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PARP Inhibitor

Niraparib + Dostarlimab for Cancer

Phase 1

Recruiting

Led By Elizabeth M. Swisher

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1

Participant must have breast, pancreas, ovary, fallopian tube or primary peritoneal cancer that is unresectable or metastatic, with a pathogenic mutation in BRCA1 or BRCA2 (either germline or somatic) as confirmed by next generation gene sequencing such as University of Washington (UW) OncoPlex assay or equivalent, and who have experienced progression or been intolerant to standard therapies for their disease

Must not have

Participant has received a live vaccine within 14 days of initiating protocol therapy

Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the combination of two drugs to treat patients with BRCA-mutated cancer. Niraparib is an inhibitor of PARP, an enzyme that helps repair DNA. TSR-042 is an immunotherapy that may help the body's immune system attack the cancer.

Who is the study for?

Adults with certain types of cancer (breast, pancreas, ovary, fallopian tube, or primary peritoneal) that can't be surgically removed or has spread and have a BRCA mutation. They must have acceptable blood counts and organ function, agree to contraception if applicable, not breastfeed during the trial period, and could undergo biopsies. Excluded are those with recent major surgeries or therapies, active infections or other serious health issues.

What is being tested?

The trial is testing niraparib (a PARP inhibitor that stops cancer cells from repairing their DNA) combined with TSR-042 (an immunotherapy drug). The goal is to see if this combination helps the immune system fight cancer better and prevents tumor growth in patients with specific advanced cancers.

What are the potential side effects?

Possible side effects include allergic reactions to medication components; blood count changes leading to increased infection risk; fatigue; digestive issues; potential complications for those who've had prior severe immune-related adverse events.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or have some restrictions but can still care for myself.

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I have advanced cancer in specific areas with a confirmed BRCA mutation and standard treatments haven't worked or caused intolerance.

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I can take medicine by mouth.

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I am willing to have biopsy procedures before and during treatment.

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My kidney function, measured by creatinine levels, is within the normal range.

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I am 18 years old or older.

Exclusion Criteria

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

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I have not received a live vaccine in the last 14 days.

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I do not have any serious health issues that are not under control.

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I do not have a bowel blockage that prevents me from eating or absorbing pills.

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I have an autoimmune disease but haven't needed strong medication for it in the last 2 years.

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I have been diagnosed with HIV.

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I have never had myelodysplastic syndrome or acute myeloid leukemia.

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I have an immune system disorder or have taken immune-weakening medicines in the last week.

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I haven't been treated for any cancer other than skin or in situ cervical cancer in the last 2 years.

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I haven't had significant radiation therapy affecting my bone marrow recently.

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I am not allergic to niraparib or dostarlimab.

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I have active hepatitis B or C.

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I have never had interstitial lung disease.

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I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Best objective response

Secondary study objectives

Disease control (DC)

Duration of response (DOR)

Incidence of adverse events

+1 more

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347

74%

Fatigue

52%

Nausea

39%

Constipation

39%

Anorexia

30%

Anemia

30%

Alkaline phosphatase increased

26%

Weight loss

22%

Abdominal pain

22%

Dizziness

22%

Insomnia

22%

Dyspnea

17%

Platelet count decreased

17%

Headache

17%

Mucositis oral

17%

Creatinine increased

13%

Rash maculo-papular

13%

Vomiting

13%

Aspartate aminotransferase increased

13%

Sinus tachycardia

Dehydration

Cough

Urinary tract infection

Dry mouth

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Upper respiratory infection

Hoarseness

Hypotension

Postnasal drip

Head injury

Hyponatremia

Flu like symptoms

Hyperglycemia

Neutrophil count decreased

Tremor

Hot flashes

Hypokalemia

Diarrhea

Depression

Itchy eyes

Edema limbs

Bruising

Esophageal ulcer

Hyperkalemia

Peripheral sensory neuropathy

Leukocytosis

White blood cell decreased

Skin tear

Oral petechia

Lung infection

Bloating

Unknown infection

Hematuria

Ascites

Sinus pain

Sore throat

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

Cohort B

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: Treatment (niraparib, dostarlimab)Experimental Treatment6 Interventions

Patients receive niraparib PO QD on days 1-28 of cycle 1. Beginning cycle 2, patients receive niraparib PO QD on days 1-21 and dostarlimab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 6, patients receive niraparib PO QD on days 1-42 and dostarlimab IV over 30 minutes on day 1. Cycles repeat every 42 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo biopsy, blood sample collection, and CT or MRI throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1150

Biospecimen Collection

2004

Completed Phase 3

~2030