Head and Neck Squamous Cell CarcinomaPhase 2NCT02777385
Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer
A Phase 2 study testing Pembrolizumab, Cisplatin and IMRT in people with Head and Neck Squamous Cell Carcinoma, run by Dan Zandberg at 1 site in United States.
Trial summary
The goal of this research study is to learn which therapy order (adding pembrolizumab during vs. after cisplatin and radiation) may be more effective in treating head and neck cancer, as well as learn the side effects of these combinations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Pembrolizumab, Cisplatin and IMRT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2016to 4 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written informed consent
- If a woman of childbearing potential, documentation of negative pregnancy
- Histologically-confirmed head and neck squamous cell carcinoma with no evidence of distant metastasis. The primary site may be the oral cavity, oropharynx, larynx, or hypopharynx. Patients with squamous cell carcinoma of unknown primary, metastatic to cervical lymph nodes, are permitted to enroll.
- High risk or intermediate risk disease, defined below. Staging evaluation should be determined by imaging studies and complete head and neck exam in accordance with the American Joint committee on Cancer Staging Manual, 7th edition.
- o High risk patient must meet one of the following criteria:
- Surgically unresectable oral cavity. Patients who are technically resectable but refuse surgery due to morbidity (eg. total glossectomy) are also eligible. Medically inoperable patients are not eligible.
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- Larynx: T4 any N; T2-3 and ≥ N2a
- Hypopharynx: T1-2N1-3 or T3-4N0-3
- Oropharynx: p16(-) AND T3-4 or ≥ N2a
- Unknown primary: p16(-) AND ≥ N2a
- o Intermediate risk patients must meet one of the following criteria:
- Oropharynx: p16(+) AND one of the following
- T3 or ≥ N2a AND ≥ 10 pack-years tobacco exposure (see Tobacco Assessment Form, Appendix A)
- T4 or N3 disease irrespective of tobacco exposure
- Unknown primary: p16(+) AND one of the following
- ≥ N2a AND ≥ 10 pack-years tobacco exposure
- N3 disease irrespective of tobacco exposure
- Patients must be untreated with curative-intent surgery for current diagnosis of Stage III, IVa, or IVb disease. Diagnostic biopsy of primary tumor and/or nodal sites is permitted.
- Diagnostic simple tonsillectomy is permitted, provided patient has RECIST-measurable nodal disease.
- Patients with a second HNSCC primary tumor are eligible for this study, provided more than 2 years have elapsed since the first diagnosis of HNSCC, the original tumor was managed with surgery only (no adjuvant chemotherapy or radiotherapy), and has not recurred.
- 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 (resected or management deferred), who are eligible.
- No prior systemic (chemotherapy or biologic/molecular targeted therapy) or radiation treatment for head and neck cancer.
- Patients may have received chemotherapy or radiation for a previous, curatively treated non-HNSCC malignancy, provided at least 2 years have elapsed.
- Patients must be untreated with radiation above the clavicles.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Age ≥ 18
- Patients must have measurable disease according to RECIST 1.1
- Patients must demonstrate adequate organ function as defined.
- Sexually active patients must agree to use adequate contraceptive measures, while on study and for 30 days after the last dose of study drug.
Who cannot join
- Nasopharyngeal primary site
- Current participation in or previous participation in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment.
- History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent.
- Distant metastatic disease including CNS or leptomeningeal metastases is not allowed.
- History of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Received prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e. ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
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- History of second malignancy within 2 years prior to Study Day 1 (except for excised and cured non-melanoma skin cancer, carcinoma in situ of breast or cervix, superficial bladder cancer, or T1a or T1b prostate cancer comprising < 5% of resected tissue with normal prostate specific antigen (PSA) since resection).
- Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
- Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Received a live vaccine within 30 days prior to the first dose of trial treatment.
- Received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Significant pulmonary disease, including pulmonary hypertension, interstitial lung disease, or active, non-infectious pneumonitis.
- History or current evidence of any other medical or psychiatric condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Peripheral neuropathy ≥ Grade 2
- Significant cardiovascular disease, including:
- Cardiac failure New York Heart Association (NYHA) class III or IV.
