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PD-1 Inhibitor
Niraparib + Dostarlimab for Brain Cancer
Phase 2
Recruiting
Led By Timothy Yap, MBBS,PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial is testing if a combo of drugs can help control advanced cancer that has spread to the brain.
Who is the study for?
Adults (18+) with advanced cancers that have spread to the brain, including specific types such as BRCA1/2m cancer and various lung and breast cancers. Participants must have had previous treatment, possess measurable brain metastasis not requiring immediate intervention or steroids, and adequate organ function. They cannot be pregnant or breastfeeding and must agree to contraception.Check my eligibility
What is being tested?
The trial is testing a combination of two drugs: Niraparib, a PARP inhibitor, and Dostarlimab, a PD-1 inhibitor. The goal is to see if these drugs can control advanced cancer in patients whose disease has progressed into the brain.See study design
What are the potential side effects?
Potential side effects may include fatigue, nausea, blood count changes for Niraparib; immune-related reactions like inflammation in organs or skin rashes for Dostarlimab. Each patient's experience with side effects could vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: MonotherapyExperimental Treatment2 Interventions
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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,993 Previous Clinical Trials
1,792,560 Total Patients Enrolled
Timothy Yap, MBBS,PHDPrincipal InvestigatorM.D. Anderson Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of my waking hours.I cannot swallow pills or have a gut condition affecting medication absorption.My organs are functioning well.I am 18 years old or older.I do not have untreated spinal issues causing symptoms.I am not currently on any cancer treatment trials.I do not have cancer spread to the lining of my brain and spinal cord.I had another cancer but have been cancer-free for 2 years after treatment.I haven't had specific brain radiation treatments in the last 1-2 weeks.I have a brain tumor that can be measured.I haven't had radiation therapy affecting more than 20% of my bone marrow in the last 2 weeks.My high blood pressure is not under control.I haven't had cancer treatment in the last 2 weeks.I had brain surgery or radiation at least a week ago.I am HIV positive, on effective treatment, and my viral load is undetectable with a CD4 count ≥350.My genetic test shows actionable changes in certain genes related to cancer repair.I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.I have never had interstitial lung disease.I do not have prostate cancer.I have cancer that has spread to my brain and it is one of the specified types.I have an active hepatitis B or C infection.I have not received any live vaccines in the last 30 days.I have received at least one treatment for my cancer.I am a male and agree to follow specific study conditions.I was previously diagnosed with MDS or AML.I have previous tumor tissue samples available.I am not pregnant and agree to use effective birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy
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.
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