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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

To evaluate the antitumor activity and safety/tolerability of the combination (mFOLFOX + Pembrolizumab) in patients with potentially resectable adenocarcinoma of the Gastroesophageal Junction (GEJ) and stomach.

Research Team

Weijing Sun, MD

Principal Investigator

The University of Kansas - Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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