A Study of the IDH1 Inhibitor AG-120 in Combination With the Checkpoint Blockade Inhibitor, Nivolumab, for Patients With IDH1 Mutated Relapsed/Refractory AML and High Risk MDS

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04044209
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • AG-120 — DRUG
    The IDH1 inhibitor ivosidenib (AG-120) that will be administered orally on a continuous basis at the dose of 500 mg/day starting at day 1 of each cycle. A cycle will be defined as a 28-day period.
  • Nivolumab — DRUG
    On Cycle 2 day 1 the patient will receive nivolumab 480mg once. This will be repeated on Day 1 of every subsequent cycle.

Study Details

In this trial the investigators aim to evaluate safety and efficacy of combination Ivosidenib (AG-120) and nivolumab in the context of adult patients with Isocitrate dehydrogenase-1 (IDH1) mutated acute myeloid leukemias (AML) or Myelodysplastic syndromes (MDS).

Key Dates

Start date
Feb 12, 2020
Status verified
Jan 2022
Primary completion
Sep 30, 2021
Completion
Sep 30, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients receiving nivolumab and ivosidenib
    Patients who meet eligibility criteria will initiate therapy with the IDH1 inhibitor ivosidenib (AG-120) that will be administered orally on a continuous basis at the dose of 500 mg/day starting at day 1 of each cycle. A cycle will be defined as a 28-day period. On Cycle 2 day 1 the patient will receive nivolumab 480mg once. This will be repeated on Day 1 of every subsequent cycle. Patient will be treated until progression, transplant or unacceptable toxicity. The patient will be continually monitored on therapy and will undergo scheduled response assessments to evaluate response.

Primary Outcome Measure

Overall response rate [ Time Frame: 168 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06519-

Find similar trials in New Haven, CT

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Yale Cancer Center· New Haven, CT

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