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PD-L1 Inhibitor
Neoantigen Vaccine + Durvalumab for Small Cell Lung Cancer
Phase 2
Recruiting
Led By Jeffrey Ward, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least one lesion must be able to be biopsied at the time of enrollment
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of treatment (estimated to be 2 years)
Awards & highlights
Study Summary
This trial is testing a new vaccine for lung cancer. The hope is that it will help people with lung cancer live longer without the disease getting worse.
Who is the study for?
Adults with extensive stage small cell lung cancer (ES-SCLC) suitable for platinum-based chemo and durvalumab as a first treatment. They must have good organ function, be willing to use birth control, weigh over 30 kg, and have a life expectancy of at least 12 weeks. Exclusions include those with certain medical conditions or treatments that could interfere with the trial.Check my eligibility
What is being tested?
The trial is testing if adding a personalized neoantigen vaccine to the drug durvalumab improves survival without disease progression in ES-SCLC patients. Participants will receive regular blood draws and injections using the TDS-IM v2.0 Device alongside their standard treatment.See study design
What are the potential side effects?
Potential side effects may include typical reactions from vaccines such as soreness at injection site, fatigue, flu-like symptoms; Durvalumab can cause immune-related issues like inflammation in organs, infusion reactions similar to allergic responses, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that can be biopsied.
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I am post-menopausal or not pregnant if pre-menopausal.
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I weigh more than 30 kilograms.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I am 18 years old or older.
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My lung cancer is confirmed to be extensive stage small cell.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of treatment (estimated to be 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of treatment (estimated to be 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of combining durvalumab with a neoantigen vaccine as measured by the number of participants that had a vaccine produced for them
Safety and tolerability of the combination of durvalumab and a neoantigen vaccine as measured by number of participants experiencing adverse events
Secondary outcome measures
Duration of response (DOR)
Overall survival (OS)
Progression-free survival (PFS)
+1 moreSide 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: Neoantigen DNA vaccine+durvalumabExperimental Treatment4 Interventions
Patients will receive durvalumab (1500mg Q3W) in combination with standard of care carboplatin and etoposide for a total of 4 cycles given every 3 weeks
Beginning 4 weeks following Cycle 4 of carboplatin/etoposide/durvalumab, patients on will then receive 6 cycles of durvalumab 1500 mg with the polyepitope neoantigen DNA vaccine, both administered once every 4 weeks
Patients may then receive durvalumab every 4 weeks until disease progression or drug toxicity
Should a delay in vaccine preparation occur, patients will begin durvalumab and the vaccine will be added with the subsequent cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peripheral blood draws
2017
Completed Phase 1
~20
Durvalumab
2017
Completed Phase 2
~3870
Neoantigen DNA vaccine
2018
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,543 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,267 Previous Clinical Trials
288,612,184 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,780 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have shots or blood taken from my veins due to medical reasons.You have had an organ transplant from someone else.I agree to use effective birth control during and up to 90 days after treatment.I have been treated with a PD-1 or PD-L1 inhibitor before.I do not have any ongoing or chronic neurological conditions, except for a one-time fever-related seizure in childhood.My organs and bone marrow are functioning well.I do not have any current infections.You have a metal implant or device near where the injection will be given.I have a severe side effect that won't worsen with durvalumab, as confirmed by a specialist.I have had cancer spread to the lining of my brain and spinal cord.I have or had an autoimmune or inflammatory disorder.I am deemed fit for a specific chemotherapy combined with durvalumab for my small cell lung cancer.I have a tumor that can be biopsied.I may have significant nerve pain or damage, and will discuss this with the study leader.I am post-menopausal or not pregnant if pre-menopausal.You are expected to live for at least 12 weeks.I have fewer than 2 suitable spots for injection and electroporation.I don't have major side effects from past cancer treatments.I have had brain metastases.I weigh more than 30 kilograms.I haven't taken immunosuppressive drugs in the last 14 days.I haven't had major surgery in the last 28 days.You are currently using an electronic stimulation device that cannot be removed.I have not received a live vaccine in the last 30 days.I am fully active and can carry on all my pre-disease activities without restriction.I am 18 years old or older.My lung cancer is confirmed to be extensive stage small cell.I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.You have a history of a weak immune system that is currently active.I do not have any uncontrolled illnesses.You have had allergic reactions to drugs that are similar to durvalumab or other drugs being used in the study.I have had cancer before, but it fits the exceptions.You have a condition that can be measured accurately.
Research Study Groups:
This trial has the following groups:- Group 1: Neoantigen DNA vaccine+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.
What conditions is Durvalumab typically indicated for?
"Durvalumab is typically employed to treat unresectable Stage III non-small cell lung cancer, as well as metastatic ureteroileal carcinoma and other advanced directives."
Answered by AI
Is this trial currently accepting new participants?
"As displayed on clinicaltrials.gov, this study is actively seeking participants; it was initially announced on March 30th 2022 and has since been revised in early April of the same year."
Answered by AI
What other research initiatives have explored the use of Durvalumab?
"Presently, 333 clinical trials are actively researching the effects of Durvalumab with 52 in Phase 3. Most studies on this medication are situated in Cordoba, Texas; however, it is being trialed at 12,937 different sites across the world."
Answered by AI
What is the main aim of this medical research endeavor?
"According to AstraZeneca, the primary endpoint of this trial is assessing the feasibility of combining durvalumab with a neoantigen vaccine. This outcome will be gauged over an approximate 2-year and 3 month time frame after treatment completion. As secondary objectives, researchers are looking at Progression-free Survival (PFS), Progressive Disease (PD), Overall Survival (OS) and Duration of Response (DOR). PFS focusses on tracking time since start of durvalumab until progression or death; PD looks for a 20% increase in sum diameters plus 5mm absolute change from baseline value; OS benchmarks"
Answered by AI
Has Durvalumab been granted authorization by the FDA?
"Durvalumab's safety rating on our internal scale is a 2, since there are some data points indicating it can be safely administered but no evidence that it has any therapeutic effect."
Answered by AI
How many participants is the trial recruiting?
"Indeed, according to the clinicaltrials.gov database, this trial is presently seeking enrollees. It was initially posted on March 30th 2022 and its details were last modified April 11th of that year. This study requires 27 patients from a single medical centre to participate."
Answered by AI
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