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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best objective response
Secondary outcome measures
Disease control (DC)
Duration of response (DOR)
Incidence of adverse events
+2 moreSide 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%
Back pain
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (niraparib, dostarlimab)Experimental Treatment2 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) 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 on day 1. Cycles repeat every 42 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dostarlimab
2020
Completed Phase 2
~1000
Niraparib
2018
Completed Phase 4
~1540
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,748 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,798 Total Patients Enrolled
Elizabeth M. SwisherPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 14 days.My brain metastases are stable, not bleeding, and I haven't needed steroids or seizure meds for over a week.I do not have any serious health issues that are not under control.I had a severe reaction to previous immunotherapy, except for minor lab changes.I am not pregnant, can avoid pregnancy, or cannot become pregnant.I am fully active or have some restrictions but can still care for myself.I do not have a bowel blockage that prevents me from eating or absorbing pills.I have an autoimmune disease but haven't needed strong medication for it in the last 2 years.I agree not to donate blood during and for 3 months after the study.I have been diagnosed with HIV.I have never had myelodysplastic syndrome or acute myeloid leukemia.I have been on a stable dose of corticosteroids for at least 4 weeks.I have advanced cancer in specific areas with a confirmed BRCA mutation and standard treatments haven't worked or caused intolerance.I have an immune system disorder or have taken immune-weakening medicines in the last week.I haven't been treated for any cancer other than skin or in situ cervical cancer in the last 2 years.Your absolute neutrophil count must be at least 1,500 per microliter.I haven't had significant radiation therapy affecting my bone marrow recently.I am not allergic to niraparib or dostarlimab.I agree to use birth control from the first to 180 days after the last treatment dose.I have been treated with immune checkpoint inhibitors but not with PARP inhibitors.I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.I can take medicine by mouth.I haven't had a blood transfusion in the last 4 weeks.I am willing to have biopsy procedures before and during treatment.Your hemoglobin level is 9 grams per deciliter or higher.Your platelet count is at least 100,000 per microliter.My kidney function, measured by creatinine levels, is within the normal range.Your total bilirubin level must be within a certain range, unless you have a specific condition called Gilbert's syndrome.I am 18 years old or older.My breast cancer is tested for HER2, ER, and PR.You are expected to live for at least 4 months.I have active hepatitis B or C.Your tumor can be measured using specific guidelines called RECIST 1.1.Your liver enzymes (AST and ALT) should not be more than 2.5 times the upper limit of normal, unless you have cancer that has spread to your liver, in which case they should not be more than 5 times the upper limit of normal.I haven't taken PARP inhibitors and immune checkpoint inhibitors for my condition.I have never had interstitial lung disease.I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.I haven't taken any colony stimulating factors in the last 4 weeks.I've had PARP inhibitor treatment but no immune checkpoint inhibitors.Your blood clotting time is not too high unless you are already taking medication to prevent blood clots.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (niraparib, dostarlimab)
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.
Has Niraparib's efficacy been confirmed by the FDA?
"The safety of Niraparib has been assessed a score 1, as this is only the first phase in its clinical trials. This implies that there exists limited data on both efficacy and safety."
Answered by AI
What is the uppermost cap on participants in this investigation?
"Affirmative. Data on clinicaltrials.gov shows that this trial is actively recruiting participants, with the initial posting occurring on October 18th 2021 and most recent update being made on September 27th 2022. This medical experiment necessitates 18 candidates at a single location."
Answered by AI
Are there any related investigations into the effects of Niraparib?
"At the moment, 115 clinical trials involving Niraparib are taking place—14 of which are in Phase 3. The primary hub for these studies is Washington DC, though 3321 locations worldwide have active research being conducted on this medication."
Answered by AI
Are there current opportunities to join the testing group?
"According to clinicaltrials.gov, this research is currently in a recruitment phase; it was originally posted on October 18th 2021 and last edited on September 27 2022."
Answered by AI
What effects has Niraparib been proven to produce therapeutically?
"Niraparib is commonly used to treat primary peritoneal cancer, as well as advanced mismatch repair-deficient (dmmr) endometrial cancer, disease progression during or after chemotherapy with platinum agents and fallopian tubes carcinoma."
Answered by AI
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