Metastatic Gastric CancerPhase 2NIVOFGFR2NCT05859477
Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer
A Phase 2 study testing Nivolumab, Capecitabine and Oxaliplatin in people with Metastatic Gastric Cancer and PD-L1 Gene Amplification, run by Kidney Cancer Research Bureau at 1 site in United States.
Trial summary
The goal of this phase 2 clinical trial is to evaluate the efficacy of nivolumab in combination with CAPOX in patients with FGFR2-positive/PD-L1-positive/HER2-negative metastatic gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Gastric Cancer, PD-L1 Gene Amplification, FGFR2 Amplification
- What is being tested?
- Nivolumab, Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2022to 1 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated, unresectable advanced or metastatic gastric adenocarcinoma
- Measurable lesions according to the RECIST 1.1 criteria
- PD-L1 Combined Positive Score (CPS) of five or more assessed by Dako PD-L1 immunohistochemistry 28-8 pharmDx assay
- Positive FGFR2 overexpression status by immunohistochemistry defined as exhibiting any moderate (2+) to strong (3+) membranous staining in more than 1% of tumor cells
- Possibility to assess the amplification of FGFR2
- HER2-negative status
Show all 11Show fewer
- ECOG PS 0-2
- Age >= 18 years old
- Adequate function of organs
- Absence of any psychological, family, social or geographical circumstances that could potentially serve as obstacles to the implementation of the study
- Signed Informed Consent
Who cannot join
- Participation in another clinical study and concomitant treatment with any research drug or any study of antitumor therapy, including radiation, within 28 days before inclusion in this study
- Presence of metastases in the central nervous system and / or carcinoma of the meninges at the time of inclusion in the study
- Presence or history of present signs of any condition, therapy or laboratory abnormalities that could limit the interpretation of the results of this study
- Any malignant tumor within the previous 5 years, with the exception of adequately cured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancer with limited growth, subject to adequate control over the course of this disease
- Pregnancy
- Known positive status for human immunodeficiency virus (HIV) or active hapatitis B and C
- Surgery within 7 days before the first dose of the study drug
- Signs of bleeding or hemorrhagic diathesis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bureau for Cancer Research
New York, New York, 10032
Magnolia Rouge, 917-981-6485, bucare@bucare.org
About this study
Official title: Nivolumab and CAPOX in Patients With FGFR2/PD-L1-positive Metastatic Gastric Adenocarcinoma: a Single-arm, Phase 2 Study
The goal of this phase 2 clinical trial is to evaluate the efficacy of nivolumab in combination with CAPOX in patients with FGFR2-positive/PD-L1-positive/HER2-negative metastatic gastric cancer.
Read the detailed description
On April 16, 2021, the Food and Drug Administration approved first-line therapy with nivolumab and fluoropyrimidine-platinum-containing chemotherapy for metastatic gastric adenocarcinoma. Patients with PD-L1 expression benefit the most from this treatment.
Fibroblast growth factor receptor 2 (FGFR2) is a predictor of poor overall survival and a potential target for targeted therapy. However, there is no data of nivolumab efficacy in patients with combined expression of PD-L1 and FGFR2.
The aim of this study is to evaluate the preliminary efficacy of nivolumab in this patient population.
- Being tested
- Nivolumab, Capecitabine, Oxaliplatin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
360 mg, i.v., every 3 weeks
CapecitabineDrug
Also called Xeloda
capecitabine 1000 mg/m², orally, twice a day, days 1-14 of each cycle
OxaliplatinDrug
130 mg/m², i.v., day 1, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab in combination with chemotherapy | Experimental | Nivolumab 360 mg with CAPOX (capecitabine and oxaliplatin) every 3 weeks Receives: Drug: Nivolumab; Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year progression-free survival (PFS)
Proportion of patients who will be progression-free at 1 year
Measured: 12 months
Secondary outcomes (4)
Median PFS
From first day of treatment to the first observation of disease progression or death due to any cause
Measured: 18 months
Median overall survival (OS)
From first day of treatment to time of death due to any cause.
