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Cancer Vaccine

Cancer Vaccine + Nivolumab for Brain Tumor

Phase 1 & 2

Waitlist Available

Research Sponsored by Sabine Mueller, MD, PhD

Eligibility Criteria Checklist

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

Must have

Stratum C: Newly diagnosed children 3-21 years of age with DIPG or midline glioma other than DIPG positive for H3.3K27M mutation, underwent standard radiation therapy

Stratum B: Newly diagnosed children (3-21 years old) with glioma other than DIPG positive for H3.3K27M mutation, underwent standard radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

Study Summary

This trial will test a new cancer vaccine in children with brain tumors. The vaccine will be given with two different drugs, poly-ICLC and nivolumab, to see if it is safe and if it can help the immune system fight the tumor.

Who is the study for?

This trial is for children aged 3-21 with newly diagnosed DIPG or other gliomas positive for H3.3K27M mutation, who've had standard radiation therapy but no prior chemo, immunotherapy, or bone marrow transplant. They must have good organ function and agree to use contraception if applicable. Those on stable steroids can join; however, those with certain health conditions or treatments are excluded.Check my eligibility

What is being tested?

The study tests a synthetic peptide vaccine targeting the H3.3.K27M epitope combined with poly-ICLC and nivolumab (a PD-1 inhibitor) in children who express a specific genetic marker (HLA-A*02:01). It aims to evaluate safety and immune response across three groups within this patient population.See study design

What are the potential side effects?

Potential side effects include typical reactions to vaccines such as soreness at injection site, fever, fatigue; nivolumab may cause immune-related issues like inflammation of organs, skin rash, hormone gland problems (like thyroid), digestive tract symptoms and could potentially worsen pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

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

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I am a child aged 3-21 with a specific brain tumor type and have completed standard radiation therapy.

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I am a child (3-21) with a specific brain tumor (not DIPG) and have had standard radiation.

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I am not on steroids, or I am on a stable dose of dexamethasone.

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I have tested positive for the HLA-A*02:01 gene.

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I have not had chemotherapy, immunotherapy, or a bone marrow transplant for my cancer.

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I am mostly able to care for myself and carry out daily activities.

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I have had radiation therapy and surgery for my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Adverse Events related to treatment

Overall survival (OS) at 12 months (OS12)

Other outcome measures

Analyze circulating tumor DNA

T-Lymphocyte

Assessment of Quality of Life and cognitive measures in HLA-A2 (02:01)+ children with H3.3K27M positive DIPG or other midline gliomas.

+1 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

Nausea

54%

Anaemia

51%

Fatigue

39%

Decreased appetite

36%

Malignant neoplasm progression

32%

Constipation

31%

Diarrhoea

30%

Cough

29%

Vomiting

29%

Dyspnoea

25%

Oedema peripheral

24%

Back pain

21%

Pyrexia

21%

Neutropenia

19%

Headache

19%

Hypomagnesaemia

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Hyponatraemia

14%

Rash

14%

Weight decreased

14%

Platelet count decreased

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Pruritus

12%

Abdominal pain

12%

Pain in extremity

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Bronchitis

Blood alkaline phosphatase increased

Chills

Hypertension

Dehydration

Hyperkalaemia

Hyperglycaemia

Lymphocyte count decreased

Anxiety

Leukopenia

Hypophosphataemia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Musculoskeletal chest pain

Malaise

Pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Hypercalcaemia

Neoplasm progression

Small intestinal haemorrhage

Femur fracture

Pericardial effusion malignant

Cancer pain

Confusional state

Pneumothorax

Circulatory collapse

Bone pain

Atrial flutter

Bronchial obstruction

Superior vena cava syndrome

Syncope

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

Trial Design

3Treatment groups

Experimental Treatment

Group I: Stratum C: Newly Diagnosed DIPG or other Midline GliomaExperimental Treatment2 Interventions

Newly diagnosed children with DIPG or other midline gliomas (excluding primary spinal cord tumors) who are positive for HLA-A2 (02:01) and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Nivolumab will also be given via IV. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks. Nivolumab will continue to be given every 3 weeks throughout all of treatment.