- Myocardial infarction, severe or unstable angina within 6 months prior to Study Day 1.
- History of serious arrhythmia (i.e., ventricular tachycardia, or ventricular fibrillation).
- Ventricular cardiac arrhythmias requiring anti-arrhythmic medications.
- Known left ventricular ejection fraction (LVEF) ≤ 50%.
- Significant thrombotic or embolic events within 3 months prior to Study Day 1.
- Major surgery within 6 weeks prior to Study Day 1 (subjects must have completely recovered from any previous surgery prior to Study Day 1). Biopsy, diagnostic tonsillectomy, airway tumor debulking or excisional lymph node biopsy do not constitute major surgery.
- Active infection requiring antibiotics or antifungals within 7 days prior to first dose of study drug.
- Significant electrolyte imbalance prior to enrollment (note that patients may be supplemented to achieve acceptable electrolyte values):
- Hypomagnesemia <1.2 mg/dL or 0.5 mmol/L.
- Hypokalemia < 3.0 mmol/L.
- Women must not be pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Randomized, Phase II Study Evaluating Concurrent or Sequential Fixed-Dose Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy in Intermediate or High Risk, Previously Untreated, Locally Advanced Head and Neck Cancer
The goal of this research study is to learn which therapy order (adding pembrolizumab during vs. after cisplatin and radiation) may be more effective in treating head and neck cancer, as well as learn the side effects of these combinations. Pembrolizumab is an immune therapy, a drug that stimulates the immune system to fight cancer, and is FDA approved in lung cancer and melanoma.
Read the detailed description
The study regimen consists of cisplatin and radiation for all patients, the standard treatment for head and neck cancer. All patients will also receive pembrolizumab (the study drug), and will be randomized to two treatment schedules: either pembrolizumab with cisplatin-radiation, or pembrolizumab after completing cisplatin-radiation.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Pembrolizumab, Cisplatin, IMRT
- Keywords
- Head and Neck, Locally Advanced, Squamous Cell Carcinoma, SCCHN, Untreated, High Risk, Intermediate Risk, Radiation Therapy, Cisplatin
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
CisplatinDrug
Also called Platinol
Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
IMRTRadiation
IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplating and radiation. Receives: Drug: Pembrolizumab; Drug: Cisplatin; Radiation: IMRT |
| Arm 2 | Experimental | Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisp/radiation and given every 3 weeks Receives: Drug: Pembrolizumab; Drug: Cisplatin; Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival at ≤12 Months
Probability of participants (expressed as a percentage) without disease progression at less than or equal to12 after start of treatment: Complete Response (CR) + Partial Response (PR)/total number of patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Measured: Up to 12 months
Progression-free Survival at ≤ 36 Months
Probability of participants (expressed as a percentage) without disease progression at less than or equal to 36 months after start of treatment: Complete Response (CR) + Partial Response (PR)/total number of patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Measured: Up to 36 months
Progression-free Survival at ≤ 48 Months
Probability of participants (expressed as a percentage) without disease progression time from treatment initiation to disease progression or death from any cause or last follow up. Per RECIST v1.1: Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Measured: Up to 48 months
Acute Toxicity / DLT Rate
The number of patients who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 4.0
Measured: Up to 6 months
1-year Locoregional Failure Rate
Percent probability of participants for which time to locoregional failure (TTLRF) (calculated from treatment initiation to locoregional failure, or censored at other failure, death, or the last follow up; death is not an event) is less than 1 year. Locoregional failure is disease recurrence in either the location or regional location of the original disease, as opposed to a distant site.
Measured: Up to 1 year
3-year Locoregional Failure Rate
Percent probability of participants for which time to locoregional failure (TTLRF) (calculated from treatment initiation to locoregional failure, or censored at other failure, death, or the last follow up; death is not an event) is less than 3 years. Locoregional failure is disease recurrence in either the location or regional location of the original disease, as opposed to a distant site.
