AzTrials
AzTrials

Metastatic Pancreatic AdenocarcinomaPhase 1/2NCT02077881

Study of IDO Inhibitor in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer

A Phase 1/2 study testing Nab-Paclitaxel, Gemcitabine and Indoximod in people with Metastatic Pancreatic Adenocarcinoma and Metastatic Pancreatic Cancer, run by NewLink Genetics Corporation at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase I/II trial is designed to efficiently identify the regimen limiting toxicity (RLT) and recommended phase 2 dose (RP2D) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nab-Paclitaxel, Gemcitabine and Indoximod
Could I receive a placebo?
No, everyone receives an active treatment
How many people
157 participants
Where
11 sitesUnited States
Study dates
Aug 2014to 17 Oct 2018
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Augusta University

    Augusta, Georgia, 30912

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Greenville Health Systems

    Greenville, South Carolina, 29605

  • University of Kentucy

    Lexington, Kentucky, 40536

  • The West Clinic

    Memphis, Tennessee, 38120

  • Stanford University

    Palo Alto, California, 94304

  • The Vally Hospital

    Paramus, New Jersey, 07652

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Huntsman Cancer Center

    Salt Lake City, Utah, 84112

  • Gibbs Cancer Center and Research Institute

    Spartanburg, South Carolina, 29303

  • Washington University in St. Louis

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase I/II Study of Indoximod in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Adenocarcinoma of the Pancreas

This phase I/II trial is designed to efficiently identify the regimen limiting toxicity (RLT) and recommended phase 2 dose (RP2D) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. All subjects will receive the same standard gemcitabine plus nab-paclitaxel regimen, plus indoximod in doses increasing from 600 mg twice daily to, potentially, 1200 mg twice daily.

Read the detailed description

This is a Phase I/II trial designed to evaluate the combination of the immunotherapeutic agent indoximod and the standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. The phase 1 portion is designed to identify the regimen-limiting toxicity (RLT) and recommended phase 2 dose (RP2D) for the combination. The phase 2 portion of the study will evaluate the potential efficacy of this combination. All subjects will receive the standard 28-day gemcitabine plus nab-paclitaxel regimen. Twice daily oral indoximod will be administered concurrently in continuous 28 day cycles.

In the phase 1 portion, dose escalation of indoximod will begin at 600 mg twice a day and potentially escalate to 1200 mg twice a day. There will be no intra-subject dose escalation. Regimen-limiting toxicity will be considered as those toxicities related to indoximod that significantly limit the administration of the backbone chemotherapy gemcitabine plus nab-paclitaxel. The period for determination of dose-limiting toxicities will be the initial 28 days of treatment. The recommended phase 2 dose will include an assessment of toxicities that occur at later time points.

Once a RP2D is determined, the phase 2 portion of the study will be initiated. In both phase 1 and phase 2, every 2 cycles subjects will have repeat imaging to assess response. Corollary biomarkers will be assessed at the same interval as will PET-CT after the 1st 8 week cycle. Up to 18 patients will be enrolled in the phase 1 portion of the study and 80 patients will be enrolled in the phase 2 portion.

Being tested
Nab-Paclitaxel, Gemcitabine, Indoximod
Keywords
metastatic, metastasis, Pancreatic, Pancreas, Cancer, adenocarcinoma
Medical subject headings
Pancreatic Neoplasms, Neoplasm Metastasis, Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nab-PaclitaxelDrug

    Also called Abraxane, Paclitaxel

    Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.

  • IndoximodDrug

    Also called 1-methyl-D-tryptophan, D-1MT

    Indoximod administered BID by mouth in the form of 200 mg capsules. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity.

Study groups in NCT02077881
Study groupRoleWhat they receive
Indoximod and Gemcitabine + Nab-paclitaxel - Phase 1ExperimentalParticipants received indoximod (600mg, 100mg, or 1200mg according to their assigned dose cohort) PO BID for 28 days concurrently with IV Nab-paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 weekly for 3 weeks with one week rest. Each cycle is 28 days. Patients will continue until they experience disease progression or significant toxicity.
Receives: Drug: Nab-Paclitaxel; Drug: Gemcitabine; Drug: Indoximod
Indoximod and Gemcitabine + Nab-paclitaxel - Phase 2ExperimentalOral indoximod 1200mg BID concurrent with the first backbone chemotherapy cycle. Patients will receive gemcitabine plus nab-paclitaxel on a standard 4 week cycle schedule. Oral indoximod at 1200mg BID will continue throughout.
Receives: Drug: Nab-Paclitaxel; Drug: Gemcitabine; Drug: Indoximod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Regimen Limiting Toxicity

    Phase 1 component:

    To identify the regimen limiting toxicity (RLT) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas.

    RLT will be considered as only grade 3 and 4 toxicities that are attributable to the test agent and result in the delay of the administration of the backbone chemotherapy, gemcitabine plus nab-paclitaxel.

    Measured: 10 months

  2. Overall Survival

    Phase 2 component:

    To evaluate efficacy as determined by overall survival (OS) in patients with metastatic adenocarcinoma of the pancreas.

    Measured: 22 months

Secondary outcomes (2)

  1. Response Rate

    To determine the response rate of the combination indoximod with gemcitabine plus nab-paclitaxel. Imaging assessments to be performed at protocol-specified time points and evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).

    Measured: 22 months

  2. Progression Free Survival

    Time to progression with the combination indoximod with gemcitabine plus nab-paclitaxel. Progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).

    Measured: 22 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2014 (estimated)
  2. Study startAug 2014
  3. Primary completion17 Jan 2018
  4. Study completion17 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
157 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02077881
Sponsor's protocol ID
NLG2104
Status last verified
Mar 2026
First submitted
28 Feb 2014
Last updated
3 Apr 2026
Data monitoring committee
Yes

Publications

  • Beatty GL, Delman D, Yu J, Liu M, Li JH, Zhang L, Lee JW, Chang RB, Bahary N, Kennedy EP, Wang-Gillam A, Rossi GR, Garrido-Laguna I. Treatment Response in First-Line Metastatic Pancreatic Ductal Adenocarcinoma Is Stratified By a Composite Index of Tumor Proliferation and CD8 T-Cell Infiltration. Clin Cancer Res. 2023 Sep 1;29(17):3514-3525. doi: 10.1158/1078-0432.CCR-23-0535.

    PubMed 37534996

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nab-Paclitaxel, Gemcitabine and Indoximod in people with Metastatic Pancreatic Adenocarcinoma and Metastatic Pancreatic Cancer, run by NewLink Genetics Corporation at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Regimen Limiting Toxicity (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02077881, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in