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

• Status: Active, not recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Antibodies, Monoclonal; Avelumab; Talazoparib

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.