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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. Identifier: NCT03964532
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : September 2, 2020
Information provided by (Responsible Party):
Georgetown University

Brief Summary:
This is a multi-institutional pilot trial for patients with advanced breast cancer. The trial is designed to assess the safety and tolerability of induction talazoparib followed by combination of talazoparib and avelumab. As an exploratory endpoint, the study team will evaluate the immunomodulatory effects of induction talazoparib followed by the combination of talazoparib and avelumab in patients with advanced breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Talazoparib Drug: Avelumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Avelumab

Arm Intervention/treatment
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.
Drug: Talazoparib
Talazoparib (formerly MDV3800 and BMN673) is an oral small molecule, selective inhibitor of PARP-1 and PARP-2.
Other Name: Talzenna

Drug: Avelumab
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. The anti-tumor efficacy as measured by Progression Free Survival (PFS). [ Time Frame: Up to 5 years ]
  2. The anti-tumor efficacy as measured by Overall Survival (OS). [ Time Frame: Up to 5 years ]
  3. The anti-tumor efficacy as measured by Duration of Response (DOR). [ Time Frame: Up to 5 years ]
  4. The anti-tumor efficacy as measured by Disease Control Rate (DCR). [ Time Frame: Up to 5 years ]
  5. PDL1 expression in serial biopsies by IHC. [ Time Frame: Up to 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed advanced breast cancer not amenable to curative treatment by surgery or radiotherapy, that is amenable to biopsy
  • Radiographically measurable disease by RECIST v1.1
  • Age ≥ 18 years
  • Life expectancy of more than 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Signed informed consent form
  • Adequate hepatic, bone marrow, and renal function as defined below in the body of the protocol

Exclusion Criteria:

  • Prior exposure to PARP inhibitor-based therapy
  • Prior disease progression while receiving anti-PD-1 or anti-PD-L1 therapy within 6 months of use
  • Recent severe infection or antibiotic use, or known chronic infection with human immunodeficiency virus (HIV) or hepatitis B virus
  • Diagnosis of immunodeficiency or is receiving systemic steroid or other immunosuppressive therapy
  • Active autoimmune disease that has required systemic treatment in the past 2 years
  • History of tuberculosis
  • History of allogenic bone marrow transplant or solid organ transplant
  • Live vaccine administration within 30 days of planned start of study therapy
  • Cardiovascular disease problems including unstable angina, therapy for lifethreatening ventricular arrhythmia, or myocardial infarction, stroke within the last 6 months, or a diagnosis of congestive heart failure
  • Women who are pregnant or breastfeeding
  • Patients with known untreated central nervous system (CNS) metastases
  • Patients with history of another active malignancy within the past 2 years, excluding non-melanoma carcinoma of the skin
  • Patients receiving any other investigational agents

Information from the National Library of Medicine

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 identifier (NCT number): NCT03964532

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Contact: Julie Collins, MD 202-444-2223
Contact: Nellie Novielli, RN 202-784-3923

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United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Nellie Novielli, RN    202-784-3923   
Principal Investigator: Julie Collins, MD         
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Melani Terry    704-863-2318   
Principal Investigator: Arielle Heeke, MD         
Sponsors and Collaborators
Georgetown University
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Responsible Party: Georgetown University Identifier: NCT03964532    
Other Study ID Numbers: STUDY00000023
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Georgetown University:
Breast Cancer
Advanced Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents