NCT05330429|TerminatedPhase 2ResultsFDA Drug

Study Stopped

Sponsor decision to terminate study

Study of Magrolimab Given Together With FOLFIRI/Bevacizumab (BEV) in Participants With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)

ELEVATE CRC

A Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Bevacizumab and FOLFIRI Versus Bevacizumab and FOLFIRI in Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)

Gilead Sciences ClinicalTrials.gov

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2 other identifiers

GS-US-587-61562022-500177-13

Study Type

interventional

Target

Locations

10 countries

Sites

Timeline

RegisteredApr 2022

StartedJul 2022

CompletionJun 2024

Brief Summary

The goals of this clinical study are to learn more about the safety, tolerability and effectiveness of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC). The primary objectives of this study are: (safety run-in cohort) to evaluate safety and tolerability, and the recommended Phase 2 dose (RP2D) and (randomized cohort) to evaluate the efficacy of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jul 2022

Geographic Reach

10 countries

51 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

April 8, 2022

Completed

7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed

3 months until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2024

Completed

1 year until next milestone

Results Posted

Study results publicly available

July 1, 2025

Completed

Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

April 8, 2022

Results QC Date

June 3, 2025

Last Update Submit

June 27, 2025

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

Safety Run-in Cohort: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
DLT was defined as any, * Grade 3 or higher hematologic toxicity including, serious hemolytic anemia, grade 4 neutropenia lasting \> 7 days * An event meeting Hy's Law criteria: * Treatment-emergent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation (≥ 3 x ULN) and, * Treatment-emergent total bilirubin elevation (\> 2 x ULN), and absence of cholestasis (defined as alkaline phosphatase \< 2 x ULN), and * No other good explanation for the injury (hepatitis A, B, C, or other viral hepatic injury, alcohol ingestion, congestive heart failure, worsening liver metastases, hemolysis)) * Grade 3 or higher nonhematologic toxicity that has worsened in severity from pretreatment baseline during the DLT-assessment period * Grade 3 fatigue lasting \> 7 days * In the opinion of the investigator, the AE was at least possibly related to magrolimab
First dose date up to 28 days
Safety Run-in Cohort: Percentage of Participants Experiencing Adverse Events (AEs) According to the NCI-CTCAE Version 5.0
Treatment-emergent adverse events (TEAEs) were defined as any AE that begun on or after the date of first dose of study drug up to the date of last dose of study treatment plus 30 days or the day before initiation of subsequent anticancer therapy, whichever came first. An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily have a causal relationship with the treatment.
First dose date up to last dose date (up to 36 weeks) plus 30 days
Safety Run-in Cohort: Percentage of Participants Experiencing Laboratory Abnormalities According to NCI-CTCAE Version 5.0
Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade after the date of first dose of study drug up to the date of last dose of study treatment plus 30 days or the day before initiation of subsequent anticancer therapy, whichever came first.
First dose date up to last dose date (up to 36 weeks) plus 30 days
Randomized Cohort: Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS was defined as the time from the date of randomization until the earliest date of documented disease progression (PD) as determined by investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1), or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier (KM) estimates were used in outcome measure analysis.
Up to 83.4 weeks

Secondary Outcomes (9)

Randomized Cohort: Objective Response Rate (ORR) as Determined by Investigator Assessment Using RECIST Version 1.1
Up to 83.4 weeks
Randomized Cohort: Duration of Response (DOR) as Determined by Investigator Assessment Per RECIST Version 1.1
Up to 83.4 weeks
Randomized Cohort: Overall Survival (OS)
Up to 83.4 weeks
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Baseline, Day 1 of Cycles 2, 3, 4 and last cycle (Cycle 8) (Each cycle was of 28 days)
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Day 1 of Cycles 2, 3, 4 and last cycle (Cycle 8) (Each cycle is of 28 days)
+4 more secondary outcomes

Study Arms (3)

Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI

EXPERIMENTAL

Participants will receive magrolimab + bevacizumab + FOLFIRI as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. * Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. * FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.

Drug: MagrolimabDrug: BevacizumabDrug: IrinotecanDrug: FluorouracilDrug: Leucovorin

Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI

EXPERIMENTAL

Participants will receive magrolimab + bevacizumab + FOLFIRI as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. * Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. * FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.

Drug: MagrolimabDrug: BevacizumabDrug: IrinotecanDrug: FluorouracilDrug: Leucovorin

Randomized Cohort: Bevacizumab + FOLFIRI

ACTIVE COMPARATOR

Participants will receive bevacizumab + FOLFIRI as mentioned below: * Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. * FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.

Drug: BevacizumabDrug: IrinotecanDrug: FluorouracilDrug: Leucovorin