Phase 2 Peripheral Arterial 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:

General requirements (all participants):

• People who have a confirmed genetic change in the NF2 gene, or who meet recognised medical diagnostic criteria for a condition called NF2 (neurofibromatosis type 2), which can involve tumours on the hearing nerves, brain, or spinal cord
• People who have a specific NF2-related tumour (such as a tumour on the hearing nerve, another nerve, a meningioma, or an ependymoma) that has shown clear growth on scans within the past 3 years — either growing by at least 20% in volume or by at least 2mm in size
• People whose tumour can be measured on a specialised MRI scan (meeting specific size requirements described in the trial protocol)
• People whose tumour cannot safely be treated with surgery, either because the person has declined surgery or because surgery carries a high risk of serious complications such as nerve damage
• People aged 12 years or older at the start of treatment
• People with a life expectancy of more than one year
• People who are in reasonably good general health, as assessed using standard medical scoring systems (confirm with trial site)
• People who are able to understand the trial and are willing to sign consent forms (and an assent form where required)
• People who have an established relationship with a primary care doctor and can provide their contact details

Sub-Study B (Neratinib arm) — additional requirements:

• People aged 12 or older who weigh at least 40 kg at the start of treatment
• People who are able to swallow pills
• People whose blood test results for liver function, kidney function, blood cell counts, and heart function fall within the ranges specified in the trial protocol, measured within 14 days before the first dose
• People who have recovered from significant side effects of any previous treatments (with the exception of hair loss, nerve-related changes, or nail changes)
• Female patients who are not pregnant, as confirmed by a negative pregnancy test before starting treatment (confirm with trial site)
• Female patients who are postmenopausal (at least 12 months without periods, not due to hormone therapy), have been surgically sterilised, or agree to use two effective non-hormonal methods of contraception — or to abstain completely from heterosexual intercourse — from the time of signing consent until 4 months after the last dose (note: this drug may reduce the effectiveness of hormonal contraceptives)
• Male patients who agree to use effective barrier contraception, or to abstain completely from heterosexual intercourse, throughout treatment and for 4 months after the last dose

Sub-Study C (Retifanlimab plus bevacizumab arm) — additional requirements:

• People aged between 12 and 25 years at the start of treatment
• People whose blood test results for white blood cells, platelets, liver function, kidney function, and urine protein fall within the ranges specified in the trial protocol
• Female patients who are postmenopausal, surgically sterilised, or agree to use two effective methods of contraception — or to abstain completely from heterosexual intercourse — from the time of signing consent until 4 months after the last dose
• Male patients who agree to use effective barrier contraception, or to abstain completely from heterosexual intercourse, throughout treatment and for 4 months after the last dose

Who may not be able to join:

General exclusions (all participants):

• People who have received chemotherapy within approximately 4 weeks before joining the trial (or within 5 half-lives of the drug, whichever is longer), unless side effects have resolved to an acceptable level
• People who have had radiation treatment to the target tumour within the past 3 years
• People who are currently taking part in another clinical trial involving an experimental treatment
• People whose tumours — in the treating doctor's judgement — are likely to need active treatment such as surgery within 6 months of joining
• People who have a history of a different cancer, unless they have been free of that cancer for at least 2 years and the treating doctor considers the risk of it returning to be low
• People with serious uncontrolled health conditions, such as active infections, heart failure, unstable chest pain, irregular heart rhythm, or mental health or personal circumstances that would make it difficult to follow the trial requirements
• People who are pregnant (excluded because the experimental treatments may harm an unborn baby)
• People who are breastfeeding (excluded because of unknown potential risks to a nursing infant)

Sub-Study B (Neratinib arm) — additional exclusions:

• Female patients who are breastfeeding or who test positive for pregnancy at screening or on the first day of treatment
• People with a serious medical or psychiatric illness that, in the investigator's opinion, could interfere with completing treatment
• People who have taken any other experimental treatment within 28 days or 5 half-lives (whichever is longer) before the first dose
• People who have had major surgery within 30 days before the first dose (minor procedures such as catheter placement or small biopsies are generally acceptable)
• People with significant, uncontrolled, or active heart or blood vessel disease (as detailed in the trial protocol)
• People with a history of heart attack, unstable chest pain, heart failure, significant heart rhythm problems, stroke or mini-stroke within 6 months before the first dose
• People with a QTc interval above the specified threshold on a heart tracing, or a known history of a related heart rhythm condition (confirm with trial site)
• People known to have HIV infection
• People with conditions that affect the absorption of food or medicines in the gut, including those with ongoing diarrhoea at a moderate or higher level
• People who have had serious allergic reactions to medicines with a similar composition to neratinib
• People currently taking certain anti-seizure medications that affect how the body processes drugs (including phenytoin, carbamazepine, oxcarbazepine, and others listed in the protocol)
• People who have taken certain medications that affect liver enzymes within 14 days before joining (confirm specific medications with trial site)

Sub-Study C (Retifanlimab plus bevacizumab arm) — additional exclusions:

• People with a history of allergic reactions to medicines with a similar composition to retifanlimab or bevacizumab
• Female patients who are breastfeeding or who test positive for pregnancy at screening
• People who have taken any experimental treatment or chemotherapy within 28 days or 5 half-lives (whichever is longer) before the first dose
• People who have previously received bevacizumab or a type of immunotherapy called a PD-1/PD-L1 inhibitor within the past 180 days
• People who have had major surgery within 30 days before the first dose
• People with a serious wound, ulcer, or bone fracture that has not healed properly
• People with a history of an abnormal opening or hole in the bowel, a bowel tear, or a serious abdominal infection within the past 6 months
• People whose scans show significant bleeding considered important by the treating doctor
• People taking blood-thinning medications (other than low preventative doses), or who have a history of blood clotting problems or significant bleeding
• People who have not recovered from side effects of previous cancer treatments (side effects must have resolved to a mild level or below, except for hair loss)
• People with lung inflammation or scarring of the lung (interstitial lung disease), or active non-infectious lung inflammation
• People who experienced serious immune-related side effects during previous immunotherapy treatment that required prolonged immune-suppressing treatment to manage, or that led to the permanent stopping of that therapy
• People with an active autoimmune disease requiring immune-suppressing doses of steroids above a low maintenance level (some exceptions apply — confirm with trial site)
• People with active infections requiring antibiotics, antifungal, or antiviral treatment within 10 days before the first dose
• People who have received a live vaccine within 28 days before starting treatment (some COVID-19 vaccines and injected flu vaccines may be acceptable — confirm with trial site)
• People who have had an organ transplant or a stem cell transplant from a donor
• People with poorly controlled high blood pressure, recent stroke, heart attack, unstable chest pain, moderate-to-severe heart failure, serious heart rhythm problems, or significant blood vessel disease

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