IMM-101 Immunization for COVID-19 in Cancer Patients

(COV-IMMUNO Trial)

Recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Canadian Cancer Trials Group

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: COVID-19 positive, Active infection, Leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 7 weeks

195 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic steroids or immunosuppressive drugs, you may need to stop them 14 days before joining the trial.

How is the IMM-101 treatment different from other COVID-19 treatments for cancer patients?

IMM-101 is unique because it is an immunotherapy that may help boost the immune system of cancer patients, who are at higher risk for severe COVID-19, unlike standard COVID-19 vaccines that primarily target the virus itself. ^{1 2 3 4 5}

Research Team

Rebecca A Auer

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

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.

Inclusion Criteria

Patient must be willing to provide identifying information including provincial health insurance number to facilitate data linkage and follow up.

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.

Exclusion Criteria

Patient is pregnant or breast-feeding

I have had a bone marrow transplant in the past.

I have never tested positive for COVID-19.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IMM-101 immunization with doses on Day 0, Day 14, and Day 45

7 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• IMM-101

Trial Overview 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.

Participant Groups

Group I: IMM-101 Experimental Treatment 1 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: Observation Active Control 1 Intervention

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

Ontario Institute for Cancer Research

Collaborator

Trials

24

Recruited

9,200+

Immodulon Therapeutics Ltd

Industry Sponsor

Trials

9

Recruited

440+

BioCan Rx

Collaborator

Trials

1

Recruited

200+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

ATGen Canada Inc

Industry Sponsor

Trials

5

Recruited

1,800+

Canadian Centre for Applied Research in Cancer Control (ARCC)

Collaborator

Trials

1

Recruited

200+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Post-SARS-CoV-2 Infection Scenarios in Vaccinated and Non-Vaccinated Cancer Patients in Three German Cancer Centers: A Retrospective Analysis. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[COVID-19 Vaccination for Cancer Patients: Progress and Preliminary Recommendations]. [2023]

3. England pubmed.ncbi.nlm.nih.gov

COVID-19 vaccines for patients with cancer: benefits likely outweigh risks. [2023]

4. England pubmed.ncbi.nlm.nih.gov

mRNA-1273 COVID-19 vaccination in patients receiving chemotherapy, immunotherapy, or chemoimmunotherapy for solid tumours: a prospective, multicentre, non-inferiority trial. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Factors affecting the serologic response to SARS-CoV-2 vaccination in patients with solid tumors: A prospective study. [2022]