- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02252042
Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040)
June 30, 2023 updated by: Merck Sharp & Dohme LLC
A Phase III Randomized Trial of MK-3475 (Pembrolizumab) Versus Standard Treatment in Subjects With Recurrent or Metastatic Head and Neck Cancer
This is a study of pembrolizumab (MK-3475, KEYTRUDA®) versus standard treatment (methotrexate, docetaxel or cetuximab) for the treatment of recurrent or metastatic head and neck squamous cell cancer (HNSCC).
Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment.
The primary study hypothesis is that pembrolizumab treatment prolongs Overall Survival (OS) when compared to standard treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
495
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Has histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies
- Failure of prior platinum therapy
- Radiographically-measurable disease based on RECIST 1.1
- Tumor tissue available for PD-L1 biomarker analysis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Female participants of childbearing potential must be willing to use 2 methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after last dose of pembrolizumab or through 120-180 days after the last dose of docetaxel, methotrexate or cetuximab, acccording to local standard of care
- Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after last dose of pembrolizumab or through 120-180 days after the last dose of docetaxel, methotrexate or cetuximab, acccording to local standard of care
Exclusion Criteria
- Disease is suitable for local therapy administered with curative intent
- Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to randomization
- Previously treated with 3 or more systemic regimens given for recurrent and/or metastatic disease
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy
- Not recovered from adverse events due to therapy more than 4 weeks earlier
- Prior anti-cancer monoclonal antibody (mAb) therapy within 4 weeks prior to study Day 1, or not recovered from adverse events due to agents administered more than 4 weeks earlier
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1
- Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast cancers
- Active autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, corticosteroids, or immunosuppressive agents
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active, non-infectious pneumonitis
- Active infection requiring systemic therapy
- Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial therapy according to local standard of care
- Prior therapy with an anti-PD-1 or anti-PD1-L1 or -L2 therapy or previously participated in a Merck pembrolizumab (MK-3475) trial
- Human immunodeficiency virus (HIV)
- Hepatitis B or C
- Live vaccine within 30 days of planned start of study therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pembroliziumab
Participants will receive pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle for up to approximately 24 months.
Eligible participants who stop pembrolizumab with Stable Disease (SD) or better but progress after discontinuation may be able to initiate a second course of pembrolizumab for up to approximately 1 additional year at the investigator's discretion.
|
200 mg intravenous (IV) on Day 1 of each 3-week cycle.
Other Names:
|
Active Comparator: Standard Treatment
Participants will receive standard treatment of either methotrexate 40 mg/m^2 IV (may be escalated to 60 mg/m^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m^2 IV loading dose on Day 1 and 250 mg/m^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.
|
40 mg/m^2 IV (may be escalated to 60 mg/m^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle
75 mg/m^2 IV on Day 1 of each 3- week cycle
400 mg/m^2 IV loading dose on Day 1 and 250 mg/m^2 IV on Days 8 and 15 of Cycle 1, followed by 250 mg/m^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial Overall Survival (OS) for All Participants
Time Frame: Up to approximately 2 years
|
OS was defined as the time from randomization to death due to any cause.
Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up.
The OS for all participants is presented.
These initial OS results are based on a data cutoff date of 15-May-2017 with a database lock date of 04-Jun-2017.
At the time of the database lock of 04-Jun-2017, there was incomplete collection of survival data for 12 participants.
|
Up to approximately 2 years
|
Updated Final OS for All Participants
Time Frame: Up to approximately 2 years
|
OS was defined as the time from randomization to death due to any cause.
Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up.
The updated OS for all participants is presented.
These OS results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
|
Up to approximately 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Expression Defined by ≥1% Combined Positive Score (CPS)(PD-L1 ≥1% CPS)
Time Frame: Up to approximately 2 years
|
OS was defined as the time from randomization to death due to any cause.
Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
The OS for all participants with PD-L1 expression ≥1% CPS was presented.
