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 (NCT03765918) enrolled 363 people in the pembrolizumab-plus-standard-care group and 351 people in the standard-care-only group — a total of 714 participants. The trial was looking at treatments for a type of head and neck cancer, and was measuring how well tumours responded to treatment before surgery. Specifically, it tracked two things after surgeons removed the tumour: whether very little cancer remained (called a "major pathological response," or mPR — meaning 10% or less of the removed tissue still contained active cancer cells), and whether no cancer cells at all remained (called a "pathological complete response," or pCR). The reported data shows that, across all participants, 9.4% of those who received pembrolizumab plus standard care had a major pathological response, compared with 0.0% in the standard-care-only group. For the complete disappearance of cancer cells, the figures were 3.0% in the pembrolizumab-plus-standard-care group versus 0.0% in the standard-care-only group. The trial also looked at a subgroup of participants whose tumours had higher levels of a protein called PD-L1 (a marker measured on cancer cells). Among those with a PD-L1 score of 10 or above, the reported major pathological response rate was 13.7% (pembrolizumab group) versus 0.0% (standard care), and the complete response rate was 4.3% versus 0.0%. In participants with a PD-L1 score of 1 or above, the figures were 9.8% versus 0.0% for major pathological response, and 3.2% versus 0.0% for complete response. 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 ↗ · Read the linked publication on PubMed (PMID 40532178) ↗
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 Parkinson's Disease Trial, Active, Not Recruiting
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 a specific type of head and neck cancer (squamous cell carcinoma) that has been confirmed by a tissue sample, has not spread to other parts of the body, and can be surgically removed
- Your cancer is either: a Stage III throat cancer (oropharyngeal) that is HPV-positive with a large tumor; a Stage III or IVA throat cancer that is HPV-negative; or a Stage III or IVA cancer of the voice box, lower throat, or mouth
- Your doctor has determined you are a suitable candidate for surgery as a primary treatment
- You are able to have a CT scan or MRI that shows your tumor(s)
- You have been able to provide a fresh tissue sample (biopsy) from a tumor area that has not previously been treated with radiation
- You have had HPV status testing done (for throat cancers), using a test called p16
- You are generally healthy and active enough to carry out daily activities, based on a standard medical scoring scale (score of 0 or 1), confirmed within 10 days of joining the trial
- If you are female, you are not currently pregnant or breastfeeding
- If you or your partner could become pregnant, you agree to use reliable contraception during the study and for up to 6 months after your last dose of study treatment
- If you are male, you agree not to donate sperm during the study and for up to 6 months after your last dose of study treatment
Who may not be able to join:
- Your cancer is at a very advanced local stage (T4B and/or N3) or has spread to other parts of the body
- Your cancer is in a different area of the head and neck, such as the nasopharynx, sinuses, or is of unknown origin
- You are female and have a positive pregnancy test shortly before starting the study or before starting radiation therapy
- You have previously been treated with certain immune-based cancer drugs (such as PD-1, PD-L1, or PD-L2 inhibitors, or similar checkpoint therapies)
- You have previously received radiation therapy or any systemic cancer treatment for the head and neck cancer being studied
- You have received a live vaccine within 30 days before joining the trial
- You are currently taking part in, or have recently taken part in, another clinical trial involving an experimental treatment or device within the past 4 weeks
- You have an immune system disorder, or are taking high-dose steroid medications or other drugs that suppress the immune system within 7 days before joining the trial
- You have another cancer that is active or has needed treatment in the past 3 years (with some exceptions, such as certain skin cancers or early-stage cancers that have been successfully treated)
- You have cancer that has spread to the brain or the lining around the brain, even if it is not causing symptoms
- You have significant hearing loss (Grade 2 or higher) confirmed by a hearing test
- You have significant nerve damage causing weakness or numbness (Grade 2 or higher neuropathy)
- You have had serious bleeding (Grade 3–4) related to your cancer
- You have recently had major surgery and have not fully recovered from it before joining the trial
- You have previously had an organ or tissue transplant from another person
- You have had a severe allergic reaction to pembrolizumab, radiotherapy, cisplatin, or similar treatments
- You have an active autoimmune disease that has needed medical treatment in the past 2 years
- You have a history of lung inflammation (pneumonitis) that required steroid treatment, or you currently have pneumonitis
- You have an active infection that requires treatment with medication
- You have a known history of HIV infection
- You have a known history of, or have tested positive for, active Hepatitis B or Hepatitis C
- You have a mental health condition or substance use problem that could make it difficult to follow the requirements of the trial
- You have any other condition, treatment, or abnormal test result that the trial doctor believes could affect the study results or your safety (confirm with trial site)
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: Medical Director, Merck Sharp & Dohme LLC
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
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Event-free Survival (EFS); EFS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10; EFS in Participants With PD-L1 CPS ≥1
Can't join this trial?
Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.