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Checkpoint Inhibitor

Sorafenib + Pembrolizumab for Liver Cancer

Phase 1 & 2
Waitlist Available
Led By Renuka Iyer
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky >= 60%)
Participant must have histologically or radiographically confirmed hepatocellular cancer (HCC) that is advanced or metastatic and if archival tissue is available, have archival tissue submitted for PD-L1, PD-L2 testing
Must not have
Participants with known brain metastases should be excluded from this clinical trial
Pregnant or nursing female participants
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This trial is testing a combination of two drugs to treat patients with liver cancer that has spread to other parts of the body.

Who is the study for?
This trial is for adults with advanced or metastatic liver cancer who have not had prior treatments with sorafenib or PD1 blockers. They must have good physical function, adequate blood counts, and controlled hepatitis if present. Pregnant women, those with HIV, recent chemotherapy or radiotherapy recipients, and individuals with certain heart conditions cannot participate.
What is being tested?
The study is testing the combination of Sorafenib Tosylate (a drug that blocks tumor growth enzymes) and Pembrolizumab (an antibody that may prevent tumor cells from growing) to see if they are more effective together in treating liver cancer than when used separately.
What are the potential side effects?
Potential side effects include fatigue, skin reactions, high blood pressure due to Sorafenib; immune-related issues like inflammation of organs or infusion reactions from Pembrolizumab. The exact side effects can vary between patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or have some restrictions but can take care of myself.
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I have advanced liver cancer and can provide tissue for testing if needed.
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I can swallow and keep down pills.
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My kidney function is within the normal range.
Select...
My liver functions well despite my illness.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have brain metastases.
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I am currently pregnant or breastfeeding.
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I've had one treatment for my condition, but not with sorafenib or PD1 blockers.
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I do not have a bleeding disorder and am not on blood thinners like warfarin or heparin.
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I do not have HIV.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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I have or had lung inflammation not caused by an infection.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate Defined as Partial or Complete Response Per Immune-related Response Evaluation Criteria in Solid Tumors
Secondary study objectives
Overall Survival
Time to Tumor Progression
Other study objectives
Change in Functional Activity of Effector T Cells
Change in Levels of Immunosuppressive Cells

Side effects data

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (sorafenib tosylate, pembrolizumab)Experimental Treatment3 Interventions
Patients receive sorafenib tosylate PO BID on days -28 to -1 and 1-21. Patients also receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Sorafenib
FDA approved

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
408 Previous Clinical Trials
32,381 Total Patients Enrolled
5 Trials studying Liver Cancer
225 Patients Enrolled for Liver Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,946 Total Patients Enrolled
2 Trials studying Liver Cancer
134 Patients Enrolled for Liver Cancer
Renuka IyerPrincipal InvestigatorRoswell Park Cancer Institute
7 Previous Clinical Trials
170 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03211416 — Phase 1 & 2
Liver Cancer Research Study Groups: Treatment (sorafenib tosylate, pembrolizumab)
Liver Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03211416 — Phase 1 & 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03211416 — Phase 1 & 2
~5 spots leftby Sep 2025
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