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PARP Inhibitor

Talazoparib + Avelumab for Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Claudine Isaacs, MD

Research Sponsored by Georgetown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed advanced breast cancer not amenable to curative treatment by surgery or radiotherapy, that is amenable to biopsy

Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Must not have

Prior exposure to PARP inhibitor-based therapy

Diagnosis of immunodeficiency or is receiving systemic steroid or other immunosuppressive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment combining two drugs. It will assess how well the treatment works and how safe it is.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include fatigue, nausea, blood cell count changes which could lead to increased infection risk or bleeding problems, potential heart issues due to ECG changes required for eligibility screening, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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I, or my legal representative, can understand and follow the study's requirements and have signed the consent form.

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I am 18 years old or older.

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I can swallow pills whole.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with PARP inhibitors before.

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I have an immune system disorder or am taking medication that weakens my immune system.

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I have not had major heart problems or strokes in the last 6 months.

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I have a history of specific lung conditions or signs of lung inflammation on a CT scan.

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I am not pregnant or breastfeeding.

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

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I haven't had radiation on more than 20% of my bone marrow.

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My condition worsened within 6 months while on anti-PD-1 or PD-L1 therapy.

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I have not had a severe infection, recent antibiotics, or chronic HIV or hepatitis B.

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I have brain metastases that have not been treated.

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I have had a bone marrow or organ transplant.

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I do not have any severe illnesses that would make it unsafe for me to join the study.

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I have had tuberculosis in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quantification of Grade 3 and 4 toxicities (Adverse Events)

Secondary study objectives

The anti-tumor efficacy as measured by Objective Response Rate (ORR).

Other study objectives

The anti-tumor efficacy as measured by Disease Control Rate (DCR).

The anti-tumor efficacy as measured by Duration of Response (DOR).

The anti-tumor efficacy as measured by Overall Survival (OS).

+1 more

Side effects data

From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777

100%

Fatigue

100%

Headache

67%

Platelet count decreased

67%

Hyperglycemia

67%

Anemia

67%

Back pain

33%

Lymphocyte count decreased

33%

Muscle weakness lower limb

33%

Fever

33%

Pain in extremity

33%

Weight loss

33%

Nervous system disorders - Other, PARALYSIS

33%

Hyponatremia

33%

Hypoglycemia

33%

Neutrophil count decreased

33%

White blood cell decreased

33%

Skin infection

33%

Hypokalemia

33%

Insomnia

33%

Sinus tachycardia

33%

Creatinine increased

33%

Alanine aminotransferase increased

33%

Peripheral sensory neuropathy

33%

Peripheral motor neuropathy

33%

Diarrhea

33%

Hypermagnesemia

33%

Constipation

33%

Hypophosphatemia

33%

Gastroesophageal reflux disease

33%

Skin ulceration

33%

Cough

33%

Non-cardiac chest pain

33%

Scoliosis

33%

Urinary incontinence

33%

Nystagmus

33%

Arthralgia

33%

Gait disturbance

33%

Edema limbs

33%

Hypertension

33%

Chills

33%

Investigations - Other, AST DECREASED

33%

Nervous system disorders - Other, HYPOTONIC

33%

Alopecia

33%

Aspartate aminotransferase increased

33%

Blurred vision

33%

Investigations - Other, ALT DECREASED

33%

Hypothyroidism

33%

Nausea

33%

Investigations - Other, BUN DECREASED

33%

Alkaline phosphatase increased

33%

Neuralgia

33%

Skin and subcutaneous tissue disorders - Other, LEFT LOWER LEG ERYTHEMA

33%

Anorexia

100%

80%

60%

40%

20%

Study treatment Arm

400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day

600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day

600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day

400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day

600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day

600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day

600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase I/Phase IIExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Talazoparib

2021

Completed Phase 2

~2810

Avelumab

2017

Completed Phase 2

~2440