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PD-L1 Inhibitor

Durvalumab for Pancreatic Adenocarcinoma

Q: Has Durvalumab received the regulatory go-ahead from the Food and Drug Administration?

There is evidence to suggest that Durvalumab has a degree of safety, as such it was rated with a score of 2 due to the fact that this Phase 2 trial does not yet have any efficacy data.

Q: What is the enrollment size of this experiment?

This medical trial is not currently accepting candidates. It was initially posted on November 9th 2018 and last edited on November 18 2022. For those interested in other trials, there are 787 clinical studies looking for adenocarcinoma patients and 333 Durvalumab related investigations actively recruiting participants.

Q: Are new participants being accepted into this research project?

Contrary to what is posted on clinicaltrials.gov, this study has closed its recruitment and no longer seeks patients. It was initially published in November 2018 before being last edited four years later; however, 1120 other trials are currently enrolling participants at the time of writing.

Q: Have any other research initiatives studied Durvalumab?

At present, 333 clinical trials involving Durvalumab are active with 52 in the final stage of testing. Although a few are based out of Cordoba, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>, there is an expansive network of 12937 sites that have enlisted to run trial studies on this medication.

Q: What has Durvalumab been empirically demonstrated to address?

Durvalumab is usually used as a therapeutic option for individuals with inoperable stage 3 non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>. It can also be utilized to treat metastatic ureter urothelial carcinoma and other advanced conditions.

Phase 2

Waitlist Available

Led By Michael D. Chuong, MD

Research Sponsored by Baptist Health South Florida

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 1 year

Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines a drug called Durvalumab with Radiation Therapy.

Eligible Conditions

Pancreatic Adenocarcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival

Secondary outcome measures

Clinical Benefit Rate (CBR)

Overall Response Rate (ORR)

Overall Survival (OS)

+1 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129

65%

Fatigue

63%

Abdominal pain

55%

Diarrhea

43%

Pain

40%

Weight loss

35%

Hypertension

30%

Constipation

30%

Anorexia

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Back pain

15%

Cough

15%

Abdominal Pain

15%

Weight gain

15%

Increased Urinary Frequency

13%

Arthralgia

10%

Anxiety

10%

Bladder infection

10%

Dizziness

10%

Nasal congestion

10%

Vaginal discharge

Edema limbs

Fever

Anal pain

Dry skin

Colitis

Thromboembolic event

Dry mouth

Flatulence

Headache

Hot flashes

Myalgia

Urinary tract pain

Urinary frequency

Small intestinal obstruction

Anemia

Ascites

Confusion

Pneumonitis

Sinus bradycardia

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Memory impairment

Vaginal hemorrhage

Hypomagnesemia

Upper respiratory infection

Mucositis oral

Rash acneiform

Urinary urgency

Gastroesophageal reflux disease

Lymphedema

Rectal hemorrhage

Colonic perforation

Generalized muscle weakness

Hyperkalemia

Lethargy

Myocarditis

Fall

Skin infection

Hypothyroidism

Muscle weakness left-sided

Alanine aminotransferase increased

Hyperglycemia

Pleural effusion

Creatinine increased

Rectal pain

Aspartate aminotransferase increased

Dysarthria

Myositis

CPK increased

Pain in extremity

Peripheral sensory neuropathy

Alkaline phosphatase increased

Blood bilirubin increased

Left ventricular systolic dysfunction

Weight Loss

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Durvalumab plus Radiation TherapyExperimental Treatment2 Interventions

Durvalumab 1500 mg (or 20 mg/m2 if <30 kg) IV every 4 weeks plus 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

Radiation Therapy

2017

Completed Phase 3

~7250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Baptist Health South FloridaLead Sponsor

48 Previous Clinical Trials

7,822 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,267 Previous Clinical Trials

288,606,972 Total Patients Enrolled

Michael D. Chuong, MDPrincipal InvestigatorMiami Cancer Institute at Baptist Health, Inc.

Frequently Asked Questions

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

Has Durvalumab received the regulatory go-ahead from the Food and Drug Administration?

"There is evidence to suggest that Durvalumab has a degree of safety, as such it was rated with a score of 2 due to the fact that this Phase 2 trial does not yet have any efficacy data."

Answered by AI

What is the enrollment size of this experiment?

"This medical trial is not currently accepting candidates. It was initially posted on November 9th 2018 and last edited on November 18 2022. For those interested in other trials, there are 787 clinical studies looking for adenocarcinoma patients and 333 Durvalumab related investigations actively recruiting participants."

Answered by AI

Are new participants being accepted into this research project?

"Contrary to what is posted on clinicaltrials.gov, this study has closed its recruitment and no longer seeks patients. It was initially published in November 2018 before being last edited four years later; however, 1120 other trials are currently enrolling participants at the time of writing."

Answered by AI

Have any other research initiatives studied Durvalumab?

"At present, 333 clinical trials involving Durvalumab are active with 52 in the final stage of testing. Although a few are based out of Cordoba, Texas, there is an expansive network of 12937 sites that have enlisted to run trial studies on this medication."

Answered by AI

What has Durvalumab been empirically demonstrated to address?

"Durvalumab is usually used as a therapeutic option for individuals with inoperable stage 3 non-small cell lung cancer. It can also be utilized to treat metastatic ureter urothelial carcinoma and other advanced conditions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Durvalumab and "Booster" Radiation in Metastatic Adenocarcinoma of the Pancreas

2018. "Durvalumab and "Booster" Radiation in Metastatic Adenocarcinoma of the Pancreas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03490760.