The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
600
Oral tablets administered once daily.
Pembrolizumab + berahyaluronidase alfa fixed-dose combination administered via subcutaneous (SC) injection once every 3 weeks (Q3W).
Placebo to match zanzalintinib oral tablets administered once daily.
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Council Bluffs
Council Bluffs, Iowa, United States
RECRUITINGOncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
Disease-Free Survival (DFS) in Zanzalintinib + MK-3475A Versus Placebo as Assessed by the Investigator
Time frame: Up to 24 months
DFS in Zanzalintinib Monotherapy Versus Placebo as Assessed by the Investigator
Time frame: Up to 24 months
Proportion of Participants with ctDNA Clearance in Zanzalintinib + MK-3475A Versus Placebo
Time frame: Up to 24 months
Proportion of Participants with ctDNA Clearance in Zanzalintinib Monotherapy Versus Placebo
Time frame: Up to 24 months
Overall Survival (OS) in Zanzalintinib + MK-3475A Versus Placebo
Time frame: Up to 24 months
OS in Zanzalintinib Monotherapy Versus Placebo
Time frame: Up to 24 months
DFS in Zanzalintinib + MK-3475A Versus Zanzalintinib Monotherapy as Assessed by the Investigator
Time frame: Up to 24 months
Proportion of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 24 months
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Grand Island, Nebraska, United States
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Grand Island, Nebraska, United States
RECRUITINGOncology Hematology West, PC dba Nebraska Cancer Specialists - Methodist
Omaha, Nebraska, United States
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Omaha, Nebraska, United States
RECRUITINGOncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy
Omaha, Nebraska, United States
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RECRUITINGAstera Cancer Care
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East Brunswick, New Jersey, United States
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RECRUITING...and 3 more locations