Testing Nivolumab to Prevent Disease From Coming Back After Treatment in Patients With Acute Myeloid Leukemia, REMAIN Trial

Conditions

• Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow biopsy
• Clinical Observation — OTHER
  Undergo standard of care clinical observation
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Nivolumab — BIOLOGICAL
  Given IV

Study Details

This phase II trial studies how well nivolumab works in eliminating any remaining cancer cells and preventing cancer from returning in patients with acute myeloid leukemia that had a decrease in or disappearance of signs and symptoms of cancer after receiving chemotherapy. 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.

Key Dates

Start date

Jul 2, 2015

Status verified

Apr 2026

Primary completion

Jul 28, 2025

Completion

Oct 8, 2026

Study Design

Enrollment

82 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (nivolumab)
  Patients receive nivolumab IV over 60 minutes once every 2 weeks. Treatment repeats every 2 weeks for 46 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy at screening, months 3, 6, and 12, as clinically indicated, and during off-study evaluation. Patients also undergo collection of blood samples at screening, weeks 9, 13, 25, and 53, and during off-study evaluation or at time of clinically suspected relapse. Patients may undergo ECHO as clinically indicated.
• Active Comparator: Arm II (observation)
  Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I. Patients also undergo bone marrow biopsy at screening, months 3, 6, and 12, as clinically indicated, and during off-study evaluation. Patients also undergo collection of blood samples at screening, weeks 9, 13, 25, and 53, and during off-study evaluation or at time of clinically suspected relapse. Patients may undergo ECHO as clinically indicated.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Assessed up to 5 years ]

Locations (45)

Related coverage on Hipa.ai

• Nivolumab Shows Improved Overall Survival in Acute Myeloid Leukemia
  Nivolumab · Nov 6, 2025 · ClinicalTrials.gov

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