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

Stopped early · Phase 2

Conditions studied: Locally Advanced or Metastatic Solid Tumors, Genes, BRCA 1

In brief

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

Key facts

Study ID

NCT03565991

Run by

Pfizer

People needed

202

Starts

2018-06-18

Expected to finish

2023-02-03

Last updated by the study team

2023-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford Women's Cancer Center — Palo Alto, California, United States
• Stanford Healthcare — Stanford, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• Atlanta Cancer Care -Alpharetta — Alpharetta, Georgia, United States
• Northside Hospital, Inc. - GCS/Athens — Athens, Georgia, United States
• Northside Hospital, Inc. - GCS/Annex — Atlanta, Georgia, United States
• Atlanta Cancer Care - Atlanta — Atlanta, Georgia, United States
• Northside Hospital, Inc. - Central Research Department — Atlanta, Georgia, United States
• Northside Hospital, Inc. - GCS/Northside — Atlanta, Georgia, United States
• Northside Hospital, Inc. - GCS/Canton — Canton, Georgia, United States
• Atlanta Cancer Care - Cumming — Cumming, Georgia, United States
• Atlanta Cancer Care - Decatur — Decatur, Georgia, United States
• Northside Hospital, Inc.-GCS/Stemmer — Decatur, Georgia, United States
• Atlanta Cancer Care - Stockbridge — Jonesboro, Georgia, United States
• Northside Hospital, Inc.-GCS/Macon — Macon, Georgia, United States
• Northside Hospital, Inc.-GCS/Kennestone — Marietta, Georgia, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer institute — Boston, Massachusetts, United States
• Siteman Cancer Center - St.Peters — City of Saint Peters, Missouri, United States
• Siteman Cancer Center - West County — Creve Coeur, Missouri, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Washington University Infusion Center Pharmacy — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Stanford Cancer Center — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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