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Study of Cisplatin, Carboplatin and Durvalumab Treatment for Patients with Intermediate and High-Risk Oropharyngeal Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on oropharyngeal cancer, which is a type of cancer that affects the middle part of the throat, including the base of the tongue and tonsils. The study aims to compare different treatment approaches to improve survival rates in patients with intermediate and high-risk forms of this disease.

The treatment combines several medications given through intravenous infusion. These include cisplatin and carboplatin, which are chemotherapy drugs that help fight cancer cells, along with durvalumab, which is a type of medication that helps the body's immune system detect and fight cancer cells. These medications will be given together with radiation therapy, which uses high-energy rays to target cancer cells.

The study will monitor how well patients respond to the treatment combinations by tracking their overall health, quality of life, and ability to swallow. The treatment schedule includes regular visits to receive the medications and check-ups to monitor the patient's progress. Throughout the study, doctors will carefully watch for and manage any side effects that may occur from the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eligibility will be confirmed through medical tests including blood work to check kidney function, liver function, and blood cell counts

    A physical examination will be performed to assess your overall health status and ECOG performance status (a measure of your ability to perform daily activities)

  2. Step 2

    Treatment assignment

    You will be assigned to one of the treatment groups for oropharyngeal cancer (cancer affecting the throat area)

    Your specific treatment plan will be determined based on your cancer characteristics and risk factors

  3. Step 3

    Treatment administration

    You will receive a combination of treatments that may include:

    Chemotherapy medications (cisplatin or carboplatin) given through an intravenous line

    Durvalumab (an immunotherapy medication) given through an intravenous line

    Radiotherapy will be administered alongside these medications

  4. Step 4

    Monitoring during treatment

    Regular assessments will track any side effects using standardized criteria

    Blood tests will continue to monitor your kidney function, liver function, and blood counts

    Your ability to swallow will be evaluated using specific assessment tools

  5. Step 5

    Follow-up assessments

    Quality of life assessments using questionnaires at specified intervals

    Evaluation of swallowing function at 24 months after treatment starts

    Regular check-ups to monitor your recovery and cancer status

    Assessment of any late side effects up to 2 years after treatment

Who can join the trial?

14 criteria

  • Age between 18 and 70 years
  • Diagnosed with oropharyngeal squamous cell carcinoma (cancer in the throat area, specifically in the base of tongue, tonsil, or uvula)
  • Must be recommended for treatment with combined chemotherapy and radiation therapy by a team of medical specialists
  • No other cancers in the past 5 years (except for non-melanoma skin cancer and certain cervical conditions)
  • Body weight more than 30 kg
  • Good overall physical condition (able to carry out all normal activities)
  • Expected survival of at least 3 months
  • Normal kidney function
  • Healthy blood cell counts
  • Normal liver function
  • Normal blood clotting function
  • For women who can become pregnant: must have either confirmation of post-menopausal status or a negative pregnancy test
  • Must provide written informed consent to participate in the trial
  • Must be willing to follow the study protocol, including attending all scheduled visits and examinations

Who cannot join the trial?

13 criteria

  • Age below 18 years or above 65 years
  • Previous chemotherapy (drug treatment) for head and neck cancer
  • Previous radiotherapy (radiation treatment) to the head and neck area
  • Previous surgery for oropharyngeal cancer
  • Presence of distant metastases (cancer spread to other parts of body)
  • Inability to give informed consent
  • Pregnancy or breastfeeding
  • Active serious infection including HIV (human immunodeficiency virus)
  • Serious heart or lung conditions that could interfere with treatment
  • Other active cancers in the past 5 years (except successfully treated non-melanoma skin cancer)
  • Mental health conditions that could affect participation in the study
  • Drug or alcohol dependency
  • Participation in other clinical trials within 30 days
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Investigated drugs

  • Durvalumab

    is an immunotherapy drug that helps the body’s immune system notice and attack cancer cells. In this trial it is given through a vein (intravenously) as part of the treatment plan for patients with intermediate or high‑risk oropharyngeal cancer, with the goal of improving survival and quality of life.

  • Carboplatin

    is a chemotherapy medication that works by interfering with the DNA inside cancer cells, which stops the cells from growing and causes them to die. It is administered intravenously and is being tested in combination with other drugs to see if it can better control oropharyngeal cancer and reduce side effects compared with other regimens.

  • Cisplatin

    is another chemotherapy drug that damages the DNA of cancer cells, leading to their death. Like the other agents, it is given through a vein and is being evaluated as part of alternative treatment schedules to determine if it can improve overall survival and preserve swallowing function for patients with intermediate or high‑risk oropharyngeal cancer.

What is already known about the treatment

  • DURVALUMAB

    This drug is given by intravenous infusion, usually over 30 to 60 minutes. It is an approved cancer medicine that works by blocking a protein called PD‑L1, helping the immune system see and attack tumor cells. It is mainly used for treating certain head and neck cancers, including oropharyngeal cancer. Durvalumab belongs to the class of immune checkpoint inhibitors.

  • CARBOPLATIN

    Carboplatin is administered as an intravenous injection, often diluted in a fluid bag and given over several minutes. It is a widely used chemotherapy drug that is approved for many solid tumors, including cancers of the head and neck. The medicine works by attaching to DNA in cancer cells, which prevents the cells from dividing and leads to their death. Carboplatin is classified as a platinum‑based chemotherapy agent.

  • CISPLATIN

    Cisplatin is also given by intravenous infusion, usually over a short period of time. It is an established cancer drug that has been used for decades to treat various solid tumors, such as oropharyngeal cancer. The drug damages the DNA inside cancer cells, stopping them from growing and causing them to die. Cisplatin belongs to the group of platinum‑based chemotherapy agents.

Investigated diseases

Oropharyngeal Cancer - A cancer that develops in the oropharynx, which is the middle part of the throat behind the mouth, including the base of the tongue, tonsils, and surrounding tissues. The disease typically begins in the squamous cells that line the throat and can spread to nearby lymph nodes. It may cause difficulty swallowing, persistent sore throat, and changes in voice quality. The condition can affect speech and swallowing functions as it progresses. Oropharyngeal cancer may develop gradually, often starting with changes in the cells of the throat tissue.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516108-41-00Protocol codeRG_14-093Estimated enrolment785 patientsSponsorThe University Of Birmingham

sourced from the EU Clinical Trials Register and site verification

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