Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer

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

Will assess the proportion of subjects with partial response or complete response as defined by Response Evaluation Criteria in Solid Tumors version 1.1 response criteria. ORR will be calculated with 95% confidence interval by binomial distribution. The ability of biomarkers to predict ORR will be estimated by chi-square test and/or logistic regression model.

Source null

→

secondary · POSTED

The median PFS will be estimated by Kaplan-Meier method along with 95% confidence interval. The biomarker association with PFS will be assessed by the Kaplan-Meier method, log-rank test, and Cox model.

Source null

→

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: NCT03468218
trial label: Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer
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
NCT03468218
outcome key
om-0000
source section id
NCT03468218-om-0000
source outcome index
0
endpoint
Overall Response Rate (ORR)
endpoint definition
Will assess the proportion of subjects with partial response or complete response as defined by Response Evaluation Criteria in Solid Tumors version 1.1 response criteria. ORR will be calculated with 95% confidence interval by binomial distribution. The ability of biomarkers to predict ORR will be estimated by chi-square test and/or logistic regression model.
time origin
Up to 2 years after treatment start
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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
NCT03468218
outcome key
om-0001
source section id
NCT03468218-om-0001
source outcome index
1
endpoint
Progression Free Survival (PFS)
endpoint definition
The median PFS will be estimated by Kaplan-Meier method along with 95% confidence interval. The biomarker association with PFS will be assessed by the Kaplan-Meier method, log-rank test, and Cox model.
time origin
Duration from date of treatment start to the date of objectively documented progression or death due to any cause, whichever status is recorded first, assessed up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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
NCT03468218
outcome key
om-0000
arm key
OG000
arm label
Treatment (Pembrolizumab, Cabozantinib)
regimen
Patients receive pembrolizumab IV over 30 minutes on day 1 and cabozantinib PO QD on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given PO Pembrolizumab: Given IV
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03468218-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
NCT03468218
outcome key
om-0001
arm key
OG000
arm label
Treatment (Pembrolizumab, Cabozantinib)
regimen
Patients receive pembrolizumab IV over 30 minutes on day 1 and cabozantinib PO QD on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given PO Pembrolizumab: Given IV
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03468218-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
NCT03468218
harm key
EG000
source section id
NCT03468218-ae
event group key
EG000
event group label
Treatment (Pembrolizumab, Cabozantinib)
serious affected
18
serious at risk
36
other affected
24
other at risk
36
frequency threshold
0
collection period
2 years
event definition
CTCAE Version 4
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