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Monoclonal Antibodies

Nivolumab + Standard Treatment for Stomach and Esophageal Cancer

Phase 2 & 3

Recruiting

Led By Anwaar Saeed

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Participants must be ≥ 18 years old

Participants must not have received more than one prior line of systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if adding nivolumab, a type of immunotherapy drug, to the standard treatment of paclitaxel and ramucirumab is more effective in treating patients

Who is the study for?

The PARAMUNE trial is for adults with advanced stomach or esophageal cancer that has spread. They must have had no more than one prior systemic therapy, not be on high-dose steroids or other immunosuppressants, and should not have severe previous reactions to immunotherapy. No recent live vaccines and controlled brain metastases are required. Participants need a PD-L1 CPS score ≥ 1 and must show disease progression after standard chemotherapy.

What is being tested?

This study tests if adding Nivolumab (a monoclonal antibody that boosts the immune system) to the usual treatment of Paclitaxel and Ramucirumab (drugs that stop cancer growth) improves outcomes in patients with advanced gastric or esophageal adenocarcinoma compared to just Paclitaxel and Ramucirumab alone.

What are the potential side effects?

Possible side effects include immune-related issues like inflammation in organs, infusion reactions from antibodies, fatigue from treatment, potential blood disorders, as well as risks associated with disrupting normal cell growth which could affect various body systems.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have had only one or no systemic therapy treatments.

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My cancer is confirmed as MSS and HER2 negative in the stomach or esophagus.

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I do not plan to have any major surgery during the trial.

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My cancer has a PD-L1 score of 1 or higher.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My scans show cancer that cannot be removed by surgery and were done within the last 28-42 days.

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My recent urine test shows low or normal protein levels.

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My cancer is in the stomach or esophagus and cannot be removed with surgery.

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I have fully recovered from any previous surgeries without complications in the last 8 weeks.

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I have not received a live vaccine in the last 28 days.

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I haven't had serious bleeding or GI issues in the last 84 days.

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I have never had a severe allergic reaction to monoclonal antibody therapy.

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My white blood cell count is high enough for treatment.

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I am not planning to take any other cancer treatments while on this study.

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I haven't had a heart attack or stroke in the last 6 months.

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I had hepatitis C but am now cured, or I am being treated with no detectable virus.

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I haven't needed steroids for lung inflammation in the last year.

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I am HIV positive, on effective treatment, and my viral load is undetectable.

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My heart is healthy enough for the trial, meeting the class 2 or better requirement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Overall survival (OS) (Phase III)

Progression free survival (PFS) (Phase II)

Secondary study objectives

Disease control rate (DCR)

Objective response rate (ORR)

Other study objectives

Disease-free survival (DFS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1 (nivolumab, ramucirumab, paclitaxel)Experimental Treatment7 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 of each cycle, ramucirumab IV over 30-60 minutes on days 1 and 15 of each cycle, and paclitaxel IV over 60 minutes on days 1, 8 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. Patients may also optionally undergo blood sample collection on study.

Group II: Arm 2 (ramucirumab, paclitaxel)Active Control6 Interventions

Patients receive ramucirumab IV over 30-60 minutes on days 1 and 15 of each cycle and paclitaxel IV over 60 minutes on days 1, 8 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. Patients may also optionally undergo blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180