Pembrolizumab + Liver-Directed/PRRT for Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of pembrolizumab and liver-targeted treatments or PRRT for patients with specific liver-spread neuroendocrine tumors. The treatments aim to boost the immune system and directly attack tumors. It focuses on patients whose tumors are difficult to treat with standard methods. Everolimus has demonstrated effectiveness in neuroendocrine neoplasms and has shown a synergistic effect with radiation therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it does allow concurrent somatostatin analog therapy, and you should not be on systemic steroid therapy or immunosuppressive therapy within 7 days before starting the trial treatment.
Is the combination of Pembrolizumab and liver-directed therapies generally safe for humans?
Pembrolizumab has been used in various cancer treatments and is generally considered safe, but it can cause side effects like fatigue, nausea, and immune-related issues such as liver problems. Liver injury during pembrolizumab treatment is more often due to cancer spread rather than the drug itself, but it can still occur in 1%-10% of patients.12345
How is the drug pembrolizumab unique for liver cancer treatment?
What data supports the effectiveness of the treatment Pembrolizumab + Liver-Directed/PRRT for Liver Cancer?
Who Is on the Research Team?
Nicholas Fidelman, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for adults with well-differentiated neuroendocrine tumors that have spread to the liver. Participants must show tumor progression, have a life expectancy over 3 months, and adequate organ function. They should not be pregnant or breastfeeding and agree to use contraception. Exclusions include severe liver involvement by the tumor, active infections, certain medical treatments within specific timeframes before the trial starts, and known allergies to pembrolizumab.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab intravenously every 21 days for up to 35 courses, with PRRT using 177Lu-DOTATATE administered every 8 weeks for up to four treatments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Arterial Embolization
- Pembrolizumab
- Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate
- Yttrium-90 Microsphere Radioembolization
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nicholas Fidelman, MD
Lead Sponsor
BTG International Inc.
Collaborator
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