Colorectal Cancer
Conditions
Keywords
Colorectal Cancer, Telisotuzumab Adizutecan, Bevacizumab, Trifluridine and Tipiracil, AndroMETa-CRC-560
Brief summary
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 700 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally. In this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine/tipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Interventions
Intravenous (IV)
DRUGBevacizumab
Intravenous (IV)
DRUGTrifluridine/Tipiracil
Oral
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator. * Life expectancy \>= 12 weeks per investigator assessment
Exclusion criteria
* Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any other unapproved investigational agent. * History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil. * History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies. * History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR) | Up to Approximately 15 Months | Confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. |
| Phase 3: Overall Survival (OS) | Up to Approximately 36 Months | OS is defined as the time from randomization to the event of death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 3: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) | Up to Approximately 24 Months | PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST v1.1 or death from any cause, whichever occurs earlier. |
| Phase 3: Duration Of Response (DoR) as assessed by BICR | Up to Approximately 24 Months | DoR defined as time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first. DoR is defined for subjects with confirmed CR/PR. |
| Phase 3: Disease Control (DC) as assessed by BICR: | Up to Approximately 24 Months | DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, v1.1 |
| Phase 3: Change from baseline in the EORCT QLQ-C30 physical functioning domain at Week 13 | Up to Approximately 13 Weeks | The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much). |
| Phase 3: Change from baseline in the remaining EORCT QLQ-C30 domains | Up to Approximately 13 Weeks | The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much). |
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed