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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02999295
• Other study ID #: NCCH-1611
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2017
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: National Cancer Center, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 2019
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastroesophageal Junction Region (GEJ) Cancer
• Stomach Neoplasms

Intervention

Biological:
• Ramucirumab
Ramucirumab (8 mg/kg) is administered.
• Nivolumab
Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Tokyo

Sponsors (3)

Lead Sponsor	Collaborator
National Cancer Center, Japan	Fiverings Co., Ltd., Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with dose limiting toxicities (DLTs)	Number of participants with dose limiting toxicities (DLTs)	Phase 1, course 1 (up to 28 days)
Primary	Progression free survival rate after 6 months	Progression free survival rate after 6 months	from baseline to 6 months
Secondary	Number of participants with adverse events	Number of participants with adverse events	from baseline to date of treatment cessation, approximately 24 months
Secondary	Objective response rate (ORR)	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
Secondary	Disease control rate (DCR)	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
Secondary	Overall survival (OS)	Overall survival (OS)	from baseline to date of death, approximately 24 months
Secondary	Progression free survival (PFS)	Progression free survival (PFS)	from baseline to date of disease progression or death, approximately 24 months