These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
|
Up to approximately 2 years
|
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 for All Participants
Time Frame: Up to approximately 2 years
|
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first.
Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.
Note: The appearance of one or more new lesions was also considered progression.
The PFS per RECIST 1.1 for all participants is presented.
These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
|
Up to approximately 2 years
|
PFS Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS
Time Frame: Up to approximately 2 years
|
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first.
Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.
Note: The appearance of one or more new lesions was also considered progression.
The PFS per RECIST 1.1 for all participants with PD-L1 expression ≥1% CPS is presented.
These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
|
Up to approximately 2 years
|
Objective Response Rate (ORR) Per RECIST 1.1 in All Participants
Time Frame: Up to approximately 2 years
|
ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based on blinded central imaging vendor review with or without confirmation.
The ORR per RECIST 1.1 for all participants is presented.
These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
|
Up to approximately 2 years
|
ORR Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS
Time Frame: Up to approximately 2 years
|
ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1 based on blinded central imaging vendor review with or without confirmation.
The ORR per RECIST 1.1 for all participants with PD-L1 expression ≥1% CPS is presented.
These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
|
Up to approximately 2 years
|
Duration of Response (DOR) Per RECIST 1.1 in All Participants
Time Frame: Up to approximately 2 years
|
For participants who demonstrated a confirmed CR or PR per RECIST 1.1, DOR was defined as the time from first documented evidence of a confirmed CR or PR per RECIST 1.1 until disease progression per RECIST 1.1 or death due to any cause, whichever occurred first.
Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.
Note: The appearance of one or more new lesions was also considered progression.
DOR assessments were based on blinded central imaging vendor review with confirmation.
The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented.
These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
|
Up to approximately 2 years
|
DOR Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS
Time Frame: Up to approximately 2 years
|
For participants who demonstrated a confirmed CR or PR per RECIST 1.1, DOR was defined as the time from first documented evidence of a confirmed CR or PR per RECIST 1.1 until disease progression per RECIST 1.1 or death due to any cause, whichever occurred first.
Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.
Note: The appearance of one or more new lesions was also considered progression.
DOR assessments were based on blinded central imaging vendor review with confirmation.
The DOR per RECIST 1.1 for all participants with PD-L1 ≥1% CPS who experienced a confirmed CR or PR is presented.
These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
|
Up to approximately 2 years
|
Time to Progression (TTP) Per RECIST 1.1 in All Participants
Time Frame: Up to approximately 2 years
|
TTP was defined as the time from randomization to the first documented disease progression based on assessments by the blinded central imaging vendor review per RECIST 1.1.
Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.
Note: The appearance of one or more new lesions was also considered progression.
The TTP per RECIST 1.1 for all participants is presented.
These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
|
Up to approximately 2 years
|
TTP Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS
Time Frame: Up to approximately 2 years
|
TTP was defined as the time from randomization to the first documented disease progression based on assessments by the blinded central imaging vendor review per RECIST 1.1.
Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.
Note: The appearance of one or more new lesions was also considered progression.
The TTP per RECIST 1.1 for all participants with PD-L1 ≥1% CPS is presented.
These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
|
Up to approximately 2 years
|
PFS Per Modified RECIST in All Participants
Time Frame: Up to approximately 2 years
|
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first.
Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm.
Note: The appearance of one or more new lesions was also considered PD.
Modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1.
The PFS per modified RECIST for all participants is presented.
These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
|
Up to approximately 2 years
|
PFS Per Modified RECIST 1.1 in Participants With PD-L1 ≥1% CPS
Time Frame: Up to approximately 2 years
|
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first.
Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm.
Note: The appearance of one or more new lesions was also considered PD.
Modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1.
The PFS per modified RECIST for all participants with PD-L1 ≥1% CPS is presented.
These efficacy results were reported after complete acquisition of all outstanding survival data using a 15-May-2017 data cut-off date with a database update date of 13-Oct-2017.
|
Up to approximately 2 years
|
Number of Participants Who Experienced At Least One Adverse Event (AE) in All Participants
Time Frame: Up to approximately 33 months
|
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE.
