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Anti-tumor antibiotic

Combination Chemotherapy for Stomach and Esophageal Cancer

Phase 2

Recruiting

Led By Nataliya Uboha, MD, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histological or cytological confirmed locally advanced or metastatic EGA

Known PDL1 CPS status prior to treatment initiation

Must not have

Major surgery within 28 days or minor surgery within 14 days of the start of the study treatment, except for tumor biopsy or placement of central infusion device (port placement)

Participants who receive nivolumab or pembrolizumab in addition to chemotherapy should not have any contraindications to immune checkpoint inhibitors and should not have received immunotherapy agents for the treatment of EGA prior to study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs for people with advanced esophageal and gastric cancer. Thenew combination is hoped to be better tolerated than current first-line chemotherapy combinations.

Who is the study for?

This trial is for adults with advanced Esophageal and Gastric Adenocarcinoma who haven't had systemic therapy for it. They should be relatively fit (ECOG 0-2), have certain blood counts, organ function within set limits, known HER2/PDL1 status, measurable disease by RECIST v1.1 standards, and not pregnant or breastfeeding. Participants must agree to use effective contraception.

What is being tested?

The study tests a combination of chemotherapy drugs (5-FU, oxaliplatin, nal-IRI) with immunotherapy agents (pembrolizumab or nivolumab; trastuzumab added if HER2-positive). It's an open-label phase II trial aiming to see if this mix is safer and more effective than current treatments for these cancers.

What are the potential side effects?

Possible side effects include allergic reactions to the drugs used, nerve damage from oxaliplatin leading to numbness or tingling in hands/feet, diarrhea from irinotecan, heart problems due to trastuzumab especially in those with pre-existing conditions; immune-related issues like inflammation of organs can occur due to pembrolizumab/nivolumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced or has spread and was confirmed by a lab test.

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I know my PDL1 status before starting treatment.

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My white blood cell count is healthy without needing medication to boost it.

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I can take care of myself and am up and about more than half of my waking hours.

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I haven't received any systemic therapy for my advanced disease.

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My kidney function is within the required range.

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I know my cancer's HER2 status before starting treatment.

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My liver enzyme AST levels are within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had major surgery in the last 28 days or minor surgery in the last 14 days, except for a biopsy or port placement.

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I haven't had immunotherapy for EGA before and can safely receive drugs like nivolumab or pembrolizumab.

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I have a known DPD deficiency.

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I have severe heart failure, irregular heartbeats, or high blood pressure that isn't controlled.

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I am allergic to certain chemotherapy drugs like 5-FU or oxaliplatin.

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I have been diagnosed with HIV.

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I am currently on medication for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohort 1: Objective Response Rate (ORR)

Cohort 3: Objective Response Rate (ORR)

Cohorts 2 and 4: Incidence of Adverse Events

Secondary study objectives

Cohorts 1 and 3: Incidence of Adverse Events

Cohorts 2 and 4: Overall Response Rate

Disease Control Rate (DCR)

+3 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4: HER2 PositiveExperimental Treatment5 Interventions

Participants in Cohort 4 (HER2-positive) will be treated with nal-IRI (50 mg/m\^2 - intravenously over 90 min), trastuzumab (6 mg/kg C1D1, then 4 mg/kg on each subsequent treatment days), 5-FU (2400 mg/m\^2 over 46 hrs), oxaliplatin (60 mg/m\^2), and pembrolizumab (400 mg). Each cycle is 42 days. Participants will receive chemotherapy and trastuzumab treatments on day 1, 15, and 29 of each cycle. Pembrolizumab will be given on day 1 of each cycle.

Group II: Cohort 3: HER2 NegativeExperimental Treatment4 Interventions

Participants in Cohort 3 (HER2-negative) will be treated with nal-IRI (50 mg/m\^2 - intravenously over 90 min), 5-FU (2400 mg/m\^2 over 46 hrs), oxaliplatin (60 mg/m\^2), and nivolumab. (240 mg). Each cycle is 28 days. Participants will receive treatments on day 1 and 15 of each cycle

Group III: Cohort 2: HER2 PositiveExperimental Treatment4 Interventions

Participants in Cohort 2 (HER2-positive) will be treated with nal-IRI (50 mg/m\^2 - intravenously over 90 min), trastuzumab (6 mg/kg C1D1, then 4 mg/kg on each subsequent treatment days), 5-FU (2400 mg/m\^2 over 46 hrs), and oxaliplatin (60 mg/m\^2). Each cycle is 28 days. Participants will receive treatments on day 1 and 15 of each cycle.

Group IV: Cohort 1: HER2 NegativeExperimental Treatment3 Interventions

Participants in Cohort 1 (HER2-negative) will be treated with nal-IRI (50 mg/m\^2 - intravenously over 90 min), 5-FU (2400 mg/m\^2 over 46 hrs), and oxaliplatin (60 mg/m\^2). Each cycle is 28 days. Participants will receive treatments on day 1 and 15 of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Oxaliplatin

2011

Completed Phase 4

~2890

5-FU

2014