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Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7Phase 1NCT02775812

Cisplatin, Intensity-Modulated Radiation Therapy, and Pembrolizumab in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma

A Phase 1 study testing Cisplatin, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis in people with Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7 and Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7, run by National Cancer Institute (NCI) at 69 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase I trial studies the side effects and best dose of pembrolizumab when given together with cisplatin and intensity-modulated radiation therapy, in treating patients with stage III-IV squamous cell carcinoma of the head and neck. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cisplatin, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
69 sitesUnited States
Study dates
28 Nov 2016to 20 May 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • STEP 1 (REGISTRATION)
  • Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity (excluding lips), oropharynx (p16 negative), hypopharynx or larynx
  • Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx squamous cell carcinoma (SCC) within 63 days prior to registration; note: patients may have a biopsy under general anesthesia in an operating room followed by definitive ablative cancer surgery representing gross total resection; the gross total resection has to be done within 63 days prior to registration; if, however, patients have ablative resection but demonstrate rapid gross recurrence or are determined to have gross persisting disease requiring re-resection to achieve gross total resection, then the patient is not eligible
  • Patients must have at least one of the following high risk pathologic features:
  • Extracapsular nodal extension
  • Invasive cancer at the primary tumor resection margin (tumor on ink); Note: Patients who have a positive margin and undergo re-resection with final negative margin are eligible only if they can be enrolled within 63 days of initial gross total resection AND extracapsular nodal extension was also present; patients who have a positive margin and undergo re-resection with final negative margin and do not have extracapsular nodal extension, are NOT eligible
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  • Pathologic stage III or IV HNSCC, including no distant metastases, based on the following minimum diagnostic workup:
  • General history/physical examination by a radiation oncologist and/or medical oncologist within 84 days prior to registration
  • Examination by an ear nose and throat (ENT) or head \& neck surgeon prior to surgery; a laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure), if appropriate, is recommended but not required; intra-operative examination is acceptable documentation
  • Pre-op Imaging of the head and neck: a neck computerized tomography (CT) (with contrast) or CT/positron emission tomography (PET) (with contrast) and/or an magnetic resonance imaging (MRI) of the neck (T1 with gadolinium and T2) within 84 days prior to surgery; note: this imaging data (diagnostic pre-operative scan showing gross disease) is to be submitted in Digital Imaging and Communications in Medicine (DICOM) format via transfer of images and data (TRIAD); the report is to be uploaded into Rave
  • Chest imaging with either a CT scan (with or without contrast) or CT/PET (with or without contrast) that includes the chest within 120 days prior to registration; Note: if the CT/PET with or without contrast is done within 84 days prior to surgery, it fulfills the chest imaging requirement
  • For patients with oropharyngeal cancer only: the institution will do p16 testing, and if p16 is negative, this tissue must be submitted for central review for confirmation before Step 2 registration; note: if the institution finds that the patient is p16 positive, the patient is excluded from this trial on the basis of distinct biology, prognosis, and low- or intermediate-risk rather than high-risk status
  • Zubrod performance status of 0-1 within 28 days prior to registration
  • Absolute neutrophil count (ANC): >= 1,500 /mm^3
  • Platelets: >= 100,000 / mm^3
  • Hemoglobin: >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
  • Creatinine clearance (CrCl) >= 50 ml/min within 14 days prior to registration as determined by 24-hour collection or estimated by Cockcroft-Gault formula
  • Serum total bilirubin: =< 1.5 X ULN OR
  • Direct bilirubin: =< ULN for patients with total bilirubin levels > 1.5 ULN
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN
  • International normalized ratio (INR) or prothrombin time (PT): =< 1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
  • Activated Partial Thromboplastin Time (aPTT): =< 1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chlorine (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator's discretion
  • For women of childbearing potential, a negative serum pregnancy test within 14 days of registration
  • Female patients of childbearing potential and men receiving MK-3475 (pembrolizumab) who are sexually active with women of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of MK-3475 (pembrolizumab); note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient
  • Patients with feeding tubes are eligible for the study
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry, including consent for mandatory tumor tissue, serum, and blood submission for immune correlatives (all patients) and p16 analysis (oropharyngeal cases only)
  • STEP 2 (REGISTRATION)
  • For patients with oropharyngeal cancer only: p16 negative, confirmed by central pathology review

