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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
Life expectancy of greater than 3 months.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 17 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Study Summary

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

Eligible Conditions
  • Pancreatic Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are expected to live for more than 3 months.

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%
Abdominal distension
33%
Aortic valve disease
33%
Back pain
33%
Diarrhea
33%
Edema limbs
33%
Fever
33%
Hypocalcemia
33%
Sinus tachycardia
27%
Depression
27%
White blood cell decreased
27%
Chills
27%
Ascites
27%
Hyponatremia
20%
Urine discoloration
20%
Pain
20%
Sore throat
20%
Delirium
20%
Cough
20%
Dizziness
20%
Lymphocyte count decreased
20%
Paresthesia
13%
Thrush
13%
Neutrophil count decreased
13%
Pain in extremity
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%
Insomnia
13%
Localized edema
13%
Palpitations
7%
Urinary frequency
7%
Tremor
7%
Hematuria
7%
Encephalopathy
7%
Oral pain
7%
Osteoporosis
7%
Skin infection
7%
Obesity
7%
Oral hemorrhage
7%
Erectile dysfunction
7%
Superficial thrombophlebitis
7%
Skin ulceration
7%
Stroke
7%
Generalized muscle weakness
7%
Urinary retention
7%
Endocarditis infective
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Hemorrhoidal hemorrhage
7%
Thyroid stimulating hormone increased
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%
Papulopustular rash
7%
Restlessness
7%
Scleral disorder
7%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Niraparib+Dostarlimab + Radiation

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~1020
Dostarlimab
FDA approved
Niraparib
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,898 Previous Clinical Trials
13,184,168 Total Patients Enrolled
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,532 Total Patients Enrolled
Theodore S Hong, MDPrincipal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
171 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What physical ailments is Dostarlimab generally employed to alleviate?

"Generally, dostarlimab is primarily prescribed for primary peritoneal cancer. In other cases, it can be applied to advanced mismatch repair-deficient (dmmr) endometrial cancer which has not responded to platinum-based chemotherapy and fallopian tubes cancer."

Answered by AI

To what extent has this research study been populated by participants?

"This trial is no longer accepting participants. Initially posted on July 23rd 2020, and last updated September 7th 2022, the study has since concluded its recruitment phase. For those looking for other clinical trials related to malignant neoplasm of pancreas or Dostarlimab there are presently 704 and 115 studies respectively that are actively enrolling patients."

Answered by AI

Are there any vacancies available in this clinical research program?

"The recruitment for this clinical trial has since concluded, with the initial posting on July 23rd 2020 and a final update on September 7th 2022. Nonetheless, there are still numerous studies recruiting patients affected by malignant neoplasm of pancreas (704) and Dostarlimab (115)."

Answered by AI

Has Dostarlimab received regulatory endorsement from the FDA?

"Based on prior research, the safety of Dostarlimab is rated as a 2 since this Phase 2 trial includes data suggesting its security but lacks evidence for efficacy."

Answered by AI

What prior research exists regarding Dostarlimab's efficacy?

"As of now, 115 clinical trials are underway to test the efficacy of Dostarlimab with 14 in Phase 3. Most have been set up near Washington DC and a total of 3320 sites are hosting these studies."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New Jersey
Colorado
How old are they?
65+
18 - 65
What site did they apply to?
Massachusetts General Hospital Cancer Center
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Most responsive sites:
  1. Beth Israel Deaconess Medical Center: < 24 hours
Typically responds via
Email
Average response time
  • < 1 Day
~4 spots leftby Feb 2025