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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

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs and radiation therapy to treat pancreatic cancer that has spread. It aims to help patients whose cancer may not respond to usual treatments. The drugs work by boosting the immune system and preventing cancer cells from fixing themselves, while radiation directly damages the cancer cells. Gemcitabine was the first agent investigated for its potential to improve symptoms and overall well-being in patients with advanced pancreatic cancer.

Eligible Conditions

Pancreatic Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 17 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease Control Rate With RECIST 1.1 Criteria

Secondary study objectives

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%

Paresthesia

20%

Sore throat

20%

Urine discoloration

20%

Delirium

20%

Cough

20%

Dizziness

20%

Lymphocyte count decreased

13%

Insomnia

13%

Palpitations

13%

Neutrophil count decreased

13%

Thrush

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%

Localized edema

Papulopustular rash

Skin infection

Hematuria

Oral pain

Stroke

Superficial thrombophlebitis

Urinary retention

Tremor

Obesity

Thyroid stimulating hormone increased

Hemorrhoidal hemorrhage

Erectile dysfunction

Skin ulceration

Urinary frequency

Oral hemorrhage

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Osteoporosis

Generalized muscle weakness

Encephalopathy

Endocarditis infective

Eye disorders - Other, specify

Pelvic pain

Prostatic obstruction

Pruritus

Rash acneiform

Rectal pain

Renal calculi

Reproductive system and breast disorders - Other, specify

Wheezing

Portal vein thrombosis

Vaginal dryness

Alopecia

Arthralgia

Arthritis

Bacteremia

Biliary tract infection

Blood lactate dehydrogenase increased

Buttock pain

Dry skin

Dysgeusia

Flank pain

Gastric anastomotic leak

Gastric ulcer

Gastritis

Gastrointestinal disorders - Other, specify

Gastrointestinal pain

Hyperlipidemia

Hypoglycemia

Lethargy

Memory impairment

Mucositis oral

Muscle cramp

Muscle weakness lower limb

Myocarditis

Restlessness

Scleral disorder

Sepsis

100%

80%

60%

40%

20%

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 2

~780

Dostarlimab

FDA approved

Niraparib

FDA approved