Clinical Trials /

Nivolumab in AML in Remission at High Risk for Relapse

NCT02532231

Description:

This phase II trial studies how well nivolumab works in treating patients with acute myeloid leukemia that has decreased or disappeared but may still be in the body (remission), and is at high risk for returning (relapse). 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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Nivolumab in Acute Myeloid Leukemia (AML) in Remission at High Risk for Relapse
  • Official Title: PD-1 Inhibition With Nivolumab for the Treatment of Patients With Acute Myeloid Leukemia in Remission at High Risk for Relapse

Clinical Trial IDs

  • ORG STUDY ID: 2015-0213
  • SECONDARY ID: NCI-2015-01522
  • NCT ID: NCT02532231

Conditions

  • Leukemia
  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
NivolumabBMS-936558, OpdivoNivolumab

Purpose

The goal of this clinical research study is to learn if opdivo (nivolumab) can help to control AML. The safety of nivolumab will also be studied. This is an investigational study. Nivolumab is FDA approved and commercially available for the treatment of melanoma. It is considered investigational to use nivolumab to treat AML. The study doctor can explain how the study drug is designed to work. Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.

Detailed Description

      Study Drug Administration:

      Each study cycle is 28 days.

      If you are found to be eligible to take part in this study, you will receive nivolumab by
      vein over about 1 hour on Days 1 and 15 of each cycle. After Cycle 6, you may receive
      nivolumab 1 time each month. After you have been on study for about 1 year, you may receive
      the study drug 1 time every 3 months. If during this time, the disease appears to get worse,
      you may go back to receiving the study drug on Days 1 and 15 of each cycle. The study doctor
      will discuss this with you.

      On Day 1 of Cycle 1, you will stay in the clinic for up to 2 hours after the end of your
      infusion so the study staff can check on your health. After that, you will stay in the clinic
      for about 1 hour after the end of your infusion.

      Study Visits:

      On Days 1 and 15 of Cycle 1, one time during Cycles 2 and 3, and then every 8-12 weeks after
      that until Cycle 6, you will have a physical exam. If you continue therapy after Cycle 6, you
      will have a physical exam every 2-3 months.

      One (1) time each week during Cycle 1, every 2 weeks during Cycles 2 and 3, and then 1 time
      during each cycle after that, blood (about 2-3 teaspoons) will be drawn for routine tests.
      These tests may be done more often if your doctor thinks it is needed.

      On Day 28 of Cycles 1, 3, and 5 and then one time every 3 months after that, you will have a
      bone marrow aspiration to check the status of the disease and for cytogenetic testing.

      Length of Study:

      You may continue receiving the study drug for as long as the doctor thinks it is in your best
      interest. You will no longer be able to take the study drug if the disease gets worse, if
      intolerable side effects occur, or if you are unable to follow study directions.

      Your participation on this study will be over after you have completed the End-of-Treatment
      Visit.

      End-of-Treatment Visit:

      Within 30 days after your last dose of study drug:

        -  You will have a physical exam.

        -  Blood (about 2-3 teaspoons) will be drawn for routine tests.

        -  If it has not been done within the last 6 weeks and the doctor thinks it is possible,
           you will have a bone marrow aspirate to check the status of the disease and for
           cytogenetic testing.

      If you cannot come to the clinic for the End-of-Treatment visit, you will be called by the
      study staff and asked about your health. This call should last about 5-10 minutes.
    

Trial Arms

NameTypeDescriptionInterventions
NivolumabExperimentalParticipants receive Nivolumab 3 mg/kg by vein every 2 weeks for 6 cycles. One cycle defined as 4 weeks. Continuation beyond 6 cycles allowed for participants deriving benefit without unacceptable toxicity. The dose after 6 cycles may be modified to an every 4 weeks schedule until 12 months from start of therapy, then every 3 months until disease progression.
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with AML in remission (defined as CR, CR with incomplete platelet recovery
             -CRp-, CR with incomplete hematologic recovery -CRi-, or partial remission defined as
             a bone marrow with <10% blasts after therapy with or without hematologic recovery).

          2. High risk for relapse defined as: 1st CR with high risk features for relapse
             (including history of prior malignancy treated with chemotherapy or radiotherapy, or
             history of myelodysplastic syndrome, myeloproliferative disorder, chronic
             myelomonocytic leukemia, MDS/MPN or other hematologic malignancy thought to have
             evolved to AML [i.e., secondary AML, sAML]; high risk cytogenetics at diagnosis; FLT3
             mutated at diagnosis; or presence or minimal residual disease assessed by PCR,
             cytogenetics, and/or flow cytometry at time of enrollment) 2nd CR regardless of
             disease characteristics at the time of diagnosis.

          3. Have received induction chemotherapy and at least one cycle of consolidation
             chemotherapy. Patients should have achieved a CR within 12 months of enrollment onto
             protocol.

          4. No further chemotherapy or SCT planned at the time of enrollment.

          5. Age 18 years or older.

          6. Adequate organ function: creatinine </= 1.5 x ULN; serum bilirubin </= 1.5 x ULN; AST
             and ALT </= 2.5 x ULN.

          7. ECOG performance status </= 2

          8. Females of childbearing potential must have a negative serum or urine beta human
             chorionic gonadotrophin (b-hCG) pregnancy test result within 24 hours prior to the
             first dose of treatment and must agree to use an effective contraception method during
             the study and for 23 weeks after the last dose of the study drug. Females of non-
             childbearing potential are those who are postmenopausal greater than 1 year or who
             have had a bilateral tubal ligation or hysterectomy.

          9. Males who have partners of childbearing potential must agree to use an effective
             contraceptive method during the study and for 31 weeks following the last dose of
             study drug

         10. Patients or their legally authorized representative must provide written informed
             consent.

        Exclusion Criteria:

          1. History of another primary invasive malignancy that has not been definitively treated
             or in remission for at least 2 years. Patients with non-melanoma skin cancers or with
             carcinomas in situ are eligible regardless of the time from diagnosis (including
             concomitant diagnoses).

          2. Any major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy,
             experimental therapy within 2 weeks prior to the first dose of the study drugs.

          3. Patients with any other known concurrent severe and/or uncontrolled medical condition
             (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure
             NYHA Class III or IV, myocardial infarction within 6 months, and poorly controlled
             hypertension; chronic renal failure; or active uncontrolled infection) which, in the
             opinion of the investigator could compromise participation in the study.

          4. Patients unwilling or unable to comply with the protocol.

          5. Patients who are on steroids (> 10 mg/day or equivalent) or immune suppression
             medications.

          6. Patients with autoimmune diseases (e.g., rheumatoid arthritis, systemic progressive
             sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g.,
             Wegener's Granulomatosis]).

          7. Patients with a history of Inflammatory Bowel Disease such as Crohn's disease and
             ulcerative colitis.

          8. Patients known to be positive for hepatitis B surface antigen expression or with
             active hepatitis C infection (positive by polymerase chain reaction or on antiviral
             therapy for hepatitis C within the last 6 months), or with known HIV infection.

          9. Current therapy with other systemic anti-neoplastic or anti-neoplastic investigational
             agents.

         10. Females who are pregnant or lactating

         11. Patients with history of previous immunomodulatory therapy.(not including lenalidomide
             or thalidomide).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Recurrence-Free Survival (RFS)
Time Frame:6 months
Safety Issue:
Description:Status disease determined by bone marrow aspiration. Kaplan-Meier methodology used to compute the RFS rate.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Trial Keywords

  • Leukemia
  • Acute myeloid leukemia
  • AML
  • High risk for relapse
  • Nivolumab
  • BMS-936558
  • Opdivo

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