What is the mechanism of action of this treatment?

Immunotherapy, such as the vaccine IMM-101, works by enhancing the body's immune response to recognize and attack cancer cells. This can involve checkpoint inhibitors that release the brakes on immune cells, allowing them to target cancer more effectively, or vaccines that prime the immune system to identify cancer cells as threats. Other common treatments include chemotherapy, which targets and kills rapidly dividing cells, and targeted therapy, which blocks specific molecules essential for cancer cell growth. Understanding these mechanisms helps cancer patients grasp how their treatments work, the potential side effects, and the reasons behind their specific treatment plans.

What side effects are associated with this type of intervention?

Common side effects of immunotherapy treatments, such as immune checkpoint inhibitors (e.g., nivolumab, ipilimumab), include skin reactions (rash, pruritus), endocrine events (thyroid dysfunction, adrenal insufficiency), and gastrointestinal issues (diarrhea, colitis). More severe adverse events can include pneumonitis, hepatitis, and nephritis. These treatments can also lead to immune-related adverse events that may require management with steroids or other immunosuppressive agents.

What prior FDA approvals exist?

Several immunotherapies have received FDA approval for the treatment of various cancers, focusing on enhancing the immune response. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are PD-1 inhibitors approved for multiple cancers, including melanoma and non-small cell lung cancer (NSCLC). Atezolizumab (Tecentriq), a PD-L1 inhibitor, is approved for NSCLC and other cancers. Additionally, ipilimumab (Yervoy), a CTLA-4 inhibitor, is approved for melanoma. These therapies work by blocking inhibitory pathways that prevent the immune system from attacking cancer cells, thereby boosting the body's immune response against tumors.

What other types of research exist?

Promising novel alternatives to IMM-101 for cancer patients in 2024 include: 1) T-cell immunotherapy, 2) Natural killer (NK) cell therapy, 3) Immune checkpoint inhibitors like nivolumab and ipilimumab, 4) Monoclonal antibodies targeting PD-1/PD-L1, such as pembrolizumab and avelumab, and 5) Cancer vaccines like IMA901. These approaches are being actively researched and have shown potential in various clinical trials.

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Cancer Vaccine

IMM-101 Immunization for COVID-19 in Cancer Patients (COV-IMMUNO Trial)

Phase 3

Waitlist Available

Research Sponsored by Canadian Cancer Trials Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 for a severe COVID-19 infection: Age > 65 years old, Hypertension (on medications), Type 1 or 2 Diabetes (on medication), relevant chronic conditions as per the investigator based on the medical record, including heart, lung, liver cirrhosis, serious kidney disease requiring dialysis, receiving systemic therapy, Body Mass Index > 40, living in a nursing home or long term care facility.

Must not have

Patient has had a prior bone marrow transplant.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of IMM-101 are not listed here, similar vaccines may cause injection site reactions, flu-like symptoms such as fever and fatigue, muscle pain, and potentially allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently receiving or about to receive treatment for cancer.

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I am at high risk for severe COVID-19 due to my age, health conditions, or living situation.

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I am 18 years old or older.

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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a bone marrow transplant in the past.

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I have never tested positive for COVID-19.

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I have bladder cancer and am being treated with BCG.

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I haven't had flu-like symptoms in the last 14 days.

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I have been treated with IMM-101 before.

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I have had leukemia before or have it now.

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I have a severe autoimmune disease or condition requiring steroids or immunosuppressants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The rate of "flu-like illness" which includes

Side effects data

From 2016 Phase 2 trial • 110 Patients • NCT01303172

47%

Abdominal pain

45%

Asthenia

44%

Diarrhoea

44%

Decreased appetite

44%

Nausea

41%

Constipation

31%

Anaemia

29%

Vomiting

25%

Fatigue

24%

Pyrexia

23%

Back pain

21%

Neutropenia

19%

Weight decrased

17%

Dysquesia

16%

Oedema peripheral

15%

Thrombocytopenia

12%

Jaundice

12%

Insomnia

12%

Anxiety

12%

Abdominal pain upper

12%

Lethargy

11%

Stomatitis

11%

Headache

11%

Dizziness

Vitamin D deficiency

Urinary tract infection

Ascites

Dyspepsia

Platelet count decrased

Arthralgia

Dyspnoea

Cough

Pruritis

Chills

Abdominal distension

Abdominal discomfort

Gastrooesophageal reflux

Mucosal inflammation

Alanine aminotransferase increased

Rash

Neutrophil count decreased

Blood bilirubin increased

Depression

Vitamin D decreased

Nasopharyngitis

Pain

Injection site reaction

Dry skin

Alopecia

Malabsorption

Rectal haemorrhage

Biliary sepsis

Aspartate aminotransferase increased

Blood alkaline phosphatase increased

Oedema

Leukopenia

Respiratory tract infection

Parasthesia

Injection site pain

Infection

Pneumonia

Haemoglobin deceased

Disease progression

Blood potassium decreased

Hypokalaemia

WBC count deceased

Pleural effusion

Lower respiratory tract infection

Bile duct obstruction

Convulsion

Peroneal nerve palsy

Cholecystitis

Epistaxis

Gastroenteritis

Liver abscess

Lung infection

Gastrointestinal hemorrhage

Diabetic ketoacidosis

Hypoglycaemia

Large intestine perforation

Cerebral infarction

Sepsis

Biliary tract infection

Device related infection

Upper gastrointestinal haemorrhage

General physical health deterioration

Pneumonitis

Pneumothorax

Pulomonary embolism

Toxicity to various agents

Febrile neutropenia

Splenomegaly

Arrhymia

Cardiac failure congestive

Pancreatic carcinoma metastatic

Urinary tract infection fungal

Clostridium difficile colitis

Intestinal obstruction

Pancreatic duct stenosis

Chest pain

Nerve root compression

Cerebellar infarction

Syncope

Incisional hernia

Cholangitis

100%

80%

60%

40%

20%

Study treatment Arm

Experimental

Control

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IMM-101Experimental Treatment1 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: ObservationActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IMM-101

2018

Completed Phase 2

~130

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immunotherapy, such as the vaccine IMM-101, works by enhancing the body's immune response to recognize and attack cancer cells. This can involve checkpoint inhibitors that release the brakes on immune cells, allowing them to target cancer more effectively, or vaccines that prime the immune system to identify cancer cells as threats. Other common treatments include chemotherapy, which targets and kills rapidly dividing cells, and targeted therapy, which blocks specific molecules essential for cancer cell growth. Understanding these mechanisms helps cancer patients grasp how their treatments work, the potential side effects, and the reasons behind their specific treatment plans.