Study: NCT02073123

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Indoximod
Description: 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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Indoximod
Description: 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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Indoximod
Description: 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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ipilimumab
Description: Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: Nivolumab administered intravenously at 240 mg every 2 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: Pembrolizumab administered intravenously at 2 mg/kg every three weeks.