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Monoclonal Antibodies
Atezolizumab + Bevacizumab for Gastrointestinal Cancer (MRD-GI Trial)
Phase 3
Recruiting
Led By John L. Marshall, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will enroll 20 patients with gastrointestinal cancers who have completed all standard treatments but still have evidence of the disease. Patients will receive intravenous atezolizumab and bevacizumab once every 21 days for a maximum of 12 months.
Who is the study for?
Adults who've completed all standard treatments for certain GI cancers (like colorectal, stomach, liver cancer) with curative intent but still have detectable ctDNA. They must be in good physical condition, not pregnant or breastfeeding, willing to use contraception and not have any active infections or severe health conditions that could interfere with the trial.
What is being tested?
The trial is testing Atezolizumab and Bevacizumab on patients with GI cancers who are ctDNA positive after standard treatment. It's an open-label study where everyone gets the drugs through IV every 21 days for up to a year unless their disease returns or side effects become too much.
What are the potential side effects?
Possible side effects include high blood pressure, bleeding risks like nosebleeds or coughing up blood, potential immune system reactions leading to inflammation in organs like lungs or liver, infection risk increase due to weakened immune defenses, and allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of Enrollment
Rate of ctDNA Complete Response (CR)
Rate of ctDNA Partial Response (PR)
+2 moreSecondary study objectives
Reasons for failure of enrollment
Toxicity by CTCAE v5.0 criteria
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Febrile neutropenia
6%
Pneumonia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
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
1Treatment groups
Experimental Treatment
Group I: Atezolizumab plus BevacizumabExperimental Treatment2 Interventions
atezolizumab 1200 mg and bevacizumab 15 mg/kg given intravenously on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for a maximum of 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5540
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,560 Previous Clinical Trials
569,414 Total Patients Enrolled
Natera, Inc.Industry Sponsor
53 Previous Clinical Trials
43,191 Total Patients Enrolled
Georgetown UniversityLead Sponsor
348 Previous Clinical Trials
137,282 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have high calcium levels in my blood that are causing symptoms.I am 18 years old or older.I might have or know I have cancer that has come back or spread within the last 28 days.I have a serious heart condition.I have a history of bleeding disorders.I had a biopsy or minor surgery within the last week.I haven't received all the standard treatments for my condition within the suggested time.I have a history of lung conditions.I am currently taking or have recently taken certain medications.I have a serious wound or bone fracture that is not healing.I have pain from my cancer that isn't relieved by treatment.I frequently need procedures to remove excess fluid from my chest or abdomen.I have brain metastases that are untreated or getting worse.I haven't had any major stomach or intestine issues like fistulas, perforations, abscesses, or bleeding in the last 6 months.I have had leptomeningeal disease.My high blood pressure is not well controlled.I have serious blood vessel problems.I have had cancer before, but it's one of the exceptions.I have not had certain vaccines or therapies recently.I have had blood clots in my veins before.My liver function is good despite my liver cancer diagnosis.I am not on IV antibiotics for an infection when starting the study treatment.My blood and organ tests meet the required health standards.I have not had a severe infection in the last 4 weeks.I have had a previous transplant of stem cells or an organ.My recent scans show no signs of cancer coming back or spreading.My cancer was treated with the goal of curing it, but there's a high risk it might come back.I agree to use contraception or remain abstinent.I am able to get out of my bed or chair and move around.I tested negative for HIV or am stable on HIV treatment.I had treatment aimed at curing a small number of cancer spread and currently have no evidence of disease.I don't have any health issues that would prevent me from taking a new drug.I have not had any local treatments to my liver or any other organ in the last 28 days.My cancer is confirmed as a type of adenocarcinoma in the colorectal, gastric, pancreatic, liver, or gallbladder area.I have not had surgery or a major injury in the last 28 days.I have coughed up blood before.I have untreated or partially treated varices in my esophagus or stomach that are bleeding or at high risk of bleeding.I have active tuberculosis.I have had bleeding in my brain.I have had bleeding from varices in my esophagus or stomach.My ctDNA test for cancer was positive within the last year and before joining this study.I have finished all my cancer treatments as recommended by my doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab plus Bevacizumab
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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