A Phase II 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

NCT04044209 Phase 2 WITHDRAWN

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).

Details

Lead sponsor	Yale University
Phase	Phase 2
Status	WITHDRAWN
Start date	2020-02-12
Completion	2023-09

Conditions

• Myelodysplastic Syndromes
• Acute Myeloid Leukemia

Interventions

• AG-120
• Nivolumab

Primary outcomes

• Overall response rate — 168 days
  1\) Overall response rate (ORR) of 60%, i.e., a 20% ORR improvement (historical control ORR = 40% with Ivosidenib\[AG-120\] monotherapy after 2 lines of therapy20) after 6 cycles of treatment based on MDS International Working Group 2006 criteria and AML MDS International Working group MDS/AML criteria33, 34Cumulative ORR will include complete remission (CR), morphologic complete remission with incomplete blood count recovery (CRi), CR with incomplete platelet recovery (CRp) and Partial response (PR).
• Change in duration of response — 12 months
  2\) In the patients who respond, Improvement in duration of response to 12 months (compared to single agent ivosidenib \[AG-120\] 8.2 months with ivosidenib \[AG-120\] monotherapy)

Countries

United States