The number of all participants who experienced at least one AE is presented.
|
Up to approximately 33 months
|
Number of Participants Who Experienced At Least One AE in Participants With PD-L1 ≥1% CPS
Time Frame: Up to approximately 33 months
|
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE.
The number of all participants with PD-L1 ≥1% CPS who experienced at least one AE is presented.
|
Up to approximately 33 months
|
Number of Participants Who Discontinued Study Treatment Due to an AE in All Participants
Time Frame: Up to approximately 30 months
|
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE.
The number of all participants who discontinued study treatment due to an AE is presented.
|
Up to approximately 30 months
|
Number of Participants Who Discontinued Study Treatment Due to an AE in Participants With PD-L1 ≥1% CPS
Time Frame: Up to approximately 30 months
|
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE.
The number of all participants with PD-L1 ≥1% CPS who discontinued study treatment due to an AE is presented.
|
Up to approximately 30 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Guo T, Califano JA. Molecular biology and immunology of head and neck cancer. Surg Oncol Clin N Am. 2015 Jul;24(3):397-407. doi: 10.1016/j.soc.2015.03.002. Epub 2015 Apr 20.
- Pai SI, Faivre S, Licitra L, Machiels JP, Vermorken JB, Bruzzi P, Gruenwald V, Giglio RE, Leemans CR, Seiwert TY, Soulieres D. Comparative analysis of the phase III clinical trials of anti-PD1 monotherapy in head and neck squamous cell carcinoma patients (CheckMate 141 and KEYNOTE 040). J Immunother Cancer. 2019 Apr 3;7(1):96. doi: 10.1186/s40425-019-0578-0.
- Xin W, Ding H, Fang Q, Zheng X, Tong Y, Xu G, Yang G. Cost-effectiveness of pembrolizumab for treatment of platinum-resistant recurrent or metastatic head and neck squamous cell carcinoma in China: an economic analysis based on a randomised, open-label, phase III trial. BMJ Open. 2020 Dec 18;10(12):e038867. doi: 10.1136/bmjopen-2020-038867.
- Emancipator K, Huang L, Aurora-Garg D, Bal T, Cohen EEW, Harrington K, Soulieres D, Le Tourneau C, Licitra L, Burtness B, Swaby R. Comparing programmed death ligand 1 scores for predicting pembrolizumab efficacy in head and neck cancer. Mod Pathol. 2021 Mar;34(3):532-541. doi: 10.1038/s41379-020-00710-9. Epub 2020 Nov 25.
- Cohen EEW, Soulieres D, Le Tourneau C, Dinis J, Licitra L, Ahn MJ, Soria A, Machiels JP, Mach N, Mehra R, Burtness B, Zhang P, Cheng J, Swaby RF, Harrington KJ; KEYNOTE-040 investigators. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. Lancet. 2019 Jan 12;393(10167):156-167. doi: 10.1016/S0140-6736(18)31999-8. Epub 2018 Nov 30. Erratum In: Lancet. 2019 Jan 12;393(10167):132.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 17, 2014
Primary Completion (Actual)
May 15, 2017
Study Completion (Actual)
August 15, 2022
Study Registration Dates
First Submitted
September 25, 2014
First Submitted That Met QC Criteria
September 25, 2014
First Posted (Estimated)
September 29, 2014
Study Record Updates
Last Update Posted (Actual)
July 17, 2023
Last Update Submitted That Met QC Criteria
June 30, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Carcinoma, Squamous Cell
- Neoplasms, Squamous Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Immunological
- Dermatologic Agents
- Immune Checkpoint Inhibitors
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Docetaxel
- Pembrolizumab
- Methotrexate
- Cetuximab
Other Study ID Numbers
- 3475-040
- MK-3475-040 (Other Identifier: Merck Protocol Number)
- 2014-001749-26 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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