18 and older, any sex, with Hepatocellular Carcinoma. 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 approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2
ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target and non-target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target and non-target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded central imaging vendor. Participants with missing data were considered non-responders. The percentage of participants who experienced a CR or PR per RECIST 1.1 is presented.
Group
Value
95% CI
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
18.3
11.4 – 27.1
Cohort 2: HCC-Systemic Therapy Naïve
15.7
7.0 – 28.6
Duration of Response (DOR)Secondary· Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2
DOR was determined in participants who demonstrated a confirmed Complete Response (CR: disappearance of all target and non-target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target and non-target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded central imaging vendor. DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed, started a new anti-cancer therapy, been lost to follow-up, or died at the time of analysis w
Group
Value
95% CI
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
21.0
10.7 – NA
Cohort 2: HCC-Systemic Therapy Naïve
16.2
3.1 – NA
Disease Control Rate (DCR)Secondary· Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2
DCR was defined as the percentage of participants who had a CR (disappearance of all target and non-target lesions), PR (at least a 30% decrease in the sum of diameters of target and non-target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD was at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, OR unequivocal progression for non-target lesions, OR appearance of one or more new lesions.\]). CR, PR, and SD were evaluated per Response Evaluatio
Group
Value
95% CI
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
61.5
51.5 – 70.9
Cohort 2: HCC-Systemic Therapy Naïve
56.9
42.2 – 70.7
Time to Progression (TTP)Secondary· Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2
TTP was defined as the time from the first dose to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded central imaging vendor. PD was at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, OR unequivocal progression for non-target lesions, OR appearance of one or more new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. The TTP was analyzed using the product-limit (Kaplan-Meier) method for censored da
Group
Value
95% CI
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
4.8
3.9 – 7.0
Cohort 2: HCC-Systemic Therapy Naïve
4.4
2.5 – 8.6
Progression-Free Survival (PFS)Secondary· Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2
PFS was defined as the time from the first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded central imaging vendor. PD was at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, OR unequivocal progression for non-target lesions, OR appearance of one or more new lesions. If there was no disease progression or death, participants were censored at the date of their last disease assessment. T
Group
Value
95% CI
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
4.9
3.5 – 6.7
Cohort 2: HCC-Systemic Therapy Naïve
4.3
2.1 – 7.8
Overall Survival (OS)Secondary· Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2
OS was determined for all participants and was defined as the time from the first dose to death due to any cause. Participants were censored at the last known alive date. The OS was analyzed using the product-limit (Kaplan-Meier) method for censored data. The OS is presented.
Group
Value
95% CI
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
13.2
9.7 – 15.3
Cohort 2: HCC-Systemic Therapy Naïve
16.9
8.3 – 23.1
Number of Participants Who Experienced At Least One Adverse Event (AE)Secondary· Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clini
Group
Value
95% CI
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
101
Cohort 2: HCC-Systemic Therapy Naïve
49
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)Secondary· Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clini
Group
Value
95% CI
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
23
Cohort 2: HCC-Systemic Therapy Naïve
8
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to approximately 87 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-First Course
Serious: 44/104 (42%)
Deaths: 94/105
Cohort 2: HCC-Systemic Therapy Naïve-First Course
Serious: 21/51 (41%)
Deaths: 42/51
Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib-Second Course
This is a efficacy and safety study of pembrolizumab (MK-3475, KEYTRUDA®) as monotherapy in participants with hepatocellular carcinoma (HCC) in two cohorts: participants with advanced HCC and with no curative option after disease progression on sorafenib or intolerance of sorafenib (Cohort 1) or who had not received treatment for systemic disease (Cohort 2). Study participants may receive pembrolizumab once every 3 weeks for up to 35 initial cycles (up to approximately 2 years) and a potential additional 17 cycles in a re-treatment phase (approximately an additional 1 year of treatment) .
The primary objective of this study is to determine the Objective Response Rate (ORR) of pembrolizumab given as monotherapy in participants with HCC.
Effective with Amendment 7: Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.
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
· Phase 2, PHASE3
· not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
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 Hepatocellular Carcinoma
Currently open trials in the same condition.
NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma
· Phase 2
· recruiting
NCT07417397 — Adjuvant TACE in HCC With High-risk Recurrence Factors
· Phase 3
· recruiting
NCT07317414 — β-alanine in the Treatment of Advanced Hepatocellular Carcinoma
· Phase 2
· recruiting
NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer
· Phase 1
· recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005)
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· 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
· Phase 1
· not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M
· Phase 3
· not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti
· Phase 1
· not yet recruiting
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: 4 September 2024
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/NCT02702414.