TEMPUS STUDIES

PAVO is an open-label Phase II study investigating if the study drug, a PARP inhibitor called niraparib (Zejula), is safe and effective for certain people who have been diagnosed with an advanced solid tumor with either an inherited or tumor PALB2 mutation.

All participants will receive the study drug, niraparib. Study participants will be dosed with niraparib orally once daily throughout each 28-day cycle and be evaluated via CT or MRI scans every 8 weeks for approximately one year.

Key Inclusion Criteria

• Positive test for a pathogenic PALB2 gene mutation (inherited or tumor)
• Provide archival tissue representative of current tumor status
• Received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the Investigator, the patient would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy

Key Exclusion Criteria

• Do not have a histologically or cytologically confirmed diagnosis of an advanced or metastatic solid cancer
• Ovarian or prostate cancer
• Variants of undetermined significance (VUS), but not pathogenic variants of PALB2, at the time of screening
• Inherited or tumor BRCA1 or BRCA2 mutations
• Received prior PARP inhibitor(s) in prior lines of treatment