IMM-101 Immunization for COVID-19 in Cancer Patients

(COV-IMMUNO Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the IMM-101 vaccine can reduce serious respiratory and COVID-19 infections in cancer patients. Cancer patients often have weaker immune systems, making them more vulnerable to infections. The study aims to find a way to offer better protection. It includes two groups: one receiving the IMM-101 vaccine and another observed without it. People undergoing active cancer treatment and having conditions like high blood pressure or diabetes might be suitable for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer care advancements.

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.

Is there any evidence suggesting that IMM-101 is likely to be safe for humans?

Research has shown that IMM-101 has undergone testing to ensure its safety for people. IMM-101 aims to strengthen the immune system, potentially helping to protect against infections. Previous studies demonstrated that it can be safely used after cancer surgery. No major safety concerns have been reported, and it appears to be well-tolerated. The treatment is now in a phase 3 trial, indicating it has passed earlier safety tests. This phase aims to confirm its effectiveness and continued safety in a larger group of people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

Unlike the standard COVID-19 vaccines, which primarily focus on generating an immune response against the virus, IMM-101 is unique because it leverages an immune-boosting approach specifically tailored for cancer patients. This treatment uses a heat-killed bacterium, Mycobacterium obuense, to stimulate the body's innate immune system, aiming to enhance the overall immune response against COVID-19. Researchers are excited about IMM-101 because it offers a potential dual benefit: improving immune function in individuals with compromised immune systems due to cancer, while also providing protection against COVID-19. This dual-action approach could make a significant difference in safeguarding a vulnerable population.

What evidence suggests that IMM-101 might be an effective treatment for COVID-19 in cancer patients?

Research has shown that IMM-101 might strengthen the immune system in cancer patients, potentially reducing serious respiratory infections and COVID-19. A previous study examined its use after surgery and suggested it might protect against severe effects of COVID-19. IMM-101 boosts the body's immune response. Early results indicate it could help cancer patients, who are often more at risk for infections, by enhancing their immune systems. In this trial, some participants will receive the IMM-101 treatment regimen, while others will be in the observation group. This treatment is being considered to help these patients better fight off severe infections. ^{1 2 3 4 6}

Who Is on the Research Team?

Rebecca A Auer

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04442048

Immunization With IMM-101 vs Observation for Prevention ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7465907/

Cancer Management during COVID-19 Pandemic: Is Immune ... We suggest that ICIs not only can be safely administered to cancer patients, but they might even be beneficial in COVID-19-positive cancer patients.

3. ajmc.com ajmc.com/view/drug-that-boosts-immunotherapy-studied-as-tool-to-battle-covid-19-in-patients-with-cancer

Drug That Boosts Immunotherapy Studied as Tool to Battle ... First, Auer studied the use of IMM-101 post-surgery, and then she suggested it could protect cancer patients from COVID-19's respiratory wrath, ...

4. withpower.com withpower.com/trial/phase-3-infections-5-2020-ee3b5

IMM-101 Immunization for COVID-19 in Cancer Patients 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7498663/

Mitigating Coronavirus Induced Dysfunctional Immunity for At ... Here we describe dysfunctional immune responses induced by coronaviruses, representing potentially difficult to overcome obstacles to safe, effective vaccine ...

6. clinicallab.com clinicallab.com/protecting-cancer-patients-from-covid-19-23269

Protecting Cancer Patients from COVID-19 The researchers hope that boosting cancer patients' immune systems with IMM-101 will protect them from developing severe COVID-19 and other dangerous lung ...