Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
Trial ID or NCT#
Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect.
A PHASE 2 STUDY TO EVALUATE SAFETY AND ANTI-TUMOR ACTIVITY OF AVELUMAB IN COMBINATION WITH TALAZOPARIB IN PATIENTS WITH BRCA OR ATM MUTANT TUMORS JAVELIN BRCA/ATM
- - BRCA1, BRCA2 and/or ATM gene defect. - Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent - Availability a tumor tissue sample from a diagnostic biopsy/surgery or a metastatic tumor biopsy. - Progressive disease at study enrollment. - Minimum age 18 years (in Japan, minimum age 20 years). - ECOG performance status 0 or 1. - Adequate bone marrow, renal and liver function. - For childbearing female patients, negative serum or urine pregnancy test at screening - Signed and dated informed consent document.
- - Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment. Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been completed at least 2 days prior to enrolment and no significant toxicity are expected. - Major surgery within 4 weeks prior to study enrollment. - Current use of immunosuppressive medication at the time of study enrollment. - Known prior severe hypersensitivity to investigational products or any component in their formulations - Known history of immune-mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis. - Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent. - Prior organ transplantation including allogenic stem-cell transplantation. - Administration of live attenuated vaccines within 4 weeks of study enrollment. - Diagnosis of myelodysplastic syndrome. - Known symptomatic brain metastases requiring steroids. - Persisting toxicity related to prior therapy Grade >1. - Known history of HIV or AIDS. - Positive HBV or HCV test indicating acute or chronic infection. - Active infection requiring systemic therapy. - Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study enrollment; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication. - Diagnosis of any other malignancy within 2 years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast, bladder, or cervix, or low-grade prostate cancer or other early-stage low-risk cancers. - Pregnant or breastfeeding female patients; female or male patients who are able to have children who are unable or unwilling to use contraception as outlined in the protocol.
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