SWOG clinical trial number
CTSU/EA8143

A Phase III RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

Closed
Phase
Abbreviated Title
Phase 3 Rando Peri-Op Nivo vs. Obs for RC Carcinoma w/ Nephrectomy
Status Notes
This study is close to accrual effective June 9, 2021.
Activated
02/02/2017
Closed
06/09/2021
Participants
CTSU

Research committees

Genitourinary Cancer

Treatment

Nivolumab

Publication Information Expand/Collapse

2024

Perioperative nivolumab versus observation in patients with renal cell carcinoma undergoing nephrectomy (PROSPER ECOG-ACRIN EA8143): an open-label, randomised, phase 3 study

M Allaf;S Kim;V Master;D McDermott;L Harshman;L Harshman;S Cole;C Drake;S Signoretti;S Signoretti;M Akgul;N Baniak;E Li-Ning;M Palmer;H Emamekhoo;N Adra;H Kaimakliotis;Y Ged;P Pierorazio;E Abel;M Bilen;K Ogan;H Moon;K Ramaswamy;E Singer;T Mayer;J Lohrey;V Margulis;J Gills;S Delacroix;M Waples;A James;P Wang;T Choueiri;M Michaelson;A Kapoor;D Heng;B Shuch;B Leibovich;P Lara;J Manola;D Maskens;D Battle;R Uzzo;G Bratslavsky;N Haas;M Carducci Lancet Oncology Aug;25(8):1038-1052

PMid: PMID38942046 | PMC number: PMC11323681

2021

PROSPER: Phase III RandOmized Study Comparing PERioperative Nivolumab versus Observation in Patients with Renal Cell Carcinoma (RCC) Undergoing Nephrectomy (ECOG-ACRIN EA8143)

M Allaf;S Kim;V Master;D McDermott;C Drake;S Signoretti;D Cella;R Gupta;S Cole;B Shuch;P Lara;A Kapoor;D Heng;B Leibovich;M Michaelson;T Choueiri;M Jewett;D Maskens;L Harshman;M Carducci;N Haas J Clin Oncol 39, 2021 (suppl 15; abstr TPS4596) (American Society of Clinical Oncology Annual Meeting 2021, poster session)

2020

PROSPER: A phase III randomized study comparing perioperative nivolumab (nivo) vs. observation in patients with localized renal cell carcinoma (RCC) undergoing nephrectomy (EA8143): A trial of the ECOG-ACRIN Cancer Research Group

L Harshman;A Puligandla;N Haas;M Allaf;C Drake;D McDermott;S Signoretti;D Cella;R Gupta;B Shuch;T Choueiri;P Lara;A Kapoor;D Heng;M Jewett;V Master;M Michaelson;B Leibovich;D Maskens;M Carducci J Clin Oncol 38: 2020 (suppl; abstr TPS5101); American Society of Clinical Oncology 2020 Annual Meeting, poster

2019

PROSPER: A phase III randomized study comparing perioperative nivolumab (nivo) vs. observation in patients with localized renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN 8143)

L Harshman;A Puligandla;N Haas;M Allaf;C Drake;D McDermott;S Signoretti;D Cella;RT Gupta;B Shuch;T Choueiri;PN Lara;A Kapoor;D Heng;M Jewett;V Master;M Michaelson;B Leibovich;D Maskens;M Carducci ASCO GU Cancers Symposium (Feb 14-16, 2019, San Francisco, CA), poster

PROSPER: A phase III randomized study comparing perioperative nivolumab (nivo) vs. observation in patients with renal cell carcinoma (RCC) undergoing nephrectomy (ECOGACRIN 8143)

L Harshman;M Puligandla;N Haas;M Allaf;CD Drake;DF McDermott;S Signoretti;D Cella;RT Gupta;B Shuch;T Choueiri;PN Lara;A Kapoor;D Heng;M Jewett;V Masters;M Michaelson;B Leibovich;D Maskens;M Carducci J Clin Oncol 37(suppl; abstr TPS4597); ASCO (5/31-6/4/19, Chicago IL) TIPS, poster session

The future of perioperative therapy in advanced renal cell carcinoma: how can we PROSPER?

HD Patel;M Puligandla;B Shuch;B Leibovich;A Kapoor;V Master;C Drake;DY Heng;PN Lara;T Choueiri;T Maskens;EA Singer;EC Eggener;RS Svatek;WM Stadler;S Cole;S Signoretti;RG Gupta;MD Michaelson;DF McDermott;D Cella;LI Wagner;NB Haas;MA Carducci;LC Harshman;ME Allaf Future Oncology May;15(15):1683-1695

PMid: PMID30968729 | PMC number: PMC6595543

2018

PROSPER: A phase III randomized study comparing perioperative nivolumab (nivo) vs. observation in patients with localized renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN 8143)

L Harshman;M Puligandla;NB Haas;M Allaf;CG Drake;DF McDermott;S Signoretti;D Cella;RT Gupta;R Satish Bhatt;E Mendel Van Allen;T Choueiri;P Lara;A Kapoor;D Yick;C Heng;B Shuch;MAS Jewett;DJ George;M Dror Michaelson;MA Carducci J Clin Oncol 36, 2018 (suppl; abstr TPS4597); ASCO Annual Meeting (June 1- 5, 2018, Chicago, IL), poster session

2017

A phase 3 randomized study comparing perioperative nivolumab vs. observation in patients with localized renal cell carcinoma undergoing nephrectomy (PROSPER RCC, EA8143)

LC Harshman;M Puligandla;N Haas;M Allaf;D McDermott;S Signoretti;R Gupta;TK Choueiri;P Lara;A Kapoor;D Heng;B Shuch;M Jewett;D George;D Michaelson;R Bhat;E Van Allen;V Master;MA Carducci J Clin Oncol 35, 2017 (suppl; abstr TPS4596);American Society of Clinical Oncology (ASCO) Annual Meeting (June 2-6, 2017, Chicago, IL), poster session (TIP)

Other Clinical Trials

SWOG Clinical Trial Number
S2312
SWOG Clinical Trial Number
S2210

S2210, "Targeted Neoadjuvant Treatment for Patients with Localized Prostate Cancer and Germline DNA Repair Deficiency"

Research Committee(s)
Genitourinary Cancer
Activated
08/14/2023
Accrual
7%
Open
Phase
SWOG Clinical Trial Number
S2200