Who cannot join

  • Definitive clinical or radiologic evidence of metastatic disease
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years); noninvasive cancers (for example, carcinoma in situ of the breast, oral cavity, or cervix) are permitted even if diagnosed and treated < 3 years ago
  • Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 differentiated thyroid carcinoma, who are eligible
  • Prior systemic therapy, including cytotoxic chemotherapy, biologic/targeted therapy, or immune therapy for the study cancer; note: prior cytotoxic chemotherapy or biologic/targeted therapy for a different cancer is allowable; however, a prior anti-programmed cell death (PD)-1, anti-PD-L1, or anti-programmed cell death 1 ligand 2 (PD-L2) agent is not permitted
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity defined as follows:
Show all 27Show fewer
  • Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to registration
  • Transmural myocardial infarction within 6 months prior to registration
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Note: if the infection resolves and the patient is on oral (p.o.) and still within, the required registration timeframe, then the patient is eligible
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to registration
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control and Prevention (CDC) definition; note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the cisplatin and IMRT involved in this protocol may be significantly immunosuppressive; patients with known HIV, CD4 counts >= 250/uL, and undetectable viral loads who are stable on an antiretroviral regimen may be included
  • A diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of the MK-3475 (pembrolizumab)
  • Known history of active TB (Bacillus tuberculosis)
  • Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis c virus [HCV] ribonucleic acid [RNA] [qualitative] is detected); Note: patients who have been curatively treated for hepatitis C and have no detectable viral load are eligible
  • Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Grade 3-4 electrolyte abnormalities (CTCAE, v. 4):
  • Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels
  • Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14mmol/L)
  • Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels
  • Potassium < 3.0 mmol/L or > 6 mmol/L despite intervention to normalize levels
  • Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels
  • Patients who are pregnant, nursing, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of MK-3475 (pembrolizumab)
  • Hypersensitivity to MK-3475 (pembrolizumab) or any of its excipients;
  • Patients who have received a live vaccine within 30 days of planned start of study therapy; Note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
  • Patients for whom it is not in the best interest to participate in the study, in the opinion of the treating investigator

Trial locations and contacts

69 sites in 1 country.

69 sites in 1 country

United States69 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • The University of Kansas Cancer Center-South

    Kansas City, Missouri, 64131

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Cleveland Clinic Cancer Center Mansfield

    Mansfield, Ohio, 44906

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Yale University

    New Haven, Connecticut, 06520

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Cleveland Clinic Cancer Center Strongsville

    Strongsville, Ohio, 44136

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Cleveland Clinic Wooster Family Health and Surgery Center

    Wooster, Ohio, 44691

Other trials in United States

About this study

Official title: A Phase I and Expansion Cohort Study of Adjuvant Cisplatin, Intensity-Modulated Radiotherapy, and MK-3475 (Pembrolizumab) in High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC)

This phase I trial studies the side effects and best dose of pembrolizumab when given together with cisplatin and intensity-modulated radiation therapy, in treating patients with stage III-IV squamous cell carcinoma of the head and neck. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Intensity-modulated radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab with cisplatin and intensity-modulated radiation therapy may work better in treating patients with squamous cell carcinoma of the head and neck.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the recommended phase II dose (RP2D) for the combination of MK-3475 (pembrolizumab) and standard, adjuvant cisplatin-radiotherapy in patients with high-risk, human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC), based upon dose-limiting toxicity (DLT).

SECONDARY OBJECTIVES:

  1. To describe 1-year disease-free survival (DFS), overall survival (OS), local-regional failure (LRF), and rate of distant metastases following treatment with adjuvant cisplatin-radiotherapy and MK-3475 (pembrolizumab).

