A Phase 3 study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 positive Colorectal Cancer (KEYFORM-007)

Conditions

Colorectal Cancer

Brief summary

Overall Survival (OS)

Detailed description

Progression-Free Survival (PFS) according per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR), Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR, Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, Number of Participants Who Experience at least One Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score, Change from Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score, Change from Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score, Time to Deterioration (TTD) in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score, TTD in EORTC QLQ-C30 Appetite Loss (Item 13) Score, TTD in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGMK-4280A

DRUGTRIFLURIDINE

DRUGCOMBINATIONS

DRUGREGORAFENIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	—

Secondary

Measure	Time frame
Progression-Free Survival (PFS) according per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR), Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR, Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, Number of Participants Who Experience at least One Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score, Change from Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score, Change from Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score, Time to Deterioration (TTD) in EORTC QLQ-C30 Global Health Stat	—

Measure

Time frame

Progression-Free Survival (PFS) according per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR), Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR, Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, Number of Participants Who Experience at least One Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score, Change from Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score, Change from Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score, Time to Deterioration (TTD) in EORTC QLQ-C30 Global Health Stat

—

Countries

France, Italy, Norway, Spain

Outcome results

None listed