Cancer of Head and NeckPhase 2NCT02296684
Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing MK-3475 (neoadjuvant), Surgery and Intensity modulated radiation therapy in people with Cancer of Head and Neck and Head and Neck Cancer, run by Washington University School of Medicine at 3 sites in United States.
Trial summary
The goal of this trial is to test the ability of MK-3475 (pembrolizumab) to improve locoregional recurrence and distant metastatic rates in high-risk patients with locally advanced head and neck squamous cell carcinomas (HNSCCs) that are treated with current standard of care surgical approaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck, Head and Neck Cancer, Neoplasms, Head and Neck
- What is being tested?
- MK-3475 (neoadjuvant), Surgery and Intensity modulated radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Mar 2015to 21 Jul 2025
- 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
- Histologically or cytologically confirmed stage III or IV HNSCC oral cavity, hypopharynx, oropharynx, larynx (excluding p16 or HPV-positive oropharynx primaries and sinonasal primaries).
- Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm with CT scan, as >20 mm by chest x-ray, or >10 mm with calipers by clinical exam by RECIST 1.1.
- At least 18 years of age.
- ECOG performance status ≤ 1
- Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1,500/mcl
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- Platelets ≥ 100,000/mcl
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 x IULN OR Direct bilirubin ≤ IULN for patients with total bilirubin > 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN (or ≤ 5 x IULN for patients with liver metastases)
- Serum creatinine ≤ 1.5 x IULN OR Creatinine clearance by Cockcroft-Gault ≥ 30 mL/min/1.73 m2 for patients with creatinine levels > 1.5 x IULN
- INR ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or PTT is within therapeutic range of intended use of anticoagulants
- aPTT ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or PTT is within therapeutic range of intended use of anticoagulants
- Sexually active women of childbearing potential and men must agree to use 2 methods of contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 120 days after last dose of MK-3475. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- Prior treatment for head and neck cancer.
- Patients with HPV-positive or p16-positive oropharyngeal SCCA.
- Patients with sinonasal SCCAs
- Patients with metastatic SCCA neck disease with an unknown primary tumor site
- Prior treatment 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).
- Received a live vaccine within 30 days prior to the first dose of MK-3475. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated viruses and are not allowed.
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- A history of other malignancy ≤ 3 years previous with the exception of previous head and neck cancer treated only by surgery, basal cell or squamous cell carcinoma of the skin which were treated with local resection only, or carcinoma in situ of the cervix.
- Note: patients with synchronous head and neck cancer primaries are an exception to this criterion and may qualify for the study.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of MK-3475.
- Currently receiving any other investigational agents or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of MK-3475.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-3475 or other agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, immunosuppression, autoimmune conditions, underlying pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements.
- Has an 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.
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Pregnant and/or breastfeeding. Patient must have a negative serum or urine pregnancy test within 72 hours of study entry.
- Known history of active TB (bacillus tuberculosis).
- Known history of hepatitis B (defined as hepatitis B survace antigen [HBsAg] reactive) or known active hepatitis C (defined as HCV RNA [qualitative] is detected) infection. Note: know testing for hepatitis B and hepatitis C is required unless mandated by local health authority.
- Known history of HIV (HIV 1/2 antibodies).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Immunotherapy With MK-3475 in Locoregionally Advanced, Surgically Resectable Head and Neck Squamous Cell Carcinoma
The goal of this trial is to test the ability of MK-3475 (pembrolizumab) to improve locoregional recurrence and distant metastatic rates in high-risk patients with locally advanced head and neck squamous cell carcinomas (HNSCCs) that are treated with current standard of care surgical approaches.
- Conditions
- Cancer of Head and Neck, Head and Neck Cancer, Neoplasms, Head and Neck, Carcinoma, Squamous Cell of Head and Neck, Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma, Head and Neck
- Being tested
- MK-3475 (neoadjuvant), Surgery, Intensity modulated radiation therapy, Image-guided radiation therapy, Cisplatin
- Medical subject headings
- Head and Neck Neoplasms, 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.
