A Multicenter, Phase 1/2 Study of Ramucirumab Plus Nivolumab as Second-line Therapy in Participants With Gastric or GEJ Cancer

National Cancer Center, Japan1 site in 1 country46 target enrollmentJanuary 2017

ConditionsGastric Cancer Gastroesophageal Junction Region (GEJ) Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Gastric Cancer
Sponsor: National Cancer Center, Japan
Enrollment: 46
Locations: 1
Primary Endpoint: Number of participants with dose limiting toxicities (DLTs)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

August 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Cancer Center, Japan

Responsible Party

Principal Investigator

Ken Kato

Head Physician

National Cancer Center, Japan

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of participants with dose limiting toxicities (DLTs)

Time Frame: Phase 1, course 1 (up to 28 days)

Number of participants with dose limiting toxicities (DLTs)

Progression free survival rate after 6 months

Time Frame: from baseline to 6 months

Progression free survival rate after 6 months

Secondary Outcomes

Objective response rate (ORR)(from baseline to date of disease progression, approximately 24 months)
Number of participants with adverse events(from baseline to date of treatment cessation, approximately 24 months)
Overall survival (OS)(from baseline to date of death, approximately 24 months)
Progression free survival (PFS)(from baseline to date of disease progression or death, approximately 24 months)
Disease control rate (DCR)(from baseline to date of disease progression, approximately 24 months)