Group II: Stratum B: Newly Diagnosed Glioma (non-DIPG)Experimental Treatment1 Intervention

Newly diagnosed children with gliomas other than DIPG who are positive for HLA-A2 and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks.

Group III: Stratum A: Newly Diagnosed DIPGExperimental Treatment1 Intervention

Newly diagnosed children with diffuse intrinsic pontine glioma who are positive for HLA-A2 and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid (TT) peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

K27M peptide

2016

Completed Phase 2

~50

Nivolumab

2014

Completed Phase 3

~4750

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pacific Pediatric Neuro-Oncology ConsortiumOTHER

14 Previous Clinical Trials

687 Total Patients Enrolled

4 Trials studying Diffuse Intrinsic Pontine Glioma

100 Patients Enrolled for Diffuse Intrinsic Pontine Glioma

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,464 Total Patients Enrolled

Sabine Mueller, MD, PhDLead Sponsor

8 Previous Clinical Trials

433 Total Patients Enrolled

3 Trials studying Diffuse Intrinsic Pontine Glioma

43 Patients Enrolled for Diffuse Intrinsic Pontine Glioma

Media Library

K27M peptide (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02960230 — Phase 1 & 2

Diffuse Intrinsic Pontine Glioma Research Study Groups: Stratum C: Newly Diagnosed DIPG or other Midline Glioma, Stratum B: Newly Diagnosed Glioma (non-DIPG), Stratum A: Newly Diagnosed DIPG

Diffuse Intrinsic Pontine Glioma Clinical Trial 2023: K27M peptide Highlights & Side Effects. Trial Name: NCT02960230 — Phase 1 & 2

K27M peptide (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02960230 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to partake in this clinical experiment?

"This clinical trial is seeking 50 pediatric patients who have been diagnosed with glioma and are between the ages of 3 and 21."

Answered by AI

What are the primary conditions for which Nivolumab is employed?

"Nivolumab has a plethora of therapeutic applications, including combatting malignant neoplasms and unresectable melanoma. It can also be utilized to treat squamous cell carcinoma and metastatic esophageal adenocarcinoma."

Answered by AI

Are there vacancies available for willing participants in this clinical experiment?

"Confirmed, this clinical investigation is not currently accepting candidates. It was initially posted on November 18th 2016 and last updated October 5th 2022; in contrast, 1,079 other studies are presently open for enrollment."

Answered by AI

What is the current size of the cohort involved in this investigation?

"At this particular moment, this experiment is not actively enrolling candidates. It was first published on November 18th 2016 and underwent its most recent update on October 5th 2022. Alternately, there are 361 studies admitting people with glioma and 718 trials recruiting patients for Nivolumab treatment."

Answered by AI

Is this endeavor pioneering in nature?

"Currently, there are 718 active medical trials related to Nivolumab taking place in 2354 cities and 49 different countries. Ono Pharmaceutical Co. Ltd kicked off the first clinical study back in 2012 when they initiated phase 1 & 2 of their drug approval process; 659 participants took part at that time. In total, 252 studies have been concluded since then."

Answered by AI

What precedent has been set with regard to Nivolumab research?

"Currently, there are 718 active clinical trials using nivolumab as the intervention with 82 of these in Phase 3. Of those trials, many are based around Basel, BE but overall 40237 sites have been established to run research into this drug."

Answered by AI

Are adolescents within the age range of eligibility for this trial?

"This medical study is searching for participants between 3 years old and 21 years of age."

Answered by AI

How far-reaching is the current scope of this trial?

"For this particular clinical trial, 13 sites are currently recruiting patients. Two of these locations include Rady Children's Hospital-San Diego in San Diego and Texas Children's Hospital in Houston, with the other 11 distributed throughout the United States."

Answered by AI