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TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer

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

Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE May 28, 2019
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE April 17, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
To evaluate 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
To assess 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.
Current Other Pre-specified Outcome Measures
 (submitted: June 24, 2019)
  • 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 ]
Original Other Pre-specified Outcome Measures
 (submitted: May 24, 2019)
  • To assess the anti-tumor efficacy as measured by Progression Free Survival (PFS). [ Time Frame: Up to 5 years ]
  • To assess the anti-tumor efficacy as measured by Overall Survival (OS). [ Time Frame: Up to 5 years ]
  • To assess the anti-tumor efficacy as measured by Duration of Response (DOR). [ Time Frame: Up to 5 years ]
  • To assess the anti-tumor efficacy as measured by Disease Control Rate (DCR). [ Time Frame: Up to 5 years ]
  • To measure PDL1 expression in serial biopsies by IHC. [ Time Frame: Up to 5 years ]
 
Descriptive Information
Brief Title  ICMJE TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer
Official Title  ICMJE TALAVE: A Pilot Trial of Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Talazoparib
  • Drug: Avelumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julie Collins, MD 202-444-2223 Julie.Collins@gunet.georgetown.edu
Contact: Nellie Novielli, RN 202-784-3923 noviella@georgetown.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03964532
Other Study ID Numbers  ICMJE STUDY00000023
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Georgetown University
Study Sponsor  ICMJE Georgetown University
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Georgetown University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP