What is the mechanism of action of this treatment?

Common treatments for solid tumors, such as cancer vaccines and immune checkpoint inhibitors, work by harnessing the body's immune system to fight cancer. Cancer vaccines like VB10.NEO introduce tumor-specific antigens to the immune system, prompting it to recognize and attack cancer cells. Atezolizumab, a PD-L1 inhibitor, prevents cancer cells from evading immune detection by blocking the interaction between PD-L1 on tumor cells and PD-1 on T-cells. This combination can significantly enhance the immune response against tumors, offering a targeted and potentially more effective treatment for solid tumor patients.

What side effects are associated with this type of intervention?

Treatments for solid tumors, particularly those involving immune checkpoint inhibitors like Atezolizumab and cancer vaccines such as VB10.NEO, commonly cause immune-related adverse events. These include fatigue, rash, diarrhea, and inflammation of organs like the lungs (pneumonitis), liver (hepatitis), endocrine glands (thyroiditis, adrenal insufficiency), and intestines (colitis). Cancer vaccines can also cause injection site reactions, flu-like symptoms, and occasionally autoimmune reactions. Combining these therapies may heighten the risk of immune-related side effects, requiring careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of solid tumors. Atezolizumab, a PD-L1 inhibitor, has been approved for various cancers, including non-small cell lung cancer (NSCLC) and metastatic renal cell carcinoma (RCC). Other similar PD-1/PD-L1 inhibitors include Pembrolizumab and Nivolumab, which have been approved for cancers such as melanoma, NSCLC, and colorectal cancer. These approvals highlight the growing role of immunotherapy in treating solid tumors, often in combination with other agents like chemotherapy or targeted therapies.

What other types of research exist?

Promising novel alternatives to VB10.NEO in combination with Atezolizumab for solid tumors include: 1) Neoadjuvant pembrolizumab (PD-1 inhibitor) alone or in combination with dabrafenib plus trametinib (BRAF and MEK inhibitors) for BRAF-mutant melanoma, 2) Neoadjuvant ipilimumab (CTLA-4 inhibitor) plus nivolumab (PD-1 inhibitor) for high-risk resectable melanoma, and 3) Personalized response-directed surgery and adjuvant therapy after neoadjuvant ipilimumab and nivolumab for high-risk stage III melanoma. These combinations are being actively studied and have shown promising results in clinical trials.

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Cancer Vaccine

VB10.NEO + Atezolizumab for Cancer

Phase 1

Waitlist Available

Research Sponsored by Nykode Therapeutics AS

Eligibility Criteria Checklist

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

Must have

Age ≥18 years at time of signing the Informed Consent Form

Be older than 18 years old

Must not have

Clinically significant liver disease

Active tuberculosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer vaccine combined with a drug that helps the immune system in patients whose cancer has not responded to usual treatments. The vaccine helps the immune system recognize cancer cells, and the drug boosts the immune response to attack these cells more effectively.

Who is the study for?

Adults with advanced solid tumors that have worsened after standard therapy or for whom standard therapy isn't suitable. Participants must be expected to live at least 6 months, have good organ function, and an ECOG Performance Status of 0 or 1. They should not be pregnant or breastfeeding and must agree to use effective contraception.

What is being tested?

The trial is testing VB10.NEO in combination with Atezolizumab to see how safe it is, how the body responds, and if it can shrink tumors. It's a phase 1b study where doses are increased gradually (dose-escalation) to find the right dose for future studies.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells (autoimmune responses), infusion-related reactions from receiving drugs through a vein, fatigue, liver issues, blood disorders like low platelet counts or anemia, and potential risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

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

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I have a serious liver condition.

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I have active tuberculosis.

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I am currently on or have been treated with drugs that affect my immune system.

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I do not have uncontrolled fluid buildup or high calcium levels.

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I have a history of lung conditions.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 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

Changes from baseline in clinical laboratory parameters

Changes from baseline in vital signs

Incidence and severity of adverse events (AEs)

Secondary study objectives

Assessment of the antigen-specific immune response elicited by VB10.NEO administered in combination with atezolizumab

Characterize the pharmacokinetic of atezolizumab when administered in combination with VB10.NEO.

Duration of response (DOR)

+4 more

Other study objectives

Dose finding objective

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: VB10.NEO 9 mg in combination with Atezolizumab 1200 mgExperimental Treatment1 Intervention

VB10.NEO 9 mg will be administered by IM injection for an induction course Q3W (4 doses) followed by maintenance doses Q6W (6 doses) and Q12W (5 doses). Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of 21 day cycles.

Group II: VB10.NEO 6 mg in combination with Atezolizumab 1200 mgExperimental Treatment1 Intervention

VB10.NEO 6 mg will be administered by IM injection for an induction course Q3W (4 doses) followed by maintenance doses Q6W (6 doses) and Q12W (5 doses). Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of 21 day cycles.

Group III: VB10.NEO 3 mg in combination with Atezolizumab 1200 mgExperimental Treatment1 Intervention

VB10.NEO 3 mg will be administered by IM injection for an induction course Q3W (4 doses) followed by maintenance doses Q6W (6 doses) and Q12W (5 doses). Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of 21 day cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VB10.NEO

2018

Completed Phase 2

~50

0 / 7Eligibility 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

Common treatments for solid tumors, such as cancer vaccines and immune checkpoint inhibitors, work by harnessing the body's immune system to fight cancer. Cancer vaccines like VB10.NEO introduce tumor-specific antigens to the immune system, prompting it to recognize and attack cancer cells. Atezolizumab, a PD-L1 inhibitor, prevents cancer cells from evading immune detection by blocking the interaction between PD-L1 on tumor cells and PD-1 on T-cells. This combination can significantly enhance the immune response against tumors, offering a targeted and potentially more effective treatment for solid tumor patients.

Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Nivolumab Immunotherapy in Malignant Mesothelioma: A Case Report Highlighting a New Opportunity for Exceptional Outcomes.