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New cocktail of drugs takes on tough pancreatic cancer

NCT ID NCT04999969

Disease control Sponsor: AstraZeneca 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This phase II trial is testing a combination of two experimental drugs (AZD0171 and durvalumab) plus standard chemotherapy in 126 people with advanced pancreatic cancer. The goal is to see if the combo is safe and helps patients live longer. Participants must have metastatic disease and provide tumor samples for analysis.

What this could mean

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

Active substance
AZD0171, durvalumab, gemcitabine, and nab-paclitaxel
What this could lead to
If successful, this combination could offer a new treatment option for advanced pancreatic cancer, potentially improving survival rates.
What could go wrong
This is an early phase II trial with only 126 participants, so results may not apply to all patients. The combination may cause significant side effects, and it is not yet known if it works better than standard care alone.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

126 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Nov 2026

An estimate. End dates often move.

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 to 130 years

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: * Eastern Cooperative Oncology Group performance status of 0 or 1 at screening/enrolment * Must have a Gustave Roussy Immune Score of 0 or 1 * Participants diagnosed with histologically confirmed metastatic pancreatic adenocarcinoma * Participants must have at least 1 measurable lesion to be called a target lesion according to RECIST v1.1 * All participants must consent to providing sufficient archival specimen taken during metastatic stage or fresh tumour specimens for tumoural CD8+ T cell testing for enrolment * Presence of tumoural CD8+ T cells based on a predetermined benchmarked PDAC external sample * Normal organ and bone marrow function measured within 28 days prior to first dose of study intervention * Body weight ≥ 35 kg Exclusion Criteria: * Symptomatic central nervous system metastasis or any history of leptomeningeal disease or cord compression * A participant with an already known sensitising mutation or tumour characteristic for pancreatic cancer for which there is a preferred local standard-of-care treatment * History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention * Any unresolved toxicities ≥ Grade 2 per Common Terminology Criteria for Adverse Events v5.0 from prior therapy (excluding vitiligo, alopecia, controlled diabetes) * History of solid organ transplantation * History of active primary immunodeficiency * Ongoing or an active infection, including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. A negative COVID-19 PCR test taken within 28 days of the start of the study treatment is required. * Uncontrolled intercurrent illness * Participants with prior history of myocardial infarction, transient ischemic attack, coronary bypass, or stroke within the past 3 months prior to the first dose of study intervention * Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms * Active or prior documented autoimmune or inflammatory disorders * History of another primary malignancy * Receipt of any conventional or investigational anticancer therapy prior to the scheduled first dose of study intervention * Prior receipt of any immune-mediated therapy * Use of immunosuppressive medication within 14 days prior to the first dose of study intervention * Receipt of live, attenuated vaccine within 28 days prior to the first dose of study intervention (Participants can receive non-live COVID-19 vaccines, at the discretion of the Investigator)

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Conditions

The condition(s) this trial relates to.

pancreatic adenocarcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

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

Locally advanced or metastatic solid tumours

Contacts and locations

Locations

  • Research Site

    La Jolla, California, 92037, United States

  • Research Site

    Los Angeles, California, 90025, United States

  • Research Site

    Orange, California, 92868, United States

  • Research Site

    Ventura, California, 93003, United States

  • Research Site

    Atlanta, Georgia, 30318, United States

  • Research Site

    Coeur d'Alene, Idaho, 83814, United States

  • Research Site

    Boston, Massachusetts, 02114, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Grand Rapids, Michigan, 49503, United States

  • Research Site

    Buffalo, New York, 14263, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    Portland, Oregon, 97239, United States

  • Research Site

    San Antonio, Texas, 78229, United States

  • Research Site

    Charlottesville, Virginia, 22908, United States

  • Research Site

    Seattle, Washington, 98195, United States

  • Research Site

    Madison, Wisconsin, 53792, United States

  • Research Site

    Barrie, Ontario, L4M 6M2, Canada

  • Research Site

    Toronto, Ontario, M4N 3M5, Canada

  • Research Site

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    Seongnam-si, 13620, South Korea

  • Research Site

    Seongnam-si, 463-712, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Badalona, 08916, Spain

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    Madrid, 28027, Spain

  • Research Site

    Madrid, 28034, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Madrid, 28050, Spain

  • Research Site

    Majadahonda, 28222, Spain

  • Research Site

    Pamplona, 31008, Spain

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