Clinical trial NCT02999295: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer
Gastroesophageal Junction Region (GEJ) Cancer
Lead sponsor: National Cancer Center, Japan
Sponsor class: OTHER_GOV
Collaborators: name: Ono Pharmaceutical Co. Ltd
name: Fiverings Co., Ltd.
First posted: 2016-12-21
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants with dose limiting toxicities (DLTs)
timeFrame: Phase 1, course 1 (up to 28 days)
measure: Progression free survival rate after 6 months
timeFrame: from baseline to 6 months
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: from baseline to date of treatment cessation, approximately 24 months
measure: Objective response rate (ORR)
timeFrame: from baseline to date of disease progression, approximately 24 months
measure: Disease control rate (DCR)
timeFrame: from baseline to date of disease progression, approximately 24 months
measure: Overall survival (OS)
timeFrame: from baseline to date of death, approximately 24 months
measure: Progression free survival (PFS)
timeFrame: from baseline to date of disease progression or death, approximately 24 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
Study officials:
affiliation: Department of Gastrointestinal Medical Oncology, National cancer center hospital
name: Ken Kato, M.D. / Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: