What side effects are associated with this type of intervention?

Common treatments for colon cancer, such as combination chemotherapy with drugs like oxaliplatin, leucovorin calcium, and fluorouracil, can cause side effects including nausea, vomiting, fatigue, neuropathy, and increased risk of infection. When combined with immunotherapy agents like atezolizumab, additional immune-related side effects may occur, such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. These side effects result from the heightened immune response induced by the immunotherapy.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of colon cancer, particularly for cases with specific genetic markers such as deficient DNA mismatch repair (dMMR) or high microsatellite instability (MSI-H). Pembrolizumab, an anti-PD-1 monoclonal antibody, has been approved for the treatment of MSI-H or dMMR metastatic colorectal cancer. Similarly, nivolumab, another anti-PD-1 therapy, has been approved for MSI-H or dMMR metastatic colorectal cancer, both as a single agent and in combination with ipilimumab, an anti-CTLA-4 antibody. These treatments work by enhancing the body's immune response against cancer cells, similar to the mechanism of atezolizumab.

What other types of research exist?

Promising novel alternatives to Atezolizumab for colon cancer patients include Pembrolizumab and Nivolumab. Both are immune checkpoint inhibitors that have shown efficacy in various cancers by targeting PD-1/PD-L1 pathways, potentially offering similar benefits in colon cancer treatment.

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Chemotherapy

Chemotherapy + Atezolizumab for Colon Cancer

Phase 3

Waitlist Available

Led By Frank A Sinicrope

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Age >= 12 years

Histologically proven stage III colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C); tumors must be deemed to originate in the colon including tumors that extend into/involve the small bowel (e.g. those at the ileocecal valve)

Must not have

Excluded if known active pulmonary disease with hypoxia defined as:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time from randomization to death, from any cause, assessed up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing whether adding atezolizumab to standard chemotherapy works better than chemotherapy alone for patients with stage III colon cancer who have a specific genetic defect. The chemotherapy drugs aim to kill cancer cells, while atezolizumab helps the immune system attack the cancer. Researchers hope this combination will improve survival rates and quality of life for these patients.

Who is the study for?

This trial is for patients with stage III colon cancer and deficient DNA mismatch repair. Eligible participants must not have autoimmune diseases, active hepatitis B or C, severe allergies to certain antibodies or components in atezolizumab, nor require daily steroids or immunosuppressants. They should have proper liver and kidney function, no history of severe allergic reactions to specific proteins, and no prior treatments except possibly one cycle of mFOLFOX6.

What is being tested?

The study compares the effectiveness of combination chemotherapy alone versus with atezolizumab in treating stage III colon cancer. Chemotherapy includes drugs like oxaliplatin, leucovorin calcium, and fluorouracil that kill or stop tumor cells from growing. Atezolizumab is an immunotherapy that may boost the immune system's attack on cancer.

What are the potential side effects?

Potential side effects include allergic reactions to treatment components (like CHO cell products), organ inflammation due to immunotherapy agents such as atezolizumab, fatigue from chemotherapy drugs, digestive issues caused by both chemo and immunotherapy treatments, blood disorders related to bone marrow suppression by chemotherapy.

Eligibility Criteria

Inclusion Criteria

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

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I am 12 years old or older.

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My cancer is a type of colon cancer that has not spread to distant parts of my body.

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I am 16-17 years old and mostly can take care of myself.

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My tumor was completely removed with clear margins, except possibly the sides.

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I have only had one cycle of mFOLFOX6 for my current colon cancer.

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I do not have any active autoimmune diseases like colitis or rheumatoid arthritis.

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I am on a stable HIV treatment regimen.

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I do not have active hepatitis B or C.

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My CD4 count is above 250 and my HIV is undetectable.

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I haven't taken high-dose steroids or immunosuppressants in the last week.

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I am not planning to receive any other cancer treatments or participate in other clinical trials while in this study.

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I am not allergic to 5-fluorouracil, oxaliplatin, or leucovorin.

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I am 18 or older and can do most daily activities by myself.

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My kidneys are functioning well enough, with a creatinine clearance rate of at least 45 mL/min.

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I do not have severe nerve damage in my hands or feet.

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I am under 16 and can do most activities without help.

Exclusion Criteria

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

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I do not have active lung disease causing low oxygen levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time from randomization to death, from any cause, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time from randomization to death, from any cause, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time from randomization to death, from any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Disease free survival (DFS)

Secondary study objectives

Incidence of adverse events

Overall survival

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Dysgeusia

Headache

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (combination chemotherapy, atezolizumab)Experimental Treatment8 Interventions

Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.

Group II: Arm II (combination chemotherapy)Active Control7 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Fluorouracil

2014

Completed Phase 3

~11700

Leucovorin Calcium

2011

Completed Phase 3

~12500

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Oxaliplatin

2011

Completed Phase 4

~2890

Atezolizumab

2016

Completed Phase 3

~5860

Biospecimen Collection

2004

Completed Phase 3

~2030

0 / 17Eligibility 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

Common treatments for colon cancer include combination chemotherapy and immunotherapy. Combination chemotherapy typically involves drugs like oxaliplatin, leucovorin calcium, and fluorouracil, which work by killing cancer cells, stopping their division, or preventing their spread. Immunotherapy, such as the use of monoclonal antibodies like atezolizumab, helps the immune system recognize and attack cancer cells while potentially inhibiting tumor growth and spread. These treatments are crucial for colon cancer patients as they target the cancer through multiple mechanisms, increasing the chances of effectively controlling or eliminating the disease.