Phase 2 Brain Cancer 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 who are 18 years of age or older.
• People who have cancer that has spread to the brain, and whose cancer is one of the following types: advanced BRCA1 or BRCA2 gene-mutated cancer, advanced cancer with certain DNA repair gene changes (but not BRCA1/2), advanced small cell lung cancer, advanced non-small cell lung cancer, or advanced triple-negative breast cancer.
• For certain groups in the trial, people whose cancer has a specific change in one or more DNA repair genes (such as BRCA1/2, ATM, PALB2, or related genes), as determined by a specialist team at MD Anderson Cancer Center.
• People whose brain tumour(s) are between 0.5 and 3 cm in size on MRI, are not causing neurological symptoms, have not been previously treated with radiation, do not need immediate surgery or radiation, and have not required steroid medication in the 10 days before starting the study.
• People who have already received at least one prior cancer treatment.
• People whose general physical health and ability to carry out daily activities meets a standard score of 2 or below on a medical scale (meaning they are able to care for themselves, even if unable to do strenuous activity) — (confirm with trial site).
• People whose blood counts, kidney function, liver function, and blood clotting are within acceptable ranges as measured by blood tests (confirm with trial site for specific values).
• People who have stored tumour tissue available from a previous biopsy, or who are willing to have a biopsy during the screening period if tissue is not already available.
• Women who could become pregnant must have a negative pregnancy blood test within 3 days before starting treatment, and must agree to use a highly effective form of contraception from screening until 180 days after the last dose, or must be confirmed as unable to become pregnant by medical criteria.
• Women who are not able to become pregnant (for example, after hysterectomy, removal of both ovaries, or tubal ligation, confirmed by medical records) may also be eligible.
• Women must agree not to breastfeed during the study or for 180 days after the last dose.
• Men must agree to not donate sperm and to either remain abstinent or use a condom during the study period and for at least 180 days after the last dose.
• People who have had a previous brain radiation treatment (stereotactic radiosurgery) or brain surgery must have had it at least 1 week before starting the study.
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests throughout the study.
• People who have signed an approved consent form confirming they understand and agree to participate.

Who may not be able to join:

• People who are currently receiving another active cancer treatment at the same time as this trial.
• People who cannot have an MRI scan, due to implanted metal devices or foreign bodies in the body, or who have a kidney function problem or allergy that prevents the use of MRI contrast dye.
• People who experience claustrophobia or are unable to lie flat and still for the time required in an MRI or PET/CT scanner.
• People who have symptoms from cancer pressing on the spinal cord, or whose spinal cord compression has not yet been treated.
• People who have cancer that has spread to the lining around the brain and spinal cord (leptomeningeal disease).
• People who have previously received a combination of a PARP inhibitor and a PD-1/PD-L1 inhibitor together, or who have previously received a full course of a PARP inhibitor on its own (prior PD-1/PD-L1 inhibitor treatment alone is permitted).
• People who have had major surgery within 3 weeks before starting the study, or who have not yet recovered from surgery.
• People who have received systemic cancer treatment within 2 weeks before starting the study.
• People who have received wide-field radiation therapy covering more than 20% of the bone marrow within the past 2 weeks, or whole-brain radiation within 2 weeks, or targeted brain radiation (stereotactic) within 1 week before starting.
• People with a known allergy or sensitivity to the study drugs niraparib or dostarlimab, or any of their ingredients.
• People with an active or suspected autoimmune disease (some conditions such as type 1 diabetes, thyroid conditions requiring only hormone replacement, or certain skin conditions not needing systemic treatment may still be eligible — confirm with trial site).
• People with a history of a lung condition called interstitial lung disease.
• People with serious medical, neurological, or psychiatric conditions that would prevent them from safely completing the study or its assessments.
• People with a history of a second cancer, unless treatment was completed and there has been no sign of cancer for at least 2 years.
• People with prostate cancer.
• People with a known history of active hepatitis B or hepatitis C (those with previously treated hepatitis B or C and an undetectable viral level may still be eligible — confirm with trial site).
• People living with HIV who do not have a confirmed undetectable viral load and a CD4 count of 350 or above within the past 6 months while on effective HIV treatment.
• People who are unable to have a contrast-enhanced MRI of the brain.
• People who are unable to swallow tablets or capsules, or who have a significant digestive condition that would prevent proper absorption of the study medications.
• People who have received a live vaccine within 30 days before entering the study.
• People with uncontrolled high blood pressure (above 140/90).
• People who have been diagnosed with a blood condition called myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).
• People choosing the optional spinal fluid collection procedure who have certain medical reasons that make that procedure unsafe (confirm with trial site).

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