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New drug combo aims to boost immune attack on Hard-to-Treat cancers

NCT ID NCT02671435

Disease control Sponsor: MedImmune LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two immunotherapy drugs, durvalumab and monalizumab, in about 383 adults with advanced solid tumors, including colorectal cancer. The goal is to see if the combination is safe and can shrink tumors. Some participants also receive standard chemotherapy or other targeted drugs. The trial is active but no longer recruiting new participants.

What this could mean

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

Active substance
durvalumab and monalizumab (immunotherapy drugs given by IV)
What this could lead to
If this combination works, it could offer a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is an early-phase trial, so the drugs may not shrink tumors or improve survival. Side effects from immune system activation can be serious.

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

383 people

The number who actually took part.

Started

Feb 2016

Expected to finish

Jul 2027

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 99 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: 1. Participants must have histologic documentation of advanced recurrent or metastatic cancer. 2. Participants must be at the recurrent/metastatic setting, with selected advanced solid tumors. 3. Participants must have at least one lesion that is measurable by RECIST v1.1 4. Part 3, Dose exploration, CRC participants can be treatment naïve but should not have received more than two line of systemic therapy in the recurrent/metastatic setting. Exclusion Criteria 1. Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor. 2. Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed 3. Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of study treatment 4. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable.

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Conditions

The condition(s) this trial relates to.

colorectal cancer neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

Advanced solid tumors

Contacts and locations

Locations

  • Research Site

    Birmingham, Alabama, 35233, United States

  • Research Site

    Scottsdale, Arizona, 85258, United States

  • Research Site

    Duarte, California, 91010, United States

  • Research Site

    La Jolla, California, 92093, United States

  • Research Site

    Los Angeles, California, 90089, United States

  • Research Site

    Sacramento, California, 95817, United States

  • Research Site

    Santa Monica, California, 90404, United States

  • Research Site

    Aurora, Colorado, 80045, United States

  • Research Site

    Tampa, Florida, 33612, United States

  • Research Site

    Chicago, Illinois, 60611, United States

  • Research Site

    Baltimore, Maryland, 21231, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    Detroit, Michigan, 48202, United States

  • Research Site

    New Brunswick, New Jersey, 08903, United States

  • Research Site

    New Hyde Park, New York, 11042, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    The Bronx, New York, 10461, United States

  • Research Site

    Providence, Rhode Island, 02903, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Dallas, Texas, 75235, United States

  • Research Site

    San Antonio, Texas, 78229, United States

  • Research Site

    Salt Lake City, Utah, 84112, United States

  • Research Site

    Blacktown, 2148, Australia

  • Research Site

    Clayton, 3168, Australia

  • Research Site

    Waratah, 2298, Australia

  • Research Site

    Brussels, 1200, Belgium

  • Research Site

    Edegem, 2650, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Research Site

    Toronto, Ontario, M5G 1Z5, Canada

  • Research Site

    Marseille, 13385, France

  • Research Site

    Nantes, 44093, France

  • Research Site

    Debrecen, 4032, Hungary

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Milan, 20141, Italy

  • Research Site

    Grafton, 1023, New Zealand

  • 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

    Barcelona, 08035, Spain

  • Research Site

    Madrid, 28027, Spain

  • Research Site

    Madrid, 28034, Spain

  • Research Site

    Málaga, 29010, Spain

  • Research Site

    Pamplona, 31008, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    London, SW2 6JJ, United Kingdom

  • Research Site

    Sutton, SM2 5PT, United Kingdom

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