At a glance
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A Phase 1/2 Study of the Concomitant Administration of Indoximod Plus Immune Checkpoint Inhibitors for Adult Patients With Advanced or Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating Indoximod, Ipilimumab, and 2 other interventions for Metastatic Melanoma and 2 related conditions. Completed, enrolled 131 participants across 6 sites.
Detailed Summary
To evaluate the preliminary efficacy of the established dose of indoximod in combination with immune checkpoint inhibition as measured by the best overall response rate (ORR) (complete response (CR) + partial response (PR))across both standard of care agents administered sequentially in patients with unresectable stage III or stage IV melanoma
Study Details
Timeline
Interventions
Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth Dose escalation: * If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled * If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects * If \> 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease * If \>1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If \>1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
Nivolumab administered intravenously at 240 mg every 2 weeks.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.