Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Hackensack Meridian Health
Study ID
NCT02681302
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    1 mg/kg; 6 doses Weeks 1, 4, 7, 10, 16, 22
  • Nivolumab — DRUG
    3 mg/kg; 12 doses Weeks 1, 4, 7, 10, 12, 14, 16, 18, 20, 22, 24, 26

Study Details

The goal of this study is to determine the safety and clinical effect of combined checkpoint inhibition administered after autologous hematopoietic stem cell transplantation in each of six clinical cohorts of high risk and recurrent disease. In addition to assessing the incidence and severity of adverse events and rates of complete response and progression free survival, investigators intend to monitor immune reconstitution, phenotype and TCR repertoire throughout treatment and at the time of disease progression. Investigators will also analyze the gut microbiome prior to conditioning, throughout treatment, post-transplant and at time of relapse.

Key Dates

Start date
Jun 7, 2016
Status verified
Mar 2026
Primary completion
May 10, 2024
Completion
May 10, 2024

Study Design

Enrollment
46 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All Participants
    * Ipilimumab 1 mg/kg; 6 doses Weeks 1, 4, 7, 10, 16, 22 * Nivolumab 3 mg/kg; 12 doses Weeks 1, 4, 7, 10, 12, 14, 16, 18, 20, 22, 24, 26

Primary Outcome Measure

Safety of Combined Check Point Inhibition Therapy Via Assessment of Adverse Events and Lab Findings [ Time Frame: 26 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Hackensack University medical CenterHackensackNew Jersey07601-

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