Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
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 belowSelect...
My cancer is confirmed and does not respond to standard treatments.
Select...
I have at least one tumor that can be measured.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
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 moreSecondary 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 moreOther outcome measures
Radiomic measurements
Side effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
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
~3870
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,742 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,114 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,747 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have certain levels of specific components in your blood.I have not had a live vaccine in the last 28 days.I have finished my previous cancer treatments and waited the required time before starting a new treatment.My brain metastases are stable and previously treated.My cancer is confirmed and does not respond to standard treatments.My spinal cord compression is stable, without symptoms, and I haven't needed steroids for over 4 weeks.I am still feeling side effects from previous treatments that are moderate or worse.I have or had inflammatory bowel disease.I have a history of primary immunodeficiency.I have had lung inflammation or scarring before.I do not have severe diseases like uncontrolled bleeding, HIV, or active hepatitis.I have or had an autoimmune disease in the last 2 years, with some exceptions.I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.I have another type of cancer besides the one being studied.I had severe side effects from previous immunotherapy.I have at least one tumor that can be measured.I have had an organ transplant and am on immunosuppressive drugs.I have a history of tuberculosis.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (danvatirsen, durvalumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger