Phase 3 Rare 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:

• People who have been confirmed to have a cancer with a high number of genetic mutations (called high TMB, meaning 10 or more mutations per megabase), a specific genetic instability marker (MSI-high), or a hereditary condition called CMMRD — all confirmed using an approved genetic testing method.
• Women who could become pregnant may be eligible, provided a pregnancy test taken before joining is negative, and they agree to use at least one reliable form of contraception (such as hormonal birth control, an IUD, a condom, or abstinence) from the start of treatment, throughout the trial, and for five months after the last dose.
• Men whose partners could become pregnant may be eligible, provided they agree to use barrier contraception (such as a condom with spermicide) or abstinence during treatment, ensure their partner also uses effective contraception (if the man has not had a vasectomy), and use a condom if their partner is pregnant or breastfeeding. All male participants must also avoid donating sperm during this period.
• People who are willing and able to have a fresh tissue sample (biopsy) taken at the start of the trial, as well as blood samples for research purposes (for blood cancers or neuroblastoma, bone marrow or lymph node samples may be used instead).
• Adults (aged 18 and over) whose liver, kidneys, and blood counts are within acceptable ranges as defined by the trial protocol.
• Children and teenagers (under 18) whose organ function blood test results are within acceptable ranges as defined by the trial protocol.
• People who have stable thyroid function, including those who are on a stable dose of thyroid replacement medication.

Who may not be able to join:

• People whose cancer type is bladder (urothelial) cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, liver (hepatocellular) cancer, or triple-negative breast cancer.
• People whose cancer has spread to the brain and is rapidly getting worse or causing worsening symptoms. People with previously treated brain metastases may be considered if they have been seizure-free and neurologically stable for at least 14 days (adults) or 7 days (children) before starting treatment, and are not reliant on steroid medications (or are on a stable or reducing dose for at least those same timeframes). People who have had brain radiation must have completed it at least 14 days before starting treatment. Children with brain tumours or brain metastases may only be considered if the largest brain lesion is no bigger than 6 cm in its longest measurement.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial or within five months of their last dose.
• People with a history of certain serious lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, drug-induced lung inflammation, or idiopathic pneumonitis, or who currently show signs of active lung inflammation on a chest scan.
• People with an active autoimmune disease that requires ongoing treatment with immune-modifying medications, steroids, or immunosuppressants. (Hormone replacement therapy for thyroid, adrenal, or pituitary conditions is generally acceptable.)
• People with ongoing lung conditions that the treating doctor considers a safety risk, such as active tuberculosis.
• People who have taken immune-modifying or immune-stimulating medications within 14 days (or four weeks for stimulating agents) before joining the trial — though some exceptions may apply, such as short-term or low-dose steroid use for specific conditions (confirm with trial site).
• People who have tested positive for hepatitis B, hepatitis C, or HIV using a PCR blood test.
• People who have had a severe allergic (anaphylactic) reaction to similar types of antibody-based treatments, including other immune checkpoint inhibitors.
• People with a known allergy to products derived from Chinese hamster ovary cells.
• People with a known allergy to atezolizumab or any of its ingredients.
• People who have received a live, attenuated vaccine within 28 days before joining, or who are expected to need one during treatment or within six months of the last dose.
• People with significant pre-existing heart conditions, including uncontrolled or symptomatic chest pain (angina), uncontrolled heart rhythm problems, or moderate-to-severe heart failure. This also includes people who have had a stroke, mini-stroke (TIA), or heart attack within three months before starting treatment. People with a prior history of inflammation around the heart (pericarditis), fluid around the heart (pericardial effusion), or cardiac tamponade are also excluded. (Some exceptions may apply for people with primary brain tumours — confirm with trial site.)
• People who have had an organ transplant or stem cell transplant from another person and are still on immunosuppressant medications.
• People who have previously been treated with a drug in the same class as atezolizumab (immune checkpoint inhibitors), unless genetic testing shows their cancer has a specific resistance mechanism that may still respond to atezolizumab.
• People with uncontrolled diabetes.
• People with any other significant medical condition or treatment that the trial doctor believes could interfere with the trial or pose an unacceptable risk to the person's safety.
• People who have had a serious infection within four weeks before starting treatment, or who have taken antibiotics within two weeks before starting treatment (except those taking antibiotics as a preventive measure).

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