IMM-101 Immunization for COVID-19 in Cancer Patients

(COV-IMMUNO Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Canadian Cancer Trials Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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.

Treatment Details

Interventions

• IMM-101 (Cancer Vaccine)

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+

Dr. Janet Dancey

Canadian Cancer Trials Group

Chief Medical Officer since 2014

MD, FRCPC

Susan Marlin

Canadian Cancer Trials Group

Chief Executive Officer since 2012

BSc (Hons) from Dalhousie University, MSc in Community Health and Epidemiology from Queen’s University

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+