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Monoclonal Antibodies

Pembrolizumab for Hepatocellular Carcinoma

Phase 2
Waitlist Available
Led By Ahmed O Kaseb, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing pembrolizumab with or without elbasvir/grazoprevir and ribavirin to treat patients with liver cancer that has spread and does not respond to previous treatment.

Eligible Conditions
  • Hepatocellular Carcinoma
  • Liver Cancer
  • Hepatitis C

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicity (DLT)
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Objective response rate (ORR)
+3 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (pembrolizumab, elbasvir/grazoprevir, ribavirin)Experimental Treatment3 Interventions
Patients receive pembrolizumab as in arm A. Patients also receive elbasvir/grazoprevir orally PO QD and ribavirin PO QD on days 1-28. Treatment continues for 12-16 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (pembrolizumab)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Ribavirin
2010
Completed Phase 3
~3250
Elbasvir/Grazoprevir
2016
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,969 Previous Clinical Trials
1,786,893 Total Patients Enrolled
9 Trials studying Hepatocellular Carcinoma
367 Patients Enrolled for Hepatocellular Carcinoma
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,629 Total Patients Enrolled
44 Trials studying Hepatocellular Carcinoma
6,310 Patients Enrolled for Hepatocellular Carcinoma
Ahmed O Kaseb, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to join this research endeavor?

"Unfortunately, recruitment for this trial has closed. It was initially posted on December 9th 2016 and its final edit occured February 25th 2022. However, if you are searching for other trials there are currently 2871 studies that admit participants with BCLC stage C hepatocellular carcinoma and a further 966 clinicals recruiting patients to receive Pembrolizumab treatment."

Answered by AI

Could you please outline the precedent trials with Pembrolizumab?

"Currently, 966 investigations concerning Pembrolizumab are in progress. 122 of these studies are at the Phase 3 level and Houston is the most prominent area for trials with 35754 locations running tests on this medication."

Answered by AI

How many participants are currently engaged in this research endeavor?

"At this moment, the clinical trial is not seeking out new participants. It was first posted on December 9th 2016 and modified most recently on February 25th 2022. Nevertheless, there are 2871 studies actively enrolling people with bclc stage c hepatocellular carcinoma as well as 966 trials for Pembrolizumab that require volunteers."

Answered by AI

In what cases is Pembrolizumab generally prescribed?

"Pembrolizumab is often prescribed to patients with unresectable melanoma, but can also be used for those at risk of recurrent diseases caused by microsatellite instability."

Answered by AI

How detrimental is Pembrolizumab to one's health?

"Despite lacking efficacy data, there is evidence that pembrolizumab has a degree of safety as indicated by its score of 2 on the scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab With or Without Elbasvir/Grazoprevir and Ribavirin in Treating Patients With Advanced Refractory Liver Cancer
2016. "Pembrolizumab With or Without Elbasvir/Grazoprevir and Ribavirin in Treating Patients With Advanced Refractory Liver Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02940496.
~1 spots leftby Apr 2025
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