TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03964532|
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : February 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Talazoparib Drug: Avelumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||TALAVE: A Pilot Trial of Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer|
|Actual Study Start Date :||April 17, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Phase I/Phase II
Talazoparib (1mg by mouth [PO] daily D1-28) will be provided as monotherapy for the first cycle. Starting with cycle 2 and for all subsequent cycles, treatment with avelumab (800 mg intravenously [IV] D1 every 2 weeks) will be added to talazoparib.
Talazoparib (formerly MDV3800 and BMN673) is an oral small molecule, selective inhibitor of PARP-1 and PARP-2.
Other Name: Talzenna
Avelumab (formerly MSB0010718C) is a human immunoglobulin G1 (IgG1) anti-PD-L1 monoclonal antibody131 that utilizes both adaptive and innate immune mechanisms.
Other Name: Bavencio
- The number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: 28 Days ]Toxicity analysis will be conducted in all patients receiving at least one dose of talazoparib.
- The anti-tumor efficacy as measured by Overall Response Rate (ORR). [ Time Frame: 4 Months ]The distributions of OS will be estimated using the Kaplan-Meier method.
- The anti-tumor efficacy as measured by Progression Free Survival (PFS). [ Time Frame: Up to 5 years ]
- The anti-tumor efficacy as measured by Overall Survival (OS). [ Time Frame: Up to 5 years ]
- The anti-tumor efficacy as measured by Duration of Response (DOR). [ Time Frame: Up to 5 years ]
- The anti-tumor efficacy as measured by Disease Control Rate (DCR). [ Time Frame: Up to 5 years ]
- PDL1 expression in serial biopsies by IHC. [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964532
|Contact: Julie Collins, MD||202-444-2223||Julie.Collins@gunet.georgetown.edu|
|Contact: Natalie Salsinifirstname.lastname@example.org|
|United States, District of Columbia|
|MedStar Georgetown University Hospital||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: Natalie Salsini 202-687-9016 email@example.com|
|Principal Investigator: Julie Collins, MD|
|United States, North Carolina|
|Levine Cancer Institute||Recruiting|
|Charlotte, North Carolina, United States, 28204|
|Contact: Leah Wilson 704-863-2318 Leah.J.Wilson@atriumhealth.org|
|Principal Investigator: Arielle Heeke, MD|
|United States, Utah|
|University of Utah, Huntsman Cancer Institute||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Anne Fitzgerald 801-213-6230 Anne.Fitzgerald@hci.utah.edu|
|Sub-Investigator: Mei Wei, MD|