Trial · NCT02919683

Window Study of Nivolumab With or Without Ipilimumab in Squamous Cell Carcinoma of the Oral Cavity

NCT02919683, Phase 2, Active not recruiting, Dana-Farber Cancer Institute; results first posted 2020-07-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Window Study of Nivolumab With or Without Ipilimumab in Squamous Cell Carcinoma of the Oral Cavity. Trials, record NCT02919683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02919683

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Trial

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

Title: Window Study of Nivolumab With or Without Ipilimumab in Squamous Cell Carcinoma of the Oral Cavity
NCT number: NCT02919683
Status: Active not recruiting
Phases: Phase 2
Enrollment: 30 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Head and Neck Cancer
Interventions: Nivolumab, Ipilimumab, Standard of Care Surgery
First posted: 2016-09-29
Last updated: 2026-01-28
Results first posted: 2020-07-31

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants With a Volumetric Response Rate to Treatment	At time of surgery	Response rate to window treatment with single agent nivolumab or nivolumab combined with ipilimumab is determined using bidirectional measurements (product of longest 2 diameters of lesions) of primary and nodal lesions to be removed at the time of surgery. Responders will have demonstrated any reduction in overall tumor volume as determined by the product of the longest perpendicular bidirectional tumor measurements.
Primary	Safety and Tolerability of Protocol Treatment	At the time of surgery	Outcome measure includes number of participants with treatment-related adverse events as assessed by CTCAE v4.0, number of dose-limiting toxicities in safety run-ins following a 3 + 3 design, and delays to surgery.
Secondary	Percentage of Participants Demonstrating Objective Response Using RECIST Criteria	At time of surgery	Determining the radiologic response rate following the window treatment as determined by RECIST v1.1.
Secondary	Percentage of Participants Demonstrating Pathological Response	At time of surgery	Pathologic response in the primary tumor was assessed using a quantitative grading scheme: pathologic tumor response \[nonviable tumor\] PTR0 = no or \<10% response PTR1 = ≥10% PTR2 = ≥50%
Secondary	Participant One Year Progression-Free Survival Percentage	1 year	Progression-free survival is defined as the time between first study treatment and either recurrent disease or death. Recurrent disease includes a local failure, regional failure, or distant metastasis.
Secondary	Participant Overall Survival Percentage	Data Cutoff (14.2 Months Median Follow Up)	Overall survival is defined as the time between first study treatment and death.

Source ClinicalTrials.gov

Outcomes6

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 a Volumetric Response Rate to Treatment	At time of surgery	Thirty patients were treated from 2016 to 2019. One patient was excluded from efficacy analyses as she was ineligible because of evidence of distant metastatic disease at baseline.	percentage of participants	NUMBER
PRIMARY	Safety and Tolerability of Protocol Treatment	At the time of surgery		instances	NUMBER
SECONDARY	Percentage of Participants Demonstrating Objective Response Using RECIST Criteria	At time of surgery	For this analysis, patients with no radiographically measurable lesions on imaging review were excluded. Thirty patients were treated from 2016 to 2019. One patient was excluded from efficacy analyses as she was ineligible because of evidence of distant metastatic disease at baseline.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Demonstrating Pathological Response	At time of surgery	Thirty patients were treated from 2016 to 2019. One patient was excluded from efficacy analyses as she was ineligible because of evidence of distant metastatic disease at baseline.	percentage of participants	NUMBER
SECONDARY	Participant One Year Progression-Free Survival Percentage	1 year	Thirty patients were treated from 2016 to 2019. One patient was excluded from efficacy analyses as she was ineligible because of evidence of distant metastatic disease at baseline.	percentage of participants	NUMBER
SECONDARY	Participant Overall Survival Percentage	Data Cutoff (14.2 Months Median Follow Up)	Thirty patients were treated from 2016 to 2019. One patient was excluded from efficacy analyses as she was ineligible because of evidence of distant metastatic disease at baseline.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group16

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 a Volumetric Response Rate to Treatment	Nivolumab With Ipilimumab		53	80% Confidence Interval 34.2 to 71.8	percentage of participants
Percentage of Participants With a Volumetric Response Rate to Treatment	Nivolumab		50	80% Confidence Interval 30.5 to 69.5	percentage of participants
Safety and Tolerability of Protocol Treatment	Nivolumab With Ipilimumab	Delays to Surgery	0		instances
Safety and Tolerability of Protocol Treatment	Nivolumab	Delays to Surgery	0		instances
Safety and Tolerability of Protocol Treatment	Nivolumab With Ipilimumab	Dose-Limiting Toxic Effects during Safety Run-In	0		instances
Safety and Tolerability of Protocol Treatment	Nivolumab	Dose-Limiting Toxic Effects during Safety Run-In	0		instances
Safety and Tolerability of Protocol Treatment	Nivolumab With Ipilimumab	Grade 3-4 Events At Least Possibly Related to Protocol Treatment	5		instances
Safety and Tolerability of Protocol Treatment	Nivolumab	Grade 3-4 Events At Least Possibly Related to Protocol Treatment	2		instances
Percentage of Participants Demonstrating Objective Response Using RECIST Criteria	Nivolumab With Ipilimumab		38		percentage of participants
Percentage of Participants Demonstrating Objective Response Using RECIST Criteria	Nivolumab		13		percentage of participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Pre-Surgery Intervention	STARTED	Nivolumab With Ipilimumab	15
Pre-Surgery Intervention	STARTED	Nivolumab	15
Pre-Surgery Intervention	COMPLETED	Nivolumab With Ipilimumab	15
Pre-Surgery Intervention	COMPLETED	Nivolumab	15
Pre-Surgery Intervention	NOT COMPLETED	Nivolumab With Ipilimumab	0
Pre-Surgery Intervention	NOT COMPLETED	Nivolumab	0
Post-Surgery Follow-Up	STARTED	Nivolumab With Ipilimumab	15
Post-Surgery Follow-Up	STARTED	Nivolumab	15
Post-Surgery Follow-Up	COMPLETED	Nivolumab With Ipilimumab	12
Post-Surgery Follow-Up	COMPLETED	Nivolumab	13

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events76

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	Dysphagia	Gastrointestinal disorders	Nivolumab With Ipilimumab	1	15
other	Dysphagia	Gastrointestinal disorders	Nivolumab	3	15
other	Oral pain	General disorders	Nivolumab With Ipilimumab	3	15
other	Oral pain	General disorders	Nivolumab	5	15
other	Fatigue	General disorders	Nivolumab With Ipilimumab	1	15
other	Fatigue	General disorders	Nivolumab	4	15
other	Hyperthyroidism	Endocrine disorders	Nivolumab With Ipilimumab	1	15
other	Hyperthyroidism	Endocrine disorders	Nivolumab	2	15
other	Hypothyroidism	Endocrine disorders	Nivolumab With Ipilimumab	0	15
other	Hypothyroidism	Endocrine disorders	Nivolumab	2	15

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nivolumab With Ipilimumab	2	15
Total, all-cause mortality	Nivolumab	2	15
Total, other adverse events	Nivolumab With Ipilimumab	12	15
Total, other adverse events	Nivolumab	11	15
Total, serious adverse events	Nivolumab With Ipilimumab	2	15
Total, serious adverse events	Nivolumab	3	15

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32852531	DERIVED	PubMed
35050348	DERIVED	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 With Ipilimumab vs Nivolumab: deaths from any cause	Trial comparisons
Nivolumab With Ipilimumab vs 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/NCT02919683

GET https://conductscience.org/api/trials/v1/NCT02919683/events?page=2

API reference For AI assistants