Chemotherapy + Immunotherapy for Stomach Cancer

Overseen By Kerry Hepler, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Kansas Medical Center

Must not be taking: Immunosuppressants, Corticosteroids, others

Disqualifiers: Metastatic disease, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 20

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. ^{1 2 3 4 5}

Why 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. ^{2 4 6 7 8}

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

My cancer is new, localized or locally advanced, and I haven't had chemotherapy.

I agree to use contraception and not donate sperm for 120 days after my last treatment dose.

I am a woman who can have children and have a negative pregnancy test.

Exclusion Criteria

Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study

Hypersensitivity to pembrolizumab or any of its excipients

Currently participating in or has participated in a study of an investigational agent or used an investigational device within 4 weeks prior to the first dose of study treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive neoadjuvant combination of mFOLFOX every 2 weeks for 4 doses and Pembrolizumab every 3 weeks for 3 doses

6 weeks

4 visits (in-person)

Surgical Resection

Participants undergo potentially curative surgical resection if no evidence of metastatic disease on PET-CT

4-6 weeks after neoadjuvant therapy

Adjuvant Treatment

Participants receive adjuvant combination therapy of mFOLFOX every 2 weeks for 4 doses and Pembrolizumab every 3 weeks for 12 doses

12 months

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 14 months

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?

Group I: mFOLFOX6 (Leucovorin-Fluorouracil-Oxaliplatin) + Pembrolizumab Experimental Treatment 2 Interventions

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).

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11908035/

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.

2. merck.com merck.com/news/mercks-keytruda-pembrolizumab-plus-chemotherapy-significantly-improved-overall-survival-versus-chemotherapy-alone-in-patients-with-her2-negative-gastric-or-gastroesophageal-junction/

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), ...

3. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-her2-negative-gastric-or-gastroesophageal-junction

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 ...

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2769922

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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03382600

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, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40087572/

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-w

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.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9892960/

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 ...