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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

No Placebo-Only Group

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.

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.

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

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

Primary study objectives

Overall Survival

Secondary study objectives

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%

Anorexia

30%

Constipation

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1920

Nab-paclitaxel

2014