Nivolumab + Chemotherapy for Acute Myeloid Leukemia

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Autoimmune disease, Transplantation history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies the side effects of nivolumab in combination with decitabine and venetoclax and to see how well they work in treating patients with TP53-mutated acute myeloid leukemia. 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. Drugs used in chemotherapy, such as decitabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study is being done to find out whether giving nivolumab, decitabine, and venetoclax is better or worse than the usual approach for TP53-mutated acute myeloid leukemia.

Who Is on the Research Team?

Alice Mims

Principal Investigator

Ohio State University Comprehensive Cancer Center LAO

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed, untreated acute myeloid leukemia (AML) that has a TP53 mutation. Participants must have good organ function, controlled infection if present, no severe concurrent illness or psychiatric conditions, and agree to use contraception. Prior hypomethylating therapy for MDS is allowed.

Inclusion Criteria

My white blood cell count is less than or equal to 25,000.

I have been diagnosed with acute myeloid leukemia through tissue or cell analysis.

My kidney function, measured by GFR, is above 40 mL/min.

Exclusion Criteria

My leukemia affects my central nervous system only.

Patients with uncontrolled intercurrent illness

Patients with history of prior allogeneic transplantation. This is due to this being a pilot study with a limited number of patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Patients receive nivolumab, decitabine, and venetoclax for up to 3 cycles

12 weeks

Multiple visits for IV administration and monitoring

Maintenance

Patients achieving CR or CRi continue treatment with nivolumab, decitabine, and venetoclax

Ongoing every 28 days

Regular visits for IV administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Decitabine
• Nivolumab
• Venetoclax

Trial Overview The study tests the effectiveness and side effects of combining nivolumab (an immunotherapy drug), decitabine, and venetoclax in treating AML with TP53 mutations. It aims to see if this combination works better than standard treatments.

How Is the Trial Designed?

Group I: Treatment (nivolumab, decitabine, venetoclax) Experimental Treatment 3 Interventions

INDUCTION: Patients receive nivolumab IV over 30 minutes on day 15 of cycle 1 and days 1 and 15 of subsequent cycles, decitabine IV over 60 minutes on days 1-10 of induction cycle 1 (and cycles 2 and 3 if needed), and venetoclax PO QD on days 1-21. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients who achieve a CR or CRi receive nivolumab IV over 30 minutes on days 1 and 15, decitabine IV over 60 minutes on days 1-5, and venetoclax PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Decitabine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dacogen for:

• Acute myeloid leukemia
• Myelodysplastic syndromes

Approved in United States as Dacogen for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Approved in Canada as Dacogen for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Approved in Japan as Dacogen for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+