A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination with Atezolizumab to Subjects with Locally Advanced or Metastatic Solid Tumors

A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination with Atezolizumab to Subjects with Locally Advanced or Metastatic Solid Tumors - ELE18421-184021 (XL184-021)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50370

Enrollment

Registered

2017-12-14

Start date

2018-09-12

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder cancer and kidney cancer

Interventions

Please see ICF (Standard), Appendix 4: Study Procedures and Tests.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: see protocol (enclosed to submission)

Exclusion criteria

Exclusion criteria: see protocol (enclosed to submission)

Design outcomes

Primary

Measure	Time frame
SAFETY ASSESSMENTS Safety evaluations will include assessments of AEs (including irAEs and AESIs), vital signs, ECGs, laboratory tests, and concomitant medications. Adverse event seriousness, severity grade, relationship to study treatment, and relationship to immune effects (ie, irAEs) will be assessed by the investigator. Severity grade will be defined by the NCI CTCAE version 4. TUMOR ASSESSMENTS Tumor response will be assessed using RECIST 1.1 (Appendix G). Additional exploratory efficacy evaluation will include the application of irRECIST for immune response (Appendix H). Subjects will be assessed using a magnetic resonance imaging (MRI) or a CT scan from the date of the first dose of study treatment until the later of radiographic disease progression per RECIST 1.1 as determined by the investigator or the date of the decision to permanently discontinue study treatment. Radiographic tumor assessments will continue on the protocol-defined schedule, regardless of whether study treatment is reduced, interrupted, delayed, or discontinued. Chest / Abdomen / Pelvis/ Neck: Unless otherwise described, CT of Chest/Abdomen/Pelvis (CAP) or CT chest and MRI abdomen/pelvis will be performed in all subjects at screening and every 6 weeks (± 5 days) after initiation of study treatment throughout the first 12 months on study. Upon completion of 12 months on study, these assessments will be performed every 12 weeks (± 7 days). For subjects with DTC and head & neck cancer, CT/MRI of the neck will be performed in addition to the CAP assessments. Subjects with head & neck cancer will be using the same imaging schedule after screening. For subjects with DTC the imaging frequency after screening will be every 9 weeks after initiation of study treatment throughout the first 12 months on study; upon completion of 12 months on study, these assessments will be performed every 12 weeks (± 7 days). Low dose non-contrast CT images from combined positron emission	—

Measure

Time frame

SAFETY ASSESSMENTS Safety evaluations will include assessments of AEs (including irAEs and AESIs), vital signs, ECGs, laboratory tests, and concomitant medications. Adverse event seriousness, severity grade, relationship to study treatment, and relationship to immune effects (ie, irAEs) will be assessed by the investigator. Severity grade will be defined by the NCI CTCAE version 4. TUMOR ASSESSMENTS Tumor response will be assessed using RECIST 1.1 (Appendix G). Additional exploratory efficacy evaluation will include the application of irRECIST for immune response (Appendix H). Subjects will be assessed using a magnetic resonance imaging (MRI) or a CT scan from the date of the first dose of study treatment until the later of radiographic disease progression per RECIST 1.1 as determined by the investigator or the date of the decision to permanently discontinue study treatment. Radiographic tumor assessments will continue on the protocol-defined schedule, regardless of whether study treatment is reduced, interrupted, delayed, or discontinued. Chest / Abdomen / Pelvis/ Neck: Unless otherwise described, CT of Chest/Abdomen/Pelvis (CAP) or CT chest and MRI abdomen/pelvis will be performed in all subjects at screening and every 6 weeks (± 5 days) after initiation of study treatment throughout the first 12 months on study. Upon completion of 12 months on study, these assessments will be performed every 12 weeks (± 7 days). For subjects with DTC and head & neck cancer, CT/MRI of the neck will be performed in addition to the CAP assessments. Subjects with head & neck cancer will be using the same imaging schedule after screening. For subjects with DTC the imaging frequency after screening will be every 9 weeks after initiation of study treatment throughout the first 12 months on study; upon completion of 12 months on study, these assessments will be performed every 12 weeks (± 7 days). Low dose non-contrast CT images from combined positron emission

—

Secondary

Measure	Time frame
For parameters/outcome, please see above.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)