	4	32
other	Alkaline phosphatase increased	Investigations	Stereotactic Body Radiotherapy & Nivolumab	6	33
other	Anemia	Blood and lymphatic system disorders	Nivolumab 3mg/kg IV Every 2 Weeks	16	32
other	Anemia	Blood and lymphatic system disorders	Stereotactic Body Radiotherapy & Nivolumab	18	33
other	Aspartate aminotransferase increased	Investigations	Nivolumab 3mg/kg IV Every 2 Weeks	3	32
other	Aspartate aminotransferase increased	Investigations	Stereotactic Body Radiotherapy & Nivolumab	5	33

1 to 10 of 116Source ClinicalTrials.gov

See all 116 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nivolumab 3mg/kg IV Every 2 Weeks	26	32
Total, all-cause mortality	Stereotactic Body Radiotherapy & Nivolumab	27	33
Total, other adverse events	Nivolumab 3mg/kg IV Every 2 Weeks	21	32
Total, other adverse events	Stereotactic Body Radiotherapy & Nivolumab	27	33
Total, serious adverse events	Nivolumab 3mg/kg IV Every 2 Weeks	4	32
Total, serious adverse events	Stereotactic Body Radiotherapy & Nivolumab	3	33

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32822275	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Nivolumab 3mg/kg IV Every 2 Weeks vs Stereotactic Body Radiotherapy & Nivolumab: deaths from any cause	Trial comparisons
Nivolumab 3mg/kg IV Every 2 Weeks vs Stereotactic Body Radiotherapy & Nivolumab: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02684253

GET https://conductscience.org/api/trials/v1/NCT02684253/events?page=2

API reference For AI assistants