Phase 1 Sjogren's Syndrome Trial, Recruiting

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

Who might be able to join this trial:

• People aged 18 or older who have a confirmed cancer that has spread or cannot be removed by surgery, or who have a cancer type for which a PD-1/PD-L1 immunotherapy drug has been approved (including melanoma, non-small cell lung cancer, bladder cancer, kidney cancer, certain stomach, liver, cervical, head and neck, and blood cancers, and any solid tumour confirmed to have a specific genetic marker called MSI-high status)
• People whose cancer is being treated in an early-stage setting (before or after surgery) where PD-1/PD-L1 immunotherapy is considered standard care for certain cancer types including non-small cell lung cancer, melanoma, kidney cancer, cervical cancer, and bladder cancer
• People who have previously received other types of immunotherapy (such as high-dose IL-2, interferon, or anti-CTLA-4 treatments), provided at least 4 weeks have passed since cytokine immunotherapy, or at least 6 weeks since anti-CTLA-4 therapy
• People with a general health and activity level rated as reasonably functional (confirm with trial site regarding the specific scale used)
• People with a life expectancy of more than 12 weeks
• People whose blood test results (white blood cells, neutrophils, platelets, liver enzymes, bilirubin, and kidney function) are at or above the minimum levels required by the trial (confirm specific values with trial site)
• People living with HIV who are on effective treatment and have had an undetectable level of the virus in the past 6 months
• People with a history of hepatitis B infection who are on treatment that has made the virus undetectable
• People with a history of hepatitis C who have completed treatment and have an undetectable level of the virus
• People who have cancer that has spread to the brain, if the treating doctor determines that immediate brain-specific treatment is not needed for at least 4 weeks and the patient and doctor agree that joining the trial is appropriate
• People of childbearing potential who agree to use adequate contraception during the study and for 5 months after the last dose; male participants who are sexually active with a person of childbearing potential must agree to use contraception for 7 months after the last dose
• Women of childbearing potential who have a negative pregnancy test within 24 hours before starting treatment and who are not breastfeeding
• People who are able to understand the study and are willing to sign a written consent form
• People with more than one autoimmune disease (the treating doctor will determine which disease is the primary focus for the trial)
• People with systemic sclerosis (SSc) or dermatomyositis (DM) diagnosed according to recognised classification criteria, who have had a chest CT scan within the past 6 months
• People with rheumatoid arthritis (RA) diagnosed by a rheumatologist, who were treated with disease-modifying drugs before their current cancer diagnosis; low-dose steroids (up to 10 mg/day prednisone), joint steroid injections, and anti-inflammatory pain medications are permitted
• People with lupus (SLE) diagnosed by a rheumatologist (confirm specific diagnostic criteria requirements with trial site)
• People with ulcerative colitis (UC) whose diagnosis was confirmed by colonoscopy with tissue samples, who test negative for hepatitis B and tuberculosis (or are receiving appropriate treatment for these), and who meet specific disease activity levels depending on their current medications (confirm severity category with trial site)
• People with Crohn's disease (CD) whose diagnosis has been confirmed by colonoscopy with tissue samples, who test negative for hepatitis B and tuberculosis (or are receiving appropriate treatment), and who meet specific disease activity levels depending on their current medications (confirm severity category with trial site)
• People with other autoimmune diseases not listed above, where eligibility is determined by a specialist based on relevant medical guidelines (confirm with trial site)
• People with giant cell arteritis (GCA) who had a positive temporal artery biopsy and an elevated inflammation marker at the time of diagnosis
• People with polymyalgia rheumatica (PMR) who have a clinical diagnosis and elevated inflammation markers
• People with other autoimmune diseases who are either in remission or have low-to-moderate disease activity, defined as taking no more than 10 mg prednisone or equivalent per day
• People with multiple sclerosis (MS) who meet the 2017 McDonald diagnostic criteria, are currently off MS medications (except interferon gamma), and have been off those medications for at least 2 weeks before joining
• People with Sjögren's syndrome (SjS) diagnosed by a rheumatologist or oral medicine provider, who are either not on treatment or taking only hydroxychloroquine and/or low-dose prednisone (10 mg or less per day)
• People with psoriasis (PsO) or psoriatic arthritis (PsA) diagnosed by a relevant specialist, whose condition has been stable with no change in treatment for at least 3 months (or at least 4 weeks if recently switched from a TNF inhibitor to another biologic)

Who may not be able to join:

• People who have had chemotherapy or radiation therapy within the past 2 weeks (or 6 weeks for certain specific chemotherapy drugs), or who are still experiencing side effects from earlier treatment that have not resolved
• People who have previously been treated with an anti-PD-1 or anti-PD-L1 immunotherapy drug
• People who have previously had a bone marrow or blood stem cell transplant from another person
• People who are currently taking part in another experimental cancer treatment trial
• People with serious uncontrolled health conditions such as active infection, severe heart failure, unstable chest pain, heart rhythm problems, or mental health or social circumstances that would make it difficult to follow the trial requirements
• People with ulcerative colitis who have previously received ipilimumab, have had their colon surgically removed, have a condition called primary sclerosing cholangitis, or are on immune-suppressing medications without a proper medical assessment
• People with Crohn's disease who have untreated abscesses, certain bowel complications (untreated symptomatic strictures, short gut, or isolated disease in a specific part of the bowel), who have previously received ipilimumab, or who are on immune-suppressing medications without a proper medical assessment
• People with multiple sclerosis who have a medical reason they cannot have a gadolinium-enhanced MRI scan

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