Dual PD-1 and JAK2 Inhibition in Hematological Malignancies

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT04016116
Phase
PHASE2
Status
Withdrawn

Conditions

  • Cancer
  • Hematological Malignancy

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab IV every 3 weeks
  • Ruxolitinib — DRUG
    Ruxolitinib po days 1-21

Study Details

Pembrolizumab will have significant clinical activity in patients with Intermediate and high risk MF, advanced PV who have been resistant, failed or are intolerant to JAK2 inhibitor therapy and the activity may be enhanced in combination with JAK2 inhibition by Ruxolitinib; similarly MDS/MPN and CMML patients for who no standard therapies are available will exhibit responses to PD-1 or dual JAK2 and PD-1 treatment. Adding JAK2 inhibitor Ruxolitinib to Pembrolizumab will have significant activity in patients with advanced, progressive HL who failed single agent PD-1 inhibition.

Key Dates

Start date
Dec 31, 2019
Status verified
May 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab (Cohort 1)
    Pembrolizumab IV every 3 weeks (Cohort 1: Advanced progressive MPNs)
  • Experimental: Pembrolizumab + Ruxolitinib
    Pembrolizumab IV every 3 weeks \& Ruxolitinib po days 1-21 (Cohort 1: Advanced progressive MPNs)
  • Experimental: Pembrolizumab + Ruxolitinib (Cohort 2)
    Pembrolizumab IV every 3 weeks \& Ruxolitinib po days 1-21 (Cohort 2, unresponsive to PD-1)

Primary Outcome Measure

Progression Free Survival (PFS) measured using the Kaplan-Meier Method [ Time Frame: 6 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
New York University School of MedicineNew YorkNew York10016-

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New York University School of Medicine· New York, NY

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