Pembrolizumab + Chemotherapy for Stomach Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether adding pembrolizumab, a type of immunotherapy, to standard chemotherapy can extend the lives of people with advanced stomach cancer. It compares pembrolizumab plus chemotherapy to a placebo plus chemotherapy to determine which is more effective against HER2-negative gastric or gastroesophageal junction cancer. The trial seeks participants diagnosed with this type of cancer who have not yet received treatment for their advanced condition. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the study team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that combining pembrolizumab with chemotherapy is safe for people with advanced stomach cancer. Research indicates that pembrolizumab can improve survival and response rates and is generally well-tolerated. Some participants experienced side effects, but these are often manageable.
The chemotherapy drugs used in this trial, such as cisplatin and oxaliplatin, have undergone extensive study. They can cause side effects like nausea or tiredness, but these are common with many cancer treatments and can usually be controlled with other medications.
Overall, pembrolizumab combined with chemotherapy has proven safe for people with stomach cancer. Evidence suggests that while side effects can occur, they are usually not severe and can be managed.12345Why do researchers think this study treatment might be promising for stomach cancer?
Most treatments for stomach cancer involve chemotherapy drugs like cisplatin, 5-fluorouracil, oxaliplatin, and capecitabine. Pembrolizumab, however, is exciting because it works as an immunotherapy, boosting the body's immune system to better recognize and fight cancer cells. This is different from traditional chemotherapy, which directly attacks the cancer cells but can also harm healthy cells. Researchers are particularly interested in pembrolizumab's potential to enhance the effects of chemotherapy, potentially leading to improved outcomes for patients. By combining pembrolizumab with chemotherapy, this approach could offer a more powerful treatment option for stomach cancer.
What evidence suggests that pembrolizumab plus chemotherapy could be an effective treatment for stomach cancer?
In this trial, participants will receive either pembrolizumab combined with chemotherapy or a placebo combined with chemotherapy. Research has shown that combining pembrolizumab with chemotherapy can extend the lives of people with advanced stomach and gastroesophageal junction cancers. One study found that this combination significantly increased survival time compared to chemotherapy alone, with patients living for a median of 12.9 months. This approach also improved response rates, with more patients experiencing a reduction or disappearance of their cancer. The side effects are considered manageable, making this a promising option for those battling this type of cancer.24678
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
Adults with HER2-negative advanced gastric or GEJ adenocarcinoma, who have not had previous treatments for advanced cancer, can join. They must be in good physical condition (ECOG 0-1), agree to use contraception, and have adequate organ function. People with active brain metastases, severe allergies to trial drugs, recent major surgery or other conditions that could affect participation are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab plus chemotherapy or placebo plus chemotherapy for up to 35 cycles (approximately 2 years)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Second Course Treatment (optional)
Participants who complete the initial treatment or achieve a complete response but experience progression can initiate a second course of pembrolizumab for up to 17 cycles
What Are the Treatments Tested in This Trial?
Interventions
- 5-fluorouracil
- capecitabine
- Cisplatin
- oxaliplatin
- Pembrolizumab
- Placebo for Pembrolizumab
5-fluorouracil is already approved in United States, European Union, Canada, Japan for the following indications:
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Esophageal cancer
- Anal cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Esophageal cancer
- Anal cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Esophageal cancer
- Anal cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Esophageal cancer
- Anal cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme LLC
Lead 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