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New combo tackles tough pancreatic cancer

NCT ID NCT02077881

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an experimental immunotherapy called indoximod added to standard chemotherapy (gemcitabine and nab-paclitaxel) in 157 people with metastatic pancreatic cancer. The goal was to find a safe dose and see if the combination helps people live longer. The trial has completed, and results will show whether adding indoximod improves outcomes.

What this could mean

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

Active substance
Indoximod (an experimental immunotherapy) plus gemcitabine and nab-paclitaxel (standard chemotherapy)
What this could lead to
If successful, this combination could improve survival for people with metastatic pancreatic cancer, a disease with very few treatment options.
What could go wrong
This is an early-phase trial, so the added benefit over standard chemo alone is uncertain. The immunotherapy may also increase side effects like fatigue or immune reactions.

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

157 people

The number who actually took part.

Started

Aug 2014

Finished

Oct 2018

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: * Patient has definitive histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. Patients with islet cell or neuroendocrine neoplasms are excluded. * Initial diagnosis of metastatic disease must have occurred ≤8 weeks prior to entry in the study. * Patient has one or more metastatic tumors measurable per RECIST 1.1 by CT scan ≤4 weeks prior to entry into the study * Male or non-pregnant and non-lactating female, and ≥18 years of age. * Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. * Prior treatment with gemcitabine and/or nab-paclitaxel in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. * Patients cannot have received any other immunomodulatory therapies (including vaccines) as treatment for this or any other cancer. * Patient has a Karnofsky performance status (KPS) ≥ 70. * Patients should be asymptomatic for jaundice prior to Day 1. Exclusion Criteria: * Patients may not be receiving (or received prior to enrollment) any other investigational agents for metastatic disease. * Patient has known brain metastases, * Patient has only locally advanced disease. * Lymph node only metastases even if considered M1 disease by official staging criteria. * History of malignancy in the last 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 3 years. * Patients with any active autoimmune disease * Patient has undergone major surgery, other than diagnostic surgery (ie, surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma malignant pancreatic neoplasm neoplasm Neoplasm Metastasis pancreatic adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

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

Metastatic pancreatic adenocarcinoma Metastatic pancreatic cancer

Contacts and locations

Locations

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Gibbs Cancer Center and Research Institute

    Spartanburg, South Carolina, 29303, United States

  • Greenville Health Systems

    Greenville, South Carolina, 29605, United States

  • Huntsman Cancer Center

    Salt Lake City, Utah, 84112, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • The Vally Hospital

    Paramus, New Jersey, 07652, United States

  • The West Clinic

    Memphis, Tennessee, 38120, United States

  • University of Kentucy

    Lexington, Kentucky, 40536, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63110, United States

More trials for these conditions

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