- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04442048
Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure (COV-IMMUNO)
November 20, 2023 updated by: Canadian Cancer Trials Group
COV-IMMUNO: A Randomized, Phase III Trial of Immunization With IMM-101 Versus Observation for the Prevention of Severe Respiratory and COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure
The purpose of this study is to find out if immunization with IMM-101 will reduce the incidence of severe respiratory and COVID-19 infections in cancer patients.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
IMM-101 is a new type of immune stimulating therapy being developed for the treatment of cancer that may also help in preventing severe respiratory and COVID-19 infections.
Laboratory tests show that IMM-101 works by activating parts of the immune system that are also involved with protecting against viral and bacterial infections, so that if you are exposed to these types of infections your body may be able fight off the infection better.
That could help prevent severe symptoms from respiratory and COVID-19 related infections.
It has been studied in over 300 cancer patients who have also been receiving other cancer treatments, including chemotherapy and radiation, and seems promising, but it is not clear if it can offer better results than not having the immunization at all.
Study Type
Interventional
Enrollment (Actual)
195
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre at Hamilton Health Sciences
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London, Ontario, Canada, N6A 5W9
- London Regional Cancer Program
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital Research Institute
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Toronto, Ontario, Canada, M5G 2M9
- University Health Network
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Toronto, Ontario, Canada, M4N 3M5
- Odette Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H2X 3E4
- CHUM-Centre Hospitalier de l'Universite de Montreal
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Montreal, Quebec, Canada, H4A 3J1
- The Research Institute of the McGill University
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Sherbrooke, Quebec, Canada, J1H 5N4
- CIUSSS de l'Estrie - Centre hospitalier
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 [CDC 2019] for a severe COVID-19 infection:
- Age > 65 years old
- Hypertension (on medications);
- Type 1 or 2 Diabetes (on medication)
A relevant chronic condition as per the investigator based on the medical record, including:
- heart (e.g. heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and pulmonary hypertension)
- lung (e.g. chronic obstructive pulmonary disease (COPD including emphysema and chronic bronchitis), moderate to severe asthma, idiopathic pulmonary fibrosis and cystic fibrosis)
- liver cirrhosis
- serious kidney disease requiring dialysis
- Receiving systemic therapy (such as cytotoxic chemotherapy, immunotherapy or targeted agents excluding single-agent hormonal therapy)
- Body Mass Index > 40
- Living in a nursing home or long term care facility
- Patient must have a life expectancy of >6 months as assessed by the investigator
- Patient must have an ECOG Performance Status ≤ 2
- Patient has adequate organ function appropriate for the therapy the patient is planned to receive in the opinion of the investigator and based on local assessment and practices.
- Patient is aged ≥ 18 years
- Patient has agreed to receive pneumococcal vaccination and a seasonal influenza vaccination in accordance with Canadian Guidelines.
- Patient is able (i.e. sufficiently fluent) and willing to complete the health utility questionnaires in either English or French.
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
- Patient must be willing to provide identifying information including provincial health insurance number to facilitate data linkage and follow up.
- Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method throughout the treatment period and for at least 3 months after discontinuation of treatment.
Exclusion Criteria:
- Patient previously received treatment with IMM-101.
- 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.
- Patient cannot have experienced "flu-like symptoms" within 14 days prior to enrollment, including fever, extreme fatigue, new or worsening cough, myalgias, new or worsening dyspnea, and/or sputum production.
- Patient is receiving concomitant treatment with another investigational product or has received such treatment within the 3 weeks prior to enrollment.
- Patient has any co-existing active infection that, in the opinion of the Investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
- Patient has previously experienced an allergic reaction to any mycobacterial product, including the BCG vaccine.
- Patients with superficial bladder cancer or any other condition currently receiving or planned to be treated with BCG.
- Patient has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) or a known history of or is known to have a positive test for Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA [qualitative]).
- Patients with prior or concurrent leukemia.
- Patient has had a prior bone marrow transplant.
- Patient is pregnant or breast-feeding
- Patient has documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents. This includes patient requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent, or depot corticosteroids in the 6 weeks before enrollment) or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporine, etc.) within the 14 days prior to enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. Steroids used for premedication prior to chemotherapy or as part of a chemotherapy regimen are allowed.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IMM-101
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)
|
Three doses of IMM-101 on days 0, 14, and 45.
|
Active Comparator: Observation
|
No active treatment.
Observation only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of "flu-like illness" which includes:
Time Frame: 1 year
|
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of documented COVID-19 infection (confirmed by any Health Canada approved COVID-19 test. Both symptomatic and asymptomatic infections will be documented
Time Frame: 1 year
|
1 year
|
The rate of severe respiratory and COVID-19 infection defined as a confirmed COVID-19 infection leading to hospitalization, ICU admission or death
Time Frame: 1 year
|
1 year
|
The number of events that meet the definition of the primary endpoint, as measured within the one-year follow-up (patients may meet the primary endpoint more than once and be counted multiple times).
Time Frame: 1 year
|
1 year
|
The incidence of COVID-19 seroconverted patients between baseline, 3 months, 6 months and 12 months
Time Frame: 3, 6, and 12 months
|
3, 6, and 12 months
|
The incremental cost-effectiveness ratio (in the unit of CAD$ per life-years gained) measured with EQ-5D-5L
Time Frame: 1 year
|
1 year
|
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
Time Frame: 1 year
|
1 year
|
Overall survival (OS), as time from enrollment to death from any cause
Time Frame: 1 year
|
1 year
|
Incidence, frequency, and severity of AEs considered possibly, probably or definitely related to receipt of IMM-101
Time Frame: 1 year
|
1 year
|
Incidence and frequency of local injection site reactions subsequent to IMM-101 administration
Time Frame: 1 year
|
1 year
|
Incidence and duration of ICU admission related to documented COVID-19 infection
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Rebecca A Auer, Ottawa Hospital Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
April 30, 2024
Study Registration Dates
First Submitted
June 19, 2020
First Submitted That Met QC Criteria
June 19, 2020
First Posted (Actual)
June 22, 2020
Study Record Updates
Last Update Posted (Estimated)
November 21, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IC8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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