Atezolizumab for Lynch Syndrome

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Lynch Syndrome+9 More
Atezolizumab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a combination of chemotherapy drugs with atezolizumab to see if it is more effective than chemotherapy alone in treating patients with stage III colon cancer. Atezolizumab is an immunotherapy drug that may help the body's immune system attack the cancer.

Eligible Conditions
  • Lynch Syndrome
  • Malignant Neoplasms
  • Adenocarcinoma
  • DNA Repair Disorder

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: From the time from randomization to death, from any cause, assessed up to 5 years

Year 5
Overall survival
Year 5
Disease free survival (DFS)
Day 30
Incidence of adverse events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Atezolizumab
27%Fatigue
25%Decreased appetite
24%Cough
19%Asthenia
19%Dyspnoea
18%Constipation
18%Nausea
18%Pyrexia
16%Diarrhoea
13%Arthralgia
12%Vomiting
12%Anaemia
11%Rash
11%Back pain
11%Musculoskeletal pain
10%Headache
9%Oedema peripheral
9%Weight decreased
9%Insomnia
9%Chest pain
9%Pruritus
9%Pain in extremity
8%Dizziness
7%Aspartate aminotransferase increased
7%Haemoptysis
7%Upper respiratory tract infection
7%Myalgia
6%Influenza like illness
6%Alanine aminotransferase increased
6%Bronchitis
6%Nasopharyngitis
6%Productive cough
5%Dry skin
5%Depression
5%Musculoskeletal chest pain
4%Urinary tract infection
4%Paraesthesia
4%Neuropathy peripheral
4%Abdominal pain
3%Stomatitis
3%Pneumonia
3%Dysgeusia
2%Pleural effusion
2%Malaise
2%Neutropenia
1%Respiratory tract infection
1%Pulmonary embolism
1%Peripheral sensory neuropathy
1%Sepsis
1%Pneumonitis
1%Alopecia
1%Mucosal inflammation
1%Bone pain
1%Lacrimation increased
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02008227) in the Atezolizumab ARM group. Side effects include: Fatigue with 27%, Decreased appetite with 25%, Cough with 24%, Asthenia with 19%, Dyspnoea with 19%.

Trial Design

2 Treatment Groups

Arm II (combination chemotherapy)
1 of 2
Arm I (combination chemotherapy, atezolizumab)
1 of 2

Active Control

Experimental Treatment

700 Total Participants · 2 Treatment Groups

Primary Treatment: Atezolizumab · No Placebo Group · Phase 3

Arm I (combination chemotherapy, atezolizumab)Experimental Group · 9 Interventions: Leucovorin Calcium, Oxaliplatin, Biospecimen Collection, Fluorouracil, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Computed Tomography, Quality-of-Life Assessment, Atezolizumab · Intervention Types: Drug, Drug, Procedure, Drug, Other, Procedure, Procedure, Other, Drug
Arm II (combination chemotherapy)ActiveComparator Group · 8 Interventions: Leucovorin Calcium, Oxaliplatin, Biospecimen Collection, Fluorouracil, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Computed Tomography, Quality-of-Life Assessment · Intervention Types: Drug, Drug, Procedure, Drug, Other, Procedure, Procedure, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
FDA approved
Oxaliplatin
FDA approved
Biospecimen Collection
2004
Completed Phase 1
~670
Fluorouracil
FDA approved
Magnetic Resonance Imaging
2017
Completed Phase 2
~1100
Computed Tomography
2017
Completed Phase 2
~3410
Atezolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from the time from randomization to death, from any cause, assessed up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,993 Previous Clinical Trials
41,299,751 Total Patients Enrolled
18 Trials studying Lynch Syndrome
52,146 Patients Enrolled for Lynch Syndrome
Frank A SinicropePrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
107 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Tumors must have been completely resected; near or positive radial margins are acceptable so long as en bloc resection was performed; near or positive distal margin positivity is not permitted.
Patients with rectal cancer and a tumor in the colon must have a complete resection of the colon and rectum
The primary tumor is located in the cecum, ascending colon, transverse colon, descending colon, or rectosigmoid colon.
The treating physician determines if the patient is eligible based on the criteria in the eligibility criteria.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: November 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Alabama100.0%
How old are they?
65+100.0%
What site did they apply to?
Cookeville Regional Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%