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EO2040 + Nivolumab for Colorectal Cancer (CLAUDE Trial)
Phase 2
Waitlist Available
Led By Arvind Dasari, MD
Research Sponsored by Enterome
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of minimal residual disease as defined by a positive ctDNA assay after completion of all planned standard of care therapies
Human leukocyte antigen (HLA)-A2 positive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
CLAUDE Trial Summary
This trialwill test a vaccine and an immunotherapy drug to see if they can reduce colorectal cancer after standard treatments.
Who is the study for?
This trial is for adults over 18 with colorectal cancer who've had surgery and standard therapy, but still have tiny amounts of cancer DNA in their blood. They must be HLA-A2 positive, not pregnant, willing to use contraception, and able to follow the study plan. People can't join if they're on certain medications or treatments, have unresolved side effects from past therapies (except minor ones like hair loss), are pregnant or breastfeeding, have HIV/HBV/HCV infections, serious heart or other health issues that could affect safety or results.Check my eligibility
What is being tested?
The trial tests a new vaccine called EO2040 combined with an existing drug named Nivolumab in patients whose blood tests show minimal residual disease of colorectal cancer after standard treatment. The goal is to see if this combination helps prevent the cancer from coming back.See study design
What are the potential side effects?
Potential side effects aren't specified here but based on similar treatments may include immune-related reactions affecting organs, fatigue, skin rash, digestive problems like diarrhea or colitis; liver inflammation; hormonal gland issues; infusion reactions; and increased risk of infection.
CLAUDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have traces of cancer detected by a blood test after finishing all standard treatments.
Select...
I am HLA-A2 positive.
Select...
I am willing and able to follow the study's schedule and procedures.
Select...
I've had surgery to remove my stage II-IV colorectal cancer and completed all standard treatments.
Select...
My colorectal cancer has been confirmed through a biopsy.
Select...
I am 18 years old or older.
Select...
I am a woman who can have children and have a recent negative pregnancy test.
CLAUDE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response to treatment at 6 months
Secondary outcome measures
DIsease-free survival
Immunogenicity and cross-reactivity
NCI-CTCAE grading
+4 moreSide 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%
Blood alkaline phosphatase increased
7%
Dehydration
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%
Hypercalcaemia
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%
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
CLAUDE Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients With Minimal Residual Disease of Colorectal CancerExperimental Treatment1 Intervention
Patients With Circulating Tumor DNA-defined Minimal Residual Disease of Colorectal Cancer Stage II, III, or IV After Completion of Curative Therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
EnteromeLead Sponsor
8 Previous Clinical Trials
552 Total Patients Enrolled
Arvind Dasari, MDPrincipal InvestigatorMDAnderson Cancer Center
1 Previous Clinical Trials
15 Total Patients Enrolled
Jan Fagerberg, MDStudy DirectorEnterome
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have traces of cancer detected by a blood test after finishing all standard treatments.I am not on any immune-affecting drugs or herbal remedies that could harm my organs.I haven't had any live vaccines, including the flu shot, in the last 4 weeks.I am HLA-A2 positive.I am willing and able to follow the study's schedule and procedures.I have a history or current case of HIV, HBV, or HCV.I have a history or current diagnosis of tuberculosis.I haven't had radiotherapy in the last 12 weeks or chemotherapy in the last 28 days.You have had an organ transplant or a type of stem cell transplant from another person.I haven't had treatments targeting PD1, PD-L1, CTLA-4, or similar.I am allergic to certain medications or their ingredients.I've had surgery to remove my stage II-IV colorectal cancer and completed all standard treatments.My side effects from previous treatments are mild and have been stable for at least 2 weeks.My colorectal cancer has been confirmed through a biopsy.I am 18 years old or older.I am a woman who can have children and have a recent negative pregnancy test.I am taking more than 2 mg/day of dexamethasone or its equivalent.You cannot have received any experimental treatments or participated in another clinical trial.I have another active cancer besides the one being treated.I have or might have an autoimmune disorder, including conditions like Guillain-Barré syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Patients With Minimal Residual Disease of Colorectal Cancer
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open enrolment slots for this clinical experiment?
"Affirmative. In accordance with clinicaltrials.gov, this medical trial initiated on March 1st 2023 is currently recruiting participants. There are 34 spots available at a single site to be filled by the end of January 26th 2023."
Answered by AI
How many participants can the clinical trial accommodate?
"Affirmative. According to the information published on clinicaltrials.gov, this study is presently recruiting participants. It was initially posted in March 1st of 2023 and recently updated by January 26th of the same year. 34 individuals are needed from a single site for the trial's completion."
Answered by AI
Has the FDA sanctioned Patients With Minimal Residual Disease of Colorectal Cancer?
"There is some evidence indicating the safety of this treatment for patients with minimal residual disease of colorectal cancer, resulting in a score of 2. However, there are no studies that have been conducted to verify its efficacy."
Answered by AI
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