Measured: 24 months
Objective response rate (ORR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: 18 months
Toxicity Summary
toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 3 and above adverse events possibly, probably or definitely related to treatment.
Measured: Up to 30 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start5 Jun 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Nivolumab in combination with chemotherapy
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kidney Cancer Research Bureau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilya Tsimafeyeu, Study chair, Bureau for Cancer Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859477
- Sponsor's protocol ID
- NIVOFGFR2
- Acronym
- NIVOFGFR2
- Status last verified
- Dec 2023
- First submitted
- 1 May 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nivolumab and CAPOX in Patients With FGFR2/PD-L1-positive Metastatic Gastric Adenocarcinoma: a Single-arm, Phase 2 Study
- ClinicalTrials.gov ID
- NCT05859477
- Acronym / sponsor ID
- NIVOFGFR2 / NIVOFGFR2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Kidney Cancer Research BureauUniversity, hospital or other
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this phase 2 clinical trial is to evaluate the efficacy of nivolumab in combination with CAPOX in patients with FGFR2-positive/PD-L1-positive/HER2-negative metastatic gastric cancer.
Detailed description
On April 16, 2021, the Food and Drug Administration approved first-line therapy with nivolumab and fluoropyrimidine-platinum-containing chemotherapy for metastatic gastric adenocarcinoma. Patients with PD-L1 expression benefit the most from this treatment.
Fibroblast growth factor receptor 2 (FGFR2) is a predictor of poor overall survival and a potential target for targeted therapy. However, there is no data of nivolumab efficacy in patients with combined expression of PD-L1 and FGFR2.
The aim of this study is to evaluate the preliminary efficacy of nivolumab in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Nivolumab in combination with chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Nivolumab in combination with chemotherapy | Experimental | Drug: Nivolumab, Drug: Capecitabine, Drug: OxaliplatinNivolumab 360 mg with CAPOX (capecitabine and oxaliplatin) every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Previously untreated, unresectable advanced or metastatic gastric adenocarcinoma
- Measurable lesions according to the RECIST 1.1 criteria
- PD-L1 Combined Positive Score (CPS) of five or more assessed by Dako PD-L1 immunohistochemistry 28-8 pharmDx assay
- Positive FGFR2 overexpression status by immunohistochemistry defined as exhibiting any moderate (2+) to strong (3+) membranous staining in more than 1% of tumor cells
- Possibility to assess the amplification of FGFR2
Key exclusion criteria (8 listed)
- Participation in another clinical study and concomitant treatment with any research drug or any study of antitumor therapy, including radiation, within 28 days before inclusion in this study
- Presence of metastases in the central nervous system and / or carcinoma of the meninges at the time of inclusion in the study
- Presence or history of present signs of any condition, therapy or laboratory abnormalities that could limit the interpretation of the results of this study
- Any malignant tumor within the previous 5 years, with the exception of adequately cured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancer with limited growth, subject to adequate control over the course of this disease
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: Opdivo360 mg, i.v., every 3 weeks | Drug | Nivolumab in combination with chemotherapy |
| CapecitabineAlso: Xelodacapecitabine 1000 mg/m², orally, twice a day, days 1-14 of each cycle | Drug | Nivolumab in combination with chemotherapy |
| Oxaliplatin130 mg/m², i.v., day 1, every 3 weeks | Drug | Nivolumab in combination with chemotherapy |
Primary outcome
1-year progression-free survival (PFS)
Time frame: 12 months
Proportion of patients who will be progression-free at 1 year
4 secondary outcomes
Median PFS
Time frame: 18 months
Median overall survival (OS)
Time frame: 24 months
Objective response rate (ORR)
Time frame: 18 months
Toxicity Summary
Time frame: Up to 30 days post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilya Tsimafeyeu study chair
Bureau for Cancer Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Capecitabine and Oxaliplatin in people with Metastatic Gastric Cancer and PD-L1 Gene Amplification, run by Kidney Cancer Research Bureau at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilya Tsimafeyeu (+19178914943, director@bucare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year progression-free survival (PFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.