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Monoclonal Antibodies
Magrolimab + FOLFIRI/BEV for Colorectal Cancer (ELEVATE CRC Trial)
Phase 2
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previously treated individuals with inoperable metastatic colorectal cancer (mCRC) who are ineligible for checkpoint inhibitor therapy (microsatellite instability (MSI)-H or mismatch repair deficient (dMMR) and are excluded)
Individuals must have an eastern cooperative oncology group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
ELEVATE CRC Trial Summary
This trial is testing a new drug for people with mCRC who have already tried other treatments. The goal is to see if it is safe and effective.
Who is the study for?
This trial is for adults with advanced inoperable metastatic colorectal cancer who've had one prior treatment excluding those with certain genetic mutations or conditions. Participants must have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory, and meet specific blood count and organ function criteria.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Magrolimab combined with FOLFIRI/BEV (a chemotherapy regimen) in patients who have previously treated mCRC. It aims to determine the best dose for Phase 2 trials and how well this combination works against the cancer.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions, infusion-related symptoms, fatigue, gastrointestinal issues like diarrhea or nausea, low blood counts increasing infection risk, liver function changes, and possibly hypertension due to Bevacizumab.
ELEVATE CRC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have colorectal cancer that cannot be removed by surgery and I can't receive certain immune therapies.
Select...
I am fully active or can carry out light work.
ELEVATE CRC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Randomized Cohort: Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Safety Run-in Cohort: Percentage of Participants Experiencing Adverse Events (AEs) According to the NCI-CTCAE Version 5.0
Safety Run-in Cohort: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
+1 moreSecondary outcome measures
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire EORTC-QLQ-C30 Score
Randomized Cohort: Change From Baseline of the 5-level EuroQol 5 dimensions questionnaire (EQ-5D-5L) Score
Randomized Cohort: Duration of Response (DOR) as Assessed by Investigator Assessment Per RECIST Version 1.1
+5 moreSide effects data
From 2020 Phase 1 & 2 trial • 78 Patients • NCT0295378267%
Dry skin
44%
Diarrhoea
44%
Dermatitis acneiform
44%
Fatigue
44%
Lymphocyte count decreased
33%
Infusion related reaction
33%
Abdominal pain
22%
Myalgia
22%
Decreased appetite
22%
Small intestinal obstruction
22%
Tinnitus
22%
Nausea
22%
Chills
22%
Oedema peripheral
22%
Back pain
22%
Headache
22%
Pruritus
22%
Dehydration
22%
Rash maculo-papular
11%
Hypokalaemia
11%
Dyspepsia
11%
Tumour pain
11%
Hypertension
11%
Dyspnoea
11%
Lymphopenia
11%
Malignant neoplasm progression
11%
Cerebrovascular accident
11%
Anaemia
11%
Palpitations
11%
Conjunctivitis allergic
11%
Dry eye
11%
Abdominal distension
11%
Constipation
11%
Gastrooesophageal reflux disease
11%
Hypoaesthesia oral
11%
Folliculitis
11%
Sinusitis
11%
Gastrointestinal stoma complication
11%
Aspartate aminotransferase increased
11%
Blood bilirubin increased
11%
Hypomagnesaemia
11%
Hypophosphataemia
11%
Dizziness
11%
Confusional state
11%
Depression
11%
Haematuria
11%
Dysphonia
11%
Ingrowing nail
11%
Skin infection
11%
Tinea cruris
11%
Platelet count decreased
11%
Alanine aminotransferase increased
11%
Photopsia
11%
Conjunctivitis
11%
Gastroenteritis viral
11%
Hyperglycaemia
11%
Arthralgia
11%
Neck pain
11%
Somnolence
11%
Nasal congestion
11%
Deep vein thrombosis
11%
Oesophageal pain
11%
Vomiting
11%
Chest discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Magrolimab 10 mg/kg
Magrolimab 20 mg/kg
Magrolimab 30 mg/kg
Magrolimab 45 mg/kg
Magrolimab Priming Dose Only
ELEVATE CRC Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRIExperimental Treatment5 Interventions
Participants will receive magrolimab in de-escalating doses to establish recommended Phase 2 dose (RP2D) in combination with + bevacizumab (5 mg/kg every 2 weeks) + FOLFIRI (irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous on Days 1, 2, 15, and 16 of a 28-Day Cycle).
Group II: Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRIExperimental Treatment5 Interventions
Participants will receive the RP2D determined in the Safety Run-in cohort of magrolimab in combination with bevacizumab (5 mg/kg every 2 weeks) + FOLFIRI (irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous on Days 1, 2, 15, and 16 of a 28-Day Cycle).
Group III: Randomized Cohort: Bevacizumab + FOLFIRIActive Control4 Interventions
Participants will receive bevacizumab (5 mg/kg every 2 weeks) + FOLFIRI (irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous on Days 1, 2, 15, and 16 of a 28-Day Cycle).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11540
Magrolimab
2021
Completed Phase 2
~170
Irinotecan
2017
Completed Phase 4
~2680
Leucovorin
2005
Completed Phase 4
~5730
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,706 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,700 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My colon or rectum cancer has worsened after one treatment including specific chemotherapy.I have colorectal cancer that cannot be removed by surgery and I can't receive certain immune therapies.I am fully active or can carry out light work.I have brain involvement but it's stable and I haven't needed steroids for 4 weeks.My liver is working well.I have previously been treated with irinotecan.I do not have severe numbness or pain in my hands or feet.I haven't had a heart attack or significant heart disease in the last 6 months.My kidneys are working well.I have a known bleeding disorder.I needed more than 2 blood transfusions in the last month.I have had cancer before, but it was either skin cancer treated successfully or localized prostate cancer.I have fluid buildup in my chest that isn't managed.I have an unhealed wound, stomach ulcer, or broken bone.I haven't had hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.I haven't had serious gut or abdominal infections or holes in the past 6 months.I have ongoing serious GI bleeding.I have a history of serious gut issues or have a device in my colon.I haven't had a stroke or similar event in the last 6 months, except for treatable deep vein thrombosis.My high blood pressure is not under control.I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.My cancer has a specific BRAF mutation or is MSI-H/dMMR.I haven't had cancer treatment within the last 3 weeks or 4 half-lives before starting magrolimab.
Research Study Groups:
This trial has the following groups:- Group 1: Randomized Cohort: Bevacizumab + FOLFIRI
- Group 2: Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
- Group 3: Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has recruitment for this clinical trial been initiated yet?
"Affirmative. Clinicaltrials.gov lists this medical trial as currently enrolling participants, which began on July 8th 2022 and was last updated in November 7th 2022. The experiment requires 215 individuals to be enrolled from seven different sites."
Answered by AI
How many people are partaking in this clinical experiment?
"The trial sponsor, Gilead Sciences, requires a total of 215 eligible patients to operate the study. Data suggests that enrolment will take place at Virginia Cancer Specialists PC in Arlington and the University of Michigan in Ann Arbor."
Answered by AI
In what geographical areas are these trials taking place?
"At this point in time, there are 7 sites enrolling participants. These enrolment centres span from Arlington to Redondo Beach and several other locations in between. To reduce the need for travelling, prospective patients should select the nearest medical facility if they decide to join the trial."
Answered by AI
Has Magrolimab been given the official green light by the FDA?
"Magrolimab was evaluated and scored a 2 on our team's 1 to 3 scale due to the fact that Phase 2 trials have collected enough evidence for safety, but not yet sufficient data regarding efficacy."
Answered by AI
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