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Monoclonal Antibodies

Radiation + Immunotherapy + PARP Inhibitor for Breast Cancer (NADiR Trial)

Phase 2

Recruiting

Led By Alice Ho, MD, MBA

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Prior progression on immune-checkpoint inhibitor and/or PDL1-negative

ECOG performance status ≤ 1

Must not have

Receipt of >2 lines of chemo in the metastatic setting

Known history of active TB (Bacillus Tuberculosis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment to end of treatment up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test to see if the addition of Dostarlimab and Niraparib to Radiation Therapy will be safe and effective in treating participants with metastatic triple negative breast cancer.

Who is the study for?

This trial is for adults with metastatic triple negative breast cancer who need radiation therapy and haven't had a positive response to immune-checkpoint inhibitors or are PDL1-negative. Participants must have good organ function, not be pregnant, agree to use contraception, and can't have certain conditions like active hepatitis, known BRCA mutations, brain metastases, recent major surgery or immunosuppressive treatments.

What is being tested?

The study tests the safety and effectiveness of combining Dostarlimab (an immunotherapy drug) with Niraparib (a PARP inhibitor) alongside standard Radiation Therapy in treating metastatic triple negative breast cancer. The goal is to see if this combination works better than current treatments.

What are the potential side effects?

Possible side effects include fatigue, allergic reactions to medication components, digestive issues such as nausea or constipation from Niraparib; skin reactions from radiation; and immune-related effects like inflammation from Dostarlimab.

Eligibility Criteria

Inclusion Criteria

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

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My cancer progressed after treatment with immune-checkpoint inhibitors or is PDL1-negative.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I need radiation therapy for symptom relief or to control the cancer's spread.

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I am 18 years old or older.

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I have a tumor that is suitable for radiation therapy.

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I agree to use birth control during and for 3 months after the study.

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I have at least one tumor that can be measured and has not been treated with radiation.

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My breast cancer has spread or come back.

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I can swallow and keep down pills.

Exclusion Criteria

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

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I have received more than 2 chemotherapy treatments for my cancer after it spread.

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I have an active tuberculosis infection.

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I had a severe reaction to previous immunotherapy.

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I am currently on medication for an infection.

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I have been treated with both a PARP inhibitor and an immune checkpoint inhibitor.

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I have not had any major surgery in the last 3 weeks.

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I have or had lung inflammation or disease needing steroid treatment.

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I have active Hepatitis B or C.

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I have a positive BRCA gene mutation.

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I have active brain metastases or leptomeningeal disease.

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I have been treated for an autoimmune disease in the last 2 years.

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I do not have any serious, uncontrolled medical conditions or active infections.

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I have a history of MDS or AML.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment to end of treatment up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment to end of treatment up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to end of treatment 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

Overall response rate (ORR)-RECIST

Secondary study objectives

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0

Overall response rate (ORR) by irRECIST criteria

Overall survival (OS)

+1 more

Other study objectives

Changes in TILs

ctDNA

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%

Vomiting

13%

Rash maculo-papular

13%

Aspartate aminotransferase increased

13%

Sinus tachycardia

Cough

Urinary tract infection

Dry mouth

Dehydration

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Upper respiratory infection

Hoarseness

Hypotension

Postnasal drip

Head injury

Hypokalemia

Hyponatremia

Flu like symptoms

Hyperglycemia

Neutrophil count decreased

Tremor

Hot flashes

Diarrhea

Depression

Itchy eyes

Oral petechia

Edema limbs

Bruising

Esophageal ulcer

Hyperkalemia

Peripheral sensory neuropathy

Leukocytosis

White blood cell decreased

Skin tear

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: Niraparib + Dostarlimab + Radiation therapyExperimental Treatment3 Interventions

Study cycle length is 3 weeks. Participants will receive: * Niraparib 1x daily during each study cycle * Dostarlimab 1x every 3 weeks for 4 study cycles, then 1x every 6 weeks beginning on Cycle 5 * Radiation therapy will be given on Days 1, 2, and 3 of Cycle 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

2018

Completed Phase 4

~2400

Dostarlimab

2019

Completed Phase 3

~1940