NCT03488667

Perioperative mFOLFOX Plus Pembrolizumab in Gastroesophageal Junction (GEJ) and Stomach Adenocarcinoma

A Phase II Study of Perioperative mFOLFOX (Fluorouracil, Leucovorin, and Oxaliplatin) Chemotherapy Plus Pembrolizumab(MK-3475) Combination in Patients With Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) and Stomach (MISP #52216)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study will evaluate the efficacy and safety of perioperative mFOLFOX plus Pembrolizumab combination regimen in participants with potentially resectable adenocarcinoma of the GEJ and stomach. * The study is a non-randomized, open-label, single-arm phase II study. * The enrolled participants will receive neoadjuvant combination of mFOLFOX every 2 weeks for 4 doses (on Days 1, 15, 29, 43) and Pembrolizumab every 3 weeks for 3 doses (on Days 1, 22, 43). * Serious adverse events (SAEs) will be assessed on an ongoing basis using CTCAE v4.0, and the Thall, Simon, and Estey's design to monitor the efficacy and toxicity continuously together. * Repeat PET-CT will be obtained approximately 2-3 weeks after completion of neoadjuvant combination therapy. * If no evidence of metastatic disease on PET-CT, participants will undergo potentially curative surgical resection 4-6 weeks after completion of neoadjuvant combination therapy. This will be followed by adjuvant combination therapy (to be started 6-8 weeks after surgery) consisting of mFOLFOX every 2 weeks for additional 4 doses (total 4 months of therapy) plus Pembrolizumab every 3 weeks for additional 12 doses (total 1 year of therapy). If there is evidence of metastatic disease on PET-CT, participant will come off the study (i.e., will not undergo surgical resection and adjuvant therapy). * Participants will continue to receive treatment until either one of the following occurs: completion of adjuvant therapy, development of radiographically confirmed progression, participant withdraws consent, intercurrent illness that prevents further administration of treatment, or sponsor-investigator decides to withdraw the participant. * Efficacy outcomes during the adjuvant chemotherapy phase will be determined by radiologic measurements by CT using RECIST v1.1. Assessment of response will be performed every 3 months for the first year and as per the standard institutional guidelines thereafter.

Conditions

• Gastro Esophageal Junction Cancer
• Stomach Cancer
• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Neoadjuvant Treatment - mFOLFOX6 & Pembrolizumab	Pembrolizumab, mFOLFOX Chemotherapy
DRUG	Adjuvant Treatment - mFOLFOX & Pembrolizumab	Pembrolizumab, mFOLFOX Chemotherapy

Timeline

• Start date: 2018-06-27
• Primary completion: 2024-04-30
• Completion: 2025-04-30
• First posted: 2018-04-05
• Last updated: 2023-05-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study