Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 2019-07-03
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NewLink Genetics Corporation
• Treatments: Antibodies, Monoclonal; Ipilimumab; Nivolumab; Pembrolizumab; Tryptophan

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).