Clear cell renal cell carcinoma (ccRCC, first-, second- and third-line) - metastatic castration-resistant prostate cancer (mCRPC, second-line post NHT) - urothelial carcinoma (UC) ICI naïve and ICI-experienced - non-clear cell renal (nccRCC, first-line) cell carcinoma - Colorectal cancer (CRC) - Hepatocellular cancer (HCC) - Non-small cell lung caner (NSCLC) - Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions
Brief summary
Dose-Escalation Stage (Zanzalintinib Combination Therapy): - Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including immune-mediated adverse events (imAEs), Expansion Stage (Zanzalintinib Monotherapy and Combination Therapy): - Objective Response Rate (ORR) in subjects with measurable disease as assessed by the Investigator per RECIST 1.1, - For Cohort 3 (mCRPC): duration of radiographic PFS as determined per Prostate Working Group 3 (PCWG3) criteria (Scher et al 2016) by Blinded Independent Radiology Committee (BIRC), - For Cohort 10 (CRC): Overall survival (OS) rate at 6 months., - Incidence and severity of nonserious AEs and SAEs, including imAEs
Detailed description
Expansion Stage (Zanzalintinib Monotherapy and Combination Therapy): • DOR based on assessment by the Investigator per RECIST 1.1, • PFS for subjects with measurable disease as assessed by the Investigator per RECIST 1.1, • For Cohort 3 (mCRPC): o Proportion of subjects achieving a > 50% decrease in prostate-specific antigen (PSA) from baseline confirmed by a second consecutive PSA assessment at least 3 weeks later o Change in bone biomarkers - Duration of radiographic PFS as determined by Investigator per PCWG3 criteria (Scher et al 2016), • ORR, DOR, and PFS for subjects with measurable disease as assessed by a BIRC per RECIST 1.1 for selected cohorts as determined by the Sponsor, • Overall survival (OS), • Concentration of study treatments (zanzalintinib, nivolumab, ipilimumab and relatlimab) in plasma or serum at different timepoints, • Change in tumor and blood biomarkers, • The number and percentage of subjects who develop ADA response to nivolumab, ipilimumab or relatlimab
Interventions
Sponsors
Exelixis Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-Escalation Stage (Zanzalintinib Combination Therapy): - Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including immune-mediated adverse events (imAEs), Expansion Stage (Zanzalintinib Monotherapy and Combination Therapy): - Objective Response Rate (ORR) in subjects with measurable disease as assessed by the Investigator per RECIST 1.1, - For Cohort 3 (mCRPC): duration of radiographic PFS as determined per Prostate Working Group 3 (PCWG3) criteria (Scher et al 2016) by Blinded Independent Radiology Committee (BIRC), - For Cohort 10 (CRC): Overall survival (OS) rate at 6 months., - Incidence and severity of nonserious AEs and SAEs, including imAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Expansion Stage (Zanzalintinib Monotherapy and Combination Therapy): • DOR based on assessment by the Investigator per RECIST 1.1, • PFS for subjects with measurable disease as assessed by the Investigator per RECIST 1.1, • For Cohort 3 (mCRPC): o Proportion of subjects achieving a > 50% decrease in prostate-specific antigen (PSA) from baseline confirmed by a second consecutive PSA assessment at least 3 weeks later o Change in bone biomarkers - Duration of radiographic PFS as determined by Investigator per PCWG3 criteria (Scher et al 2016), • ORR, DOR, and PFS for subjects with measurable disease as assessed by a BIRC per RECIST 1.1 for selected cohorts as determined by the Sponsor, • Overall survival (OS), • Concentration of study treatments (zanzalintinib, nivolumab, ipilimumab and relatlimab) in plasma or serum at different timepoints, • Change in tumor and blood biomarkers, • The number and percentage of subjects who develop ADA response to nivolumab, ipilimumab or relatlimab | — |
Countries
Austria, Belgium, France, Germany, Italy, Poland, Spain
Outcome results
None listed