TriangleNCT03765918 · CITED IN SOURCE DOCUMENTS
Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-07-31
This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Major Pathological Response (mPR) Rate
mPR Rate in Participants With PD-L1 CPS ≥10
mPR Rate in Participants With PD-L1 CPS ≥1
Pathological Complete Response (pCR) Rate
pCR Rate in Participants With PD-L1 CPS ≥10
pCR Rate in Participants With PD-L1 CPS ≥1
Neoadjuvant Treatment: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Scale Combined Score at Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QOL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 6
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 25
Adjuvant Treatment: Change in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 51
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 4
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 4
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 4
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 6
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 6
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 6
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 25
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 25
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 25
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 51
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 51
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 51
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-Head and Neck Module 35 [H&N35] (Items 35-38) Swallowing Combined Score at Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 6
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 51
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 6
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 51
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 4
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 6
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 6
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 25
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 51
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 51
Overall Survival (OS)
OS in Participants With PD-L1 CPS ≥10
OS in Participants With PD-L1 CPS ≥1
Number of Participants Who Experienced an Adverse Event (AE)
Number of Participants Who Discontinued Study Treatment Due to an AE
Event-free Survival (EFS)
EFS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
EFS in Participants With PD-L1 CPS ≥1
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries. * Is eligible for primary surgery based on investigator decision and per local practice * Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy. * Male participants must refrain from donating sperm throughout the study period and for up to 180 days after the last dose of study therapy * Female participant that is not pregnant or breastfeeding * Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) * Has provided newly obtained core or excisional biopsy of a tumor lesion not previously irradiated * Has results from testing of HPV status for oropharyngeal cancer defined as p16 * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of randomization Exclusion Criteria: * Has Stage T4B and/or N3 locoregionally advanced head and neck squamous cell carcinoma (LA HNSCC) and/or distant metastases * Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity. such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer (HNC) * Female participant who has a positive urine pregnancy test within 72 hours prior to study start or within 24 hours prior to the start of radiotherapy with or without cisplatin. * Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1(PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor * Has received prior radiotherapy treatment or systemic anti-cancer therapy including investigational agents for the HNC under study prior to study start * Has received a live vaccine within 30 days prior to randomization * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization * 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 randomization * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy * Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis * Has Grade ≥2 audiometric hearing loss * Has Grade ≥2 neuropathy * Has Grade 3-4 bleeding due to the underlying malignancy * Has received major surgery or has not recovered adequately from the toxicity and/or complications from the intervention prior to study start * Has had previous allogeneic tissue/solid organ transplant * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, radiotherapy, cisplatin or their analogs * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis * Has an active infection requiring systemic therapy * Has a known history of human immunodeficiency virus (HIV) infection * Has a known history of or is positive for Hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C (defined as Hepatitis C virus \[HCV\] ribonucleic acid is detected). * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the investigator * Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
- intervention Names
- Biological: Pembrolizumab 200 mg
- Radiation: Radiotherapy 60 Gray
- Radiation: Radiotherapy 66 Gray
- Radiation: Radiotherapy 70 Gray
- Drug: Cisplatin 100 mg/m^2
- label
- Pembrolizumab + Standard of Care (SOC)
- type
- EXPERIMENTAL
- description
- Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
- intervention Names
- Radiation: Radiotherapy 60 Gray
- Radiation: Radiotherapy 66 Gray
- Radiation: Radiotherapy 70 Gray
- Drug: Cisplatin 100 mg/m^2
- label
- Standard of Care (SOC)
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Pembrolizumab + Standard of Care (SOC)
- description
- 200 mg administered IV infusion on Day 1 of each 21-day cycle
- name
- Pembrolizumab 200 mg
- other Names
- KEYTRUDA®
- MK-3475
- type
- BIOLOGICAL
- arm Group Labels
- Pembrolizumab + Standard of Care (SOC)
- Standard of Care (SOC)
- description
- Low risk participants administered 2 Gray in 30 fractions. Administered using intensity modulated radiation therapy.
- name
- Radiotherapy 60 Gray
- type
- RADIATION
- arm Group Labels
- Pembrolizumab + Standard of Care (SOC)
- Standard of Care (SOC)
- description
- High risk participants administered 2 Gray in 33 fractions. Administered using intensity modulated radiation therapy.
- name
- Radiotherapy 66 Gray
- type
- RADIATION
- arm Group Labels
- Pembrolizumab + Standard of Care (SOC)
- Standard of Care (SOC)
- description
- Participants with gross residual disease administered 2 Gray in 35 fractions. Administered using intensity modulated radiation therapy.
