Pembrolizumab + Azacitidine + Venetoclax for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+33 other locations

Overseen by Amer M. Zeidan

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well azacitidine and venetoclax with or without pembrolizumab work in treating older patients with newly diagnosed acute myeloid leukemia. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving azacitidine and venetoclax with pembrolizumab may increase the rate of deeper/better responses and reduce the chance of the leukemia coming back in patients with newly diagnosed acute myeloid leukemia compared to conventional therapy of azacitidine and venetoclax alone.

Research Team

Amer M. Zeidan

Principal Investigator

Yale University Cancer Center LAO

Eligibility Criteria

This trial is for patients aged 60 or older with newly diagnosed acute myeloid leukemia who are unfit for intensive chemotherapy. They should have an ECOG performance status of 0-3, specific risk profiles of AML, and adequate organ function. Pregnant women, those unwilling to use contraception, and individuals with certain medical conditions or prior treatments are excluded.

Inclusion Criteria

My AML is not considered low risk, except for a good-risk cytogenetic profile.

Bone marrow biopsy, aspirate or peripheral blood obtained up to 3 weeks before signing consent allowed for confirming AML diagnosis

Willingness to use adequate contraception for female and male patients with partners of childbearing potential

Exclusion Criteria

I don't have any health issues that could affect the trial's results or my participation.

You have a mental illness or social situation that might make it difficult for you to follow the study guidelines.

I have or had lung inflammation treated with steroids.

Treatment Details

Interventions

• Azacitidine (Anti-metabolite)
• Pembrolizumab (PD-1 Inhibitor)
• Venetoclax (BCL-2 Inhibitor)

Trial Overview The study tests azacitidine and venetoclax combined with pembrolizumab (an immunotherapy drug) against the same chemotherapy drugs without pembrolizumab. The goal is to see if adding pembrolizumab improves treatment outcomes in these patients by helping the immune system fight cancer more effectively.

Participant Groups

Group I: Arm II (AZA, VEN, pembrolizumab) Experimental Treatment 9 Interventions

See Detailed Description

Group II: Arm I (AZA, VEN) Active Control 8 Interventions

See Detailed Description

Azacitidine is already approved in Canada, Japan for the following indications:

Approved in Canada as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Approved in Japan as Vidaza 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+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School