A Phase 4 interventional study of Pembrolizumab and Carboplatin in Squamous Cell Carcinoma of Head and Neck, sponsored by Merck Sharp & Dohme LLC. Completed at 35 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by Merck Sharp & Dohme LLC · Phase 4, Interventional, and Treatment
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.
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's enrollment of 101 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab will be administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Carboplatin will be administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months). At investigator's choice, paclitaxel will be administered via IV infusion at a dose of 100 mg/m\^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to \~4 months) or at a dose of 175 mg/m\^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to \~4 months).
Drug: Pembrolizumab · Drug: Carboplatin · Drug: Paclitaxel
Pembrolizumab 200 mg IV infusion given on Day 1 of each 21-day cycle
Also known as: MK-3475, KEYTRUDA®
Carboplatin AUC 5 mg/mL/minute IV infusion given on Day 1 of each 21-day cycle
Also known as: PARAPLATIN®
At investigator's choice, paclitaxel 100 mg/m\^2 IV infusion given on Day 1 and Day 8 of each 21-day cycle or paclitaxel 175 mg/m\^2 IV infusion given on Day 1 of each 21-day cycle
Also known as: TAXOL®, ONXAL®
Objective Response Rate (ORR)
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 1.1 was presented.
Time frame: Up to ~25 months
Duration of Response (DOR)
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 central review based on RECIST 1.1 was presented.
Time frame: Up to ~25 months
Progression-free Survival (PFS)
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 independent central review based on RECIST 1.1 was from product-limit (Kaplan-Meier) method for censored data.
Time frame: Up to ~25 months
Overall Survival (OS)
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.
Time frame: Up to ~25 months
Percentage of Participants Who Experienced an Adverse Event (AE)
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.
Time frame: Up to ~39 months
Percentage of Participants Who Discontinued Study Treatment Due to an AE
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.
Time frame: Up to ~25 months
101 participants were enrolled in the All Participants as Treated (APaT) population. The APaT population consisted of all allocated participants who received at least one dose of study intervention.
| Milestone | Pembrolizumab + Carboplatin + Paclitaxel |
|---|---|
| Started | 101 |
| Completed | 0 |
| Not completed | 101 |
| Withdrew: Death | 75 |
| Withdrew: Sponsor decision | 26 |
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 1.1 was presented.
| Percentage of Participants | Pembrolizumab + Carboplatin + Paclitaxel |
|---|---|
| Objective Response Rate (ORR) | 48.5 (38.4 to 58.7) |
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 central review based on RECIST 1.1 was presented.
| Months | Pembrolizumab + Carboplatin + Paclitaxel |
|---|---|
| Duration of Response (DOR) | 5.5 (4.2 to 6.7) |
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 independent central review based on RECIST 1.1 was from product-limit (Kaplan-Meier) method for censored data.
| Months | Pembrolizumab + Carboplatin + Paclitaxel |
|---|---|
| Progression-free Survival (PFS) | 5.6 (5.1 to 6.7) |
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.
| Months | Pembrolizumab + Carboplatin + Paclitaxel |
|---|---|
| Overall Survival (OS) | 13.1 (9.6 to 15.2) |
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.
| Percentage of participants | Pembrolizumab + Carboplatin + Paclitaxel |
|---|---|
| Percentage of Participants Who Experienced an Adverse Event (AE) | 100.0 |
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.
| Percentage of Participants | Pembrolizumab + Carboplatin + Paclitaxel |
|---|---|
| Percentage of Participants Who Discontinued Study Treatment Due to an AE | 36.6 |
Collected over Up to approximately 39 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab + Carboplatin + Paclitaxel | 75/101 (74.3%) | 52/101 (51.5%) | 100/101 (99%) |
| Event | Pembrolizumab + Carboplatin + Paclitaxel |
|---|---|
| PneumoniaInfections and infestations | 12/101 |
| Febrile neutropeniaBlood and lymphatic system disorders | 6/101 |
| Pneumonia aspirationInfections and infestations | 6/101 |
| Neutrophil count decreasedInvestigations | 5/101 |
| SepsisInfections and infestations | 4/101 |
| AnaemiaBlood and lymphatic system disorders | 3/101 |
| DehydrationMetabolism and nutrition disorders | 3/101 |
| Tumour haemorrhageNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/101 |
| Acute kidney injuryRenal and urinary disorders | 3/101 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 3/101 |
| Event | Pembrolizumab + Carboplatin + Paclitaxel |
|---|---|
| Neutrophil count decreasedInvestigations | 57/101 |
| AnaemiaBlood and lymphatic system disorders | 47/101 |
| FatigueGeneral disorders | 47/101 |
| ConstipationGastrointestinal disorders | 40/101 |
| NauseaGastrointestinal disorders | 36/101 |
| AlopeciaSkin and subcutaneous tissue disorders | 35/101 |
| White blood cell count decreasedInvestigations | 34/101 |
| DiarrhoeaGastrointestinal disorders | 32/101 |
| Platelet count decreasedInvestigations | 32/101 |
| Lymphocyte count decreasedInvestigations | 25/101 |
| Age, Continuous(Years) | Pembrolizumab + Carboplatin + Paclitaxel |
|---|---|
| Mean | 63.8 ± 9.6 |
| Sex: Female, Male(Participants) | Pembrolizumab + Carboplatin + Paclitaxel |
|---|---|
| Female | 16 |
| Male | 85 |
| Ethnicity (NIH/OMB)(Participants) | Pembrolizumab + Carboplatin + Paclitaxel |
|---|---|
| Hispanic or Latino | 43 |
| Not Hispanic or Latino | 58 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Pembrolizumab + Carboplatin + Paclitaxel |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 88 |
| More than one race | 7 |
| Unknown or Not Reported | 0 |
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Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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