MK-3475 (neoadjuvant)Biological
Also called SCH 900475, Pembrolizumab, Keytruda
SurgeryProcedure or surgery
Standard of care
Intensity modulated radiation therapyRadiation
Also called IMRT
Recommended, standard of care
Image-guided radiation therapyRadiation
Also called IGRT
Recommended, standard of care
CisplatinDrug
Also called cis-DDP, cis-Platinum II, cis-Diamminedichloroplatinum, DDP
Standard of care
MK-3475 (adjuvant)Biological
Also called SCH 900475, Pembrolizumab, Keytruda
Peripheral bloodProcedure or surgery
-Baseline, time of surgery (between day 14-24 inclusive), 3 months post surgery, 6 months post surgery, 9 months post surgery, 12 months post surgery
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 | Experimental | * MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery.
* Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of:
* risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions)
* optional image-guided radiation therapy
* risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course
* MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less. Receives: Biological: MK-3475 (neoadjuvant); Procedure: Surgery; Radiation: Intensity modulated radiation therapy; Radiation: Image-guided radiation therapy; Drug: Cisplatin; Biological: MK-3475 (adjuvant); Procedure: Peripheral blood |
| Cohort 2: Neoadjuvant MK-3475 | Experimental | -MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery) Receives: Biological: MK-3475 (neoadjuvant); Procedure: Surgery; Radiation: Intensity modulated radiation therapy; Radiation: Image-guided radiation therapy; Drug: Cisplatin; Procedure: Peripheral blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional Recurrence Rates in Cohorts 1 and 2
-The percentage of participants who developed local-regional recurrence within one year of surgery
Measured: Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose)
Distant Failure Rate in Cohorts 1 and 2
-The percentage of participants who developed distant failure within one year of surgery. Distant disease is cancer that is found in another part of the body that is far away from where the original (primary) tumor first formed.
Measured: Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose)
Rate of Major Pathologic Treatment Effect in Cohort 1
- Major pathologic treatment effect=pathologic tumor response (pTR).
- pTR was defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor): pTR-0 (>10%), pTR-1 (10-49%), and pTR-2 (≥50%).
Measured: At the time of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose)
Rate of Major Pathologic Treatment Effect in Cohort 2
- Major pathologic treatment effect=pathologic tumor response (pTR).
- pTR was defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor): pTR-0 (>10%), pTR-1 (10-49%), and pTR-2 (≥50%).
Measured: At the time of surgery (surgery occurred within 13-22 days after last neoadjuvant MK-3475 dose)
Secondary outcomes (7)
Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events
Reportable adverse events will be tracked for 30 days following the last day of study treatment. For the purposes of this protocol, reportable adverse events are events thought to be possibly, probably, or definitely related to MK-3475. Events thought to be probably or definitely related to surgery, adjuvant chemotherapy, or radiotherapy need not be recorded.
Measured: Through 30 days after last dose of MK-3475
Number of Surgical Complications and/or Delays in Cohorts 1 and 2
Measured: At the time of surgery (approximately 2-3 weeks after registration)
Number of Participants With Locoregional Recurrence Rates in Cohorts 1 and 2
Measured: Through completion of follow-up (median total time 58.7 months (IQR 23.2-61.4))
Number of Participants With Distant Metastases (DM) in Cohorts 1 and 2
Measured: Through completion of follow-up (median total time 58.7 months (IQR 23.2-61.4))
Kaplan-Meier Estimate of Median 5-year Event-free Survival (EFS) in Cohorts 1 and 2
Event-free survival will be defined as time from surgery to time to disease recurrence, distant metastasis, new primary, or death due to any cause, whichever occurred first.
Measured: Through completion of follow-up (median total time 58.8 months (IQR 25.1-61.4))
Kaplan-Meier Estimate of Median 5-year Event-free Survival (EFS) Differences by Presence Versus Absence and by Predicted Impact of Recurrent Genomic Alterations, Specifically in TP53, in Cohort 1
Event-free survival will be defined as time from surgery to time to disease recurrence, distant metastasis, new primary, or death due to any cause, whichever occurred first.
Measured: Through completion of follow-up (median total time 60.9 months (IQR: 21.2-63.9))
Kaplan-Meier Estimate of Median 5-year Overall Survival (OS) Differences by Presence Versus Absence and by Predicted Impact of Recurrent Genomic Alterations, Specifically in TP53, in Cohort 1
Overall survival will be defined as time from surgery to death from any cause.
