Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

Part of paid clinical trials in Detroit, Michigan.

Sponsor
University of Utah
Study ID
NCT05723055
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Axatilimab — DRUG
    Axatilimab (SNDX-6352) is a humanized IgG4 monoclonal antibody (mAb) with high affinity against colony stimulating factor-1 receptor (CSF-1R).
  • Nivolumab — DRUG
    Nivolumab is a programmed death receptor-1 (PD-1)-blocking antibody

Study Details

The goal of this clinical trial is to study the combination of nivolumab and axatilimab in patients with relapsed/refractory classical Hodgkin Lymphoma. This study will mainly look at if the combination works as expected.

Key Dates

Start date
May 3, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Nov 30, 2028

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment: All Patients
    Nivolumab 480 mg IV Q4 weeks Axatilimab (SNDX 6532) dose (3mg/kg IV) Q4 weeks. If DLT criteria are met, Axatilimab dosing will be reduced to 2mg/kg IV Q4W for the remainder of patients on the study. The combination will be continued until progression/toxicity up to a maximum of 12 cycles.

Primary Outcome Measure

Objective response rate (ORR) as measured by Best Overall Response Rate (BOR) measured by the proportion of subjects achieving a confirmed PR and CR as defined by Lugano Criteria [ Time Frame: At the end of 6 cycles of Treatment. Each cycle is 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Karmanos Cancer InstituteDetroitMichigan48201-
Huntsman Cancer Institute at the University of UtahSalt Lake CityUtah84112-

Find similar trials in Detroit, MI

By research site
Karmanos Cancer Institute· Detroit, MIHuntsman Cancer Institute at the University of Utah· Salt Lake City, UT

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