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Cancer Vaccine
IMM-101 Immunization for COVID-19 in Cancer Patients (COV-IMMUNO Trial)
Phase 3
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be undergoing (or be planned to undergo) active treatment for one or more solid malignancy, lymphoma or myeloma. Active treatment includes adjuvant, neoadjuvant and palliative intent treatment with surgery, radiation, chemotherapy, targeted therapy or immunotherapy.
Patients must have one or more of the following risk factors for a severe COVID-19 infection: Age > 65 years old, Hypertension (on medications), Type 1 or 2 Diabetes (on medication), relevant chronic conditions as per the investigator based on the medical record, including heart, lung, liver cirrhosis, serious kidney disease requiring dialysis, receiving systemic therapy, Body Mass Index > 40, living in a nursing home or long term care facility.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
COV-IMMUNO Trial Summary
This trial will test whether IMM-101 can reduce the incidence of severe respiratory and COVID-19 infections in cancer patients.
Who is the study for?
This trial is for cancer patients over 18, at high risk for severe COVID-19 (65+, hypertension, diabetes, obesity, living in care facilities), undergoing active cancer treatment with a life expectancy >6 months. They must not have had COVID-19 before and agree to vaccinations as per Canadian guidelines. Participants need proper organ function and an ECOG Performance Status ≤ 2. Pregnant or breastfeeding individuals or those with certain infections or immune conditions are excluded.Check my eligibility
What is being tested?
The study tests whether IMM-101 immunization can prevent serious respiratory and COVID-19 infections in cancer patients compared to just observation without the vaccine. Patients will be observed for their response to the immunization versus standard health monitoring practices.See study design
What are the potential side effects?
While specific side effects of IMM-101 are not listed here, similar vaccines may cause injection site reactions, flu-like symptoms such as fever and fatigue, muscle pain, and potentially allergic reactions.
COV-IMMUNO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently receiving or about to receive treatment for cancer.
Select...
I am at high risk for severe COVID-19 due to my age, health conditions, or living situation.
Select...
I am 18 years old or older.
Select...
I can take care of myself and perform daily activities.
COV-IMMUNO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The rate of "flu-like illness" which includes
Secondary outcome measures
Failure-free survival, as time from enrollment to recurrence or progression declared by the investigator on the basis of objective standard evaluation consistent with the disease site or death
Incidence and duration of ICU admission related to documented COVID-19 infection
Incidence and frequency of local injection site reactions subsequent to IMM-101 administration
+7 moreSide effects data
From 2016 Phase 2 trial • 110 Patients • NCT0130317247%
Abdominal pain
45%
Asthenia
44%
Diarrhoea
44%
Decreased appetite
44%
Nausea
41%
Constipation
31%
Anaemia
29%
Vomiting
25%
Fatigue
24%
Pyrexia
23%
Back pain
21%
Neutropenia
19%
Weight decrased
17%
Dysquesia
16%
Oedema peripheral
15%
Thrombocytopenia
12%
Anxiety
12%
Insomnia
12%
Jaundice
12%
Abdominal pain upper
12%
Lethargy
11%
Stomatitis
11%
Headache
11%
Dizziness
9%
Vitamin D deficiency
9%
Urinary tract infection
9%
Ascites
9%
Dyspepsia
9%
Platelet count decrased
9%
Arthralgia
9%
Dyspnoea
9%
Cough
9%
Pruritis
8%
Chills
8%
Abdominal distension
8%
Abdominal discomfort
8%
Gastrooesophageal reflux
8%
Mucosal inflammation
8%
Alanine aminotransferase increased
8%
Rash
7%
Neutrophil count decreased
7%
Depression
7%
Blood bilirubin increased
7%
Vitamin D decreased
7%
Nasopharyngitis
7%
Pain
7%
Injection site reaction
7%
Dry skin
7%
Alopecia
5%
Biliary sepsis
5%
Aspartate aminotransferase increased
5%
Rectal haemorrhage
5%
Malabsorption
5%
Blood alkaline phosphatase increased
5%
Oedema
5%
Leukopenia
5%
Respiratory tract infection
5%
Parasthesia
5%
Injection site pain
4%
Infection
4%
Pneumonia
4%
Haemoglobin deceased
4%
Disease progression
4%
Blood potassium decreased
3%
Hypokalaemia
3%
WBC count deceased
3%
Pleural effusion
3%
Lower respiratory tract infection
3%
Bile duct obstruction
1%
Convulsion
1%
Epistaxis
1%
Cholecystitis
1%
Peroneal nerve palsy
1%
Gastroenteritis
1%
Liver abscess
1%
Lung infection
1%
Gastrointestinal hemorrhage
1%
Diabetic ketoacidosis
1%
Hypoglycaemia
1%
Large intestine perforation
1%
Cerebral infarction
1%
Sepsis
1%
Biliary tract infection
1%
Device related infection
1%
Upper gastrointestinal haemorrhage
1%
General physical health deterioration
1%
Pneumonitis
1%
Pneumothorax
1%
Pulomonary embolism
1%
Toxicity to various agents
1%
Febrile neutropenia
1%
Splenomegaly
1%
Arrhymia
1%
Cardiac failure congestive
1%
Pancreatic carcinoma metastatic
1%
Urinary tract infection fungal
1%
Clostridium difficile colitis
1%
Intestinal obstruction
1%
Pancreatic duct stenosis
1%
Chest pain
1%
Nerve root compression
1%
Cerebellar infarction
1%
Syncope
1%
Incisional hernia
1%
Cholangitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental
Control
COV-IMMUNO Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IMM-101Experimental Treatment1 Intervention
The treatment regimen with IMM-101 will be one 1.0 mg (= 0.1 mL) dose given on Day 0, followed by a second dose of 0.5 mg (= 0.05 mL) on Day 14 (-2/+5 days), and a third Dose of 0.5 mg (= 0.05 mL) on Day 45 (+/-14 days)
Group II: ObservationActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMM-101
2018
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Ontario Institute for Cancer ResearchOTHER
23 Previous Clinical Trials
8,990 Total Patients Enrolled
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,258 Total Patients Enrolled
Immodulon Therapeutics LtdIndustry Sponsor
8 Previous Clinical Trials
249 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can and will fill out health questionnaires in English or French.My organs are functioning well enough for the treatment, according to my doctor.I can attend all treatments and follow-ups for the study.I have had a bone marrow transplant in the past.I am currently receiving or about to receive treatment for cancer.I am at high risk for severe COVID-19 due to my age, health conditions, or living situation.I agree to get pneumococcal and flu shots as per Canadian guidelines.I agree to use effective birth control during and for 3 months after treatment.I am 18 years old or older.I have never tested positive for COVID-19.I have bladder cancer and am being treated with BCG.You have HIV, Hepatitis B, or Hepatitis C.You have had an allergic reaction to a mycobacterial product, like the BCG vaccine.I haven't had flu-like symptoms in the last 14 days.I have been treated with IMM-101 before.I have had leukemia before or have it now.I have a severe autoimmune disease or condition requiring steroids or immunosuppressants.I can take care of myself and perform daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: IMM-101
- Group 2: Observation
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
What does the FDA's opinion of IMM-101?
"IMM-101 has been studied in Phase 3 trials, which indicates that there is some data supporting its efficacy and multiple rounds of data supporting its safety. Our team at Power estimates that IMM-101 is safe to use, with a score of 3 on a scale from 1 to 3."
Answered by AI
Does this experiment have a large geographic scope?
"So far, 8 patients have been enrolled in this study at locations such as CIUSSS de l'Estrie - Centre hospitalier in Sherbrooke, The Research Institute of the McGill University in Montreal, and Odette Cancer Centre in Toronto."
Answered by AI
What are some other studies that have used IMM-101 as a treatment?
"IMM-101 was first studied in 2020 at the Ottawa Hospital Research Institute. Since then, there have been a total of 90 completed clinical trials. Currently, there is 1 live trial, with many of these trials taking place in Sherbrooke, Quebec."
Answered by AI
Are people with this condition able to sign up for the trial at this time?
"Unfortunately, this particular clinical trial is not recruiting patients at this time. It was originally posted on 2020-06-25, with the most recent update taking place on 2022-09-12. For individuals interested in other trials, there are 2323 clinical trials actively recruiting patients with malignancies and 1 trial for IMM-101 that is also recruiting patients."
Answered by AI
How many people fit the bill for this clinical research?
"Unfortunately, this particular clinical trial is not seeking patients at the moment. It was initially posted on 2020-06-25 and updated for the last time on 2022-09-12. However, there are 2323 trials for patients with malignancies and 1 study for IMM-101 that are actively recruiting participants."
Answered by AI
Is this research the inaugural effort of its type?
"right now, there is a single ongoing trial for IMM-101 in 6 locations and 1 nation. The first such study was in 2020. Conducted by Immodulon Therapeutics Ltd, the Phase 3 clinical trial had 195 patients and completed drug approval in 2020. As of now, 90 similar studies have been undertaken."
Answered by AI
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