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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to end of treatment up to 5 years
Awards & highlights
NADiR Trial 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.Check my eligibility
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.See study design
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.
NADiR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer progressed after treatment with immune-checkpoint inhibitors or is PDL1-negative.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
I need radiation therapy for symptom relief or to control the cancer's spread.
Select...
I am 18 years old or older.
Select...
I have a tumor that is suitable for radiation therapy.
Select...
I agree to use birth control during and for 3 months after the study.
Select...
I have at least one tumor that can be measured and has not been treated with radiation.
Select...
My breast cancer has spread or come back.
Select...
I can swallow and keep down pills.
NADiR Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)-RECIST
Secondary outcome measures
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 moreOther outcome measures
Changes in TILs
ctDNA
Side effects data
From 2022 Phase 2 trial • 37 Patients • NCT0320734774%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Alkaline phosphatase increased
30%
Anemia
26%
Weight loss
22%
Abdominal pain
22%
Dyspnea
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Vomiting
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Back pain
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Flu like symptoms
4%
Leukocytosis
4%
Oral petechia
4%
Sinus pain
4%
Syncope
4%
Bruising
4%
Unknown infection
4%
Ascites
4%
Itchy eyes
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Depression
4%
Edema limbs
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Head injury
4%
Hypokalemia
4%
Hyperkalemia
4%
Postnasal drip
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
NADiR 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
~1540
Dostarlimab
2020
Completed Phase 2
~1000
Radiation therapy
2013
Completed Phase 3
~2850
Find a Location
Who is running the clinical trial?
University of North CarolinaOTHER
167 Previous Clinical Trials
1,449,595 Total Patients Enrolled
5 Trials studying Breast Cancer
1,341,652 Patients Enrolled for Breast Cancer
Johns Hopkins UniversityOTHER
2,266 Previous Clinical Trials
14,837,465 Total Patients Enrolled
27 Trials studying Breast Cancer
23,476 Patients Enrolled for Breast Cancer
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,449 Total Patients Enrolled
80 Trials studying Breast Cancer
132,880 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received more than 2 chemotherapy treatments for my cancer after it spread.You have a sample of tumor tissue collected within the last 28 days.I have an active tuberculosis infection.I have had another cancer that got worse or needed treatment in the past 2 years.I had a severe reaction to previous immunotherapy.My cancer progressed after treatment with immune-checkpoint inhibitors or is PDL1-negative.I am currently on medication for an infection.You have a known history of HIV.I have not received a live vaccine in the last 14 days.I am fully active and can carry on all my pre-disease activities without restriction.My breast cancer is triple-negative or has low hormone receptor levels and is HER2-negative.I have been treated with both a PARP inhibitor and an immune checkpoint inhibitor.I need radiation therapy for symptom relief or to control the cancer's spread.I am not pregnant and agree to avoid pregnancy during the study.You are allergic to the ingredients in niraparib or dostarlimab.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I haven't had cancer drugs or targeted therapy in the last 2 weeks and have recovered from any side effects.I have not had any major surgery in the last 3 weeks.I have or had lung inflammation or disease needing steroid treatment.I am 18 years old or older.I have a tumor that is suitable for radiation therapy.I have active Hepatitis B or C.I haven't taken any colony stimulating factors in the last 4 weeks.I have a positive BRCA gene mutation.I have active brain metastases or leptomeningeal disease.I have previously received targeted therapy or immunotherapy.I agree to use birth control during and for 3 months after the study.I have at least one tumor that can be measured and has not been treated with radiation.I have been treated for an autoimmune disease in the last 2 years.I haven't been in a drug study or used a new medical device in the last 4 weeks.I haven't had a blood transfusion in the last 4 weeks.I do not have any serious, uncontrolled medical conditions or active infections.I have a history of MDS or AML.My organs are functioning well, as tested within the last 8 days.My breast cancer has spread or come back.I can swallow and keep down pills.
Research Study Groups:
This trial has the following groups:- Group 1: Niraparib + Dostarlimab + Radiation therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How hazardous are the effects of Niraparib on human health?
"Our team at Power gave Niraparib a rating of 2, as this is an experimental Phase 2 trial and there is limited evidence to support its safety in humans."
Answered by AI
How many participants are allotted for this clinical experiment?
"This clinical trial requires 32 candidates who meet the outlined eligiblity requirements. Patients can join this investigation at several locations, such as Johns Hopkins in Baltimore and Massachusetts General Hospital Cancer Centre in Boston."
Answered by AI
What medical condition does Niraparib typically aim to rectify?
"Niraparib is a promising treatment for primary peritoneal cancer, advanced mismatch repair-deficient (dmmr) endometrial cancer, and malignancies that have grown resistant to platinum-based chemotherapy."
Answered by AI
Is this clinical experiment open for enrollment at the present time?
"Affirmative. According to clinicaltrials.gov, this health investigation is in the process of enrolling individuals and has been since July 21st 2021. As of April 13th 2022, 32 participants have to be gathered from 5 different medical facilities."
Answered by AI
To what extent have prior investigations explored Niraparib's potential?
"Presently, 115 medical trials are underway for Niraparib with 14 of those in the final phase. Although most studies originate from Washington D.C., 3,320 locations globally have opened their doors to participants wanting to take part."
Answered by AI
What is the breadth of localities where this clinical research project is running?
"The trial is operated from 8 different sites, the most prominent of which are Johns Hopkins in Baltimore, Maryland; Massachusetts General Hospital Cancer Center in Boston, Massachusetts; and University of North carolina Medical Centre in Chapel Hill, North Carolina."
Answered by AI
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