← Back to Search

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

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
Select...
I am 18 years old or older.
Select...
I have had only one or no systemic therapy treatments.
Select...
My cancer is confirmed as MSS and HER2 negative in the stomach or esophagus.
Select...
I do not plan to have any major surgery during the trial.
Select...
My cancer has a PD-L1 score of 1 or higher.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
My scans show cancer that cannot be removed by surgery and were done within the last 28-42 days.
Select...
My recent urine test shows low or normal protein levels.
Select...
My cancer is in the stomach or esophagus and cannot be removed with surgery.
Select...
I have fully recovered from any previous surgeries without complications in the last 8 weeks.
Select...
I have not received a live vaccine in the last 28 days.
Select...
I haven't had serious bleeding or GI issues in the last 84 days.
Select...
I have never had a severe allergic reaction to monoclonal antibody therapy.
Select...
My white blood cell count is high enough for treatment.
Select...
I am not planning to take any other cancer treatments while on this study.
Select...
I haven't had a heart attack or stroke in the last 6 months.
Select...
I had hepatitis C but am now cured, or I am being treated with no detectable virus.
Select...
I haven't needed steroids for lung inflammation in the last year.
Select...
I am HIV positive, on effective treatment, and my viral load is undetectable.
Select...
My heart is healthy enough for the trial, meeting the class 2 or better requirement.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS) (Phase III)
Progression free survival (PFS) (Phase II)
Secondary outcome measures
Disease control rate (DCR)
Objective response rate (ORR)
Other outcome measures
Disease-free survival (DFS)

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 30 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 30 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
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Nivolumab
2014
Completed Phase 3
~5220
Paclitaxel
2011
Completed Phase 4
~5810
Computed Tomography
2017
Completed Phase 2
~2740
Ramucirumab
2017
Completed Phase 3
~5050
Biospecimen Collection
2004
Completed Phase 3
~2020

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,841 Previous Clinical Trials
41,002,665 Total Patients Enrolled
Anwaar SaeedPrincipal InvestigatorSWOG Cancer Research Network
~149 spots leftby Oct 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top