Measured: Through completion of follow-up (median total time 60.9 months (IQR: 25.1 - 63.9 months))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study start25 Mar 2015
- Primary completion5 Apr 2022
- Study completion21 Jul 2025
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 (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Douglas R Adkins, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296684
- Sponsor's protocol ID
- 201412118
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2014
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uppaluri R, Campbell KM, Egloff AM, Zolkind P, Skidmore ZL, Nussenbaum B, Paniello RC, Rich JT, Jackson R, Pipkorn P, Michel LS, Ley J, Oppelt P, Dunn GP, Barnell EK, Spies NC, Lin T, Li T, Mulder DT, Hanna Y, Cirlan I, Pugh TJ, Mudianto T, Riley R, Zhou L, Jo VY, Stachler MD, Hanna GJ, Kass J, Haddad R, Schoenfeld JD, Gjini E, Lako A, Thorstad W, Gay HA, Daly M, Rodig SJ, Hagemann IS, Kallogjeri D, Piccirillo JF, Chernock RD, Griffith M, Griffith OL, Adkins DR. Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus-Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial. Clin Cancer Res. 2020 Oct 1;26(19):5140-5152. doi: 10.1158/1078-0432.CCR-20-1695. Epub 2020 Jul 14.
PubMed 32665297
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy With MK-3475 in Locoregionally Advanced, Surgically Resectable Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02296684
- Acronym / sponsor ID
- 201412118
- Conditions
- Cancer of Head and Neck, Head and Neck Cancer, Neoplasms, Head and Neck, Carcinoma, Squamous Cell of Head and Neck, Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma, Head and Neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 25 Mar 2015 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Posted 11 May 2023
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 trial is to test the ability of MK-3475 (pembrolizumab) to improve locoregional recurrence and distant metastatic rates in high-risk patients with locally advanced head and neck squamous cell carcinomas (HNSCCs) that are treated with current standard of care surgical approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 | Experimental | Biological: MK-3475 (neoadjuvant), Procedure: Surgery, Radiation: Intensity modulated radiation therapy, Radiation: Image-guided radiation therapy, Drug: Cisplatin, Biological: MK-3475 (adjuvant), Procedure: Peripheral blood* MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery. * Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of: * risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions) * optional image-guided radiation therapy * risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course * MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less. |
| Cohort 2: Neoadjuvant MK-3475 | Experimental | Biological: MK-3475 (neoadjuvant), Procedure: Surgery, Radiation: Intensity modulated radiation therapy, Radiation: Image-guided radiation therapy, Drug: Cisplatin, Procedure: Peripheral blood-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed stage III or IV HNSCC oral cavity, hypopharynx, oropharynx, larynx (excluding p16 or HPV-positive oropharynx primaries and sinonasal primaries).
- Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm with CT scan, as >20 mm by chest x-ray, or >10 mm with calipers by clinical exam by RECIST 1.1.
- At least 18 years of age.
- ECOG performance status ≤ 1
- Normal bone marrow and organ function as defined below:
Key exclusion criteria (18 listed)
- Prior treatment for head and neck cancer.
- Patients with HPV-positive or p16-positive oropharyngeal SCCA.
- Patients with sinonasal SCCAs
- Patients with metastatic SCCA neck disease with an unknown primary tumor site
- Prior treatment 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).
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 |
|---|---|---|
| MK-3475 (neoadjuvant)Also: SCH 900475, Pembrolizumab, Keytruda | Biological | Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475, Cohort 2: Neoadjuvant MK-3475 |
| SurgeryStandard of care | Procedure or surgery | Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475, Cohort 2: Neoadjuvant MK-3475 |
| Intensity modulated radiation therapyAlso: IMRTRecommended, standard of care | Radiation | Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475, Cohort 2: Neoadjuvant MK-3475 |
| Image-guided radiation therapyAlso: IGRTRecommended, standard of care | Radiation | Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475, Cohort 2: Neoadjuvant MK-3475 |
| CisplatinAlso: cis-DDP, cis-Platinum II, cis-Diamminedichloroplatinum, DDPStandard of care | Drug | Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475, Cohort 2: Neoadjuvant MK-3475 |
| MK-3475 (adjuvant)Also: SCH 900475, Pembrolizumab, Keytruda | Biological | Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475 |
| Peripheral blood-Baseline, time of surgery (between day 14-24 inclusive), 3 months post surgery, 6 months post surgery, 9 months post surgery, 12 months post surgery | Procedure or surgery | Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475, Cohort 2: Neoadjuvant MK-3475 |
Primary outcome
Locoregional Recurrence Rates in Cohorts 1 and 2
Time frame: Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose)
-The percentage of participants who developed local-regional recurrence within one year of surgery
Distant Failure Rate in Cohorts 1 and 2
Time frame: Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose)
-The percentage of participants who developed distant failure within one year of surgery. Distant disease is cancer that is found in another part of the body that is far away from where the original (primary) tumor first formed.
