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Could an immune-boosting pill make melanoma treatments work better?

NCT ID NCT02073123

Disease control Sponsor: NewLink Genetics Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called indoximod, taken as a pill, together with standard immune checkpoint inhibitors (ipilimumab or pembrolizumab) in 131 adults with advanced or metastatic melanoma that could not be removed by surgery. The goal was to see if the combination was safe and improved tumor shrinkage. The trial has been completed, and results may help design future treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Indoximod (a drug that may boost the immune system against cancer)
What this could lead to
If successful, this combination could improve response rates and survival for people with advanced melanoma that cannot be surgically removed.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply broadly. The combination may cause significant side effects or fail to improve outcomes over existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

131 people

The number who actually took part.

Started

Jul 2014

Finished

Jul 2019

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic melanoma Stage III melanoma Stage IV melanoma

Contacts and locations

Locations

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • New Mexico Cancer Center Alliance

    Albuquerque, New Mexico, 87106, United States

  • Penn State Hershey Cancer Institue

    Hershey, Pennsylvania, 17033, United States

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.