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Cancer Vaccine
EO2401 + Nivolumab for Adrenocortical Cancer (Spencer Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Enterome
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients should have adrenocortical carcinoma(ACC), or malignant pheochromocytoma/paraganglioma (MPP), as defined below for Cohorts 2A and 3A
Males or non-pregnant, non-lactating, females
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Spencer Trial Summary
This trial is testing a new drug for safety and effectiveness in treating people with a certain type of cancer.
Who is the study for?
Adults over 18 with advanced or metastatic adrenocortical carcinoma or malignant pheochromocytoma/paraganglioma, who are HLA-A2 positive and have measurable disease progression. They must be in good physical condition (ECOG ≤ 1), not pregnant, able to follow the study plan, and have no history of immune checkpoint inhibitor treatment or certain other treatments within specific time frames.Check my eligibility
What is being tested?
The trial is testing EO2401 combined with Nivolumab for safety, tolerability, immune response, and initial effectiveness against certain types of cancer. It's a first-in-human study involving multiple centers where patients receive these interventions to see how well they work.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with immunotherapies such as fatigue, skin reactions, inflammation in various organs including the liver and lungs, potential autoimmune responses where the body attacks its own cells, infusion-related reactions like fever or chills.
Spencer Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with either adrenocortical carcinoma or malignant pheochromocytoma/paraganglioma.
Select...
I am a male or a female not pregnant or breastfeeding.
Select...
My cancer is advanced adrenocortical carcinoma that cannot be surgically removed.
Select...
I am HLA-A2 positive.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Spencer Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events assessment
Secondary outcome measures
Assessment of the immunogenicity
Evaluation of Progression Free Survival at 6 months
Evaluation of survival
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Spencer Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: randomized extension of Cohort 2A (3 arms): C2A-IIExperimental Treatment1 Intervention
11 patients belonging to this extension of Cohort 2A will be treated by EO2401 alone.
Group II: randomized extension of Cohort 2A (3 arms): C2A-IExperimental Treatment2 Interventions
Randomized extension of Cohort 2A (65 patients using a 4:1:1 ratio): 43 patients belonging to this extension of Cohort 2A will be treated by EO2401 and nivolumab in combination.
Group III: 5-cohort study designExperimental Treatment2 Interventions
Cohort 1:3-by-3 design of EO2401 in combination with nivolumab at standard dose. Three to 12 evaluable patients with adrenal carcinoma or progressive malignant pheochromocytoma/paraganglioma will be included depending on the safety profile of the administered treatments.
Cohorts 2A (previously treated patients) and 2B (previously untreated patients): evaluation of EO2401in combination with nivolumab in 33 patients with adrenal carcinoma.
Cohorts 3A (previously treated patients) and 3B (previously untreated patients) : evaluation of EO2401 combination with nivolumab in 20 patients (globally for both Cohorts 3A and 3B) with progressive malignant pheochromocytoma/ paraganglioma.
Group IV: randomized extension of Cohort 2A (3 arms): C2A-IIIActive Control1 Intervention
11 patients belonging to this extension of Cohort 2A who will be treated by nivolumab alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
EnteromeLead Sponsor
8 Previous Clinical Trials
483 Total Patients Enrolled
Jean-Michel PaillarseStudy DirectorEnterome
1 Previous Clinical Trials
100 Total Patients Enrolled
Jan FagerbergStudy DirectorEnterome
1 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with either adrenocortical carcinoma or malignant pheochromocytoma/paraganglioma.I am a male or a female not pregnant or breastfeeding.I have a history or current diagnosis of tuberculosis.I am willing and able to follow the study's schedule and procedures.I have severe side effects from previous treatments.Your doctor believes you have more than 4 months to live.I am allergic to some ingredients in the study medication.I have adrenal cancer with uncontrolled hormone levels.I haven't taken more than 2 mg/day of dexamethasone or its equivalent in the last 14 days, unless it was to treat a side effect.I was diagnosed with ACC less than 9 months ago.I have or might have an autoimmune disorder, including those affecting the nervous system.I have had an organ or stem cell transplant.My tumor is a type that can't be surgically removed and has grown in the last 18 months.You have unusual results in your lab tests.My cancer is advanced adrenocortical carcinoma that cannot be surgically removed.Patients must have at least one specific spot that can be measured according to the RECIST 1.1 guidelines.I haven't had immunotherapy or similar treatments in the last 28 days.My cancer has spread to my brain and is not under control.I have not used herbal remedies that affect the immune system or major organs.I have been cancer-free from any other cancer for less than 3 years.I have MPP and my blood pressure is not under control.You are currently misusing drugs or alcohol.I am 18 years old or older.I am HLA-A2 positive.I have been treated with drugs that boost the immune system.I am fully active and can carry on all my pre-disease activities without restriction.I have previously been treated with EO2401.I have a tumor larger than 125 mm in diameter.My ACC has spread to more than three organs and cannot be surgically removed.My condition significantly affects my daily life.You have a history of HIV, hepatitis B, or hepatitis C infection.I have not received any live vaccines, including the flu shot, in the last 4 weeks.
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.
Research Study Groups:
This trial has the following groups:- Group 1: randomized extension of Cohort 2A (3 arms): C2A-III
- Group 2: 5-cohort study design
- Group 3: randomized extension of Cohort 2A (3 arms): C2A-I
- Group 4: randomized extension of Cohort 2A (3 arms): C2A-II
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients currently being sought for this research study?
"The most recent information on clinicaltrials.gov suggests that this study is still looking for participants. The trial was initially posted on 7/23/2020, with the 12/7/2021 update being the most recent one."
Answered by AI
How many patients are receiving care through this clinical trial?
"The trial is currently seeking patients and has been doing so since it was originally posted on 7/23/2020. The listing was last edited on 12/7/2021. Up to 60 people from 1 location can participate in the trial."
Answered by AI
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