Phase 2
N=9
Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma
Metastatic Melanoma · Stage III Melanoma · Stage IV Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT02073123 ↗Enrolled (actual)
9
Serious AEs
35.1%
Results posted
May 2026
Primary outcome: Primary: Phase 1 Regimen Limiting Toxicity of the Combination of Indoximod and Ipilimumab — 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Indoximod (Drug); Ipilimumab (Drug); Nivolumab (Drug); Pembrolizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NewLink Genetics Corporation
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1 Regimen Limiting Toxicity of the Combination of Indoximod and Ipilimumab |
0; 1 | — |
| PRIMARY Overall Response Rate |
0; 0; 18; 0; 1; 29 | — |
| SECONDARY Overall Survival |
29.8; 94.65; NA | — |
| SECONDARY Progression Free Survival |
13.55; 17.8; 43.9 | — |
| SECONDARY Disease Control Rate |
1; 2; 68 | — |
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
Eligibility Criteria
Inclusion Criteria
- Unresectable Stage III or Stage IV melanoma.
- Patients must have measurable disease, defined as lesions that can be accurately measure in in 2 perpendicular diameters with at least one diameter > 20mm and the other >10mm on conventional CT or MRI or 10mm x 10 mm by spiral CT.
- No systemic treatment in the previous 28 days.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of ipilimumab or indoximod in patients <18 years of age, children are excluded from this study.
- ECOG performance status ≤2 (Karnofsky ≥60% )
- Patients with known brain metastases will only be eligible after their tumors have been treated with definitive resection and/or radiotherapy and they are neurologically stable for at least 1 month off steroids.
Exclusion Criteria
- Patients who have had molecular targeted therapy (including vemurafenib) or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients who have had prior therapy with immune checkpoint inhibition or or indoximod are excluded from the trial.
- Any other cancer, unless the patient has been disease-free for ≥5 years
- Patients with laboratory evidence of pancreatitis are excluded.
- Patients with autoimmune disease
- Chronic use of immune-suppressive drugs (ie, systemic corticosteroids used in the management of cancer or non-cancer related illnesses, eg, COPD).
Data sourced from ClinicalTrials.gov (NCT02073123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.