Measured: Up to 3 years
Secondary outcomes (5)
Progression-free Survival (PFS)
Median number of months from treatment initiation to disease progression or death from any cause or last follow up. Per RECIST v1.1 Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Measured: Up to 48 months
Overall Survival (OS)
The length of time from start of study treatment that patients are still alive.
Measured: Up to 48 months
Overall Survival (OS) at ≤ 12 Months
Probability of patients (expressed as a percentage) still alive at less than or equal to 12 months after start of study.
Measured: Up to12 months
Overall Survival (OS) at ≤ 36 Months
Probability of patients (expressed as a percentage) still alive at less than or equal to 36 months after start of study.
Measured: Up to 36 months
Overall Survival (OS) at ≤ 48 Months
Probability of patients (expressed as a percentage) still alive at less than or equal to 48 months after start of study.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start31 May 2016
- Primary completion24 Apr 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dan Zandberg
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Dan Zandberg, University of Pittsburgh
- Investigators
- Dan Zandberg, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777385
- Sponsor's protocol ID
- HCC 15-132
- Status last verified
- Jul 2024
- First submitted
- 28 Apr 2016
- Last updated
- 1 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zandberg DP, Vujanovic L, Clump DA, Isett BP, Wang H, Sica G, Bao R, Li H, Ohr J, Skinner HD, Seethala RR, Chiosea SI, Ferris RL, Bauman JE. Randomized Phase II Study of Concurrent Versus Sequential Pembrolizumab in Combination With Chemoradiation in Locally Advanced Head and Neck Cancer. J Clin Oncol. 2025 Aug 10;43(23):2572-2582. doi: 10.1200/JCO-24-01580. Epub 2025 May 27.
PubMed 40424564Ferris RL, Moskovitz J, Kunning S, Ruffin AT, Reeder C, Ohr J, Gooding WE, Kim S, Karlovits BJ, Vignali DAA, Duvvuri U, Johnson JT, Petro D, Heron DE, Clump DA, Bruno TC, Bauman JE. Phase I Trial of Cetuximab, Radiotherapy, and Ipilimumab in Locally Advanced Head and Neck Cancer. Clin Cancer Res. 2022 Apr 1;28(7):1335-1344. doi: 10.1158/1078-0432.CCR-21-0426.
PubMed 35091445
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Phase II Study Evaluating Concurrent or Sequential Fixed-Dose Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy in Intermediate or High Risk, Previously Untreated, Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02777385
- Acronym / sponsor ID
- HCC 15-132
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and Neck, Locally Advanced, Squamous Cell Carcinoma, SCCHN, Untreated, High Risk, Intermediate Risk, Radiation Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dan ZandbergUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 31 May 2016 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Posted 1 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to learn which therapy order (adding pembrolizumab during vs. after cisplatin and radiation) may be more effective in treating head and neck cancer, as well as learn the side effects of these combinations. Pembrolizumab is an immune therapy, a drug that stimulates the immune system to fight cancer, and is FDA approved in lung cancer and melanoma.
Detailed description
The study regimen consists of cisplatin and radiation for all patients, the standard treatment for head and neck cancer. All patients will also receive pembrolizumab (the study drug), and will be randomized to two treatment schedules: either pembrolizumab with cisplatin-radiation, or pembrolizumab after completing cisplatin-radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Pembrolizumab, Drug: Cisplatin, Radiation: IMRTCisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplating and radiation. |
| Arm 2 | Experimental | Drug: Pembrolizumab, Drug: Cisplatin, Radiation: IMRTCisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisp/radiation and given every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Written informed consent
- If a woman of childbearing potential, documentation of negative pregnancy
- Histologically-confirmed head and neck squamous cell carcinoma with no evidence of distant metastasis. The primary site may be the oral cavity, oropharynx, larynx, or hypopharynx. Patients with squamous cell carcinoma of unknown primary, metastatic to cervical lymph nodes, are permitted to enroll.
- High risk or intermediate risk disease, defined below. Staging evaluation should be determined by imaging studies and complete head and neck exam in accordance with the American Joint committee on Cancer Staging Manual, 7th edition.
