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Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer

ConditionAdvanced Microsatellite Stable Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGilead Sciences

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed unresectable, recurrent, or locally advanced or metastatic microsatellite stable colorectal cancer (MSS CRC) (adenocarcinoma, excluding appendix cancer).

Documented MSS or proficient mismatch repair (pMMR) disease by local assessment using a validated polymerase chain reaction (PCR) (microsatellite status) and/or immunohistochemistry (IHC) mismatch repair (MMR) assay is required.

Has received up to 2 prior lines of systemic therapy for advanced or metastatic CRC, which must have included at least fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapies if indicated; and if applicable: anti-vascular endothelial growth factor (VEGF) therapy, anti epidermal growth factor receptor (EGFR) therapy, encorafenib or adagrasib/sotorasib.

Documented progressive disease (PD) by computed tomography (CT) or magnetic resonance imaging (MRI) during or after the most recent therapy per RECIST Version 1.1 criteria by investigator assessment.

Disqualifiers

Significant cardiovascular disease.

History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years.

History of (noninfectious) pneumonitis/interstitial lung disease or current pneumonitis/ interstitial lung disease.

History of gastrointestinal (GI) perforation, permanent ileostomy, abdominal abscess or fistula within 6 months, active or uncontrolled GI bleeding within 4 weeks, or any condition associated with significant risk of bleeding or perforation (eg, untreated varices, tumor erosion, recent GI surgery).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Denikitug

    Drug

    Administered Intravenously

  • Nivolumab

    Drug

    Administered Intravenously

  • Bevacizumab

    Drug

    Administered Intravenously

  • Trifluridine-Tipiracil

    Drug

    Administered orally

Treatment groups

170 Participants
are divided into 4 treatment groups
Group A: DEN monotherapy (Arm A)Experimental treatment 1 intervention
Group B: DEN in combination with NIVO (Arm B)Experimental treatment 2 interventions
Group C: DEN in combination with Trifluridine-Tipiracil (FTD-TPI) and BVZ (Arm C)Experimental treatment 3 interventions
Group D: Standard of care (SOC) alone: BVZ and FTD-TPI (Arm D)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gilead Sciences

Lead sponsor

Source ClinicalTrials.gov
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