Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug cocktail shows promise against tough cancers

NCT ID NCT02499328

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested combinations of the immunotherapy drug durvalumab with other drugs (danvatirsen, AZD5069, or tremelimumab) in 340 adults with advanced solid tumors or head and neck cancer. The goal was to find safe doses and see if the combinations shrink tumors. The trial has 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
durvalumab (MEDI4736), danvatirsen (AZD9150), AZD5069, and tremelimumab
What this could lead to
If successful, this could point toward a new combination treatment option for advanced head and neck cancer.
What could go wrong
This is an early-phase trial (Phase 1b/2) with a small number of participants, so results may not apply to all patients. Side effects from combining multiple drugs are possible.

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

340 people

The number who actually took part.

Started

Aug 2015

Finished

Oct 2025

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.

Key Inclusion Criteria: * Male and female patients must be at least 18 years of age. * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1. * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases). Indicator lesions must not have been previously treated with surgery, radiation therapy, or radiofrequency ablation unless there is documented progression after therapy. * Has undergone ≤3 previous regimens (depending on treatment arm) of cytoreductive therapies including, but not limited to, platinum-based compounds, taxanes, or 5-fluorouracil. for B7 \& B8, no prior systemic treatments should have been received for RM SCCHN * Adequate organ and marrow function * Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol * Additional inclusion for part A: Has a histological confirmation of a solid malignancy (other than HCC) that is refractory to standard therapy or for which no standard of care regimen currently exists. * Addition inclusion for Part A (A6) Has a histological confirmation of castrate-resistant prostate cancer * Additional inclusion for Part B:Has histologically and/or cytologically confirmed SCCHN that is RM and not amendable to curative therapy by surgery or radiation. Squamous cell carcinoma of the head and neck originating from the following sites is eligible: oral cavity, oropharynx, larynx, or hypopharynx. Has at least 1 SCCHN tumour lesion (TL) amenable to biopsy and must have failed, refused, or has been found to be ineligible for least 1 prior platinum-based chemotherapy for RM-SCCHN Additional inclusion criteria for Arms B1 \& B2: must have had prior exposure to anti PDL-1 antibody * Arms B1-B6: Has undergone 1-3 previous regimens of cytoreductive chemo-therapies Arm B7 \& B8: with no prior exposure to anti-PD-(L)1 therapies and have received no prior systemic treatment for RM SCCHN Key Exclusion Criteria: \- Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment. - Presently has a second malignancy other than SCCHN, or history of treatment for invasive cancer other than SCCHN in the past 3 years. Exceptions are: Previously treated in-situ carcinoma (ie, noninvasive) Cervical carcinoma stage 1B or less Noninvasive basal cell and squamous cell skin carcinoma Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy * Patients must have completed any previous cancer-related treatments before enrolment. Any concurrent chemotherapy \[Chemotherapy washout within 21 days or 5 half-lives (whichever is shorter) from enrolment\], radiotherapy, immunotherapy, or biologic, or hormonal therapy for cancer excludes the patient (concurrent use of hormones for noncancer-related conditions \[eg, insulin for diabetes and hormone replacement therapy\] is acceptable), * Experiencing CTCAE grade \>1 events, experienced immune-related grade ≥3AEs with prior immunotherapy * Has active or prior autoimmune disease within the past 2 years * Has active or prior inflammatory bowel disease or primary immunodeficiency * Undergone an organ transplant that requires use of immunosuppressive treatment * Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG * uncontrolled comorbid conditions * Received a live attenuated vaccine within 30 days of first study dose, unable to take oral medications * History of allergic reactions to study compounds or excepients Additional exclusion criteria Part A: Patients with clinically active brain metastases and prior exposure to AZD9150, AZD5069, MEDI4736, or any other anti PD (L)1 antibody. Additional exclusion criteria Part B: Patients with brain metastases (known or suspected) Additional exclusion criteria Part B: treatment arms B3, B4, B5, B6, B7 and B8: prior exposure to AZD9150, AZD5069, MEDI4736, or any other anti PD (L)1 antibody.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced solid malignancy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cancer head and neck squamous cell carcinoma

As listed by the trial registrant

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

Advanced solid tumors & metastatic squamous cell carcinoma of the head and neck

Contacts and locations

Locations

  • Research Site

    Birmingham, Alabama, 35294, United States

  • Research Site

    Duarte, California, 91010, United States

  • Research Site

    La Jolla, California, 92093, United States

  • Research Site

    Los Angeles, California, 90024, United States

  • Research Site

    Los Angeles, California, 90089, United States

  • Research Site

    Orange, California, 92868-3298, United States

  • Research Site

    San Francisco, California, 94158, United States

  • Research Site

    Denver, Colorado, 80218, United States

  • Research Site

    Plantation, Florida, 33324, United States

  • Research Site

    Sarasota, Florida, 34232, United States

  • Research Site

    Lafayette, Indiana, 47905, United States

  • Research Site

    Boston, Massachusetts, 02111, United States

  • Research Site

    Detroit, Michigan, 48201, United States

  • Research Site

    Billings, Montana, 59101, United States

  • Research Site

    Morristown, New Jersey, 07960, United States

  • Research Site

    Cincinnati, Ohio, 45267-2827, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Fairfax, Virginia, 22031, United States

  • Research Site

    Seattle, Washington, 98109, United States

  • Research Site

    Antwerp, 2020, Belgium

  • Research Site

    Brussels, 1000, Belgium

  • Research Site

    Brussels, 1200, Belgium

  • Research Site

    Edegem, 2650, Belgium

  • Research Site

    Namur, 5000, Belgium

  • Research Site

    Berlin, 12200, Germany

  • Research Site

    Cologne, 50670, Germany

  • Research Site

    Dresden, 1307, Germany

  • Research Site

    Frankfurt, 60488, Germany

  • Research Site

    Hamburg, 20246, Germany

  • Research Site

    Hanover, 30625, Germany

  • Research Site

    Jena, 07743, Germany

  • Research Site

    München, 81675, Germany

  • Research Site

    Milan, 20133, Italy

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    Hospitalet deLlobregat, 08907, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Toledo, 45004, Spain

  • Research Site

    Birmingham, B15 2TH, United Kingdom

  • Research Site

    London, SE1 9RT, United Kingdom

  • Research Site

    London, SW3 6JB, United Kingdom

  • Research Site

    Manchester, M20 4BX, United Kingdom

  • Research Site

    Surrey, SM2 5PT, United Kingdom

  • Research Site

    Taunton, TA1 5DA, United Kingdom

More trials for these conditions

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