Nivolumab and Tocilizumab for Relapsed Hematological Malignancy Post-allogeneic Transplant

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT03588936
Phase
PHASE1
Status
Terminated

Conditions

  • Acute Leukemia
  • Chronic Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes

Eligibility Criteria

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

Interventions

  • Nivolumab (.25 mg/kg) — DRUG
    Participants will receive Nivolumab at one of two dose levels every 2 weeks for 4 treatments.
  • Tocilizumab — DRUG
    Participants will receive 2 doses of tocilizumab
  • Nivolumab (.5 mg/kg) — DRUG
    Participants will receive Nivolumab at one of two dose levels every 2 weeks for 4 treatments.

Study Details

This is a phase 1, interventional single arm, open label, treatment study designed to evaluate the safety combination programmed cell death protein 1 (PD-1) and interleukin 6 (IL-6) inhibition in participants with relapsed disease post-allogeneic transplant.

Key Dates

Start date
Sep 14, 2018
Status verified
Oct 2021
Primary completion
Jul 15, 2020
Completion
Jul 15, 2020

Study Design

Enrollment
2 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab (0.25 mg/kg) and Tocilizumab
    Participant will receive tocilizumab 8 mg/kg IV (max dose 800 mg) on Day 0. On Day 1 participants will receive nivolumab IV (0.25 mg/kg based on dose escalation design). Nivolumab will be given every \~2 weeks for up to 4 doses and a second dose of Tocilizumab will be given on \~Day 29 on the same day as Dose # 3 of Nivolumab.
  • Experimental: Nivolumab (0.5 mg/kg) and Tocilizumab
    Participant will receive tocilizumab 8 mg/kg IV (max dose 800 mg) on Day 0. On Day 1 participants will receive nivolumab IV (0.5 mg/kg based on dose escalation design). Nivolumab will be given every \~2 weeks for up to 4 doses and a second dose of Tocilizumab will be given on \~Day 29 on the same day as Dose # 3 of Nivolumab.

Primary Outcome Measure

Maximum-tolerated Dose [ Time Frame: Up to 4 weeks after last dose of study treatment (approximately 3 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226-

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By research site
Froedtert Hospital and the Medical College of Wisconsin· Milwaukee, WI

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