Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.

Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle.

Lynn Feun, MD

This is a single-arm phase II trial of Pembrolizumab (Keytruda) in patients with advanced, unresectable hepatocellular carcinoma. The primary objective is to assess its therapeutic efficacy in patients with unresectable hepatocellular carcinoma (HCC).

Pembrolizumab (Keytruda) in Advanced Hepatocellular Carcinoma

Phase II Study of Pembrolizumab (Keytruda®) in Advanced Hepatocellular Carcinoma (HCC)

Disease control rate (DCR) will be calculated per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, as the percentage of patients with best overall response to protocol therapy of either complete response (CR), partial response (PR) or stable disease (SD) that is maintained for at least 8 weeks.

Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1)for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

The safety of Pembrolizumab in HCC patients as measured by the incidence of treatment-related adverse events, including serious adverse events (SAEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, per physician discretion. The number of participants experiencing toxicity attributed by treating physician as definitely, probably and possibly-related to study treatment will be reported.

Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment .

Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive).

Objective response rate (ORR) will be defined as the percentage of the patients with a confirmed complete or partial response (CR or PR),by MRI or CT scan as per RECIST 1.1 criteria. Complete response (CR), Disappearance of all target lesions; Partial response (PR), \>=30% decrease in sum of the longest diameter of target lesions; Overall response (OR) = (CR+PR.)Scans and assessments are performed every 9 weeks while on treatment up to 2 years if stable/responding, or up until time of disease progression.

Duration of Response (DoR) will be defined as the elapsed time from documented tumor response to documented disease progression.

Merck Sharp & Dohme LLC

Professor

Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.

Pembrolizumab in Advanced HCC

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Lynn G. Feun, MD

Disease Control Rate (DCR) in Study Participants

SAEs with Attribution of Definite Relation

SAEs with Attribution of Possible relation

SAEs with Attribution of Probable Relation

AEs with Attribution of Definite Relation

AEs with Attribution of Possible Relation

AEs with Attribution of Probable Relation

One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.

Number of Participants With Treatment-Related Adverse Events

Progression-Free Survival (PFS)

Overall Survival (OS)

Objective Response Rate (ORR)

Median duration of response was not achieved for the participants by the end of study participation at the 3-year follow up visit.

Spots Global Cancer Trial Database for Pembrolizumab (Keytruda) in Advanced Hepatocellular Carcinoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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