We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02999295
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : September 19, 2017
Sponsor:
Collaborators:
Ono Pharmaceutical Co. Ltd
Fiverings Co., Ltd.
Information provided by (Responsible Party):
Ken Kato, National Cancer Center, Japan

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Gastroesophageal Junction Region (GEJ) Cancer Biological: Ramucirumab Biological: Nivolumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase 1/2 Study of Ramucirumab Plus Nivolumab as Second-line Therapy in Participants With Gastric or GEJ Cancer
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: LY3009806
Biological: Nivolumab
Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.
Other Name: 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 Name: LY3009806
Biological: Nivolumab
Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.
Other Name: ONO-4538



Primary Outcome Measures :
  1. 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)

  2. Progression free survival rate after 6 months [ Time Frame: from baseline to 6 months ]
    Progression free survival rate after 6 months


Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: from baseline to date of treatment cessation, approximately 24 months ]
    Number of participants with adverse events

  2. 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)

  3. 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)

  4. Overall survival (OS) [ Time Frame: from baseline to date of death, approximately 24 months ]
    Overall survival (OS)

  5. Progression free survival (PFS) [ Time Frame: from baseline to date of disease progression or death, approximately 24 months ]
    Progression free survival (PFS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999295


Contacts
Contact: Hirokazu Shoji +81-3-3542-3815 hshouji@ncc.go.jp
Contact: Tatsushi Goto +81-6-6358-7004 gotou@fiverings.co.jp

Locations
Japan
National Cancer Center Hospital Recruiting
Tokyo, Japan
Contact: Ken Kato, M.D./Ph.D         
Sponsors and Collaborators
National Cancer Center, Japan
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

Responsible Party: Ken Kato, Head Physician, National Cancer Center, Japan
ClinicalTrials.gov Identifier: NCT02999295     History of Changes
Other Study ID Numbers: NCCH-1611
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Nivolumab
Ramucirumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs