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

NCT05723055 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HCI152271
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

  evaluate the efficacy of combination of Axatilimab (SNDX-6352) and Nivolumab in the study population

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

Secondary Outcomes (6)

• The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.

  up to 15 months

• Progression-free survival (PFS) as defined as the time from study drug initiation to the time documented disease progression (as assessed by Lugano Criteria) or death from any cause.

  up to 3 years

• Overall survival (OS) as defined as the time from registration until death from any cause.

  up to 3 years

• Duration of response (DoR), defined as the interval of time from the date of initial documented response (PR or better per Lugano) to the time of progression from the best response, the start of a new therapy, or death from any cause.

  up to 3 years

• TTNT (time to next treatment), defined as the interval of time from date of study drug initiation to start of subsequent therapy

  up to 3 years

Study Arms (1)

Treatment: All Patients

EXPERIMENTAL

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.

Drug: Axatilimab; Drug: Nivolumab

Interventions

Axatilimab DRUG

Axatilimab (SNDX-6352) is a humanized IgG4 monoclonal antibody (mAb) with high affinity against colony stimulating factor-1 receptor (CSF-1R).

Also known as: SNDX6532

Treatment: All Patients

Nivolumab DRUG

Nivolumab is a programmed death receptor-1 (PD-1)-blocking antibody

Also known as: OPDIVO

Treatment: All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject aged ≥ 18 years.
• Histologically confirmed relapsed or refractory Classical Hodgkin Lymphoma who have progressed on or after at least one line of prior therapy and have had prior exposure to anti-PD-1/anti-PDL-L1 therapy
• Partial response or stable disease after at least 4 cycles of anti-PD-1/ anti-PDL-1 therapy such as, but not limited to, nivolumab, pembrolizumab, atezolizumab, tislelizumab, and durvalumab or progression on anti-PD-1/ anti-PDL-1 therapy such as, but not limited to, nivolumab, pembrolizumab, atezolizumab, tislelizumab, and durvalumab. (Notes: prior combination treatment with chemotherapy and an anti-PD-1/anti-PDL-1 therapy is acceptable.)
• Subject must have at least one measurable area of disease (greater than 1.5 cm longest transverse diameter (LDi) to allow for response assessment and biopsy) by Lugano Criteria
• Subjects with prior history of allogeneic or autologous stem cell transplant must have had at least 90 days since the transplant and must be off of immunosuppressive agents for Graft vs Host disease for at least 2 months.
• Subjects with a prior autologous transplant are eligible
• Transplant ineligible subjects are permitted on this study if they have had exposure to anti-PD(L)1 therapy as defined above.
• ECOG Performance Status ≤ 2.
• Adequate organ function, without the use of transfusions or growth factors within 7 days, as defined as:
• Hematologic:
• Platelet count ≥ 50,000/mm3 (unless bone marrow involved)
• Hemoglobin ≥ 8 g/dL (unless bone marrow involved)
• Absolute Neutrophil Count (ANC) ≥.5 × 10\^9/L unless bone marrow involvement from classical Hodgkin lymphoma
• Hepatic:
• Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN). Exceptions include patients with underlying Gilbert Syndrome in whom ≤ 3x institutional upper limit of normal (ULN) of Total Bilirubin will be allowed.

You may not qualify if:

• Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study drug.
• Of note, the following are allowed:
• The use of physiologic doses of corticosteroids (i.e., ≤10 mg per day of equivalent prednisone) is allowed.
• Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
• Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
• Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
• Previously treated with a CSF-1, CSF-1R, and/or IL-34-blocking agents.
• Subjects with toxicity from prior treatment that has not resolved to Grade ≤1, except grade 2 peripheral neuropathy, any grade alopecia/vitiligo, grade 3 rash, endocrinopathy managed with replacement therapy.
• History of Grade ≥3 immune-mediated adverse event attributed to prior immune checkpoint-inhibitor therapy; other than endocrinopathy managed with replacement therapy.
• All immune-mediated adverse events related to prior cancer immunotherapy must have resolved to baseline.
• History of autoimmune disease, including, but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, with the following exceptions:
• 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.
• History or current clinically significant pulmonary disease, such as obstructive pulmonary disease, bronchospasm, or non-infectious pneumonitis (drug-induced or autoimmune).
• Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter. Patients are allowed to be actively receiving anti-PD-1(anti-PD-L1) therapy at the time of enrollment but must stop agents other than Nivolumab prior to dosing with Nivolumab.
• Evidence of muscle disorders or muscle injury that are known to cause serum creatine kinase (CK) elevation

Sponsors & Collaborators

• University of Utah: lead
• Incyte Corporation: collaborator

Study Sites (2)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease

Interventions

axatilimab; Nivolumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Harsh Shah, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Kingsford

CONTACT

801-585-0115; rachel.kingsford@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 10, 2023
• Study Start: May 3, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)