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Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
TerminatedPhase 2
Sponsor: Pfizer
Conditions: Locally Advanced or Metastatic Solid Tumors, Genes, BRCA 1
Interventions: Avelumab, Talazoparib
Countries: United States, Belgium, Denmark, France, Italy, Japan, Netherlands, Spain
Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Locations (100)
- Palo Alto, California, United States
- Palo Alto, California, United States
- Stanford, California, United States
- Stanford, California, United States
- Alpharetta, Georgia, United States
- Athens, Georgia, United States
- Atlanta, Georgia, United States
- Atlanta, Georgia, United States
- Atlanta, Georgia, United States
- Atlanta, Georgia, United States
- Canton, Georgia, United States
- Cumming, Georgia, United States
- Decatur, Georgia, United States
- Decatur, Georgia, United States
- Jonesboro, Georgia, United States
- Macon, Georgia, United States
- Marietta, Georgia, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Boston, Massachusetts, United States
- City of Saint Peters, Missouri, United States
- Creve Coeur, Missouri, United States
- St Louis, Missouri, United States
- St Louis, Missouri, United States
- St Louis, Missouri, United States
- St Louis, Missouri, United States
- St Louis, Missouri, United States
- Middletown, New Jersey, United States
- Harrison, New York, United States
- Long Island City, New York, United States
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