STELLAR-002
11 evidence topics · 2 sources
Objective
Primary endpoint
Location and study date
No evidence found.
Study design
Dose-escalation study design
Eligibility criteria
Age group eligible for the advanced-solid-tumor cohorts
Treatment
Initial combination doses in the reported escalation cohorts
Study outcomes
Rationale for using safety as the primary endpoint
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
STELLAR-002: zanzalintinib plus nivolumab cohort
Description of analysis sets
Dose-escalation design and evaluability
| Component | Quoted description |
|---|---|
| Enrollment design | “rolling six design” |
| Dose-limiting-toxicity evaluation | “DLT-evaluable pts” |
Results
Participant disposition
No evidence found.
Baseline characteristics
Colorectal cancer representation in the 19-participant nivolumab cohort
Efficacy results
STELLAR-002: response in the mixed-solid-tumor nivolumab cohort
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Study limitations
Summary
The reported zanzalintinib plus nivolumab cohort included 19 participants with multiple solid-tumor types; colorectal cancer accounted for 26%. The reported absence of responses and disease-control rate of 42% are cohort-level findings, not colorectal-specific efficacy estimates. The open-label phase 1b design and safety-focused primary endpoint do not provide a randomized comparative estimate of benefit in metastatic colorectal cancer.