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Monoclonal Antibodies

Chemotherapy Combination for Pancreatic Cancer

Phase 2

Waitlist Available

Research Sponsored by Canadian Cancer Trials Group

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 35 months

Awards & highlights

Study Summary

This trial is testing a new combination of chemotherapy drugs for treating this disease. The new combination consists of gemcitabine, nab-paclitaxel, and ipatasertib.

Who is the study for?

This trial is for adults with metastatic pancreatic ductal adenocarcinoma who haven't had treatment for their advanced disease. They must have measurable disease, be in good health otherwise, and not have used certain drugs before. Participants need to provide tissue and blood samples, complete quality of life questionnaires, use effective contraception if childbearing potential exists, and be able to follow the trial procedures.Check my eligibility

What is being tested?

The study compares standard chemotherapy (gemcitabine and nab-paclitaxel) against a combination that adds two immunotherapy drugs (durvalumab and tremelimumab). The goal is to see if adding these immune-targeting drugs can better treat this type of cancer compared to the usual approach.See study design

What are the potential side effects?

Common side effects may include reactions at the infusion site, fatigue, nausea, low blood counts increasing infection risk. Immunotherapies like durvalumab and tremelimumab could cause immune system-related effects such as inflammation in various organs or worsen pre-existing autoimmune conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 35 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~35 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 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

Secondary outcome measures

Objective Response Rate

Progression Free Survival

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

2Treatment groups

Experimental Treatment

Active Control

Group I: Gemcitabine + Nab-Paclitaxel + Durvalumab + TremelimumabExperimental Treatment4 Interventions

Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days. plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.

Group II: Gemcitabine plus Nab-PaclitaxelActive Control2 Interventions

Gemcitabine 1000 mg/m2 IV & Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~2070

Nab-paclitaxel

2014

Completed Phase 3

~2030

Durvalumab

2017

Completed Phase 2

~3870

Tremelimumab

2017

Completed Phase 2

~3380

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor

4,257 Previous Clinical Trials

288,593,606 Total Patients Enrolled

Canadian Cancer Trials GroupLead Sponsor

124 Previous Clinical Trials

67,273 Total Patients Enrolled

Derek JonkerStudy ChairOttawa Hospital Research Institute, ON Canada

4 Previous Clinical Trials

469 Total Patients Enrolled

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02879318 — Phase 2

Pancreatic Adenocarcinoma Research Study Groups: Gemcitabine plus Nab-Paclitaxel, Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab

Pancreatic Adenocarcinoma Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT02879318 — Phase 2

Durvalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02879318 — Phase 2

Frequently Asked Questions

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

Are there currently any open enrollments for this clinical trial?

"At present, this trial is not enrolling participants. It was originally listed on August 22nd 2016 and last modified on September 6th 2022. If you are seeking alternative studies in the area of adenocarcinoma there are currently 788 ongoing trials while 1396 Durvalumab trails have open enrollment."

Answered by AI

How many locations are actively conducting this experiment?

"Presently, 27 sites are offering this clinical trial to patients. Toronto, Saskatoon and Montreal are among the participating cities, with other locations listed elsewhere. Participants who wish to take part should select the closest medical centre in order to minimize travel requirements."

Answered by AI

What potential risks are associated with Durvalumab treatment?

"Durvalumab's safety has been partially demonstrated in Phase 2 trials, so it was given a rating of 2. Unfortunately, no studies have yet conclusively proved its efficacy."

Answered by AI

How have previous research endeavors with Durvalumab turned out?

"At present, there are 1396 Durvalumab trials in progress, 356 of which are currently at Phase 3. Notably, these research efforts extend beyond Shanghai as 67907 different clinical sites across the world run study on this drug."

Answered by AI

How many individuals have been recruited to participate in this trial?

"As of now, this particular research is not calling for any more volunteers. The trial was uploaded on August 22nd 2016 and its details were last updated on September 6th 2022. For those looking for other trials involving adenocarcinoma, 788 studies are recruiting while 1396 experiments demand participants to try Durvalumab treatments."

Answered by AI

What applications of Durvalumab have experienced the most success?

"Durvalumab is the standard treatment for malignant peritoneal neoplasm and can also be advantageous in treating various other pathologies, such as those that have not been treated previously or responded to adjuvant anthracycline-containg therapy."

Answered by AI

Recent research and studies

Nature CommunicationsJournal

The CCTG PA.7 Phase II Trial of Gemcitabine and Nab-paclitaxel with or Without Durvalumab and Tremelimumab as Initial Therapy in Metastatic Pancreatic Ductal Adenocarcinoma

Renouf, Daniel J., Jonathan M. Loree, Jennifer J. Knox, James T. Topham, Petr Kavan, Derek Jonker, Stephen Welch, et al.. 2022. “The CCTG PA.7 Phase II Trial of Gemcitabine and Nab-paclitaxel with or Without Durvalumab and Tremelimumab as Initial Therapy in Metastatic Pancreatic Ductal Adenocarcinoma”. Nature Communications. Springer Science and Business Media LLC. doi:10.1038/s41467-022-32591-8.

clinicaltrials.govStudy

Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma

2016. "Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02879318.

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