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

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: locally advanced (primary or recurrent) or metastatic solid tumors with a pathogenic or likely pathogenic germline or loss-of-function somatic BRCA1, or BRCA2, or ATM gene defect
Sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Enrollment: 541
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

August 9, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\. Pathogenic or likely pathogenic germline or somatic gene defect as determined by local assessment and classification:
•\- One or more BRCA1 or BRCA2 gene defect (Cohort 1\);
•\- ATM gene defect in the absence of concurrent BRCA 1/2 defect (Cohort 2\).
•2\. Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent, as follows:
•a. Recurrent Epithelial Ovarian Cancer;
•b. TNBC (defined as ER\- and PgR\-negative \[IHC nuclear staining \<5%] and HER2\-negative \[IHC 0, 1\+, or 2\+ and/or ISH non\-amplified with ratio less than 2\.0]) or hormone\-receptor\-positive (HR\+), HER2\-negative breast cancer;
•c. Metastatic castration\-resistant prostate cancer (mCRPC) without small cell features;
•d. Metastatic ductal adenocarcinoma of the pancreas;
•e. Any other advanced solid tumor.
•3\. Availability of a fresh or recent tumor tissue sample from a diagnostic biopsy/surgery or a metastatic tumor biopsy; the sample must have been obtained within 24 months prior to study enrollment. When only bone disease is present, an archival tumor tissue sample obtained within 5 years prior to study enrollment may be accepted for non\-prostate cancer patients and a fresh bone biopsy may be accepted for prostate cancer patients only).

•1\. Prior treatment with a PARP inhibitor.
•2\. Prior immunotherapy with anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, or anti\-CTLA\-4 antibody.
•3\. Prior anti\-cancer therapy within 2 weeks prior to study enrollment or prior radiation therapy within 2 weeks prior to study enrollment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed at least 2 days prior to study enrollment and no clinically significant toxicities are expected (eg, mucositis, esophagitis).
•4\. Major surgery within 4 weeks prior to study enrollment.
•5\. Current use of immunosuppressive medication at the time of study enrollment, EXCEPT for the following permitted steroids: see Section 4\.2\.
•6\. Known prior severe hypersensitivity to investigational products or any component in their formulations, including known severe hypersensitivity reactions to monoclonal antibodies (\[NCI CTCAE] v4\.03 Grade \= 3\).
•7\. Known history of immune\-mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
•8\. Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypoor hyperthyroid disease not requiring immunosuppressive treatment are eligible.
•9\. Prior organ transplantation including allogenic stem\-cell transplantation.
•10\. Administration of live attenuated vaccines within 4 weeks of study enrollment.