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Checkpoint Inhibitor
Niraparib + Dostarlimab for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Robert R McWilliams
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological/cytological confirmation of diagnosis of metastatic pancreatic ductal adenocarcinoma
At least one but no more than two prior lines of systemic therapy for metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial studies niraparib and dostarlimab as a treatment for pancreatic cancer that has spread to other places in the body and has mutations in the BRCA1/2 or PALB2 gene.
Who is the study for?
This trial is for adults with metastatic pancreatic cancer that has specific genetic mutations (BRCA1/2 or PALB2). Participants should have had no more than two prior chemotherapy treatments, including a platinum agent, and must be in fairly good health with an ECOG performance status of 0 or 1. Pregnant individuals, those who've had certain immune conditions or severe reactions to immunotherapy, and anyone unwilling to use contraception are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of Niraparib, which blocks enzymes needed for tumor growth, and Dostarlimab, an antibody that may help the immune system fight cancer. It's a phase II study designed to see how well these drugs work together in treating patients whose pancreatic cancer has spread.See study design
What are the potential side effects?
Potential side effects include allergic reactions to drug components; blood disorders like anemia; fatigue; issues from immune system overactivity such as inflammation in organs; digestive problems due to absorption interference by niraparib; and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis of pancreatic cancer was confirmed through tissue or cell testing.
Select...
I have had 1 or 2 treatments for my cancer that has spread.
Select...
I am fully active or can carry out light work.
Select...
I have a harmful genetic mutation identified in my test results.
Select...
I have received platinum-based chemotherapy as an initial or follow-up treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Disease control rate at 12 weeks (DCR12)
Secondary outcome measures
Incidence of adverse events (AEs)
Objective response rate (ORR)
Overall survival (OS)
+3 moreOther outcome measures
Changes in circulating tumor DNA (ctDNA) profile after therapy with a PARP inhibitor (i) and a PD-1 inhibitor
Changes in the cytokine profile pre- and post-treatment
Genetic profile of the tumor pre- and post-treatment
+3 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%
Alanine aminotransferase increased
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Anxiety
9%
Back pain
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Skin tear
4%
Diarrhea
4%
Flu like symptoms
4%
Oral petechia
4%
Sinus pain
4%
Syncope
4%
Esophageal ulcer
4%
Bruising
4%
Leukocytosis
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 1-21. Patients also receive dostarlimab IV over 30 minutes on day 1 Q3W for cycles 1-4 and Q6W for subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
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?
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,349 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,227 Previous Clinical Trials
3,771,646 Total Patients Enrolled
Robert R McWilliamsPrincipal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have stomach or intestine problems affecting medicine absorption.I am still recovering from side effects or complications of my last surgery or treatment.I have not had a blood transfusion or received growth factors in the last 4 weeks.I have severe anemia, low white blood cell count, or low platelet count from past chemotherapy.I have not received any live vaccines in the last 30 days and do not plan to during the study.I do not have any uncontrolled illnesses or mental health issues.I have been treated with PARP inhibitors and immunotherapy together.My diagnosis of pancreatic cancer was confirmed through tissue or cell testing.I have brain metastases, uncontrolled seizures, or an active neurological condition.I have had 1 or 2 treatments for my cancer that has spread.I have had a bone marrow transplant or intense chemotherapy needing stem cell support.I have a history of myelodysplastic syndrome or acute myeloid leukemia.I have a condition that weakens my immune system.I am not using or cannot use birth control.You are expected to live for at least 3 more months.I am fully active or can carry out light work.You have a disease that can be measured or evaluated according to iRECIST guidelines.I had severe side effects from previous immunotherapy.I have recently undergone radiotherapy or radionuclide treatment.I am willing to have more biopsies if needed.I do not have any serious bacterial infections.I had cancer treatment within the last 2 years before this study.I have a harmful genetic mutation identified in my test results.I have active hepatitis B or C.I have or had tuberculosis.I have an active or suspected unstable autoimmune disease.I have received platinum-based chemotherapy as an initial or follow-up treatment.Your blood test results for certain levels (like kidney function, red blood cells, white blood cells, and liver function) need to be within a certain range.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (niraparib, dostarlimab)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many guinea pigs are participating in this test?
"That is correct. The clinical trial, which was posted on December 28th 2020, appears to be recruiting patients based on the information available from clinicaltrials.gov . 20 individuals are required for this study that will take place across 3 medical facilities."
Answered by AI
What are the main indications for Niraparib?
"Niraparib shows efficacy in treating primary peritoneal cancer, as well as advanced endometrial cancer for patients who have not responded to platinum-based chemotherapy. Additionally, this medication can be used to treat fallopian tube cancer."
Answered by AI
What are some of the risks associated with taking Niraparib?
"Niraparib is at a Phase 2 level, so there is only some data supporting its safety. This score of 2 reflects that lack of evidence for efficacy."
Answered by AI
Is Niraparib a common drug to test in medical research?
"Niraparib is being investigated in 112 different clinical trials, 14 of which are Phase 3. Most of these studies are located in Washington D.C., though there are 3147 total locations for these Niraparib trials."
Answered by AI
Are patients currently able to sign up for this clinical trial?
"Yes, this trial is still looking for patients. 28 December 2020 was when the listing was first created and it has been updated as recently as 20 September 2022."
Answered by AI
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