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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 an Eastern Cooperative Oncology Group (ECOG) performance score (PS) score of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group

Study 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
Select...
My cancer is confirmed and does not respond to standard treatments.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have at least one tumor that can be measured.

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%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Increased Urinary Frequency
15%
Weight gain
15%
Abdominal Pain
13%
Arthralgia
10%
Dizziness
10%
Bladder infection
10%
Anxiety
10%
Nasal congestion
10%
Vaginal discharge
8%
Colitis
8%
Dry skin
8%
Hot flashes
8%
Fever
8%
Dry mouth
8%
Myalgia
8%
Thromboembolic event
8%
Anal pain
8%
Small intestinal obstruction
8%
Urinary frequency
8%
Headache
8%
Urinary tract pain
8%
Edema limbs
8%
Flatulence
5%
Renal and urinary disorders - Other, specify
5%
Gastroesophageal reflux disease
5%
Pneumonitis
5%
Upper respiratory infection
5%
Urinary urgency
5%
Vaginal hemorrhage
5%
Rash acneiform
5%
Mucositis oral
5%
Lymphedema
5%
Anemia
5%
Confusion
5%
Sinus bradycardia
5%
Hypomagnesemia
5%
Memory impairment
5%
Adrenal insufficiency
5%
Ascites
3%
Alkaline phosphatase increased
3%
Alanine aminotransferase increased
3%
CPK increased
3%
Hypothyroidism
3%
Generalized muscle weakness
3%
Pain in extremity
3%
Aspartate aminotransferase increased
3%
Left ventricular systolic dysfunction
3%
Lethargy
3%
Myocarditis
3%
Rectal hemorrhage
3%
Rectal pain
3%
Hyperglycemia
3%
Peripheral sensory neuropathy
3%
Colonic perforation
3%
Creatinine increased
3%
Myositis
3%
Hyperkalemia
3%
Blood bilirubin increased
3%
Muscle weakness left-sided
3%
Pleural effusion
3%
Skin infection
3%
Dysarthria
3%
Weight Loss
3%
Fall
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

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
~3870

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,943 Previous Clinical Trials
1,775,277 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,576 Previous Clinical Trials
41,224,136 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,219 Previous Clinical Trials
289,739,911 Total Patients Enrolled

Media Library

Danvatirsen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT02983578 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Treatment (danvatirsen, durvalumab)
Non-Small Cell Lung 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

Frequently Asked Questions

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

Are people currently being recruited for this experiment?

"Currently, this study is not enrolling new patients. It was originally posted on March 2nd 2017 but the most recent update occurred on October 20th 2022. If you are interested in other trials, there are 5671 clinical trials for carcinoma and 338 trials involving Durvalumab that are still recruiting participants."

Answered by AI

What is the total number of participants for this research project?

"Unfortunately, this clinical study is not currently looking for more patients. The trial was opened on March 2nd, 2017 and has not recruited since October 20th, 2022. However, there are 5671 other trials for carcinoma that are open and 338 studies concerning Durvalumab that are actively enrolling participants."

Answered by AI

What are the possible dangers associated with taking Durvalumab?

"Durvalumab's safety was given a 2 because, while there is some data supporting its safety, there is no evidence that it is an effective medication."

Answered by AI

What are the most similar investigations to Durvalumab?

"Durvalumab is being trialed in 338 studies, with the majority of these trials (51) being Phase 3. Most of these clinical trials are based out of Cordoba, Texas; however, there are 12905 different locations running Durvalumab trials."

Answered by AI

What are the common treatments that include Durvalumab?

"Durvalumab is indicated for the treatment of unresectable stage iii non-small cell lung cancer. In some cases, it may also be used to treat metastatic ureter urothelial carcinoma and advance directives."

Answered by AI
~1 spots leftby Apr 2024