SWOG clinical trial number
CTSU/A031501

Phase III Randomized Adjuvant Study of Pembrolizumab in Muscle Invasive and Locally Advanced Urothelial Carcinoma (ambassador) Versus Observation

Closed
Phase
Abbreviated Title
Phase III Adj Mus-Inv & Adv Uro Carc vs. Obs
Status Notes
This study is permanently closed to accrual effective 8/24/21

The FDA recently approved nivolumab, a PD-1 inhibitor (similar to pembrolizumab), as adjuvant therapy for patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. Therefore, effective immediately, A031501 is permanently closed to new patient accrual.

Sites must review the information provided by Alliance that is available on www.ctsu.org and follow the instructions.
Activated
09/21/2017
Closed
08/24/2021
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE

Research committees

Gastrointestinal Cancer
Genitourinary Cancer

Treatment

Blinatumomab Nivolumab

Eligibility Criteria Expand/Collapse

SWOG is participating in this study through the Cancer Trials Support Unit (CTSU) of the National Cancer Institute.

Publication Information Expand/Collapse

2024

AMBASSADOR Alliance A031501: Phase III Randomized Adjuvant Study of Pembrolizumab in Muscle-Invasive and Locally Advanced Urothelial Carcinoma (MIBC) vs Observation

A Apolo;K Ballman;G Sonpavde;S Berg;W Kim;R Parikh;M Teo;R Sweis;D Geynisman;P Grivas;E Levine;Z Reichert;J Kim;M Bilen;Y Wen;O Hahn;S Halabi;G Perez;M Morris;J Rosenberg ASCO GU Symposium (JAN 25-27, 2024, San Francisco, CA), oral; J Clin Oncol 42, 2024 (suppl 4; abstr LBA531)

Alliance A031501: AMBASSADOR study of Adjuvant Pembrolizumab (Pembro) in Muscle-Invasive Urothelial Carcinoma (MIUC) vs Observation (Obs): Extended follow-up results and metastatic disease recurrence distribution

A Apolo;K Ballman;G Sonpavde;S Berg;W Kim;R Parikh;M Teo;R Sweis;D Geynisman;P Grivas;G Chatta;Z Reichert;J Kim;M Bilen;B McGregor;S Srinivas;S Halabi;G Burbano;M Morris;J Rosenberg ESMO (September 13-17, 2024, Barcelona, Spain), mini-oral

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