Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 76 people in total across four groups. Participants were receiving radiation therapy for head and neck cancer and were being treated with either a placebo (an inactive substance) or one of two doses of an experimental drug called ALD518 — either 160 mg or 320 mg. The trial was primarily measuring how often participants experienced unwanted health events (called adverse events), serious adverse events, and notable changes in laboratory test results. It also measured how often participants developed a painful mouth condition called oral mucositis — soreness and ulcers in the mouth — at different points during their radiation treatment. The reported data shows that, when it came to any type of adverse event, 95.7% of placebo participants, 100% of those receiving ALD518 160 mg, and 100% of those receiving ALD518 320 mg experienced at least one such event. Serious adverse events were reported in 30.4% of the placebo group, 46.9% of the 160 mg group, and 38.1% of the 320 mg group. Regarding mouth ulcers (oral mucositis) at the key radiation dose point of 55 Gray (a measure of radiation received), the reported data shows that 79.2% of placebo participants, 100% of the randomised 160 mg group, and 77.3% of the 320 mg group had developed this condition by that stage. The trial also tracked mouth ulcers at earlier radiation doses; at 45 Gray, rates ranged from 75% to 90.9% across the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Head and Neck Cancer Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been recently diagnosed (within the last 6 months) with a type of cancer called squamous cell carcinoma (a specific type of cancer) in the mouth, throat, or voice box area, confirmed by a biopsy, and it has not spread to other parts of the body
- Your cancer will be treated with a combination of radiation therapy and chemotherapy as your first treatment — surgery beforehand (about 4–6 weeks before radiation, with enough time to heal) is also acceptable
- You are planned to receive a specific type of radiation therapy (called IMRT) given once daily in set doses, with a total radiation amount falling within a specific range (confirm with trial site)
- You are planned to receive one of several specific chemotherapy drug regimens using either cisplatin or carboplatin, given on a weekly or every-three-weeks schedule
- You are generally well enough to carry out daily activities with little or no limitation (a measure doctors use to assess overall health and strength)
- Your blood inflammation levels (a marker called CRP) are below a certain level at the time of screening
- Your blood, liver, and kidney functions are working well enough at the time of screening
Who may not be able to join:
- Your cancer is located in the lips, sinuses, salivary glands, the back of the nasal passage (nasopharynx), or the primary location of your cancer is unknown
- Your cancer has spread to other parts of the body (stage IV, advanced metastatic disease)
- You have had a head or neck cancer at any point in the past
- You have previously had radiation treatment to your head or neck area
- You have had a major surgery (unrelated to the head and neck cancer being treated) or a serious injury within 4 weeks before starting radiation, or you expect to need a major surgery during the trial
- You currently have an active infection (a mouth yeast infection called oral thrush is an exception to this)
- You already have mouth sores (oral mucositis) at the time of your first screening appointment
- You have previously had a serious allergic reaction to a type of medicine called a monoclonal antibody
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Jeffrey Smith, MD FRCP, Alder Biopharmaceuticals, Inc.
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities; Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities; Percent of Participants With All Grades of Oral Mucositis (OM) at a Radiation Dose of 55 Gy; Number of Participants With All Grades of OM at a Radiation Dose of 55 Gy
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.