CC-486 and Nivolumab for the Treatment of Hodgkin Lymphoma Refractory to PD-1 Therapy or Relapsed

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05162976
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Recurrent Classic Hodgkin Lymphoma
  • Refractory Classic Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Given IV
  • Oral Azacitidine — DRUG
    Given PO

Study Details

This phase I trial tests the safety and best dose of CC-486 (an oral form of azacitidine) when given together with nivolumab in treating patients with Hodgkin lymphoma that does not respond (refractory) to PD1-based immunotherapy or has come back (relapsed). CC-486 is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CC-486 in combination with nivolumab may render nivolumab more effective.

Key Dates

Start date
Jan 3, 2022
Status verified
Jun 2026
Primary completion
Apr 27, 2027
Completion
Apr 27, 2027

Study Design

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

Arms

  • Experimental: Treatment (CC-486, nivolumab)
    Patients receive azacitidine PO QD on days 1-7 and nivolumab IV over 30 minutes on day 8. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Dose-limiting toxicity [ Time Frame: Up to 28 days (1 cycle) ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-

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By research site
City of Hope Medical Center· Duarte, CA

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