What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) involving immunotherapies such as pembrolizumab and atezolizumab, often in combination with chemotherapy, can lead to a range of side effects. These include immune-mediated adverse events like pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Chemotherapy-related side effects often include neutropenia, febrile neutropenia, anemia, fatigue, nausea, and increased risk of infections. Combination therapies can also result in higher incidences of severe adverse events, such as hypertension and infusion reactions. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Several drugs targeting the PD-1/PD-L1 pathway have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). Atezolizumab, a PD-L1 inhibitor, is approved for front-line treatment in patients with high PD-L1 expression, showing improved overall survival (OS) and progression-free survival (PFS) compared to chemotherapy. Cemiplimab, a PD-1 inhibitor, has also been approved for advanced NSCLC with high PD-L1 expression, demonstrating significant improvements in OS and PFS. Nivolumab, another PD-1 inhibitor, is approved for use in patients with metastatic NSCLC who have progressed on platinum-based chemotherapy, offering better OS and response rates compared to docetaxel. These approvals highlight the efficacy of targeting the PD-1/PD-L1 pathway in NSCLC treatment.

What other types of research exist?

Promising alternatives to IMU-201 (PD1-Vaxx) for NSCLC patients include: 1) Pembrolizumab, especially in combination with chemotherapy, which has shown improved overall survival in patients with PD-L1 expression. 2) Nivolumab plus ipilimumab, which has demonstrated durable responses and long-term survival benefits. 3) Atezolizumab, particularly in combination with chemotherapy for patients with high PD-L1 expression. These therapies have been supported by recent clinical trials and offer effective options for NSCLC treatment.

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Cancer Vaccine

PD1-Vaxx Immunotherapy for Non-Small Cell Lung Cancer

Phase 1

Waitlist Available

Research Sponsored by Imugene Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior treatment criteria for Combination dose expansion arms: IMU-201 + atezolizumab + chemotherapy, patients naïve to prior treatment

Prior treatment criteria for Combination dose escalation arms: IMU-201 + atezolizumab + chemotherapy, patient naïve to prior treatment naive

Must not have

Active infection requiring intravenous antibiotics

Concurrent active malignancy except for adequately controlled limited basal cell carcinoma of the skin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to death from any cause (approximately 15 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests IMU-201 (PD1-Vaxx), a new treatment for adults with Non-Small Cell Lung Cancer. It aims to help the immune system create antibodies to fight cancer cells more effectively and safely than current treatments.

Who is the study for?

Adults over 18 with advanced non-small cell lung cancer (NSCLC) who have either not been treated or have progressed after treatment with PD-1/PD-L1 inhibitors. They should be in relatively good health, with a life expectancy of at least 12 weeks and able to perform daily activities with little assistance (Zubrod/ECOG score 0-1). Patients must not have received certain treatments recently, have active infections requiring IV antibiotics, known HIV/Hepatitis B/C infection, uncontrolled other cancers or brain metastases needing steroids.

What is being tested?

The trial is testing IMU-201 (PD1-Vaxx), an immunotherapy for NSCLC. It's given alone or combined with the drug Atezolizumab and/or standard chemotherapy. The study has different parts: dose escalation to find safe amounts and expansion where more patients receive these doses. Participants are grouped based on previous treatments and their tumor's PD-L1 protein levels.

What are the potential side effects?

IMU-201 could cause immune-related side effects like inflammation in various organs, potential allergic reactions during infusion into the body, fatigue, blood disorders that affect how your blood clots or fights infection, liver issues indicated by abnormal tests results, and possibly 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 not received IMU-201, atezolizumab, or chemotherapy before.

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I have not received any previous treatments for my condition.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I have not received previous treatments for my condition.

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My cancer shows high PD-L1 levels suitable for specific treatment combinations.

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My cancer progressed after treatment with a PD-1/PD-L1 inhibitor.

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I am over 18 and have advanced stage lung cancer.

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My cancer shows high PD-L1 levels suitable for specific treatment combinations.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on IV antibiotics for an infection.

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I have no active cancer except for a controlled skin cancer.

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I have a history of HIV or active Hepatitis B or C.

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I have had an organ transplant.

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I haven't had treatment for advanced lung cancer in the last 3 weeks.

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I have or had lung inflammation that needed treatment with immune-suppressing drugs.

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I need steroids for my brain metastases.

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I have experienced severe side effects from PD-1 or PD-L1 inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to death from any cause (approximately 15 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to death from any cause (approximately 15 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to death from any cause (approximately 15 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Identify Optimal Biological Dose (OBD) with safety/tolerability graded per terminology criteria for adverse events (CTCAE) version 5.00 and Immuogenicity (Dose Escalation).

Overall response rate (ORR) (Dose Expansion)

Safety and tolerability of IMU-201 graded per terminology criteria for adverse events (CTCAE) version 5.00 (Dose Escalation)

Secondary study objectives

Duration of response (DOR) (Dose Escalation/Expansion)

Overall response rate (ORR) (Dose Escalation)

Overall survival (OS) (Dose Escalation/Expansion)

+1 more

Other study objectives

Exploratory Outcome: Cellular immunogenicity of IMU-201 (Dose Escalation/Expansion)

Exploratory Outcome: Humoral immunogenicity of IMU-201 (Dose Escalation/Expansion)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

13Treatment groups

Experimental Treatment

Group I: Dose Expansion MonotherapyExperimental Treatment1 Intervention

mOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

Group II: Dose Expansion Arm 3: Combination with atezolizumab and chemotherapyExperimental Treatment3 Interventions

cOBD (TBD) dose IMU-201 as a 05 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level

Group III: Dose Expansion Arm 2: Combination with atezolizumabExperimental Treatment2 Interventions

cOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI, TPS/TC ≥50% or IC ≥10%

Group IV: Dose Expansion Arm 1: Combination with atezolizumabExperimental Treatment2 Interventions

cOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

Group V: Dose Escalation: Monotherapy Cohort 3Experimental Treatment1 Intervention

100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

Group VI: Dose Escalation: Monotherapy Cohort 2Experimental Treatment1 Intervention

50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

Group VII: Dose Escalation: Monotherapy Cohort 1Experimental Treatment1 Intervention

10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

Group VIII: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3Experimental Treatment3 Interventions

100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level

Group IX: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2Experimental Treatment3 Interventions

50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level

Group X: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1Experimental Treatment3 Interventions

10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level

Group XI: Dose Escalation Arm 1: Combination with atezolizumab Cohort 3Experimental Treatment2 Interventions

Cohort 3: 100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

Group XII: Dose Escalation Arm 1: Combination with atezolizumab Cohort 2Experimental Treatment2 Interventions

50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

Group XIII: Dose Escalation Arm 1: Combination with atezolizumab Cohort 1Experimental Treatment2 Interventions

10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Standard of care chemotherapy

2020

Completed Phase 1

~30

0 / 16Eligibility criteria met

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 Non-Small Cell Lung Cancer (NSCLC) include immunotherapies that target the PD-1/PD-L1 pathway. These treatments, such as pembrolizumab and atezolizumab, work by inhibiting the interaction between PD-1 receptors on T-cells and PD-L1 on tumor cells. This inhibition prevents the tumor cells from evading the immune system, thereby allowing T-cells to recognize and attack the cancer cells. The IMU 201 (PD1-Vaxx) trial explores a novel approach by stimulating B-cells to produce antibodies against PD-1, potentially enhancing the immune response against the tumor. This mechanism is crucial for NSCLC patients as it offers a targeted way to boost the body's natural defenses against cancer, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

Immunotherapy for non-small-cell lung cancer: the past 10 years.