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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
Must not have
Contraindication to intramuscular injections and/or blood draws
Prior treatment with a PD-1 or PD-L1 inhibitor (including durvalumab)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of treatment (estimated to be 2 years)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a custom-made vaccine combined with an immune-boosting drug called durvalumab. It aims to help patients with advanced small cell lung cancer, a severe type of lung cancer that has spread widely. The vaccine targets unique markers on cancer cells, while durvalumab helps the immune system fight these cells more effectively.

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have shots or blood taken from my veins due to medical reasons.
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I have been treated with a PD-1 or PD-L1 inhibitor before.
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I do not have any current infections.
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I have had cancer spread to the lining of my brain and spinal cord.
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I have or had an autoimmune or inflammatory disorder.
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I have fewer than 2 suitable spots for injection and electroporation.
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I have had brain metastases.
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I haven't taken immunosuppressive drugs in the last 14 days.
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I haven't had major surgery in the last 28 days.
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I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.
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I do not have any uncontrolled illnesses.
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I have had cancer before, but it fits the exceptions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of treatment (estimated to be 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of treatment (estimated to be 2 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
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 study objectives
Duration of response (DOR)
Overall survival (OS)
Progression-free survival (PFS)
+1 more

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

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
~3780
Neoantigen DNA vaccine
2018
Completed Phase 1
~20

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
The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, radiation therapy, and immunotherapy. Chemotherapy, often using etoposide combined with platinum-based drugs like carboplatin or cisplatin, works by damaging the DNA of cancer cells, leading to cell death. Radiation therapy uses high-energy rays to kill cancer cells or shrink tumors. Immunotherapy, such as the Personalized Neoantigen Vaccine and Durvalumab (a PD-L1 inhibitor), stimulates the immune system to recognize and attack cancer cells. The Personalized Neoantigen Vaccine introduces tumor-specific antigens to the immune system, enhancing its ability to target cancer cells. Durvalumab blocks the PD-L1 protein on cancer cells, preventing them from evading immune detection. These immunotherapy approaches are particularly important for SCLC patients as they offer a targeted method to boost the body's natural defenses against cancer, potentially leading to better outcomes and fewer side effects compared to traditional treatments.
The Evolving Continuum of Diagnosis in the Modern Age of Non-Small Cell Lung Cancer.Immune evasion and current immunotherapy strategies in mycosis fungoides (MF) and Sézary syndrome (SS).Combining immunotherapy and radiation therapy for small cell lung cancer and thymic tumors.

Find a Location

Who is running the clinical trial?

Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,462 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,375 Previous Clinical Trials
288,738,723 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,980 Previous Clinical Trials
2,291,260 Total Patients Enrolled

Media Library

Durvalumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04397003 — Phase 2
Small Cell Lung Cancer Research Study Groups: Neoantigen DNA vaccine+durvalumab
Small Cell Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04397003 — Phase 2
Durvalumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04397003 — Phase 2
~11 spots leftby Mar 2028