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

Last updated on September 19, 2019

Study Location
Administrative Address: UCLA Hematology/Oncology
Los Angeles, California, 90095 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Locally Advanced or Metastatic Solid Tumors, BRCA 1 Genes
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

- 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

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


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Locally Advanced or Metastatic Solid Tumors, BRCA 1 Genes
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