- name
- Radiotherapy 70 Gray
- type
- RADIATION
- arm Group Labels
- Pembrolizumab + Standard of Care (SOC)
- Standard of Care (SOC)
- description
- 100 mg/m\^2 administered by IV infusion on Day 1 of each 21-day cycle
- name
- Cisplatin 100 mg/m^2
- other Names
- Platinol®
- Platinol-AQ®
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 714
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- EFS was based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) and was defined as the time from randomization to any of the following events: radiographic disease progression (RDP; participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in all randomized participants was presented.
- measure
- Event-free Survival (EFS)
- time Frame
- Up to ~66 months
- description
- EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: RDP (participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥10 was presented.
- measure
- EFS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
- time Frame
- Up to ~66 months
- description
- EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: RDP (participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥1 was presented.
- measure
- EFS in Participants With PD-L1 CPS ≥1
- time Frame
- Up to ~66 months
- secondary Outcomes
- description
- mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by blinded independent pathologist review (BIPR) at the time of definitive surgery in all randomized participants was presented.
- measure
- Major Pathological Response (mPR) Rate
- time Frame
- Up to ~66 months
- description
- mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by BIPR at the time of definitive surgery in participants with PD-L1 CPS ≥10 was presented.
- measure
- mPR Rate in Participants With PD-L1 CPS ≥10
- time Frame
- Up to ~66 months
- description
- mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by BIPR at the time of definitive surgery in participants with PD-L1 CPS ≥1 was presented.
- measure
- mPR Rate in Participants With PD-L1 CPS ≥1
- time Frame
- Up to ~66 months
- description
- pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants was presented.
- measure
- Pathological Complete Response (pCR) Rate
- time Frame
- Up to ~66 months
- description
- pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants with PD-L1 CPS ≥10 was presented.
- measure
- pCR Rate in Participants With PD-L1 CPS ≥10
- time Frame
- Up to ~66 months
- description
- pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants with PD-L1 CPS ≥1 was presented.
- measure
- pCR Rate in Participants With PD-L1 CPS ≥1
- time Frame
- Up to ~66 months
- description
- EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants in the pembrolizumab + SOC arm was presented.
- measure
- Neoadjuvant Treatment: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Scale Combined Score at Week 4
- time Frame
- Baseline and Week 4
- description
- EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.
- measure
- Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 4
- time Frame
- Baseline and Week 4
- description
- EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.
- measure
- Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QOL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 4
- time Frame
- Baseline and Week 4
- description
- EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants in the pembrolizumab + SOC arm was presented.
- measure
- Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 6
- time Frame
- Baseline and Week 6
- description
- EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.
- measure
- Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 6
- time Frame
- Baseline and Week 6
- description
- EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.
- measure
- Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 6
- time Frame
- Baseline and Week 6
Full study description
- brief Summary
- This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
Source references
- references
- citation
- Uppaluri R, Haddad RI, Tao Y, Le Tourneau C, Lee NY, Westra W, Chernock R, Tahara M, Harrington KJ, Klochikhin AL, Brana I, Vasconcelos Alves G, Hughes BGM, Oliva M, Pinto Figueiredo Lima I, Ueda T, Rutkowski T, Schroeder U, Mauz PS, Fuereder T, Laban S, Oridate N, Popovtzer A, Mach N, Korobko Y, Costa DA, Hooda-Nehra A, Rodriguez CP, Bell RB, Manschot C, Benjamin K, Gumuscu B, Adkins D; KEYNOTE-689 Investigators. Neoadjuvant and Adjuvant Pembrolizumab in Locally Advanced Head and Neck Cancer. N Engl J Med. 2025 Jul 3;393(1):37-50. doi: 10.1056/NEJMoa2415434. Epub 2025 Jun 18.
- pmid
- 40532178
- type
- DERIVED
- see Also Links
- label
- Merck Clinical Trial Information
Source notices and limitations
Discovery and provenance
- release id
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- NCT03765918
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- ="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm">Drugs@FDA</a>. </p><h2>Efficacy and Safety</h2><p>Efficacy was evaluated in KEYNOTE-689 (NCT03765918), a randomized, multicenter, open-label trial in 714 patients with resectable locally advanced (Stage III-IVA) HNSCC [AJCC, 8th edition]. Patients were randomi
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- source event date
- 2025-06-12
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- /tmp/cancer-full-research/updates/pages/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck.html
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- FDA approves neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma
Preserved source evidence · Not medical advice