A Phase 1/2 Study of Ramucirumab Plus Nivolumab in Participants With Gastric or GEJ Cancer

National Cancer Center, Japan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Gastroesophageal Junction Region (GEJ) Cancer; Gastric Cancer

Treatments: Biological: Nivolumab; Biological: Ramucirumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02999295

NCCH-1611

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and efficacy of the combination therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable gastric or GEJ cancer.

Enrollment: 46 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced or recurrent unresectable gastric or GEJ cancer
• Histologically confirmed adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma or poorly differentiated adenocarcinoma), signet-ring cell carcinoma, mucinous adenocarcinoma or hepatoid adnocarcinoma
• Patients with normal oral intake
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Patients who have measurable target lesion
• Patients has a refractory or intolerant pretreatment by pyrimidine fluoride anticancer agent and platinum-based anticancer agent
• Patients with adequate organ function
• Patients with no pretreatment history including ramucirumab, nivolumab or other therapies targeting control of T cells
• Patients with written informed consent

Exclusion criteria

• Patients have double cancer
• Patients have infection required systemic therapy
• Known central vervous system (CNS) metastasis
• Patients with history of pneumonitis or pulmonary fibrosis
• Patients with history of serious anaphylaxis induced by antibody preparation
• Patients who have known active autoimmune disease or history of chronic recurrent autoimmune disease
• Female who is pregnant, lactating or suspected pregnancy
• Patients with psychosis or dementia to interfere to obtain informed consent appropriately

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Phase 1

Experimental group

Description:

Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks

Treatment:

Biological: Ramucirumab

Biological: Nivolumab

Phase 2

Experimental group

Description:

Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks

Treatment:

Biological: Ramucirumab

Biological: Nivolumab