Phase 2 Parkinson's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 65 years of age
• People who have been diagnosed (through tissue or cell testing) with head and neck squamous cell carcinoma that can be surgically removed, at a specific stage of the disease (T3-4a, N0-2, M0 — confirm with trial site for what this means in your case)
• People who have at least one tumor that can be measured on a scan, according to standard imaging guidelines
• People who have not previously received any systemic (whole-body) cancer treatment for advanced or spread disease — OR people who previously received platinum-based chemotherapy or chemoradiotherapy, as long as at least 6 months have passed since that treatment ended before the disease came back
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work)
• People whose doctors expect them to live longer than 3 months
• People whose blood tests show the body's organs are functioning well enough, including:
  • Sufficient white blood cells (neutrophils), without recent use of growth-stimulating injections
  • Sufficient platelets, without a recent blood transfusion
  • Sufficient red blood cells/haemoglobin, without a recent blood transfusion or red blood cell stimulating treatment
  • Liver function values within acceptable limits
  • Kidney function within acceptable limits
  • Blood clotting function within acceptable limits
  • Thyroid hormone levels within normal range (some variation may be acceptable — confirm with trial site)
  • Heart enzyme levels within normal range (minor variations may be accepted at the trial doctor's discretion)
• Women of childbearing age who test negative for pregnancy within 3 days before starting the trial treatment
• People who are willing and able to use highly effective contraception (with a failure rate of less than 1% per year) throughout the entire treatment period and for 120 days after the last dose of the study drug, or 180 days after the last chemotherapy dose

Who may not be able to join:

• People who have been diagnosed with another cancer (other than head and neck squamous cell carcinoma) within the past 5 years — exceptions may apply for certain fully treated skin cancers (confirm with trial site)
• People currently taking part in another clinical trial, or who have received another experimental drug or used an experimental device within the past 4 weeks
• People who have previously been treated with certain types of immunotherapy drugs that work on the immune system's checkpoint pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar)
• People who have received certain Chinese herbal medicines or immune-boosting treatments (such as thymosin, interferon, or interleukin) aimed at treating head and neck cancer within the past 2 weeks
• People who have had an active autoimmune disease requiring ongoing systemic medication within the past 2 years (note: hormone replacement therapies such as thyroid medication or insulin are not considered systemic treatment for this purpose)
• People who have been taking steroid medicines by mouth or injection (not including nasal sprays or inhalers) within the past 7 days, or who are on any other immune-suppressing medicine — very low-dose steroids equivalent to 10mg or less of prednisone per day may be acceptable (confirm with trial site)
• People with uncontrolled fluid build-up in the chest or abdomen
• People who have had an organ transplant (other than a corneal transplant) or a bone marrow/stem cell transplant from another person
• People known to be allergic to any of the study drugs: Pembrolizumab, carboplatin, or albumin-bound paclitaxel
• People who have not yet recovered from side effects of previous treatments (recovery must be to a mild level or back to their normal baseline — hair loss and fatigue are exceptions)
• People known to have HIV infection
• People with untreated, active hepatitis B — those with low viral levels who are receiving or willing to receive anti-hepatitis B treatment may still be considered (confirm with trial site)
• People with active hepatitis C infection (confirmed by a positive antibody test and detectable virus levels)
• People who have received a live vaccine within the past 30 days — standard inactivated flu injections are acceptable, but live nasal flu vaccines are not
• Women who are pregnant or breastfeeding
• People with serious or uncontrolled health conditions, including:
  • Significant heart rhythm or electrical conduction problems on an ECG
  • Unstable chest pain, heart failure, or moderate-to-severe chronic heart failure
  • A heart attack, stroke, or similar event within the past 6 months
  • Blood pressure that is not well controlled (above 140/90 mmHg)
  • A history of lung inflammation (not caused by infection) that required steroid treatment within the past year, or currently active lung scarring/inflammation
  • Active tuberculosis of the lungs
  • An active infection that requires systemic (whole-body) antibiotic or antiviral treatment
  • Active bowel or abdominal problems such as diverticulitis, abdominal abscess, or bowel blockage
  • Serious liver conditions such as cirrhosis or active hepatitis
  • Poorly controlled diabetes (fasting blood sugar above 10 mmol/L)
  • Significant protein in the urine, confirmed by a 24-hour urine test showing more than 1.0g of protein
  • A mental health condition that would prevent the person from participating in or cooperating with the treatment
• People with any other medical history, condition, or abnormal test results that the trial doctor considers unsuitable for participation

Important: Always verify eligibility with the trial site directly before applying.