II. To describe the toxicity of the combination of cisplatin-radiotherapy and MK-3475 (pembrolizumab) according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4, including immune-related adverse events (AEs).

III. To describe the relationship between baseline programmed cell death 1 ligand 1 (PD-L1) expression 1-year disease-free survival (DFS).

IV. To describe baseline immune-inflammatory biomarkers in both tumor and tumor-infiltrating lymphocytes (TILs), and correlate them with 1-year DFS.

  1. To describe baseline and change in expression of peripheral immune-inflammatory biomarkers, including a panel of candidate tumor antigen (TA)-specific memory T cells, and correlate with 1-year DFS.

OUTLINE:

Patients receive cisplatin intravenously (IV) over 1-2 hours once weekly for weeks 1-6 and pembrolizumab IV over 30 minutes every 3 weeks in weeks 9, 12, 15, 18, and 21. Patients also undergo intensity-modulated radiation therapy (IMRT) in weeks 1-6. Patients may also receive pembrolizumab IV over 30 minutes in weeks 3, 6, 24, and 27.

After completion of study treatment, patients are followed up at months 6, 9, 12, 15, 18, 21, 24, 30, and 36.

Being tested
Cisplatin, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Pembrolizumab
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Given IV

  • Intensity-Modulated Radiation TherapyRadiation

    Undergo IMRT

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PembrolizumabBiological

    Given IV

Study groups in NCT02775812
Study groupRoleWhat they receive
Treatment (cisplatin, pembrolizumab, IMRT)ExperimentalPatients receive cisplatin IV over 1-2 hours once weekly for weeks 1-6 and pembrolizumab IV over 30 minutes every 3 weeks in weeks 9, 12, 15, 18, and 21. Patients also undergo IMRT in weeks 1-6. Patients may also receive pembrolizumab IV over 30 minutes in weeks 3, 6, 24, and 27.
Receives: Drug: Cisplatin; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicities in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant cisplatin, intensity-modulated radiation therapy, and pembrolizumab

    Will be summarized using proportions for binary outcome per cohort.

    Measured: Up to 4 weeks post intensity-modulated radiation therapy

Secondary outcomes (9)

  1. Disease free survival

    Descriptive statistics for disease free survival will be estimated using the Kaplan-Meier method.

    Measured: Up to 1 year

  2. Overall survival

    Descriptive statistics for overall survival will be estimated using the Kaplan-Meier method

    Measured: Up to 1 year

  3. Local-regional failure

    Descriptive statistics for rates local-regional failure will be estimated using the cumulative incidence method.

    Measured: Up to 1 year

  4. Distant metastases

    Descriptive statistics for distant metastasis will be estimated using the cumulative incidence method.

    Measured: Up to 1 year

  5. Incidence of acute toxicities by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

    Adverse events will be estimated using a binomial distribution along with their associated 95% confidence intervals.

    Measured: Up to 1 year

  6. Incidence of late toxicities by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

    Adverse events will be estimated using a binomial distribution along with their associated 95% confidence intervals.

    Measured: Up to 1 year

  7. Levels of PDL1

    Will be assessed in tumor tissue by light microscopy.

    Measured: Up to 1 year

  8. Immune-inflammatory biomarkers

    Will be correlated in both tumor and tumor infiltrating lymphocytes

    Measured: Up to 1 year

  9. Change in expression of peripheral immune-inflammatory biomarkers

    Change in expression will be assessed.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2016 (estimated)
  2. Study start28 Nov 2016
  3. Primary completion3 Dec 2018
  4. Study completion20 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02775812
Sponsor's protocol ID
NCI-2016-00667
Other IDs
NCI-2016-00667, NRG-HN003, NRG-HN003, NRG-HN003, U10CA180868
Status last verified
Jun 2022
First submitted
16 May 2016
Last updated
10 Jun 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cisplatin, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis in people with Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7 and Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7, run by National Cancer Institute (NCI) at 69 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicities in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant cisplatin, intensity-modulated radiation therapy, and pembrolizumab (time frame: Up to 4 weeks post intensity-modulated radiation therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02775812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.

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