Rate of Major Pathologic Treatment Effect in Cohort 1
Time frame: At the time of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose)
* Major pathologic treatment effect=pathologic tumor response (pTR). * pTR was defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor): pTR-0 (>10%), pTR-1 (10-49%), and pTR-2 (≥50%).
Rate of Major Pathologic Treatment Effect in Cohort 2
Time frame: At the time of surgery (surgery occurred within 13-22 days after last neoadjuvant MK-3475 dose)
* Major pathologic treatment effect=pathologic tumor response (pTR). * pTR was defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor): pTR-0 (>10%), pTR-1 (10-49%), and pTR-2 (≥50%).
7 secondary outcomes
Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events
Time frame: Through 30 days after last dose of MK-3475
Number of Surgical Complications and/or Delays in Cohorts 1 and 2
Time frame: At the time of surgery (approximately 2-3 weeks after registration)
Number of Participants With Locoregional Recurrence Rates in Cohorts 1 and 2
Time frame: Through completion of follow-up (median total time 58.7 months (IQR 23.2-61.4))
Number of Participants With Distant Metastases (DM) in Cohorts 1 and 2
Time frame: Through completion of follow-up (median total time 58.7 months (IQR 23.2-61.4))
Kaplan-Meier Estimate of Median 5-year Event-free Survival (EFS) in Cohorts 1 and 2
Time frame: Through completion of follow-up (median total time 58.8 months (IQR 25.1-61.4))
Kaplan-Meier Estimate of Median 5-year Event-free Survival (EFS) Differences by Presence Versus Absence and by Predicted Impact of Recurrent Genomic Alterations, Specifically in TP53, in Cohort 1
Time frame: Through completion of follow-up (median total time 60.9 months (IQR: 21.2-63.9))
Kaplan-Meier Estimate of Median 5-year Overall Survival (OS) Differences by Presence Versus Absence and by Predicted Impact of Recurrent Genomic Alterations, Specifically in TP53, in Cohort 1
Time frame: Through completion of follow-up (median total time 60.9 months (IQR: 25.1 - 63.9 months))
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32665297Uppaluri R, Campbell KM, Egloff AM, Zolkind P, Skidmore ZL, Nussenbaum B, Paniello RC, Rich JT, Jackson R, Pipkorn P, Michel LS, Ley J, Oppelt P, Dunn GP, Barnell EK, Spies NC, Lin T, Li T, Mulder DT, Hanna Y, Cirlan I, Pugh TJ, Mudianto T, Riley R, Zhou L, Jo VY, Stachler MD, Hanna GJ, Kass J, Haddad R, Schoenfeld JD, Gjini E, Lako A, Thorstad W, Gay HA, Daly M, Rodig SJ, Hagemann IS, Kallogjeri D, Piccirillo JF, Chernock RD, Griffith M, Griffith OL, Adkins DR. Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus-Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial. Clin Cancer Res. 2020 Oct 1;26(19):5140-5152. doi: 10.1158/1078-0432.CCR-20-1695. Epub 2020 Jul 14.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Douglas R Adkins, M.D. principal investigator
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-3475 (neoadjuvant), Surgery and Intensity modulated radiation therapy in people with Cancer of Head and Neck and Head and Neck Cancer, run by Washington University School of Medicine at 3 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 15 inclusion and 18 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 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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 11 May 2023). 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?
Locoregional Recurrence Rates in Cohorts 1 and 2 (time frame: Within 1 year of surgery (surgery occurred within 13-22 days after neoadjuvant MK-3475 dose)). The study lists 4 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 NCT02296684, which also lists 1 linked publication.
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 5 Aug 2026.