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)

Conditions

Metastatic Colorectal Cancer (mCRC)

Brief summary

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 [ Time Frame: 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 [ Time Frame: First dose date up to 3 years ] • Percentage of Participants Experiencing Laboratory Abnormalities According to NCI-CTCAE Version 5.0 [ Time Frame: First dose date up to 3 years ], Randomized Cohort: • Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 3 years ] PFS is defined as the time from the date of randomization until the earliest date of documented disease progression, or death from any cause, whichever occurs first.

Related papers

No related papers found yet.

Interventions

DRUGAvastin 25 mg/ml concentrate for solution for infusion

DRUGMagrolimab

DRUGCAMPTO 20 mg/mL concentrate for solution for infusion

DRUG-

DRUGCalcio levofolinato Teva Generics 175 mg polvere per soluzione per infusione

DRUGFluorouracil 50 mg/ml Solution for Injection or Infusion

DRUGParacetamol 500 mg Film Coated Tablets

DRUGLeucovorin-Teva 10 mg/ml Concentrate for Solution for Infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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 [ Time Frame: 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 [ Time Frame: First dose date up to 3 years ] • Percentage of Participants Experiencing Laboratory Abnormalities According to NCI-CTCAE Version 5.0 [ Time Frame: First dose date up to 3 years ], Randomized Cohort: • Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 3 years ] PFS is defined as the time from the date of randomization until the earliest date of documented disease progression, or death from any cause, whichever occurs first.	—

Measure

Time frame

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 [ Time Frame: 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 [ Time Frame: First dose date up to 3 years ] • Percentage of Participants Experiencing Laboratory Abnormalities According to NCI-CTCAE Version 5.0 [ Time Frame: First dose date up to 3 years ], Randomized Cohort: • Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 3 years ] PFS is defined as the time from the date of randomization until the earliest date of documented disease progression, or death from any cause, whichever occurs first.

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Countries

Belgium, France, Germany, Italy, Spain

Outcome results

None listed