Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure

NCT04442048 | Completed Phase 3 DMC

• 1 other identifier: IC8
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Cancer; Covid-19

Outcome Measures

Primary Outcomes (1)

• The rate of "flu-like illness" which includes:

  * WHO definition of "influenza-like illness" (ILI) \[Fitzner 2018\] or confirmed viral/bacterial respiratory infection AND * Results in a change or delay in cancer treatment or requirement for and unscheduled medical assesment, hospitalization or death.

  1 year

Secondary Outcomes (10)

• The incidence of documented COVID-19 infection (confirmed by any Health Canada approved COVID-19 test. Both symptomatic and asymptomatic infections will be documented

  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

  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).

  1 year

• The incidence of COVID-19 seroconverted patients between baseline, 3 months, 6 months 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

  1 year

Study Arms (2)

IMM-101

EXPERIMENTAL

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)

Biological: IMM-101

Observation

ACTIVE COMPARATOR

Other: Observation

Interventions

IMM-101 BIOLOGICAL

Three doses of IMM-101 on days 0, 14, and 45.

IMM-101

Observation OTHER

No active treatment. Observation only

Observation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• BioCan Rx: collaborator
• Immodulon Therapeutics Ltd: collaborator
• Canadian Cancer Society (CCS): collaborator
• ATGen Canada Inc: collaborator
• Ontario Institute for Cancer Research: collaborator
• Canadian Centre for Applied Research in Cancer Control (ARCC): collaborator

Study Sites (8)

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

The Research Institute of the McGill University

Montreal, Quebec, H4A 3J1, Canada

Location

CIUSSS de l'Estrie - Centre hospitalier

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Neoplasms; COVID-19

Interventions

IMM-101; Observation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Rebecca A Auer

  Ottawa Hospital Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 22, 2020
• Study Start: October 1, 2020
• Primary Completion: May 7, 2024
• Study Completion: December 22, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)