Paclitaxel + Pembrolizumab + Olaparib for Gastric Cancer
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot take certain drugs like moderate or strong CYP3A inhibitors. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination of Paclitaxel, Pembrolizumab, and Olaparib for gastric cancer?
Research shows that combining Olaparib with Paclitaxel improved survival in patients with advanced gastric cancer, especially those with low ATM protein levels. Additionally, Pembrolizumab has been studied as a treatment for advanced gastric cancer, showing potential benefits in certain patients.12345
Is the combination of Paclitaxel, Pembrolizumab, and Olaparib safe for humans?
Studies have shown that Olaparib combined with Paclitaxel has been tested for safety in patients with advanced gastric cancer and other solid tumors, indicating it is generally safe for human use. However, specific safety data for the combination with Pembrolizumab is not detailed in the available research.34678
How is the drug combination of Paclitaxel, Pembrolizumab, and Olaparib unique for treating gastric cancer?
This drug combination is unique because it combines a chemotherapy drug (Paclitaxel), an immunotherapy drug (Pembrolizumab), and a targeted therapy drug (Olaparib) to potentially improve outcomes in gastric cancer, especially in patients with specific genetic markers like low ATM protein levels. This approach aims to enhance the effectiveness of treatment by attacking the cancer in multiple ways.345910
What is the purpose of this trial?
The purpose of this study is to evaluate the safety and clinical activity of paclitaxel plus olaparib and pembrolizumab in patients with previously treated advanced Gastric Cancer (GC).
Research Team
Katherine Bever, MD
Principal Investigator
Johns Hopkins Medical Institution
Eligibility Criteria
Adults over 18 with advanced gastric or gastroesophageal cancer, who have failed one prior therapy and have a measurable lesion. They must be in good physical condition (ECOG 0-1), not pregnant, willing to use birth control, and able to consent. Excluded are those with brain metastases, certain allergies, recent other treatments or vaccines, active infections like HIV/hepatitis B/C, severe illnesses or conditions that could affect study participation.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Paclitaxel, Olaparib, and Pembrolizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Olaparib
- Paclitaxel
- Pembrolizumab
Olaparib is already approved in European Union, United States for the following indications:
- Breast cancer
- Ovarian cancer
- Fallopian tube cancer
- Peritoneal cancer
- Pancreatic cancer
- Prostate cancer
- Endometrial cancer
- Ovarian, fallopian tube, and primary peritoneal cancer
- Breast cancer
- Prostate cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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