Active — Not RecruitingPhase 2

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

United States9 participantsStarted 2023-05-03

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓-Hematologic:
✓---Subjects with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.
✓-Renal:
✓--Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and

Exclusion criteria

✕-Of note, the following are allowed:
✕-All immune-mediated adverse events related to prior cancer immunotherapy must be resolved per Investigator.
✕-Autoimmune hypothyroidism on stable dose of thyroid replacement, controlled Type 1 Diabetes Mellitus on insulin, history of disease-related ITP or AIHA, or remote history of or well-controlled autoimmune disease with treatment-free interval from immunosuppressive therapy for at least 12 months.
✕-Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the first dose of study treatment.
✕-Note: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.
✕-Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.

What they're measuring

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

Timeframe: At the end of 6 cycles of Treatment. Each cycle is 28 days

Trial details

NCT IDNCT05723055

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

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