©2022 Stanford Medicine
Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
Not Recruiting
Trial ID: NCT03565991
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
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.
Intervention(s):
drug: Avelumab
drug: Talazoparib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ivy Lau
650-721-8899