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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.
Must not have
Patient has had a prior bone marrow transplant.
Patient cannot have either at present or in the past, a positive test for COVID-19 infection. If a patient has been tested for COVID-19, result must be confirmed as negative prior to enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing IMM-101, a new treatment that boosts the immune system, on cancer patients. The goal is to see if it can reduce severe respiratory and COVID-19 infections by helping the body fight off these infections better.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently receiving or about to receive treatment for cancer.
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I am at high risk for severe COVID-19 due to my age, health conditions, or living situation.
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I am 18 years old or older.
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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a bone marrow transplant in the past.
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I have never tested positive for COVID-19.
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I have bladder cancer and am being treated with BCG.
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I haven't had flu-like symptoms in the last 14 days.
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I have been treated with IMM-101 before.
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I have had leukemia before or have it now.
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I have a severe autoimmune disease or condition requiring steroids or immunosuppressants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The rate of "flu-like illness" which includes

Side effects data

From 2016 Phase 2 trial • 110 Patients • NCT01303172
47%
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%
Jaundice
12%
Insomnia
12%
Anxiety
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%
Blood bilirubin increased
7%
Depression
7%
Vitamin D decreased
7%
Nasopharyngitis
7%
Pain
7%
Injection site reaction
7%
Dry skin
7%
Alopecia
5%
Malabsorption
5%
Rectal haemorrhage
5%
Biliary sepsis
5%
Aspartate aminotransferase increased
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%
Cholecystitis
1%
Convulsion
1%
Peroneal nerve palsy
1%
Epistaxis
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

Awards & Highlights

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.

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

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
Immunotherapy, such as the vaccine IMM-101, works by enhancing the body's immune response to recognize and attack cancer cells. This can involve checkpoint inhibitors that release the brakes on immune cells, allowing them to target cancer more effectively, or vaccines that prime the immune system to identify cancer cells as threats. Other common treatments include chemotherapy, which targets and kills rapidly dividing cells, and targeted therapy, which blocks specific molecules essential for cancer cell growth. Understanding these mechanisms helps cancer patients grasp how their treatments work, the potential side effects, and the reasons behind their specific treatment plans.

Find a Location

Who is running the clinical trial?

Ontario Institute for Cancer ResearchOTHER
23 Previous Clinical Trials
8,978 Total Patients Enrolled
Canadian Cancer Trials GroupLead Sponsor
131 Previous Clinical Trials
69,353 Total Patients Enrolled
Immodulon Therapeutics LtdIndustry Sponsor
8 Previous Clinical Trials
249 Total Patients Enrolled

Media Library

IMM-101 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04442048 — Phase 3
Cancer Research Study Groups: IMM-101, Observation
Cancer Clinical Trial 2023: IMM-101 Highlights & Side Effects. Trial Name: NCT04442048 — Phase 3
IMM-101 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04442048 — Phase 3
~39 spots leftby Oct 2025
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