Talazoparib + Avelumab for Breast Cancer

Recruiting at 2 trial locations

Overseen By Nicole Swanson

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Georgetown University

Must not be taking: Anti-PD-1, Anti-PD-L1, PARP inhibitors, P-gp inhibitors

Disqualifiers: CNS metastases, Severe infection, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Claudine Isaacs, MD

Principal Investigator

Georgetown University

Eligibility Criteria

This trial is for adults with advanced breast cancer that can't be cured by surgery or radiation, who are in good physical condition (ECOG 0-1), and have a life expectancy over 3 months. They must not have used PARP inhibitors before, no recent severe infections or certain chronic diseases like HIV or hepatitis B, and no history of serious allergic reactions to similar drugs. Women must not be pregnant and should agree to contraception.

Inclusion Criteria

You are expected to live for at least 3 more months.

My advanced breast cancer cannot be cured with surgery or radiotherapy, but it can be biopsied.

I have fully recovered from my recent surgery.

Exclusion Criteria

I am not pregnant or breastfeeding.

I have not had any cancer except for non-melanoma skin cancer in the last 2 years.

I have not received a live vaccine in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive talazoparib monotherapy (1mg by mouth daily) for the first cycle

4 weeks

1 visit (in-person)

Combination Treatment

Participants receive talazoparib with avelumab (800 mg IV every 2 weeks) starting from cycle 2

4 months

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• Avelumab
• Talazoparib

Trial Overview The TALAVE trial tests the safety of Talazoparib alone first (induction phase) followed by its combination with Avelumab in treating advanced breast cancer. The study also looks at how this treatment might affect the body's immune response to cancer.

Participant Groups

Group I: Phase I/Phase II Experimental Treatment 2 Interventions

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 is already approved in United States, European Union for the following indications:

Approved in United States as Talzenna for:

• Deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer

Approved in European Union as Talzenna for:

• Monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University