The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based Combinations in participants with advanced microsatellite stable (MSS) colorectal cancer (CRC). The primary objective of this study is to assess the effect of DEN as monotherapy and in combination with nivolumab (NIVO) or trifluridine-tipiracil (FTD-TPI) and bevacizumab (BVZ) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Administered Intravenously
Administered Intravenously
Administered Intravenously
Administered orally
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST Version 1.1.
Time frame: Up to 60 months
Duration of response (DOR)
DOR is defined as the time from first response (CR or PR) as assessed by investigator, per RECIST Version 1.1 until the date of first documented progressive disease (PD) or death, whichever comes first.
Time frame: Up to 60 months
Progression-Free Survival (PFS)
PFS is defined as the time from date of randomization until PD or death from any cause, whichever comes first as assessed by the investigator according to RECIST Version 1.1.
Time frame: Up to 60 months
Overall Survival (OS)
OS is defined as the length of time from randomization until the date of death from any cause.
Time frame: Up to 60 months
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame: First dose date up to 120 days post last dose, up to 60 months
Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE v5.0
Time frame: First dose date up to 120 days post last dose, up to 60 months
Pharmacokinetic (PK) Parameter: Serum concentration of Denikitug
Time frame: Up to 36 months
PK Parameter: Cmax for Denikitug
Cmax is defined as the maximum observed concentration.
Time frame: Up to 36 months
PK Parameter: AUCall for Denikitug
AUCall is defined as the cumulative areas under the curve for all time points.
Time frame: Up to 36 months
Percentage of Participants who Developed Antidrug Antibody (ADA) Against Denikitug
Time frame: Up to 36 months
Gilead Clinical Study Information Center
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