Trial NCT07527858
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer
- Phase
- Phase 2
- Sponsor
- Gilead Sciences
- Conditions
- Advanced Microsatellite Stable Colorectal Cancer
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Key Inclusion Criteria:
Medical History/Physical Characteristics
* 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.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.Performance status
Laboratory Assessments
* Have adequate organ function.
Key Exclusion Criteria with:
Medical Conditions/History:
* 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).
Prior/Concurrent Therapy or Clinical Study Experience
Prior treatment with:
* Trifluridine-tipiracil, regorafenib, or fruquitinib.
* Any immuno-oncology therapy.
* Anticancer biologic agent within 4 weeks prior to randomization or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to randomization and have not recovered (ie, Grade 2 or higher is considered not recovered) from AEs from prior anticancer therapy at the time of randomization. Individuals in observational studies are eligible.
* Allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Restrictions found (1)
- Performance statusOutrightinclusion
ECOG 0-1
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Recruiting in Massachusetts
- Beth Israel Deaconess Medical Center · Boston, Suffolk County