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

Sponsor
National Cancer Center, Japan
Study ID
NCT02999295
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ramucirumab — BIOLOGICAL
    Ramucirumab (8 mg/kg) is administered.
  • Nivolumab — BIOLOGICAL
    Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.

Study Details

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.

Key Dates

Start date
Jan 31, 2017
Status verified
Aug 2019
Primary completion
Nov 30, 2017
Completion
Aug 31, 2019

Study Design

Enrollment
46 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1
    Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks
  • Experimental: Phase 2
    Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks

Primary Outcome Measure

Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Phase 1, course 1 (up to 28 days) ]

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