Chemotherapy + Immunotherapy for Stomach Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment combination for stomach cancer and cancer at the gastroesophageal junction (where the stomach meets the esophagus). Researchers are testing the effectiveness and safety of combining chemotherapy (specifically a regimen called mFOLFOX) with the immunotherapy drug pembrolizumab (also known as KEYTRUDA or MK-3475). The goal is to determine if this combination can shrink tumors and assist patients who might undergo surgery to remove the cancer. This trial may suit individuals newly diagnosed with localized stomach or gastroesophageal junction cancer who have not yet received chemotherapy. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received prior systemic anti-cancer therapy or certain other treatments recently. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the mFOLFOX6 treatment is generally well-tolerated by patients with advanced stomach cancer. Studies have found it to be safe, with high rates of disease control and few serious side effects. This drug combination is widely used and trusted in chemotherapy for stomach cancer.
Research also indicates that pembrolizumab, when combined with chemotherapy, is safe for advanced stomach and gastroesophageal junction cancers. It has improved survival rates while keeping side effects manageable.
Overall, previous studies have proven both mFOLFOX6 and pembrolizumab to be safe, making them promising options for those considering joining clinical trials.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining mFOLFOX, a chemotherapy regimen, with Pembrolizumab, an immunotherapy drug, for stomach cancer treatment. Unlike traditional chemotherapy that attacks cancer cells directly, Pembrolizumab works by boosting the immune system to recognize and fight cancer more effectively. This combination aims to enhance treatment effectiveness by using the strengths of both chemotherapy and immunotherapy. The hope is that this dual approach can improve outcomes for patients compared to using either treatment alone.
What evidence suggests that this trial's treatments could be effective for stomach cancer?
Studies have shown that mFOLFOX6 works well as an initial chemotherapy option for advanced stomach cancer. It shrinks tumors in 53% of patients and controls the disease in about 82% of them. On average, patients experience about six months without cancer progression. In this trial, participants will receive mFOLFOX6 combined with pembrolizumab. Adding pembrolizumab to chemotherapy has improved survival rates and patient response in advanced stomach and gastroesophageal junction cancers. It significantly increases overall survival compared to chemotherapy alone and is generally well tolerated. This trial tests these treatments together to determine if their combined strengths can more effectively fight stomach cancer.24678
Who Is on the Research Team?
Weijing Sun, MD
Principal Investigator
The University of Kansas - Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with newly diagnosed, potentially operable stomach or gastroesophageal junction cancer without distant spread. Participants must be fit for surgery, have no recent other cancers or major illnesses, and not be pregnant or breastfeeding. They should agree to use contraception and provide tissue samples.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive neoadjuvant combination of mFOLFOX every 2 weeks for 4 doses and Pembrolizumab every 3 weeks for 3 doses
Surgical Resection
Participants undergo potentially curative surgical resection if no evidence of metastatic disease on PET-CT
Adjuvant Treatment
Participants receive adjuvant combination therapy of mFOLFOX every 2 weeks for 4 doses and Pembrolizumab every 3 weeks for 12 doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- mFOLFOX
- Pembrolizumab
Trial Overview
The study tests the combination of mFOLFOX6 chemotherapy with Pembrolizumab (an immunotherapy drug) before and after surgery in patients with stomach or GEJ cancer. The goal is to assess how well this combo works against the tumor and its safety.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Drug: Pembrolizumab Dose: 200 mg Dose Frequency: Every three weeks (Q3W) Route: Intravenous (IV) infusion Drug: Oxaliplatin Dose: 85 milligrams per meter squared (mg/m2) Dose Frequency: Every 2 weeks (Q2W) Route: IV infusion Drug: Leucovorin Dose: 400 mg/m2 Dose Frequency: Q2W Route: IV infusion Drug: Fluorouracil Dose: 400 mg/m2 Dose Frequency: Q2W Route: IV bolus Drug: Fluorouracil Dose: 2,400 mg/m2 Dose Frequency: Q2W Route: IV continuous 46-hour infusion Pembrolizumab will be administered at a fixed dose of 200 mg IV over 30 minutes every 3 weeks. Participants will receive 3 doses of the drug on Days 1, 22, 43 during the neoadjuvant phase of the study, and 12 doses of the drug on Days 1, 22, 43 during the adjuvant phase of the study (total 15 doses). Participants will receive 4 doses of mFOLFOX6 regimen on Days 1, 15, 29, 43 during the neoadjuvant phase of the study, and 4 doses during the adjuvant phase of the study (total 8 doses).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
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
Efficacy and safety of pembrolizumab in advanced gastric and ...
Pembrolizumab combined with chemotherapy improves survival and response rates with a manageable safety profile in advanced gastric and GEJ cancers.
Merck's KEYTRUDA® (pembrolizumab) Plus ...
After a median follow-up of 31.0 months (range, 15.3-46.3 months), KEYTRUDA in combination with chemotherapy significantly improved overall survival (OS), ...
FDA approves pembrolizumab
Treatment with pembrolizumab and chemotherapy resulted in a statistically significant improvement in OS, PFS, and ORR. Median OS was 12.9 months ...
Efficacy and Safety of Pembrolizumab or ...
In cohort 1 of the phase 2 KEYNOTE-059 study, pembrolizumab provided an objective response rate (ORR) of 15.5% in patients with advanced G/GEJ ...
Safety and Efficacy of Pembrolizumab (MK-3475) in ...
The purpose of this study is to estimate objective response rates (ORRs) of pembrolizumab + oxaliplatin + TS-1 and pembrolizumab + cisplatin + TS-1, ...
Efficacy and safety of pembrolizumab in advanced gastric ...
Results: Pembrolizumab combined with chemotherapy significantly improved OS (MD = 1.92 months; 95% CI: 0.94 to 2.91) and ORR (MD = 11.05%; 95% ...
7.
bmcgastroenterol.biomedcentral.com
bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-03754-wEfficacy and safety of pembrolizumab in advanced gastric and ...
Pembrolizumab combined with chemotherapy improves survival and response rates with a manageable safety profile in advanced gastric and GEJ cancers.
KEYNOTE-859: a Phase III study of pembrolizumab plus ...
Combining pembrolizumab with chemotherapy has demonstrated efficacy and manageable safety in multiple tumor types, including gastric cancer [13,15–17]. Based on ...
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