Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The primary objective of the study is to estimate the rate of pathologic complete response (pCR) at the primary site, defined as the absence of any residual invasive cancer on H\&E evaluation of the resected specimen and all sampled ipsilateral lymph nodes, in patients with newly diagnosed and untreated Stage III-IVA SCCHN of the oral cavity, Oropharynx, Larynx, and Hypopharynx treated with standard neoadjuvant chemotherapy plus Nivolumab, paclitaxel, and carboplatin. Pathologic complete response rate and its associated score 95% confidence interval will be estimated.

The complete pathologic response rate was 45.45% (15/33) with a 95% Confidence Interval of 28.5% to 63.4%.

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secondary · POSTED

patients achieved the major pathologic response (i.e., \<10% viable tumor) or pathologic complete response

number of patients with Major response (Major or complete) was 72.73% (24/33) with a 95% Confidence Interval of 54.2% to 86.1%.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id: NCT03342911
trial label: Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 2
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id
NCT03342911
outcome key
om-0000
source section id
NCT03342911-om-0000
source outcome index
0
endpoint
Pathologic Complete Response Rate
endpoint definition
The primary objective of the study is to estimate the rate of pathologic complete response (pCR) at the primary site, defined as the absence of any residual invasive cancer on H\&E evaluation of the resected specimen and all sampled ipsilateral lymph nodes, in patients with newly diagnosed and untreated Stage III-IVA SCCHN of the oral cavity, Oropharynx, Larynx, and Hypopharynx treated with standard neoadjuvant chemotherapy plus Nivolumab, paclitaxel, and carboplatin. Pathologic complete response rate and its associated score 95% confidence interval will be estimated.
time origin
Up to 26 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The complete pathologic response rate was 45.45% (15/33) with a 95% Confidence Interval of 28.5% to 63.4%.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id
NCT03342911
outcome key
om-0001
source section id
NCT03342911-om-0001
source outcome index
1
endpoint
Number of Patients Who Achieved Major Pathologic Response (Defined as 10% or Less Residual Viable Tumor)
endpoint definition
patients achieved the major pathologic response (i.e., \<10% viable tumor) or pathologic complete response
time origin
Up to 26 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
number of patients with Major response (Major or complete) was 72.73% (24/33) with a 95% Confidence Interval of 54.2% to 86.1%.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id
NCT03342911
outcome key
om-0000
arm key
OG000
arm label
Treatment (Nivolumab, Paclitaxel, Carboplatin)
regimen
Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Nivolumab: Given IV
analyzed count
33
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03342911-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id
NCT03342911
outcome key
om-0001
arm key
OG000
arm label
Treatment (Nivolumab, Paclitaxel, Carboplatin)
regimen
Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Nivolumab: Given IV
analyzed count
33
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03342911-om-0001#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id
NCT03342911
harm key
EG000
source section id
NCT03342911-ae
event group key
EG000
event group label
Treatment (Nivolumab, Paclitaxel, Carboplatin)
serious affected
14
serious at risk
34
other affected
34
other at risk
34
frequency threshold
0
collection period
Adverse event data were collected starting Day 1 of study treatment, and continue for up to 100 days after the last study treatment (Day 156 +/- 5 days) or last day of study participation (up to Day 156 +/- 5 days). At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization for approximately 6 months.
event definition
An adverse event is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice