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Monoclonal Antibodies

Durvalumab for Mesothelioma (PrE0505 Trial)

Q: What are the general conditions that Durvalumab is meant to target?

<p>Patients with unresectable stage iii non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>, who have not undergone any treatment prior, as well as those suffering from metastatic ureter urothelial carcinoma can be helped by Durvalumab.</p>

Phase 2

Waitlist Available

Research Sponsored by PrECOG, LLC.

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 from randomization until death, up to 32 months

Awards & highlights

PrE0505 Trial Summary

This trial will test if adding durvalumab to standard chemotherapy of pemetrexed and cisplatin can help people with pleural mesothelioma live longer.

Eligible Conditions

Mesothelioma

PrE0505 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until death, up to 32 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until death, up to 32 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until death, up to 32 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

Overall Survival (OS)

Secondary outcome measures

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03

Objective Response Rate (ORR)

Progression-Free Survival (PFS)

+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

PrE0505 Trial Design

1Treatment groups

Experimental Treatment

Group I: DurvalumabExperimental Treatment1 Intervention

Pemetrexed/cisplatin will be given for up to six 3-week cycles with the addition of concurrent durvalumab every 3 weeks. The first 6 patients who are enrolled and commence treatment will be monitored for safety of the combination. Use of carboplatin in place of cisplatin will be permitted for patients who are ineligible for cisplatin due to impaired renal function at screening. For patients that receive cisplatin, carboplatin may also be substituted after Cycle 1 for cisplatin related toxicity (e.g., grade 3 ototoxicity, grade 3 nausea) at the investigator's discretion. After completion of Cycle 6 of concurrent therapy, patients with stable or responding disease per modified RECIST for malignant mesothelioma will continue on single agent durvalumab every 3 weeks until progression. Maximum duration of durvalumab treatment is 12 months starting from Cycle 1 of concurrent treatment (inclusive of any treatment delays or missed treatments).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3870

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PrECOG, LLC.Lead Sponsor

17 Previous Clinical Trials

7,403 Total Patients Enrolled

1 Trials studying Mesothelioma

214 Patients Enrolled for Mesothelioma

AstraZenecaIndustry Sponsor

4,257 Previous Clinical Trials

288,593,731 Total Patients Enrolled

8 Trials studying Mesothelioma

1,077 Patients Enrolled for Mesothelioma

Patrick Forde, MDStudy ChairJohn Hopkins

5 Previous Clinical Trials

1,542 Total Patients Enrolled

2 Trials studying Mesothelioma

244 Patients Enrolled for Mesothelioma

Frequently Asked Questions

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

What are the general conditions that Durvalumab is meant to target?

"Patients with unresectable stage iii non-small cell lung cancer, who have not undergone any treatment prior, as well as those suffering from metastatic ureter urothelial carcinoma can be helped by Durvalumab."

Answered by AI

Could you please tell me how many hospitals are trialing this medication?

"There are 20 total sites for this clinical study, with locations in Fairfax, Evanston, La Jolla and other cities. If you are considering participating in the trial, please choose the location nearest to you to reduce travel time commitments."

Answered by AI

What are some possible risks associated with Durvalumab?

"Durvalumab's safety was given a score of 2. While there is some clinical evidence that the drug is safe, none of the available data supports its efficacy."

Answered by AI

What other research has been conducted using Durvalumab?

"As of now, 338 studies are underway for Durvalumab. Out of these, 51 are in Phase 3. Many trials for Durvalumab take place in Cordoba and Texas; however, there are 12905 total locations running Durvalumab studies."

Answered by AI

How many people are eligible to participate in this research project?

"No, this particular study has stopped recruiting patients. The listing was first put up on June 13th 2017 and the most recent update was on November 10th 2022. There are other trials though! As of right now, there are 158 different clinical trials for mesothelioma and 338 for Durvalumab that are still looking for individuals to enroll."

Answered by AI

Are researchers looking for more participants in this trial?

"This study has wrapped up recruitment and is no longer taking in patients. The trial was first posted on 6/13/2017 and was most recently updated on 11/10/2022. As of right now, there are 158 trials actively admitting participants with mesothelioma and 338 trials for Durvalumab currently looking for volunteers."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Understanding the New Therapeutic Options for Mesothelioma

Kindler, Hedy Lee. 2021. “Understanding the New Therapeutic Options for Mesothelioma”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00520-9.

Nature MedicineJournal

Durvalumab with Platinum-pemetrexed for Unresectable Pleural Mesothelioma: Survival, Genomic and Immunologic Analyses from the Phase 2 Pre0505 Trial

Forde, Patrick M., Valsamo Anagnostou, Zhuoxin Sun, Suzanne E. Dahlberg, Hedy L. Kindler, Noushin Niknafs, Thomas Purcell, et al.. 2021. “Durvalumab with Platinum-pemetrexed for Unresectable Pleural Mesothelioma: Survival, Genomic and Immunologic Analyses from the Phase 2 Pre0505 Trial”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-021-01541-0.

Nature MedicineJournal

Durvalumab with Platinum-pemetrexed for Unresectable Pleural Mesothelioma: Survival, Genomic and Immunologic Analyses from the Phase 2 Pre0505 Trial

clinicaltrials.govStudy

Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma