ClinicalTrials.gg
Active, not recruitingNCT03468218Updated Jan 23, 2026Results posted

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

A Phase 2 interventional study of Cabozantinib and Pembrolizumab in Metastatic Head and Neck Carcinoma, Paranasal Sinus Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Emory University. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by Emory University · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 62 studies testing pembrolizumab in Squamous Cell Carcinoma of Head and Neck — 17 open to participants now, 31 under way, 2 of them phase 3. pembrolizumab · Squamous Cell Carcinoma of Head and Neck.

Enrollment
40th of 62
36 · median 52
Started
2018
with 3 others
Phase 2
43 of 62
13 open now
Primary completion
2022-05
later than 0 of 30 live
Registered
21st of 62
by date
Lead sponsor
2 of 62
Emory University

Among the 62 studies testing pembrolizumab in Squamous Cell Carcinoma of Head and Neck, this one is the 40th largest by enrollment, is one of 4 that started in 2018, is one of 43 in phase 2, reaches primary completion later than 0 of the 30 other live ones, and was the 21st registered.

Squamous Cell Carcinoma of Head and Neck

2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Open to participants now

17 of the 62 studies testing pembrolizumab in Squamous Cell Carcinoma of Head and Neck are open now, in 5 countries. Recruiting first, the newest first:

12 more — sign in →

By country, each count listing its studies:

All 17 open studies →

About pembrolizumab

pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 435 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 311 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 62 studies testing pembrolizumab in Squamous Cell Carcinoma of Head and Neck, or all of them as a file.
02

Study summary

This phase II trial studies how well pembrolizumab and cabozantinib in treating patients with head and neck squamous cell cancer that has come back or spread to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the pathways needed for cell growth. Giving pembrolizumab and cabozantinib may improve the chances of tumor response in patients with head and neck squamous cell cancer.

Read the detailed description

PRIMARY OBJECTIVE:

To estimate the overall response rate (ORR) of patients with recurrent/metastatic (RM) squamous cell carcinoma of the head and neck (SCCHN) who receive the combination of pembrolizumab and cabozantinib.

SECONDARY OBJECTIVES:

  • To estimate the progression-free survival (PFS) of patients treated with the combination of pembrolizumab and cabozantinib.
  • To further define the toxicities associated with these regimens in patients with SCCHN.

OUTLINE:

Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and cabozantinib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up to 2 years.

03

Conditions studied

  • Metastatic Head and Neck Carcinoma
  • Paranasal Sinus Squamous Cell Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Recurrent Hypopharyngeal Squamous Cell Carcinoma
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Recurrent Oral Cavity Squamous Cell Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma
  • Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7
  • Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
  • Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
  • Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
  • Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVC Hypopharyngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7
  • Stage IVC Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
  • Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7
  • Unresectable Head and Neck Squamous Cell Carcinoma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The subject has a histologic or cytologic diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, paranasal sinuses, hypopharynx, nasopharynx, or larynx; squamous cell carcinoma of unknown primary in cervical lymph node can be included only if human papillomavirus (HPV) status is positive
  • Patients must have , recurrent or disease, which is deemed to be inoperable
  • In case patients received prior systemic therapy within the definitive or metastatic setting, disease progression must be documented following prior therapy; this can be in the recurrent or metastatic setting or in the concurrent setting
  • per (RECIST) 1.1 as determined by the investigator
  • A maximum of one prior radiotherapy regimen, curative or palliative, to the head and neck is allowed; if the radiation is combined with chemotherapy, a minimum of 4 months must elapse between the end of radiotherapy and registration; if the radiation is given alone, a minimum of 8 weeks must elapse between the end of radiotherapy and registration; a minimum of 3 weeks must elapse between prior radiation to other areas and registration; treatment areas should be healed with no sequelae from radiation therapy (RT) that would predispose to fistula formation
  • The subject has had an assessment of all known disease sites eg, by computerized tomography (CT) scan, magnetic resonance imaging (MRI), bone scan or positron emission tomography (PET)/CT scan as appropriate, within 28 days before the first dose of cabozantinib
  • of greater than 3 months
  • The subject has an (ECOG) performance status of 0 or 1
  • Recovery to baseline or ≤ grade 1 (CTCAE) version (v.)4.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy
  • Within 7 days before the first dose of cabozantinib: The (ANC) ≥ 1000/mm³ without colony stimulating factor support
  • Within 7 days before the first dose of cabozantinib: ≥ 100,000/mm³
  • Within 7 days before the first dose of cabozantinib: ≥ 9 g/dL
  • Within 7 days before the first dose of cabozantinib: ≤ 1.5 x the (ULN); for subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg/dL
  • Within 7 days before the first dose of cabozantinib: Serum albumin ≥ 2.8 g/dl
  • Within 7 days before the first dose of cabozantinib: Serum creatinine ≤ 1.5 x ULN or (CrCl) ≥ 40 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
  • Within 7 days before the first dose of cabozantinib: (ALT) and aspartate aminotransferase (AST) ≤ 2.0 x ULN
  • Within 7 days before the first dose of cabozantinib: Lipase \< 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis
  • Within 7 days before the first dose of cabozantinib: Urine protein/creatinine ratio (UPCR) ≤ 1
  • Within 7 days before the first dose of cabozantinib: Serum phosphorus, calcium, magnesium and potassium ≥ lower limit of normal (LLN)
  • The subject is capable of understanding and complying with the protocol requirements and has signed the document
  • Sexually active subjects (men and women) must agree to use medically accepted barrier methods of (eg, male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s)
  • Female subjects of must not be pregnant at screening; females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy); however, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons

