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Antisense Oligonucleotide

Danvatirsen + Durvalumab for Advanced Resistant Cancers

Phase 2
Waitlist Available
Led By David S Hong
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a histological confirmation of pancreatic cancer, mismatch deficient colorectal cancer, or non-small cell lung cancer (NSCLC) that is refractory to standard therapy or for which no standard of care regimen currently exists
Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension with specific size criteria
Must not have
Is still experiencing toxicity related to prior treatment and assessed as Common Terminology Criteria for Adverse Events (CTCAE) grade > 1
Has active or prior documented inflammatory bowel disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Summary

This trial is testing a new combination therapy for pancreatic, lung, and colon cancers that have spread and become resistant to treatment.

Who is the study for?
This trial is for adults with advanced pancreatic, non-small cell lung cancer or mismatch repair deficient colorectal cancer that's resistant to treatment. Participants must have a good performance status, measurable disease, and meet specific blood criteria. They should not be pregnant and must agree to use contraception.Check my eligibility
What is being tested?
The trial tests danvatirsen (which blocks proteins needed for tumor growth) combined with durvalumab (an immunotherapy antibody). It aims to see if this combo is more effective in treating these cancers compared to current standards.See study design
What are the potential side effects?
Potential side effects include immune system reactions that can affect organs, infusion-related responses, allergic reactions similar to other monoclonal antibodies, and possibly worsening of pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed and does not respond to standard treatments.
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I have at least one tumor that can be measured.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am still feeling side effects from previous treatments that are moderate or worse.
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I have or had inflammatory bowel disease.
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I have a history of primary immunodeficiency.
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I have had lung inflammation or scarring before.
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I do not have severe diseases like uncontrolled bleeding, HIV, or active hepatitis.
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I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.
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I have another type of cancer besides the one being studied.
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I had severe side effects from previous immunotherapy.
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I have had an organ transplant and am on immunosuppressive drugs.
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I have a history of tuberculosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Characterization of immune infiltrates
Incidence of adverse events (AEs), serious AEs
Incidence of treatment-emergent AEs (TEAEs), SAEs and death(s)
+7 more
Secondary outcome measures
Best overall response (including CR, PR, SD, and progressive disease [PD], according to RECIST version 1.1 criteria)
Disease control
Duration of response according to RECIST version 1.1 criteria
+3 more
Other outcome measures
Radiomic measurements

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
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (danvatirsen, durvalumab)Experimental Treatment2 Interventions
Patients receive danvatirsen IV over 1 hour on days 7, 5 and 3 prior to cycle 1, then on days 1, 8, 15 and 22. Patients also receive durvalumab IV over 1 hour on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Danvatirsen
2019
Completed Phase 2
~90
Durvalumab
2017
Completed Phase 2
~3840

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,240 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,362 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,302 Previous Clinical Trials
288,624,560 Total Patients Enrolled

Media Library

Danvatirsen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT02983578 — Phase 2
Pancreatic Cancer Research Study Groups: Treatment (danvatirsen, durvalumab)
Pancreatic Cancer Clinical Trial 2023: Danvatirsen Highlights & Side Effects. Trial Name: NCT02983578 — Phase 2
Danvatirsen (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02983578 — Phase 2
~4 spots leftby Apr 2025
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