A Phase 1/2 Study of Ramucirumab Plus Nivolumab in Participants With Gastric or GEJ Cancer
Primary Purpose
Gastric Cancer, Gastroesophageal Junction Region (GEJ) Cancer
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Ramucirumab
Nivolumab
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
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
Sites / Locations
- National Cancer Center Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Phase 1
Phase 2
Arm Description
Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks
Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks
Outcomes
Primary Outcome Measures
Number of participants with dose limiting toxicities (DLTs)
Number of participants with dose limiting toxicities (DLTs)
Progression free survival rate after 6 months
Progression free survival rate after 6 months
Secondary Outcome Measures
Number of participants with adverse events
Number of participants with adverse events
Objective response rate (ORR)
percentage of participants with with a best response of complete response (CR) or partial response (PR)
Disease control rate (DCR)
percentage of participants with with a best response of CR, PR or stable disease (SD)
Overall survival (OS)
Overall survival (OS)
Progression free survival (PFS)
Progression free survival (PFS)
Full Information
NCT ID
NCT02999295
First Posted
December 19, 2016
Last Updated
August 19, 2019
Sponsor
National Cancer Center, Japan
Collaborators
Ono Pharmaceutical Co. Ltd, Fiverings Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02999295
Brief Title
A Phase 1/2 Study of Ramucirumab Plus Nivolumab in Participants With Gastric or GEJ Cancer
Official Title
A Multicenter, Phase 1/2 Study of Ramucirumab Plus Nivolumab as Second-line Therapy in Participants With Gastric or GEJ Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Japan
Collaborators
Ono Pharmaceutical Co. Ltd, Fiverings Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastroesophageal Junction Region (GEJ) Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase 1
Arm Type
Experimental
Arm Description
Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks
Arm Title
Phase 2
Arm Type
Experimental
Arm Description
Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks
Intervention Type
Biological
Intervention Name(s)
Ramucirumab
Other Intervention Name(s)
LY3009806
Intervention Description
Ramucirumab (8 mg/kg) is administered.
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
ONO-4538
Intervention Description
Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.
Primary Outcome Measure Information:
Title
Number of participants with dose limiting toxicities (DLTs)
Description
Number of participants with dose limiting toxicities (DLTs)
Time Frame
Phase 1, course 1 (up to 28 days)
Title
Progression free survival rate after 6 months
Description
Progression free survival rate after 6 months
Time Frame
from baseline to 6 months
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Description
Number of participants with adverse events
Time Frame
from baseline to date of treatment cessation, approximately 24 months
Title
Objective response rate (ORR)
Description
percentage of participants with with a best response of complete response (CR) or partial response (PR)
Time Frame
from baseline to date of disease progression, approximately 24 months
Title
Disease control rate (DCR)
Description
percentage of participants with with a best response of CR, PR or stable disease (SD)
Time Frame
from baseline to date of disease progression, approximately 24 months
Title
Overall survival (OS)
Description
Overall survival (OS)
Time Frame
from baseline to date of death, approximately 24 months
Title
Progression free survival (PFS)
Description
Progression free survival (PFS)
Time Frame
from baseline to date of disease progression or death, approximately 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Kato, M.D. / Ph.D.
Organizational Affiliation
Department of Gastrointestinal Medical Oncology, National cancer center hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center Hospital
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase 1/2 Study of Ramucirumab Plus Nivolumab in Participants With Gastric or GEJ Cancer
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