Nivolumab combined with chemotherapy for advanced gastric cancer
Nivolumab and CAPOX in Patients With FGFR2/PD-L1-positive Metastatic Gastric Adenocarcinoma: a Single-arm, Phase 2 Study
This study is testing if combining nivolumab with CAPOX chemotherapy can help people with advanced gastric cancer who have certain genetic markers and haven't had treatment before.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kidney Cancer Research Bureau Academic / other |
| Drugs / interventions | radiation, nivolumab, chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05859477 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial aims to assess the effectiveness of nivolumab when used alongside CAPOX chemotherapy in patients with FGFR2-positive and PD-L1-positive metastatic gastric cancer. The study focuses on individuals who have not received prior treatment and have measurable lesions. By targeting the FGFR2 receptor, which is associated with poor survival outcomes, the trial seeks to provide insights into the efficacy of this combination therapy in a specific patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unresectable advanced or metastatic gastric adenocarcinoma that is FGFR2-positive and PD-L1-positive.
Not a fit: Patients with HER2-positive gastric cancer or those who have received prior treatment for their condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and outcomes for patients with FGFR2-positive metastatic gastric cancer.
How similar studies have performed: While there is limited data on the specific combination of nivolumab with chemotherapy in this context, similar studies have shown promising results in treating metastatic gastric cancer with immunotherapy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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
Where this trial is running
New York, New York
- Bureau for Cancer Research — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Ilya Tsimafeyeu
- Email: director@bucare.org
- Phone: +19178914943
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.