Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorAsan Medical Center
About this trial
To investigate efficacy and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
Disqualifiers
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-interventional) clinical study or during the follow-up period of an interventional 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
Trial design
Design model
Single group
Treatments tested in this trial
Lenvatinib
DrugDescription: Lenvatinib: 12 mg (for body weight ≥ 60 kg) or 8 mg (for body weight \< 60 kg) per oral once daily * Dose level 1: 8mg per oral once daily (for \<60kg) 12mg per oral once daily (for ≥ 60kg) * Dose level 2: 4mg per oral once daily (for \<60kg) 8mg per oral once daily (for ≥ 60kg) Nivolumab: 360 mg administered intravenously every 3 weeks Chemotherapy(Oxaliplatin+Capecitabine) every 3 weeks * Capecitabine 1000 mg/m² per oral twice daily on Days 1-14 * Oxaliplatin 130 mg/m² administered intravenously on Day 1
Treatment groups
61 Participants
are divided into 1 treatment groupGroup A: Lenvatinib+Nivolumab+Chemotherapy(Capecitabine+Oxaliplatin)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1b part: Recommend phase 2 dose(RP2D)
Phase 1b part: will follow a traditional 3+3 dose-escalation design. Dose-limiting toxicities (DLTs) will be assessed after the first 3 subjects are enrolled. If no DLTs are observed among the initial 3 subjects, the dose level will be considered the recommended phase 2 dose (RP2D). If 1 of the initial 3 subjects experiences a DLT, 3 additional subjects will be enrolled at the same dose level (for a total of 6 subjects). If ≤1 of 6 subjects experience a DLT, the dose level will be defined as the RP2D. Up to 12 subjects may be enrolled in the Phase 1b part.
Time frame
At the end of Cycle 1 (each cycle is 21 days)2
Phase II part: 6 month progression-free survival (PFS) rate
6 month progression-free survival (PFS) rate
Time frame
At 6 monthsSponsors and contacts
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Source ClinicalTrials.gov