Phase 3 Head and Neck Cancer Trial, Terminated NCT03452137 Sponsor: Hoffmann-La Roche Condition: Head and Neck Cancer
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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 (NCT03452137) enrolled 406 people in total — 203 in a placebo group and 203 in a group receiving a medicine called atezolizumab. All participants had been treated for a type of head and neck cancer (squamous cell carcinoma of the head and neck). The trial was mainly measuring "event-free survival" — that is, how long people went without their cancer coming back, spreading, or progressing, or without dying. This was tracked from the point each person was randomly assigned to their group. The reported data shows that the median event-free survival (the point in time by which half the group had experienced a setback) was approximately 52.7 months in the placebo group and approximately 59.5 months in the atezolizumab group. Looking at the proportion of people who remained event-free over time, the reported figures were broadly similar between the two groups: for example, at the 4-year mark, approximately 55% of the placebo group and approximately 55% of the atezolizumab group were still event-free (based on independent review). For overall survival — how long people lived regardless of whether their cancer progressed — the median figure was not yet reached at the time of reporting, meaning not enough deaths had occurred in either group to calculate that number. At 2 years, approximately 79% of the placebo group and 82% of the atezolizumab group were still alive; at 5 years those figures were approximately 62% and 61% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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 3 Head and Neck Cancer Trial, Terminated

NCT03452137
Terminated Phase 3 🇦🇺 Australian site

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 diagnosed with squamous cell carcinoma of the head and neck (a specific type of cancer affecting the head and neck area), confirmed by a lab test.
  • Your HPV (Human Papillomavirus) status has been tested and is known.
  • You have already completed your main cancer treatment (such as chemotherapy combined with radiation).
  • Scans have shown that your cancer has not spread to other parts of your body.
  • Your blood counts and organ function (such as liver and kidneys) are at acceptable levels.
  • If you take blood thinners, your dose has been stable for a period of time.
  • If you are a woman who could become pregnant, you agree to use highly effective birth control during treatment and for 5 months after your last dose, and to avoid donating eggs during this time.
  • A scan (CT or MRI with contrast dye) done at least 8 weeks after finishing your main treatment — and within 28 days before starting the study drug — shows your cancer has completely responded, partially responded, or stayed stable.

Who may not be able to join:

  • You received surgery alone or radiation alone as your main cancer treatment (without combining other treatments).
  • Your cancer is located in the nasopharynx or paranasal sinuses, or is not the squamous cell type.
  • Your scans show that your cancer has gotten worse or spread after your main treatment.
  • You have high calcium levels in your blood that are uncontrolled or causing symptoms.
  • You have an active autoimmune disease, a history of autoimmune disease, or a weakened immune system.
  • You currently have active tuberculosis (TB).
  • You have serious heart or blood vessel disease.
  • You have had another cancer diagnosis within the past 5 years (with some exceptions for cancers that are very unlikely to spread or be life-threatening — confirm with trial site).
  • You have previously had a stem cell transplant or an organ transplant from another person.
  • You are currently taking antiviral medication for Hepatitis B.
  • You are currently taking medications that stimulate or suppress your immune system.
  • You have had a severe allergic reaction to certain types of antibody-based medicines in the past.
  • You are pregnant, breastfeeding, or planning to become pregnant during the study or within 5 months after your last dose.
  • Your previous main cancer treatment included a non-approved anti-cancer drug (specifically an anti-EGFR agent) that was not approved by the FDA or EMA, unless it was given alongside an approved drug (confirm with trial site).
  • You have received any other systemic (whole-body) treatments beyond what is allowed after your main cancer treatment.

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Terminated
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
3 April 2018
Est. completion
27 September 2023

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇵🇹 Portugal 🇷🇺 Russia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Investigator-Assessed Event-Free Survival (INV-assessed EFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov