Table 3.

Comparison between the PROSPER and IMmotion010 immune checkpoint inhibitor trials.

	PROSPER	IMmotion010	Comment
Sponsor	ECOG	Genetech (in collaboration with the SUO Clinical Trials Consortium)	-
Risk criteria & tumor stage	pT2–4, NX, M0 pTany, N1–2, M0 All grades included Only ECOG 0 or 1 included *Metastasectomy excluded	pT2, NX, M0, G4 pT3a, NX, M0, G3–4 pT3b/c, NX, M0, any grade pTany, N+, M0, any grade *Fully resected M1 disease *Selected patients	PROSPER included lower risk patients
Histology	Includes up to 15% non- clear-cell component	Clear-cell, or non-clear- cell with sarcomatoid component	-
Lymph nodes	Included N+ disease if fully resected	Included N+ disease if fully resected	-
Interventions	Neoadjuvant nivolumab x 1 month → nephrectomy → adjuvant nivolumab x 9 months *No placebo group	Adjuvant Atezolizumab or placebo x 12 months	Major differences include: no placebo arm and delay to surgery in PROSPER
Dosing	Nivolumab 3 mg/kg IV q2 weeks x 2 cycles Adjuvant: Nivolumab 3 mg/kg IV q2 weeks x 6 cycles then q4 weeks x 6 cycles	Atezolizumab 1,200 mg IV q3 weeks x 16 cycles	-
Randomization	N=766 (estimated) Stratified by: size (cT2 vs. >cT2), node status (cN0 vs. cN+), histology *Requires pre-operative biopsy	N=664 (estimated) Stratified by: disease stage (T2–3a vs. pT3b– 4/N+ vs. metastasectomy), PD-L1 status, Region	Biopsy in PROSPER potentially leading to correlative data
Outcomes	Primary: DFS Secondary: toxicity, OS, RFS with clear-cell, predictive biomarkers	Primary: DFS Secondary: OS, DFS, DSS, DMFS, toxicity, serum anti-therapeutic Abs, predictive biomarkers	Both studies have robust secondary analyses including biomarkers and tissue based outcomes IMmotion010 DFS is investigator assessed