BridgeMD
New treatment option for STOMACH NEOPLASM
Official title Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites
ClinicalTrials.gov ID: NCT07149090
What this study is testing
What is Lenvatinib?
Lenvatinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for stomach neoplasm.
Also referred to as Nivolumab+Chemotherapy(Capecitabine+Oxaliplatin).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To investigate efficacy and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Newly diagnosed pathologically proven metastatic, unresectable or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma
- Positive for peritoneal metastasis and grade ≥ 2 malignant ascites as confirmed by computed tomography (CT)
- PD-L1 combined positive score of ≥5 based on the 28-8 assay
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)...
- Age \> 19 years at time of study entry
You likely can't join if
- Disease progression within 6 months after completion of adjuvant chemotherapy.
- Participation in another clinical study with an investigational product during the last 2 weeks
- Concurrent enrollment in another clinical study, unless it is an observational (non-treatment) clinical study or during the follow-up period of an...
- Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for...
- Major surgical procedure within 28 days prior to the first dose
- Unable to take medication orally
See the full eligibility criteria
- Newly diagnosed pathologically proven metastatic, unresectable or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma
- Positive for peritoneal metastasis and grade ≥ 2 malignant ascites as confirmed by computed tomography (CT)
- PD-L1 combined positive score of ≥5 based on the 28-8 assay
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally...
- Age \> 19 years at time of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of \> 4 months
- Body weight \> 30kg
- No existing neuropathy
- Adequate normal organ and marrow function as defined below:
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) 1.5 x (\> 1500 per mm3)
- Platelet count ≥100 (or 75) x 109/L (\>75,000 per mm3)
- Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)
- AST (SGOT)/ALT (SGPT) ≤2.5 x institutional ULN
- Measured creatinine clearance (CL) \> 40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance:
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre- menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an...
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
- Disease progression within 6 months after completion of adjuvant chemotherapy.
- Participation in another clinical study with an investigational product during the last 2 weeks
- Concurrent enrollment in another clinical study, unless it is an observational (non-treatment) clinical study or during the follow-up period of an treatment study
- Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
- Major surgical procedure within 28 days prior to the first dose
- Unable to take medication orally
- Gastrointestinal bleeding
- Impaired bowel absorption
- History of allogenic organ transplantation
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial...
- History of another primary malignancy except for
- Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- History of active primary immunodeficiency
- Active infectious disease
- Tuberculosis (based on clinical history, physical examination, radiographic findings, and TB testing in line with local practice)
- Hepatitis B (known positive HBV surface antigen (HBsAg) result)
- Hepatitis C (patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA)
- Human immunodeficiency virus (positive HIV 1/2 antibodies)
- Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.
- Female patients who are pregnant or breastfeeding, as well as male or female patients of reproductive potential who are not willing to use effective contraception from the time of screening until 5 months following the...
- Known allergy or hypersensitivity to the investigational drug or any of its components.
- Patients with known deficiency of dihydropyrimidine dehydrogenase (DPD).
- Patients with known hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.