Exclusion criteria

Exclusion Criteria:

  • Patients who have HPV negative squamous cell carcinoma of unknown primary in cervical lymph node
  • The subject has received cytotoxic chemotherapy (including cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) within 4 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment
  • Prior treatment with cabozantinib or pembrolizumab
  • Radiation therapy for bone within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment; systemic treatment with radionuclides within 6 weeks before the first dose of study treatment; subjects with ongoing complications from prior radiation therapy are not eligible
  • Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before the first dose of study treatment
  • The subject has received any other type of investigational agent within 28 days or 5 half-lives, whichever is shorter, before the first dose of study treatment
  • Known or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment; eligible subjects must be neurologically asymptomatic and without treatment at the time of the start of study treatment
  • The subject has (PT)/institutional normalized ratio (INR) or partial thromboplastin time (PTT) test ≥ 1.3 x the laboratory within 7 days before the first dose of study treatment
  • Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin, direct thrombin and factor Xa inhibitors) or inhibitors (eg, clopidogrel)

    • Note: Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (\< 1 mg/day), and low dose, low molecular weight heparins (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
  • The subject has experienced any of the following:

    • Clinically-significant GI bleeding within 6 months before the first dose of study treatment
    • Hemoptysis of ≥ 0.5 teaspoon (2.5 ml) of red blood within 3 months before the first dose of study treatment
    • Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
  • The subject has radiographic evidence of cavitating pulmonary lesion(s)
  • The subject has tumor invading or encasing any major blood vessels
  • The subject has evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib
  • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:

    • Cardiovascular disorders including:

      • Congestive heart failure (CHF): (NYHA) class III (moderate) or class IV (severe) at the time of screening;
      • Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment;
      • Any history of congenital long syndrome;
      • Any of the following within 6 months before the first dose of study treatment:

        • Unstable angina pectoris;
        • Clinically-significant cardiac arrhythmias;
        • Stroke (including (TIA), or other ischemic event);
        • Myocardial infarction;
    • GI disorders particularly those associated with a high risk of perforation or fistula formation including:

      • Tumors invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction
      • Abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess within 6 months before randomization

        • Note: Complete healing of an intra-abdominal abscess must be confirmed prior to randomization. Also no pre-existing fistula of head and neck area; no pre-existing osteonecrosis of jaw (ONJ)
    • Other clinically significant disorders that would preclude safe study participation
  • Major surgery within 12 weeks before the first dose of study treatment; complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment; minor surgery (including uncomplicated tooth extractions) within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment; subjects with clinically relevant ongoing complications from prior surgery are not eligible
  • Corrected QT interval by Fridericia's formula (QTcF) > 500 msec within 1 month before the first dose of study treatment

    • Three electrocardiography ()s must be performed for eligibility determination; if the average of these three consecutive results for QTcF is ≤ 500 msec, the subject meets eligibility in this regard
  • Pregnant or lactating females
  • Inability to swallow intact tablets or inability to take pembrolizumab or cabozantinib
  • Previously identified allergy or to components of the study treatment formulations
  • Patients with a history of other prior must have been treated with curative intent and must have remained disease-free for 1 year post diagnosis; patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treated
Terms in these criteria, in plain language(29)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Treatment (pembrolizumab, cabozantinib)

    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.

