A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10)
CompletedPhase 4Results postedLast updated 19 June 2025
What this trial tests
Phase 4 trial testing Pembrolizumab in Squamous Cell Carcinoma of Head and Neck in 101 participants. Completed in 28 June 2024.
18 and older, any sex, with Squamous Cell Carcinoma of Head and Neck. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR)Primary· Up to ~25 months
ORR was defined as the percentage of participants 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, taking as reference the baseline sum of diameters) per Response Evaluation Criteria in Solid Tumors Update and Clarification 1.1 (RECIST 1.1) which was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR as assessed by blinded independent central review based on RECIST
Group
Value
95% CI
Pembrolizumab + Carboplatin + Paclitaxel
48.5
38.4 – 58.7
Duration of Response (DOR)Secondary· Up to ~25 months
For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. RECIST 1.1 was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR as assessed by blinded independent centra
Group
Value
95% CI
Pembrolizumab + Carboplatin + Paclitaxel
5.5
4.2 – 6.7
Progression-free Survival (PFS)Secondary· Up to ~25 months
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) 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. The appearance of one or more new lesions was also considered PD. RECIST 1.1 was been adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS as assessed by blinded independ
Group
Value
95% CI
Pembrolizumab + Carboplatin + Paclitaxel
5.6
5.1 – 6.7
Overall Survival (OS)Secondary· Up to ~25 months
OS was defined as the time from first dose of study treatment to death due to any cause. PFS as assessed by blinded independent central review based on RECIST 1.1 was from product-limit (Kaplan-Meier) method for censored data.
Group
Value
95% CI
Pembrolizumab + Carboplatin + Paclitaxel
13.1
9.6 – 15.2
Percentage of Participants Who Experienced an Adverse Event (AE)Secondary· Up to ~39 months
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE was reported.
Group
Value
95% CI
Pembrolizumab + Carboplatin + Paclitaxel
100.0
Percentage of Participants Who Discontinued Study Treatment Due to an AESecondary· Up to ~25 months
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study treatment due to an AE was reported.
Group
Value
95% CI
Pembrolizumab + Carboplatin + Paclitaxel
36.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to approximately 39 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Pembrolizumab + Carboplatin + Paclitaxel
Serious: 52/101 (51%)
Deaths: 75/101
Serious adverse events (65 terms)
Reaction
System
Pembrolizumab + Carboplati…
Pneumonia
Infections and infestations
—
Febrile neutropenia
Blood and lymphatic system disorders
—
Pneumonia aspiration
Infections and infestations
—
Neutrophil count decreased
Investigations
—
Sepsis
Infections and infestations
—
Anaemia
Blood and lymphatic system disorders
—
Dehydration
Metabolism and nutrition disorders
—
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with carboplatin and paclitaxel as first-line treatment in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). No statistical hypothesis will be tested in this study.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
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NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand
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NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
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NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
Other recruiting trials for Squamous Cell Carcinoma of Head and Neck
Currently open trials in the same condition.
NCT07455032 — Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous
· Phase 1
· recruiting
NCT07219212 — A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck S
· Phase 1
· recruiting
NCT07276399 — A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurre
· Phase 3
· recruiting
NCT07063212 — A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)
· Phase 2
· recruiting
NCT06487403 — HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune R
· NA
· recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
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NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
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· recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527
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NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 19 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04489888.