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PD-1 Inhibitor

Dostarlimab for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Theodore S Hong, MD
Research Sponsored by Massachusetts General Hospital
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 up to 17 months
Awards & highlights

Summary

This trial will test if a combination of dostarlimab, niraparib, and radiation therapy can help control metastatic pancreatic cancer.

Eligible Conditions
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 17 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 17 months 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 With RECIST 1.1 Criteria
Secondary outcome measures
Disease Control Rate With irRECIST Criteria
Number of Treatment-Related Adverse Events Per CTCAE v5.0
Overall Survival
+1 more

Side effects data

From 2022 Phase 2 trial • 18 Patients • NCT04409002
80%
Anemia
80%
Fatigue
73%
Abdominal pain
67%
CD4 lymphocytes decreased
67%
Alkaline phosphatase increased
67%
Nausea
60%
Anorexia
60%
Constipation
53%
Platelet count decreased
53%
Hyperglycemia
47%
Thromboembolic event
47%
Weight loss
47%
Anxiety
47%
Hypoalbuminemia
40%
Vomiting
40%
Peripheral motor neuropathy
40%
Blood bilirubin increased
40%
Dyspnea
40%
Hypertension
33%
Edema limbs
33%
Abdominal distension
33%
Aortic valve disease
33%
Back pain
33%
Diarrhea
33%
Fever
33%
Hypocalcemia
33%
Sinus tachycardia
27%
Depression
27%
White blood cell decreased
27%
Chills
27%
Ascites
27%
Hyponatremia
20%
Pain
20%
Urine discoloration
20%
Paresthesia
20%
Sore throat
20%
Delirium
20%
Cough
20%
Dizziness
20%
Lymphocyte count decreased
13%
Palpitations
13%
Pain in extremity
13%
Insomnia
13%
Thrush
13%
Neutrophil count decreased
13%
Confusion
13%
Dehydration
13%
Fall
13%
Cardiac troponin T increased
13%
Alanine aminotransferase increased
13%
Aspartate aminotransferase increased
13%
Bloating
13%
Dry mouth
13%
Dysphagia
13%
Dysuria
13%
Flatulence
13%
Gastroesophageal reflux disease
13%
Glucosuria
13%
Hiccups
13%
Hypercalcemia
13%
Hyperkalemia
13%
Hypokalemia
13%
Hypophosphatemia
13%
Hypothyroidism
13%
Localized edema
7%
Stroke
7%
Skin ulceration
7%
Hematuria
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Thyroid stimulating hormone increased
7%
Oral pain
7%
Obesity
7%
Oral hemorrhage
7%
Encephalopathy
7%
Generalized muscle weakness
7%
Osteoporosis
7%
Urinary retention
7%
Papulopustular rash
7%
Skin infection
7%
Endocarditis infective
7%
Erectile dysfunction
7%
Hemorrhoidal hemorrhage
7%
Urinary frequency
7%
Superficial thrombophlebitis
7%
Tremor
7%
Eye disorders - Other, specify
7%
Pelvic pain
7%
Prostatic obstruction
7%
Pruritus
7%
Rash acneiform
7%
Rectal pain
7%
Renal calculi
7%
Reproductive system and breast disorders - Other, specify
7%
Wheezing
7%
Portal vein thrombosis
7%
Vaginal dryness
7%
Alopecia
7%
Arthralgia
7%
Arthritis
7%
Bacteremia
7%
Biliary tract infection
7%
Blood lactate dehydrogenase increased
7%
Buttock pain
7%
Dry skin
7%
Dysgeusia
7%
Flank pain
7%
Gastric anastomotic leak
7%
Gastric ulcer
7%
Gastritis
7%
Gastrointestinal disorders - Other, specify
7%
Gastrointestinal pain
7%
Hyperlipidemia
7%
Hypoglycemia
7%
Lethargy
7%
Memory impairment
7%
Mucositis oral
7%
Muscle cramp
7%
Muscle weakness lower limb
7%
Myocarditis
7%
Restlessness
7%
Scleral disorder
7%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Niraparib+Dostarlimab + Radiation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Niraparib+Dostarlimab + RadiationExperimental Treatment3 Interventions
Each study treatment cycle lasts 21 days Niraparib oral, once a day, predetermined dose.Dosing will commence on cycle 1 day 1 and will continue until the participant is taken off treatment Dostarlimab by intravenous infusion once every cycle for as long as they remain on the study Radiation therapy on every other week day of cycle 2 only. Radiation will begin on Cycle 2 Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2003
Completed Phase 2
~780
Dostarlimab
FDA approved
Niraparib
FDA approved

Find a Location

Who is running the clinical trial?

Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,508 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,212,660 Total Patients Enrolled
Theodore S Hong, MDPrincipal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
171 Total Patients Enrolled
~4 spots leftby Jul 2025
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