Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients

Sponsor
Osaka University
Study ID
NCT02946671
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Mogamulizumab — BIOLOGICAL
    Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered.
  • Nivolumab — BIOLOGICAL
    Nivolumab (3.0 mg/kg) is administered.

Study Details

To assess the safety of preoperative combination therapy with KW-0761 (anti-CCR4) and ONO-4538 (anti-PD-1). To assess the behavior of immune cells in peripheral blood and tumor.

Key Dates

Start date
Mar 31, 2016
Status verified
Mar 2020
Primary completion
Mar 31, 2020
Completion
Mar 31, 2020

Study Design

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

Arms

  • Experimental: Cohort 1
    KW-0761 (Mogamulizumab): 0.1 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
  • Experimental: Cohort 2
    KW-0761 (Mogamulizumab): 0.3 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
  • Experimental: Cohort 3
    KW-0761 (Mogamulizumab): 1.0 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times

Primary Outcome Measure

Number of patients with adverse events including intraoperative and postoperative complications [ Time Frame: from first administration to 60 days after the final administration or to 30 days after the standard operation ]

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