Your session is about to expire
← Back to Search
Anti-metabolites
Nivolumab + Chemotherapy for Gastric Cancer (NIVOFGFR2 Trial)
Phase 2
Recruiting
Research Sponsored by Kidney Cancer Research Bureau
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
NIVOFGFR2 Trial Summary
This trial tests if a drug combo can help people with a specific type of stomach cancer.
Who is the study for?
This trial is for adults with FGFR2-positive/PD-L1-positive/HER2-negative metastatic gastric cancer who haven't had treatment before. They should have measurable lesions, be in a decent physical state (ECOG PS 0-2), and have good organ function. People can't join if they've been in other trials recently, have brain metastases or meningeal carcinomas, other cancers within the last 5 years (except certain skin cancers or cervical cancer), are pregnant, or have HIV/hepatitis B/C.Check my eligibility
What is being tested?
The study tests how well Nivolumab works alongside chemotherapy drugs Oxaliplatin and Capecitabine (CapeOX) for advanced stomach cancer that's spread and has specific genetic markers. It's a phase 2 trial to see if this combo is effective.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects like inflammation of organs, skin problems, hormone gland issues, infusion reactions; Oxaliplatin can lead to nerve damage and allergic reactions; Capecitabine might cause hand-foot syndrome, diarrhea, nausea.
NIVOFGFR2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1-year progression-free survival (PFS)
Secondary outcome measures
Median PFS
Median overall survival (OS)
Objective response rate (ORR)
+1 moreNIVOFGFR2 Trial Design
1Treatment groups
Experimental Treatment
Group I: Nivolumab in combination with chemotherapyExperimental Treatment3 Interventions
Nivolumab 360 mg with CAPOX (capecitabine and oxaliplatin) every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Oxaliplatin
2011
Completed Phase 4
~2560
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Kidney Cancer Research BureauLead Sponsor
10 Previous Clinical Trials
418 Total Patients Enrolled
Ilya TsimafeyeuStudy ChairBureau for Cancer Research
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my brain or its coverings.My cancer has a PD-L1 score of 5 or more.My cancer is not HER2 positive.I can take care of myself and perform daily activities.I have not had surgery within the last week.I have signs of bleeding or a bleeding disorder.My cancer can be tested for FGFR2 gene changes.My tumor shows moderate to strong FGFR2 protein presence.I am 18 years old or older.I don't have any health issues that could affect this study's results.My stomach cancer has not been treated and cannot be surgically removed.I have not been in another cancer study or received experimental treatments in the last 28 days.My organs are working well.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that were treated.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab in combination with chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study accepting new participants at the present time?
"Yes, the open-source data on clinicaltrials.gov indicates that recruitment for this trial is still ongoing. It was posted to the website on June 5th 2022 and has since been updated as recently as May 10th 2023. 23 patients are sought from a single medical centre."
Answered by AI
What is the enrollment size for this clinical trial?
"Affirmative. The data hosted on clinicaltrials.gov confirms that this medical investigation is currently enrolling volunteers; it was initially posted on June 5th 2022 and the most recent update came on May 10th 2023. This trial is seeking 23 participants from a single site."
Answered by AI
What implications does the concurrent use of Nivolumab and chemotherapy have on patient safety?
"The safety of Nivolumab used in tandem with chemotherapy was evaluated as a 2, given that clinical data only reveals evidence for its security and not efficacy."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger