Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma

ID: NCT02296684
Status: Recruiting
Phase: Phase 2
Start Date: March 25, 2015
First Submitted: November 17, 2014
Last Updated: February 08, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine, Merck Sharp & Dohme Corp.
Location: United States
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
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

Brief 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.

Detailed Description

Condition or disease Intervention/treatment Phase

Cancer of Head and Neck

Carcinoma, Squamous Cell of Head and Neck

Head and Neck Cancer

Neoplasms, Head and Neck

Squamous Cell Carcinoma of the Head and Neck

Squamous Cell Carcinoma, Head and Neck

Biological: MK-3475 (neoadjuvant)
Other Names
SCH 900475 Pembrolizumab Keytruda
Procedure: Surgery
Other Names
Radiation: Intensity modulated radiation therapy
Other Names
IMRT
Radiation: Image-guided radiation therapy
Other Names
IGRT
Drug: Cisplatin
Other Names
cis-DDP cis-Platinum II cis-Diamminedichloroplatinum DDP
Biological: MK-3475 (adjuvant)
Other Names
SCH 900475 Pembrolizumab Keytruda
Procedure: Peripheral blood
Other Names
Phase 2

Tracking Information

First Submitted DateNovember 17, 2014
Last Update Posted DateFebruary 08, 2018
Actual Start DateMarch 25, 2015
Anticipated Completion DateMarch 31, 2023
Actual Primary Completion DateMarch 31, 2020
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Locoregional recurrence rates in Cohorts 1 and 2 [Time Frame: 1 year]

  • Distant failure rate in Cohorts 1 and 2 [Time Frame: 1 year]

  • Rate of major pathologic treatment effect in Cohort 1 [Time Frame: After one dose of neoadjuvant MK-3475]

  • Rate of major pathologic treatment effect in Cohort 2 [Time Frame: After two doses of neoadjuvant MK-3475]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Occurrence of adverse events in Cohorts 1 and 2 [Time Frame: 90 days after last dose of MK-3475]

    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. Please note that patients must be followed for events of clinical interest for 90 days following the last day of study treatment.

  • Surgical complications and/or delays in Cohorts 1 and 2 [Time Frame: At the time of surgery (approximately 2-3 weeks after registration)]

  • Rate of locoregional recurrences (LRR) in Cohorts 1 and 2 [Time Frame: 1 year]

  • Rate of distant metastases (DM) in Cohorts 1 and 2 [Time Frame: 1 year]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleImmunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma
Official TitleImmunotherapy With MK-3475 in Locoregionally Advanced, Surgically Resectable Head and Neck Squamous Cell Carcinoma
Brief 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.

Detailed Description

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
66
Allocation
Non-Randomized
Interventional Model
Sequential Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Cancer of Head and Neck
Carcinoma, Squamous Cell of Head and Neck
Head and Neck Cancer
Neoplasms, Head and Neck
Squamous Cell Carcinoma of the Head and Neck
Squamous Cell Carcinoma, Head and Neck
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Biological: MK-3475 (neoadjuvant)

Other Names
SCH 900475
Pembrolizumab
Keytruda
Procedure: Surgery

Standard of care

Other Names
Radiation: Intensity modulated radiation therapy

Recommended, standard of care

Other Names
IMRT
Radiation: Image-guided radiation therapy

Recommended, standard of care

Other Names
IGRT
Drug: Cisplatin

Standard of care

Other Names
cis-DDP
cis-Platinum II
cis-Diamminedichloroplatinum
DDP
Biological: MK-3475 (adjuvant)

Other Names
SCH 900475
Pembrolizumab
Keytruda
Procedure: 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

Other Names
Study Groups/Cohorts
Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery

Study Arms
Experimental Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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.
Biological : MK-3475 (neoadjuvant)

Experimental Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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.
Procedure : Surgery
Standard of care

Experimental Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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.
Radiation : Intensity modulated radiation therapy
Recommended, standard of care

Experimental Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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.
Radiation : Image-guided radiation therapy
Recommended, standard of care

Experimental Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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.
Drug : Cisplatin
Standard of care

Experimental Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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.
Biological : MK-3475 (adjuvant)

Experimental Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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.
Procedure : 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

Experimental Cohort 2: Neoadjuvant MK-3475
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Procedure : 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

Experimental Cohort 2: Neoadjuvant MK-3475
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Drug : Cisplatin
Standard of care

Experimental Cohort 2: Neoadjuvant MK-3475
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Radiation : Image-guided radiation therapy
Recommended, standard of care

Experimental Cohort 2: Neoadjuvant MK-3475
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Radiation : Intensity modulated radiation therapy
Recommended, standard of care

Experimental Cohort 2: Neoadjuvant MK-3475
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Procedure : Surgery
Standard of care

Experimental Cohort 2: Neoadjuvant MK-3475
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Biological : MK-3475 (neoadjuvant)

Arm Intervention/Treatment
Experimental Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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.
Biological : MK-3475 (neoadjuvant)
Experimental Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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.
Procedure : Surgery
Experimental Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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.
Radiation : Intensity modulated radiation therapy
Experimental Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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.
Radiation : Image-guided radiation therapy
Experimental Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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.
Drug : Cisplatin
Experimental Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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.
Biological : MK-3475 (adjuvant)
Experimental Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475
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 on 's surgical pathology from standard of care surgery shows high risk features (positive margins or extracapsular extension). 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.
Procedure : Peripheral blood
Experimental Cohort 2: Neoadjuvant MK-3475
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Procedure : Peripheral blood
Experimental Cohort 2: Neoadjuvant MK-3475
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Drug : Cisplatin
Experimental Cohort 2: Neoadjuvant MK-3475
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Radiation : Image-guided radiation therapy
Experimental Cohort 2: Neoadjuvant MK-3475
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Radiation : Intensity modulated radiation therapy
Experimental Cohort 2: Neoadjuvant MK-3475
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Procedure : Surgery
Experimental Cohort 2: Neoadjuvant MK-3475
-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery
Biological : MK-3475 (neoadjuvant)

Recruitment Information

Recruitment Status:Recruiting
Enrollment66
Completion DateMarch 31, 2023
Eligibility Criteria: Inclusion Criteria:
- 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
- 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 ≥ 60 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).

Exclusion Criteria:
- 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.
- 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 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, 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 active hepatitis B (e.g. HBsAg reactsive) or hepatitis C (e.g. HCV RNA [qualitative] is detected).
- Known history of HIV (HIV 1/2 antibodies).
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02296684
Other Study ID Numbers
201412118
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Washington University School of Medicine
Collaborators
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator
Douglas R Adkins, M.D.
Washington University School of Medicine