    Drug: Cabozantinib · Biological: Pembrolizumab

Interventions

  • Given PO

    Also known as: Cabometyx, Cometriq

  • BiologicalPembrolizumab

    Given IV

    Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475

06

What researchers measure

Primary outcomes

  1. Overall Response Rate (ORR)

    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 frame: Up to 2 years after treatment start

Secondary outcomes

  1. Progression Free Survival (PFS)

    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 frame: 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

07

Results

Posted Dec 27, 2024

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Pembrolizumab, Cabozantinib)
Started36
Completed11
Not completed25
Withdrew: Adverse event5
Withdrew: Progressive disease16
Withdrew: Death1
Withdrew: Alternate therapy1
Withdrew: Withdrawal by subject2

Outcome measures

PrimaryOverall Response Rate (ORR)

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 frame:
Up to 2 years after treatment start
Reported as:
Number · percentage of participants
Overall Response Rate (ORR)
percentage of participantsTreatment (Pembrolizumab, Cabozantinib)
Overall Response Rate (ORR)52
SecondaryProgression Free Survival (PFS)

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 frame:
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
Reported as:
Number · percentage of participants
Progression Free Survival (PFS)
percentage of participantsTreatment (Pembrolizumab, Cabozantinib)
Progression Free Survival (PFS)54 (31.5 to 72)

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Pembrolizumab, Cabozantinib)7/36 (19.4%)18/36 (50%)24/36 (66.7%)
Most frequent serious events
Showing 10 of 19
Most frequent serious events
EventTreatment (Pembrolizumab, Cabozantinib)
DeathGeneral disorders7/36
Hospitalization-hyponatremiaInvestigations2/36
Hospiltaization- acute respiratory failureRespiratory, thoracic and mediastinal disorders2/36
Hospitalization- AspirationGastrointestinal disorders2/36
Hospitalization-TransanitisGastrointestinal disorders1/36
Hospitalization- Low blood pressureVascular disorders1/36
Hospitalization-drug induced hepatitisGastrointestinal disorders1/36
Hospitalization- Atrial FibrillationCardiac disorders1/36
Hospitalization-hypotensionVascular disorders1/36
Hospitalization- Ulcer in right oropharynxGastrointestinal disorders1/36
Most frequent other events
Showing 10 of 70
Most frequent other events
EventTreatment (Pembrolizumab, Cabozantinib)
FatigueGeneral disorders16/36
DiarrheaGastrointestinal disorders13/36
HypothyroidismEndocrine disorders12/36
HypertensionVascular disorders12/36
ConstipationGastrointestinal disorders11/36
Dry MouthGastrointestinal disorders10/36
AnorexiaMetabolism and nutrition disorders10/36
HeadacheNervous system disorders10/36
HyponatremiaMetabolism and nutrition disorders10/36
DysphagiaGastrointestinal disorders10/36

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treatment (Pembrolizumab, Cabozantinib)
<=18 years0
Between 18 and 65 years23
>=65 years13
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Pembrolizumab, Cabozantinib)
Female6
Male30
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Pembrolizumab, Cabozantinib)
Hispanic or Latino1
Not Hispanic or Latino34
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Pembrolizumab, Cabozantinib)
American Indian or Alaska Native0
Asian5
Native Hawaiian or Other Pacific Islander0
Black or African American4
White27
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Treatment (Pembrolizumab, Cabozantinib)
United States36
Smoking Status
Smoking Status(Participants)Treatment (Pembrolizumab, Cabozantinib)
Current Smoker9
Former Smoker8
Never Smoker19
08

Study locations

2 sites
09

References and documents

Publications

  • Saba NF, Steuer CE, Ekpenyong A, McCook-Veal A, Magliocca K, Patel M, Schmitt NC, Stokes W, Bates JE, Rudra S, Remick J, McDonald M, Abousaud M, Tan AC, Fadlullah MZH, Chaudhary R, Muzaffar J, Kirtane K, Liu Y, Chen GZ, Shin DM, Teng Y, Chung CH. Pembrolizumab and cabozantinib in recurrent metastatic head and neck squamous cell carcinoma: a phase 2 trial. Nat Med. 2023 Apr;29(4):880-887. doi: 10.1038/s41591-023-02275-x. Epub 2023 Apr 3. PubMed 37012550 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2018 to primary completion in May 2022, 43 months.

Results were first posted in Dec 2024, 2 years 7 months after primary completion.

Of 298 non-industry phase 2 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 85. This study's 43 months is below that.

Counting every sponsor, half of 366 studies reached it within 53 months; a quarter within 35 and three quarters within 82.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2018
First posted
Mar 16, 2018
StartActual
Sep 18, 2018
Primary completionActual
May 2, 2022
CompletionEst.
Oct 29, 2026
Results first posted
Dec 27, 2024
Last update
Jan 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03468218
Lead sponsor
Emory University
Responsible party
Nabil F. Saba (Principal Investigator, Emory University) — Principal investigator
First posted
Mar 16, 2018
Start date
Sep 18, 2018
Primary completion
May 2, 2022
Completion
Oct 29, 2026 (estimated)
Results posted
Dec 27, 2024
Last update
Jan 23, 2026

Study contacts

Nabil F. Saba, MD
principal investigator · Emory University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Cabozantinib · Pembrolizumab

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