Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors

Trial ID or NCT#

NCT03565991

Status

not recruiting iconNOT RECRUITING

Purpose

Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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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Contact

Ivy Lau
650-721-8899