- Surgically unresectable oral cavity. Patients who are technically resectable but refuse surgery due to morbidity (eg. total glossectomy) are also eligible. Medically inoperable patients are not eligible.
Key exclusion criteria (28 listed)
- Nasopharyngeal primary site
- Current participation in or previous participation in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment.
- History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent.
- Distant metastatic disease including CNS or leptomeningeal metastases is not allowed.
- History of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KeytrudaIn both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT. | Drug | Arm 1, Arm 2 |
| CisplatinAlso: PlatinolPatients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation. | Drug | Arm 1, Arm 2 |
| IMRTIMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan. | Radiation | Arm 1, Arm 2 |
Primary outcome
Progression-free Survival at ≤12 Months
Time frame: Up to 12 months
Probability of participants (expressed as a percentage) without disease progression at less than or equal to12 after start of treatment: Complete Response (CR) + Partial Response (PR)/total number of patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Progression-free Survival at ≤ 36 Months
Time frame: Up to 36 months
Probability of participants (expressed as a percentage) without disease progression at less than or equal to 36 months after start of treatment: Complete Response (CR) + Partial Response (PR)/total number of patients assessed. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Progression-free Survival at ≤ 48 Months
Time frame: Up to 48 months
Probability of participants (expressed as a percentage) without disease progression time from treatment initiation to disease progression or death from any cause or last follow up. Per RECIST v1.1: Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Acute Toxicity / DLT Rate
Time frame: Up to 6 months
The number of patients who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 4.0
1-year Locoregional Failure Rate
Time frame: Up to 1 year
Percent probability of participants for which time to locoregional failure (TTLRF) (calculated from treatment initiation to locoregional failure, or censored at other failure, death, or the last follow up; death is not an event) is less than 1 year. Locoregional failure is disease recurrence in either the location or regional location of the original disease, as opposed to a distant site.
3-year Locoregional Failure Rate
Time frame: Up to 3 years
Percent probability of participants for which time to locoregional failure (TTLRF) (calculated from treatment initiation to locoregional failure, or censored at other failure, death, or the last follow up; death is not an event) is less than 3 years. Locoregional failure is disease recurrence in either the location or regional location of the original disease, as opposed to a distant site.
5 secondary outcomes
Progression-free Survival (PFS)
Time frame: Up to 48 months
Overall Survival (OS)
Time frame: Up to 48 months
Overall Survival (OS) at ≤ 12 Months
Time frame: Up to12 months
Overall Survival (OS) at ≤ 36 Months
Time frame: Up to 36 months
Overall Survival (OS) at ≤ 48 Months
Time frame: Up to 48 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40424564Zandberg DP, Vujanovic L, Clump DA, Isett BP, Wang H, Sica G, Bao R, Li H, Ohr J, Skinner HD, Seethala RR, Chiosea SI, Ferris RL, Bauman JE. Randomized Phase II Study of Concurrent Versus Sequential Pembrolizumab in Combination With Chemoradiation in Locally Advanced Head and Neck Cancer. J Clin Oncol. 2025 Aug 10;43(23):2572-2582. doi: 10.1200/JCO-24-01580. Epub 2025 May 27.
- Derived from this study: PubMed 35091445Ferris RL, Moskovitz J, Kunning S, Ruffin AT, Reeder C, Ohr J, Gooding WE, Kim S, Karlovits BJ, Vignali DAA, Duvvuri U, Johnson JT, Petro D, Heron DE, Clump DA, Bruno TC, Bauman JE. Phase I Trial of Cetuximab, Radiotherapy, and Ipilimumab in Locally Advanced Head and Neck Cancer. Clin Cancer Res. 2022 Apr 1;28(7):1335-1344. doi: 10.1158/1078-0432.CCR-21-0426.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Zandberg, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Cisplatin and IMRT in people with Head and Neck Squamous Cell Carcinoma, run by Dan Zandberg at 1 site 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 28 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 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-free Survival at ≤12 Months (time frame: Up to 12 months). The study lists 6 primary outcomes in all. 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 NCT02777385, which also lists 2 linked publications.
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 1 Aug 2024.