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New hope for throat cancer patients: smarter treatments on the horizon

NCT ID NCT04116047

Disease control Sponsor: University of Birmingham 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether different drug combinations can improve survival and reduce side effects for people with intermediate or high-risk oropharyngeal (throat) cancer. About 785 participants will receive one of several experimental treatments alongside standard chemoradiotherapy. The goal is to find a regimen that works better than current options.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 785 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2015

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 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. Oropharyngeal squamous cell carcinoma (OPSCC) in base of tongue and tonsil with a Multidisciplinary Team (MDT) recommendation for treatment with definitive concurrent chemoradiotherapy 2. All OPC T4 or N3 (HPV+ and HPV-) OR all HPV -ve (negative) OPC T1-T4, N1-N3 or T3-4, N0 OR HPV +ve (positive) OPC T1-T4 with N2b-N3 nodes AND who are smokers ≥ 10 pack years current or previous smoking history 3. Minimum life expectancy of 3 months 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 5. Adequate renal function, glomerular filtration rate (GFR) \>50ml/min calculated using Cockcroft-Gault formula 6. Adequate bone marrow function (absolute neutrophil count (ANC) ≥1.5 x 109/L, haemoglobin ≥9.0g/dL and platelets ≥100 x 109/L) 7. Adequate liver function i.e. plasma bilirubin ≤1.5 times the upper limit of normal (ULN), and alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤2.5 x ULN 8. Prothrombin time (PT) ≤1.5 x ULN or International Normalised Ratio (INR) ≤1. 5 9. Magnesium ≥ lower limit of normal 10. No cancers in previous 5 years, except basal cell carcinoma of skin and cervical intra-epithelial neoplasia (CIN) 11. Aged 18-70 12. Written informed consent given for the trial 13. Surgically resectable disease if being randomised to all four arms 14. Females must either be of non-reproductive potential (i.e. post-menopausal by history: ≥55 years old and no menses for ≥1 year without an alternative medical cause; or history of hysterectomy, or history of bilateral tubal ligation or history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry 15. Willingness to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations including follow up Exclusion Criteria: 1. All T1-T2,N0 OPC (HPV +ve or HPV-ve) 2. HPV positive patients who are: T1-T3, N0-N2c non-smokers T1-T3, N0-N2c smokers with ≤10 pack years or T1-T2, N0-N2a smokers with ≥10 pack years 3. Unfit for chemoradiotherapy regimens 4. Creatinine Clearance \<50ml/min 5. Treatment with any of the following, prior to randomisation: 1. Any Investigational Medicinal Products (IMP) within 30 days 2. Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks 3. Major surgery within 4 weeks 6. History of allergic reactions to any of the IMPs and excipients used in this trial 7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent 8. Women who are pregnant or breast-feeding. Women of child- bearing potential must have a negative pregnancy test performed within 7 days prior to randomisation 9. Men or women who are not prepared to practise methods of contraception of proven efficacy during treatment and for 6 months following the end of treatment 10. Any condition that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results Additional Exclusion Criteria for Arm 5 only: 11. Any previous treatment with PD-L or PD-L1 inhibitor, including durvalumab 12. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid dose 13. Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease e.g. colitis or Crohn's disease, diverticulitis (with the exception of diverticulosis), celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis). The following are exceptions to this criterion: * Patients with vitiligo or alopecia * Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement * Any chronic skin condition that does not require systemic therapy * Patients without active disease in the last 5 years may be included but only after consultation with the study physician 14. Patients with an active non-infectious pneumonitis 15. History of primary immunodeficiency 16. History of allogeneic organ transplant 17. Known history of previous clinical diagnosis of tuberculosis 18. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab. Inactivated viruses, such as those in the influenza vaccine, are permitted

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Conditions

The condition(s) this trial relates to.

oropharyngeal carcinoma oropharynx cancer oropharynx squamous cell carcinoma

As listed by the trial registrant

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

Oropharyngeal cancer

Contacts and locations

Locations

  • Aberdeen Royal Infirmary

    Aberdeen, Aberdeen, AB25 2ZN, United Kingdom

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Aintree University Hospital

    Liverpool, L9 7AL, United Kingdom

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Belfast City Hospital

    Belfast, BT9 7AB, United Kingdom

  • Bradford Royal Infirmary

    Bradford, West Yorkshire, BD9 6RJ, United Kingdom

  • Bristol Haematology and Oncology Centre

    Bristol, Bristol, BS2 8ED, United Kingdom

  • Castle Hill Hospital

    Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

  • Cheltenham General Hospital

    Cheltenham, GL53 7AN, United Kingdom

  • Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • Churchill Hospital

    Oxford, Oxfordshire, OX3 7LE, United Kingdom

  • Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

  • Colchester General Hospital

    Colchester, Essex, CO4 5JL, United Kingdom

  • Derriford Hospital

    Plymouth, United Kingdom

  • Freeman Hospital

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

  • James Cook University Hospital

    Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom

  • Leicester Royal Infirmary

    Leicester, East Midlands, LE1 5WW, United Kingdom

  • Musgrove Park Hospital

    Taunton, TA1 5DA, United Kingdom

  • Newcross Hospital

    Wolverhampton, West Midlands, WV10 OQP, United Kingdom

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UY, United Kingdom

  • North Middlesex Hospital

    London, London, N18 1QX, United Kingdom

  • Nottingham City Hospital

    Nottingham, Nottingham, NG5 1PB, United Kingdom

  • Queen Elizabeth Hospital

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • Queen's Hospital

    Romford, Essex, RM7 0AG, United Kingdom

  • Royal Devon and Exeter Hospital

    Exeter, Devon, EX2 5DW, United Kingdom

  • Royal Preston Hospital

    Preston, Lancashire, PR2 9HT, United Kingdom

  • Royal Shrewsbury Hospital

    Shrewsbury, SY3 8XQ, United Kingdom

  • Royal United Hospital

    Bath, BA1 3NG, United Kingdom

  • Singleton Hospital

    Swansea, Swansea, SA2 8QA, United Kingdom

  • St James's Hospital

    Dublin, Dublin 8, Ireland

  • St James's University Hospital

    Leeds, West Yorkshire, LS9 7TF, United Kingdom

  • St Luke's Hospital

    Dublin, Dublin 6, Ireland

  • Torbay Hospital

    Torquay, TQ2 7AA, United Kingdom

  • University Hospital Coventry

    Coventry, West Midlands, CV2 2DX, United Kingdom

  • Velindre Cancer Centre

    Cardiff, Cardiff, CF14 2TL, United Kingdom

  • Western General Hospital

    Edinburgh, Edinburgh, EH4 2XU, United Kingdom

  • Weston Park Hospital

    Sheffield, South Yorkshire, S10 2SJ, United Kingdom

  • York Hospital

    York, North Yorkshire, YO31 8HE, United Kingdom

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