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Checkpoint Inhibitor

Niraparib + Dostarlimab for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Robert R. McWilliams, M.D.
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 below
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My diagnosis of pancreatic cancer was confirmed through tissue or cell testing.
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I have had 1 or 2 treatments for my cancer that has spread.
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I am fully active or can carry out light work.
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I am willing to have more biopsies if needed.
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I have a harmful genetic mutation identified in my test results.
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I have received platinum-based chemotherapy as an initial or follow-up treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more
Other 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 more

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347
74%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Alkaline phosphatase increased
30%
Anemia
26%
Weight loss
22%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Creatinine increased
17%
Platelet count decreased
17%
Mucositis oral
13%
Sinus tachycardia
13%
Vomiting
13%
Aspartate aminotransferase increased
13%
Rash maculo-papular
9%
Back pain
9%
Urinary tract infection
9%
Dehydration
9%
Blood bilirubin increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Depression
4%
Hyperkalemia
4%
Edema limbs
4%
Esophageal ulcer
4%
Neutrophil count decreased
4%
Lung infection
4%
Hypokalemia
4%
Peripheral sensory neuropathy
4%
White blood cell decreased
4%
Sore throat
4%
Skin tear
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Leukocytosis
4%
Syncope
4%
Itchy eyes
4%
Hyponatremia
4%
Flu like symptoms
4%
Postnasal drip
4%
Hypotension
4%
Hoarseness
4%
Sinus pain
4%
Bloating
4%
Diarrhea
4%
Head injury
4%
Oral petechia
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Upper respiratory infection
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?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,758,029 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,624 Total Patients Enrolled
Robert R. McWilliams, M.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Dostarlimab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04493060 — Phase 2
Pancreatic Cancer Clinical Trial 2023: Dostarlimab Highlights & Side Effects. Trial Name: NCT04493060 — Phase 2
Dostarlimab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04493060 — Phase 2
Pancreatic Cancer Research Study Groups: 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
~5 spots leftby Mar 2025