Phase 2 Brain Cancer 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 aged 18 or older who weigh more than 40 kg (approximately 88 pounds).
• People who have given their informed consent before any study-related procedures begin.
• People who have a specific type of brain tumour — a diffuse astrocytic or oligodendroglial tumour — confirmed by laboratory testing, classified under the World Health Organization 2016 system, and carrying a genetic change called an IDH mutation.
• People who have received up to 2 rounds of systemic treatment after their tumour came back.
• For Cohort 1: People whose tumour a doctor has determined can and should be surgically removed.
• For Cohort 2: People whose tumour cannot be surgically removed, or for whom surgery is not considered appropriate at the time of enrolment.
• People whose organs and bone marrow are functioning normally, as confirmed by tests done within the 14 days before starting treatment.
• People who are in reasonably good general health, rated 0 or 1 on a standard medical scale called the ECOG performance status (meaning fully active or able to carry out light work).
• People with a life expectancy of at least 12 weeks.
• People of childbearing potential who have had a negative pregnancy blood test within 28 days before starting treatment, and again on the first day of treatment.
• People who agree to use 2 acceptable methods of contraception for the required duration of the study.
• People who are willing and able to follow all study requirements, including attending scheduled visits and completing examinations.
• People who are willing to provide stored tumour tissue samples, and — depending on which cohort they are in — fresh tumour samples either at the time of surgery or biopsy.
• For Cohort 2 specifically: People who have measurable and progressing disease confirmed within 28 days before starting study treatment.
• People who are not currently experiencing symptoms related to their brain tumour, have been clinically stable for at least 28 days after their most recent brain-directed treatment, and have been on a stable dose of steroids and/or anti-seizure medicines for at least 14 days.

Who may not be able to join:

• People currently enrolled in another interventional clinical trial (participation in a non-interventional observational study or a follow-up phase of a completed trial may be acceptable — confirm with trial site).
• People who have received any standard or experimental cancer treatment within 28 days before the first dose of the study drug, tarlatamab.
• People who have previously received tarlatamab.
• People who have had another cancer in the last 5 years (some exceptions may apply — confirm with trial site).
• People who have received chemotherapy or radiotherapy within 28 days before starting study treatment.
• People who still have unresolved side effects from previous cancer treatment or surgery.
• People who have had major surgery within 28 days before starting the study, or who have not yet fully recovered from major surgery.
• People who have a serious or uncontrolled medical condition, a significant non-cancer illness, or an active uncontrolled infection that puts them at high medical risk.
• People who have had an arterial blood clot (such as a stroke or heart attack) within the 12 months before starting tarlatamab.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study.
• People who have signs of an acute or uncontrolled active infection anywhere in the body within 7 days before the first dose.
• People with a weakened immune system, including those known to be HIV positive, or those who have had a solid organ transplant or bone marrow transplant from a donor.
• People with a history of a condition affecting the pituitary gland (a small gland at the base of the brain) called hypophysitis or pituitary dysfunction.
• People with active or untreated hepatitis B or hepatitis C infection, based on specific blood test results within 3 months before the first dose (confirm specific test requirements with trial site).
• People who have had a whole blood transfusion within 120 days before enrolment (transfusions of packed red blood cells or platelets may be acceptable if given more than 28 days before treatment — confirm with trial site).
• People who have used immunosuppressive medications within 14 days before the first dose, or whose steroid dose has not been stable for at least 14 days before the first dose.
• People with an active or previously documented autoimmune or inflammatory condition (such as inflammatory bowel disease, coeliac disease, or Wegener's syndrome) within the last 2 years. Some milder conditions such as vitiligo, hair loss, stable thyroid conditions, or mild psoriasis not requiring systemic treatment may not be excluded — confirm with trial site.
• People who have received a live vaccine (such as measles, mumps and rubella, nasal flu spray, chickenpox, yellow fever, or others) within 30 days before the first dose, or who would need one during or within 30 days after the study.
• People with an active tuberculosis infection.
• People with a known allergy to medicines that are chemically or biologically similar to tarlatamab.
• People who are unable to stay within one hour of the study site for an additional 48 hours after being hospitalised on the first and eighth day of the first treatment cycle.
• People who are unable to stay within one hour of any hospital for 72 hours after receiving the tarlatamab infusion on the first and eighth day of the first treatment cycle.
• People who are unable to arrange for someone to live with them at home for 72 hours after the tarlatamab infusion on those same two days.
• People whose situation, in the opinion of the treating doctor, would make it difficult to properly evaluate the study drug or interpret safety results.

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