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

NCT02999295 | Completed Phase 1

• 1 other identifier: NCCH-1611
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Gastroesophageal Junction Region (GEJ) Cancer

Outcome Measures

Primary Outcomes (2)

• Number of participants with dose limiting toxicities (DLTs)

  Number of participants with dose limiting toxicities (DLTs)

  Phase 1, course 1 (up to 28 days)

• Progression free survival rate after 6 months

  Progression free survival rate after 6 months

  from baseline to 6 months

Secondary Outcomes (5)

• Number of participants with adverse events

  from baseline to date of treatment cessation, approximately 24 months

• Objective response rate (ORR)

  from baseline to date of disease progression, approximately 24 months

• Disease control rate (DCR)

  from baseline to date of disease progression, 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

Study Arms (2)

Phase 1

EXPERIMENTAL

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

Biological: Ramucirumab; Biological: Nivolumab

Phase 2

EXPERIMENTAL

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

Biological: Ramucirumab; Biological: Nivolumab

Interventions

Ramucirumab BIOLOGICAL

Ramucirumab (8 mg/kg) is administered.

Also known as: LY3009806

Phase 1; Phase 2

Nivolumab BIOLOGICAL

Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.

Also known as: ONO-4538

Phase 1; Phase 2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Japan: lead
• Ono Pharmaceutical Co. Ltd: collaborator
• Fiverings Co., Ltd.: collaborator

Study Sites (1)

National Cancer Center Hospital

Tokyo, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasms

Interventions

Ramucirumab; Nivolumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ken Kato, M.D. / Ph.D.

  Department of Gastrointestinal Medical Oncology, National cancer center hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Physician

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 21, 2016
• Study Start: January 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: August 1, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

JP (1)