Sorafenib + Pembrolizumab for Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a combination of two treatments, sorafenib tosylate and pembrolizumab, to assess their effectiveness in treating metastatic liver cancer. Sorafenib tosylate may inhibit cancer cell growth by blocking certain enzymes, while pembrolizumab (KEYTRUDA) aims to help the immune system combat cancer cells. The trial seeks to determine if these treatments together offer greater effectiveness for patients with advanced liver cancer. Suitable candidates for this trial have metastatic liver cancer and have experienced disease progression despite prior treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on antiviral therapy for hepatitis B, you should continue it during the study. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that pembrolizumab, a monoclonal antibody, is generally safe for individuals with advanced liver cancer. In the KEYNOTE-224 study, pembrolizumab proved safe for patients who had previously tried other treatments. Sorafenib, already approved for liver cancer, has established safety information. Although both medicines can cause side effects, most people find them manageable. This trial examines how well these two treatments work together, making it crucial to carefully assess their combined effects.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of sorafenib and pembrolizumab for liver cancer because it brings a fresh approach to treatment. Unlike traditional therapies that might solely target tumor growth, sorafenib works by blocking certain proteins that help cancer cells grow, while pembrolizumab is an immunotherapy that boosts the body's own ability to fight cancer by targeting the PD-1 pathway. This dual action not only aims to halt cancer progression but also enhances the immune system's response, offering a potential new avenue for patients who may not respond to existing treatments.
What evidence suggests that sorafenib tosylate and pembrolizumab might be effective for liver cancer?
Research has shown that using sorafenib and pembrolizumab together may help treat liver cancer that has spread. Sorafenib blocks certain proteins that aid cancer cell growth, while pembrolizumab, a type of targeted therapy, helps prevent cancer cells from spreading. The KEYNOTE-224 trial found that pembrolizumab alone was effective and manageable for patients with advanced liver cancer. In this trial, participants will receive a combination of sorafenib and pembrolizumab to better stop the cancer from growing and spreading. Early studies suggest this combination might lead to improved outcomes for liver cancer patients.25678
Who Is on the Research Team?
Renuka Iyer
Principal Investigator
Roswell Park Cancer Institute
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sorafenib tosylate orally twice daily and pembrolizumab intravenously every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Sorafenib Tosylate
Trial Overview
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roswell Park Cancer Institute
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Citations
Data from the Open-Label, Phase II KEYNOTE-224 Trial - PMC
KEYNOTE-224 cohort 1 demonstrated that pembrolizumab was efficacious and tolerable in patients with advanced hepatocellular carcinoma (HCC) previously treated ...
Meta-analysis Relative treatment effects of first-line ...
Progression-free survival between chemotherapy and immunotherapy treatment for hepatocellular carcinoma. The data in Table 3 show the ...
Combined Immunotherapy and Targeted Therapy for ...
Patients with hepatocellular carcinoma (HCC) often undergo liver cancer resection, but the recurrence rate can reach 70% to 100%, which seriously affects the ...
Clinical outcomes and influencing factors of PD‑1/PD‑L1 in ...
The present review discusses the clinical results and influencing factors of PD‐1/PD‐L1 inhibitors in HCC to provide insight into the development and ...
Sorafenib + Pembrolizumab for Liver Cancer
Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may ...
Sorafenib Tosylate and Pembrolizumab in Treating ...
This phase Ib/II trial studies how well sorafenib tosylate and pembrolizumab work in treating patients with liver cancer that has spread to other parts of ...
Clinical outcomes and influencing factors of PD-1/PD-L1 in ...
Hepatocellular carcinoma (HCC) has an increasing incidence worldwide, and the global 5-year survival rate ranges from 5–30%.
Tislelizumab vs Sorafenib as First-Line Treatment for ...
Tislelizumab demonstrated overall survival noninferiority compared with sorafenib, with numerically higher and more durable objective responses than sorafenib.
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