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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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My liver functions well despite my illness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate defined as partial or complete response per immune-related Response Evaluation Criteria in Solid Tumors
Secondary outcome measures
Overall survival
Time to tumor progression
Other outcome measures
Change in functional activity of effector T cells
Change in levels of immunosuppressive cells
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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
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
402 Previous Clinical Trials
30,821 Total Patients Enrolled
5 Trials studying Liver Cancer
225 Patients Enrolled for Liver Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,937 Total Patients Enrolled
2 Trials studying Liver Cancer
133 Patients Enrolled for Liver Cancer
Renuka IyerPrincipal InvestigatorRoswell Park Cancer Institute
7 Previous Clinical Trials
170 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have hepatitis B, but it is under control.I do not have brain metastases.I am currently pregnant or breastfeeding.I am fully active or have some restrictions but can take care of myself.I've had one treatment for my condition, but not with sorafenib or PD1 blockers.My cancer has grown since my last treatment, which was over 28 days ago.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.I do not have a bleeding disorder and am not on blood thinners like warfarin or heparin.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have or had lung inflammation not caused by an infection.I have advanced liver cancer and can provide tissue for testing if needed.I have not received a live vaccine in the last 30 days.I can swallow and keep down pills.My kidney function is within the normal range.I have had hepatitis C but finished treatment at least a month ago.I do not have HIV.My liver functions well despite my illness.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (sorafenib tosylate, pembrolizumab)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What therapeutic applications is pembrolizumab most often employed for?
"Pembrolizumab is a popular medication for treating inoperable melanoma, as well as other high-risk conditions characterized by microsatellite instability."
Answered by AI
How many participants are currently taking part in this research endeavor?
"Yes, clinicaltrials.gov confirms that this medical study is actively enrolling participants and has been since December 7th 2017. The researchers are searching for 41 patients across two trial sites as of July 26th 2022."
Answered by AI
Have any precedential experiments been conducted with Pembrolizumab?
"Presently, there are 1,018 ongoing clinical trials assessing the efficacy of Pembrolizumab with 143 in Phase 3. Houston is one of many hubs for this trial as it is being conducted at 38,329 locations around the world."
Answered by AI
Is enrollment for this experiment still open?
"Indeed, the information on clinicaltrials.gov demonstrates that this study is recruiting patients at present. This investigation was originally made public on December 7th 2017 and has been recently updated as of July 26th 2022. The research team requires 41 participants to be recruited from two distinct locations."
Answered by AI
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