Trial · NCT03765918
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)
NCT03765918, Phase 3, Active not recruiting, Merck Sharp & Dohme LLC; results first posted 2025-08-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT03765918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03765918
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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)
- NCT number
- NCT03765918
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 714 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Head and Neck Neoplasms
- Interventions
- Pembrolizumab 200 mg, Radiotherapy 60 Gray, Radiotherapy 66 Gray, Radiotherapy 70 Gray, Cisplatin 100 mg/m^2
- First posted
- 2018-12-05
- Last updated
- 2026-07-31
- Other registries' IDs
- eudract:2017-001139-38
- Results first posted
- 2025-08-20
Source ClinicalTrials.gov
Registered outcomes74
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) | Up to ~66 months | 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. |
| Primary | EFS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 | Up to ~66 months | 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. |
| Primary | EFS in Participants With PD-L1 CPS ≥1 | Up to ~66 months | 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. |
| Secondary | Major Pathological Response (mPR) Rate | Up to ~66 months | 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. |
| Secondary | mPR Rate in Participants With PD-L1 CPS ≥10 | Up to ~66 months | 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. |
| Secondary | mPR Rate in Participants With PD-L1 CPS ≥1 | Up to ~66 months | 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. |
| Secondary | Pathological Complete Response (pCR) Rate | Up to ~66 months | 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. |
| Secondary | pCR Rate in Participants With PD-L1 CPS ≥10 | Up to ~66 months | 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. |
| Secondary | pCR Rate in Participants With PD-L1 CPS ≥1 | Up to ~66 months | 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. |
| Secondary | 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 | Baseline and Week 4 | 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. |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 registered outcomesOutcomes74
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Major Pathological Response (mPR) Rate | Up to ~66 months | Efficacy analysis population, which included all randomized participants. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Percentage of Participants | NUMBER |
| SECONDARY | mPR Rate in Participants With PD-L1 CPS ≥10 | Up to ~66 months | Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥10. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Percentage of Participants | NUMBER |
| SECONDARY | mPR Rate in Participants With PD-L1 CPS ≥1 | Up to ~66 months | Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥1. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Pathological Complete Response (pCR) Rate | Up to ~66 months | Efficacy analysis population, which included all randomized participants. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Percentage of Participants | NUMBER |
| SECONDARY | pCR Rate in Participants With PD-L1 CPS ≥10 | Up to ~66 months | Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥10. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Percentage of Participants | NUMBER |
| SECONDARY | pCR Rate in Participants With PD-L1 CPS ≥1 | Up to ~66 months | Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥1. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Percentage of Participants | NUMBER |
| SECONDARY | 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 | Baseline and Week 4 | All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Baseline and Week 4 | All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Baseline and Week 4 | All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 6 | Baseline and Week 6 | All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 outcomesResults by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Major Pathological Response (mPR) Rate | Pembrolizumab + Standard of Care (SOC) | 9.4 | 95% Confidence Interval 6.6 to 12.8 | Percentage of Participants | |
| Major Pathological Response (mPR) Rate | Standard of Care (SOC) | 0.0 | 95% Confidence Interval 0.0 to 1.0 | Percentage of Participants | |
| mPR Rate in Participants With PD-L1 CPS ≥10 | Pembrolizumab + Standard of Care (SOC) | 13.7 | 95% Confidence Interval 9.5 to 18.8 | Percentage of Participants | |
| mPR Rate in Participants With PD-L1 CPS ≥10 | Standard of Care (SOC) | 0.0 | 95% Confidence Interval 0.0 to 1.6 | Percentage of Participants | |
| mPR Rate in Participants With PD-L1 CPS ≥1 | Pembrolizumab + Standard of Care (SOC) | 9.8 | 95% Confidence Interval 6.9 to 13.4 | Percentage of Participants | |
| mPR Rate in Participants With PD-L1 CPS ≥1 | Standard of Care (SOC) | 0.0 | 95% Confidence Interval 0.0 to 1.1 | Percentage of Participants | |
| Pathological Complete Response (pCR) Rate | Pembrolizumab + Standard of Care (SOC) | 3.0 | 95% Confidence Interval 1.5 to 5.4 | Percentage of Participants | |
| Pathological Complete Response (pCR) Rate | Standard of Care (SOC) | 0.0 | 95% Confidence Interval 0.0 to 1.0 | Percentage of Participants | |
| pCR Rate in Participants With PD-L1 CPS ≥10 | Pembrolizumab + Standard of Care (SOC) | 4.3 | 95% Confidence Interval 2.1 to 7.7 | Percentage of Participants | |
| pCR Rate in Participants With PD-L1 CPS ≥10 | Standard of Care (SOC) | 0.0 | 95% Confidence Interval 0.0 to 1.6 | Percentage of Participants |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab + Standard of Care (SOC) | 363 | |
| Overall Study | STARTED | Standard of Care (SOC) | 351 | |
| Overall Study | Treated | Pembrolizumab + Standard of Care (SOC) | 360 | |
| Overall Study | Treated | Standard of Care (SOC) | 316 | |
| Overall Study | Safety Analysis Population | Pembrolizumab + Standard of Care (SOC) | 361 | |
| Overall Study | Safety Analysis Population | Standard of Care (SOC) | 315 | |
| Overall Study | Efficacy Analysis Population | Pembrolizumab + Standard of Care (SOC) | 363 | |
| Overall Study | Efficacy Analysis Population | Standard of Care (SOC) | 351 | |
| Overall Study | Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 GHS/QoL (Items 29 & 30) Assessment | Pembrolizumab + Standard of Care (SOC) | 354 | |
| Overall Study | Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 GHS/QoL (Items 29 & 30) Assessment | Standard of Care (SOC) | 0 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events630
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab + Standard of Care (SOC) | 121 | 361 | 147 |
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care (SOC) | 102 | 315 | 117 |
| other | Tinnitus | Ear and labyrinth disorders | Pembrolizumab + Standard of Care (SOC) | 20 | 361 | 23 |
| other | Tinnitus | Ear and labyrinth disorders | Standard of Care (SOC) | 16 | 315 | 16 |
| other | Hyperthyroidism | Endocrine disorders | Pembrolizumab + Standard of Care (SOC) | 32 | 361 | 33 |
| other | Hyperthyroidism | Endocrine disorders | Standard of Care (SOC) | 10 | 315 | 10 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab + Standard of Care (SOC) | 89 | 361 | 94 |
| other | Hypothyroidism | Endocrine disorders | Standard of Care (SOC) | 17 | 315 | 19 |
| other | Constipation | Gastrointestinal disorders | Pembrolizumab + Standard of Care (SOC) | 96 | 361 | 115 |
| other | Constipation | Gastrointestinal disorders | Standard of Care (SOC) | 70 | 315 | 81 |
1 to 10 of 630Source ClinicalTrials.gov
See all 630 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab + Standard of Care (SOC) | 113 | 363 |
| Total, all-cause mortality | Standard of Care (SOC) | 131 | 351 |
| Total, other adverse events | Pembrolizumab + Standard of Care (SOC) | 335 | 361 |
| Total, other adverse events | Standard of Care (SOC) | 290 | 315 |
| Total, serious adverse events | Pembrolizumab + Standard of Care (SOC) | 179 | 361 |
| Total, serious adverse events | Standard of Care (SOC) | 116 | 315 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40532178 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pembrolizumab + Standard of Care (SOC) vs Standard of Care (SOC): deaths from any cause | Trial comparisons |
| Pembrolizumab + Standard of Care (SOC) vs Standard of Care (SOC): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03765918
GET https://conductscience.org/api/trials/v1/NCT03765918/registered?page=2