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Angiogenesis Inhibitor

Combination Therapy with Cediranib, Olaparib, and Durvalumab for Advanced Solid Tumors (DAPPER Trial)

Phase 2
Waitlist Available
Led By Lillian Siu, MD
Research Sponsored by University Health Network, Toronto
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 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a combination of medicines to help the immune system fight advanced colorectal, pancreatic, and soft tissue cancers. It aims to see if these new treatments can be more effective for patients whose cancers are hard to treat with standard therapies.

Who is the study for?
Adults with advanced colorectal cancer, pancreatic adenocarcinoma, or leiomyosarcoma that's not curable and has failed standard therapy can join. They must be willing to use effective contraception, provide tumor tissue samples, have normal organ function, and no recent major surgeries. Excluded are those with certain heart conditions, uncontrolled hypertension or seizures, recent bleeding events or blood transfusions.
What is being tested?
The trial tests combinations of Olaparib (a pill for DNA repair inhibition), Cediranib (a pill for blocking blood vessel growth in tumors), and Durvalumab (an IV drug boosting immune response against cancer). Participants will receive treatments based on their assigned cohort to see how these drugs affect tumor biomarkers.
What are the potential side effects?
Possible side effects include fatigue, nausea, diarrhea from Olaparib; high blood pressure and fatigue from Cediranib; infusion reactions like fever or chills and autoimmune-like symptoms such as skin rash or thyroid issues from Durvalumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in genomic and immune biomarkers that will be measured in the baseline biopsy and the first on-treatment biopsy by applying a log-transformation and the t-test.

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
8%
Colitis
8%
Dry mouth
8%
Dry skin
8%
Fever
8%
Anal pain
8%
Edema limbs
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Small intestinal obstruction
8%
Thromboembolic event
8%
Urinary frequency
8%
Urinary tract pain
5%
Confusion
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Anemia
5%
Ascites
5%
Gastroesophageal reflux disease
5%
Hypomagnesemia
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Rash acneiform
5%
Sinus bradycardia
5%
Upper respiratory infection
5%
Urinary urgency
5%
Vaginal hemorrhage
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Colonic perforation
3%
Dysarthria
3%
Blood bilirubin increased
3%
CPK increased
3%
Creatinine increased
3%
Myositis
3%
Rectal hemorrhage
3%
Hypothyroidism
3%
Left ventricular systolic dysfunction
3%
Lethargy
3%
Muscle weakness left-sided
3%
Myocarditis
3%
Rectal pain
3%
Weight Loss
3%
Fall
3%
Generalized muscle weakness
3%
Hyperglycemia
3%
Hyperkalemia
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Pleural effusion
3%
Skin infection
100%
80%
60%
40%
20%
0%
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
Group I: Cohort BExperimental Treatment2 Interventions
Cediranib (given orally at a dose of 20 mg daily, 5 days on 2 days off) in combination with Durvalumab (given intravenously at a dose of 1500 mg every 4 weeks)
Group II: Cohort AExperimental Treatment2 Interventions
Olaparib (given orally at a dose of 300 mg twice a day) in combination with Durvalumab (given intravenously at a dose of 1500 mg every 4 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2190
Cediranib
2016
Completed Phase 3
~4030
Durvalumab
2017
Completed Phase 2
~3780

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Leiomyosarcoma (LMS) treatments often target specific pathways to inhibit tumor growth and spread. Durvalumab, a PD-L1 inhibitor, works by blocking the PD-L1 protein on cancer cells, enhancing the immune system's ability to detect and destroy these cells. Olaparib, a PARP inhibitor, prevents cancer cells from repairing their DNA, leading to cell death, particularly in cells with existing DNA repair deficiencies. Cediranib, a VEGFR inhibitor, blocks vascular endothelial growth factor receptors, reducing blood supply to the tumor and inhibiting its growth. These mechanisms are crucial for LMS patients as they offer targeted approaches to disrupt cancer cell survival and proliferation, potentially improving treatment outcomes.
Integrating Precision Medicine into the Contemporary Management of Gynecologic Cancers.PARP Inhibition Elicits STING-Dependent Antitumor Immunity in Brca1-Deficient Ovarian Cancer.The safety of antiangiogenic agents and PARP inhibitors in platinum-sensitive recurrent ovarian cancer.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,519 Previous Clinical Trials
502,981 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
56 Patients Enrolled for Leiomyosarcoma
AstraZenecaIndustry Sponsor
4,379 Previous Clinical Trials
288,740,200 Total Patients Enrolled
Lillian Siu, MDPrincipal InvestigatorPrincess Margaret Cancer Centre
25 Previous Clinical Trials
14,557 Total Patients Enrolled

Media Library

Leiomyosarcoma Clinical Trial 2023: Cediranib Highlights & Side Effects. Trial Name: NCT03851614 — Phase 2
~3 spots leftby Jan 2025
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