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

August 19, 2019 updated by: Ken Kato, National Cancer Center, Japan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • National Cancer Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Phase 1
Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks
Biological: Ramucirumab
Ramucirumab (8 mg/kg) is administered.
Other Names:
  • LY3009806
Biological: Nivolumab
Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.
Other Names:
  • ONO-4538
EXPERIMENTAL: Phase 2
Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks
Biological: Ramucirumab
Ramucirumab (8 mg/kg) is administered.
Other Names:
  • LY3009806
Biological: Nivolumab
Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.
Other Names:
  • ONO-4538

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Phase 1, course 1 (up to 28 days)
Progression free survival rate after 6 months
Time Frame: from baseline to 6 months
Progression free survival rate after 6 months
from baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: from baseline to date of treatment cessation, approximately 24 months
Number of participants with adverse events
from baseline to date of treatment cessation, approximately 24 months
Objective response rate (ORR)
Time Frame: from baseline to date of disease progression, approximately 24 months
percentage of participants with with a best response of complete response (CR) or partial response (PR)
from baseline to date of disease progression, approximately 24 months
Disease control rate (DCR)
Time Frame: from baseline to date of disease progression, approximately 24 months
percentage of participants with with a best response of CR, PR or stable disease (SD)
from baseline to date of disease progression, approximately 24 months
Overall survival (OS)
Time Frame: from baseline to date of death, approximately 24 months
Overall survival (OS)
from baseline to date of death, approximately 24 months
Progression free survival (PFS)
Time Frame: from baseline to date of disease progression or death, approximately 24 months
Progression free survival (PFS)
from baseline to date of disease progression or death, approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Japan

Collaborators

Ono Pharmaceutical Co. Ltd
Fiverings Co., Ltd.

Investigators

  • Principal Investigator: Ken Kato, M.D. / Ph.D., Department of Gastrointestinal Medical Oncology, National cancer center hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

November 1, 2017

Study Completion (ACTUAL)

August 1, 2019

Study Registration Dates

First Submitted

December 19, 2016

First Submitted That Met QC Criteria

December 19, 2016

First Posted (ESTIMATE)

December 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCH-1611

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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