metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
mUC - L1 - all population metastatic/advanced UC (mUC) - 1st Line (L1) mUC - L1 - all population
versus gemcitabine plus platin
	atezolizumab alone
	IMvigor-130 (At-arm B vs Ch-armC), 2020 Lancet 2020; 395:1547-1557 NCT02807636	RCT	mUC - L1 - all population	atezolizumab (B)	chemotherapy (C) gemcitabine plus platine	patients with untreated locally advanced or metastatic urothelial carcinoma	360 / 400	some concern	inconclusive	inconclusive 2 % increase in deaths (OS) (PE) statistically significant 62 % decrease in objective responses (ORR)
	durvalumab alone
	DANUBE (D vs C - all population), 2020 Urologe A 2016; 55:1097-8 Lancet Oncol 2020 Sep 21;S1470-2045(20)30541-6. NCT02516241	RCT	mUC - L1 - all population	durvalumab	platine based chemotherpy (SOC) cisplatine plus gemcitabine	first line in Patients with Stage IV Urothelial Cancer.	346 / 344	some concern	inconclusive	statistically significant 64 % decrease in objective responses (ORR)
	durvalumab plus tremelimumab
	DANUBE (DT vs C - all population), 2020 Urologe A 2016; 55:1097-8 Lancet Oncol 2020 Sep 21;S1470-2045(20)30541-6. NCT02516241	RCT	mUC - L1 - all population	durvalumab plus tremelimumab	platine based chemotherpy	first line in Patients with Stage IV Urothelial Cancer.	342 / 344	some concern	inconclusive	inconclusive 15 % decrease in deaths (OS) (PE) statistically significant 41 % decrease in objective responses (ORR)
	pembrolizumab plus SoC
	KEYNOTE-361 (PC vs C), 2021 Annals of Oncology Lancet Oncol 2021 May 26;S1470-2045(21)00152-2. NCT02853305	RCT	mUC - L1 - all population	pembrolizumab plus chemotherapy	chemotherapy alone (cisplatine or carbo plus gemcitabine)	patients with histologically or cytologically confirmed unresectable/metastatic urothelial carcinoma, who received no prior systemic chemotherapy for advanced urothelial cancer	351 / 352	some concern	inconclusive	inconclusive 14 % decrease in deaths (OS) (PE) suggested 22 % decrease in progression or deaths (PFS) (PE)
versus placebo plus SoC
	atezolizumab plus SoC
	IMvigor-130 (At-arm A vs Pl-arm C), 2020 Lancet 2020; 395:1547-1557 NCT02807636	RCT	mUC - L1 - all population	atezolizumab (A) plus gemcitabine and platine	placebo (C) plus gemcitabine and platine	patients with untreated locally advanced or metastatic urothelial carcinoma	451 / 400	some concern	conclusif	inconclusive 17 % decrease in deaths (OS) (PE) demonstrated 18 % decrease in progression or deaths (PFS) (PE)
versus Standard of Care (SoC)
	pembrolizumab alone
	KEYNOTE-361 (P vs C), 2021 Annals of Oncology Lancet Oncol 2021 May 26;S1470-2045(21)00152-2. NCT02853305	RCT	mUC - L1 - all population	pembrolizumab	chemotherapy alone (cisplatine or carbo plus gemcitabine)	patients with histologically or cytologically confirmed unresectable/metastatic urothelial carcinoma, who received no prior systemic chemotherapy for advanced urothelial cancer	307 / 352	some concern	inconclusive	statistically significant 35 % increase in progression or deaths (PFS) statistically significant 47 % decrease in objective responses (ORR)
mUC - L1 - PDL1 positive metastatic/advanced UC (mUC) - 1st Line (L1) mUC - L1 - PDL1 positive
versus gemcitabine plus platin
	durvalumab alone
	DANUBE (D vs C - PDL1>25%), 2020 Urologe A 2016; 55:1097-8 Lancet Oncol 2020 Sep 21;S1470-2045(20)30541-6. NCT02516241	RCT	mUC - L1 - PDL1 positive	durvalumab	platine based chemotherapy (gemcitabine)	first line in Patients with Stage IV Urothelial Cancer whose tumours express high levels of PD-L1.	209 / 207	some concern	inconclusive	inconclusive 11 % decrease in deaths (OS) (PE) statistically significant 59 % decrease in objective responses (ORR)
	durvalumab plus tremelimumab
	DANUBE (DT vs C - PDL1>25%), 2020 Urologe A 2016; 55:1097-8 Lancet Oncol 2020 Sep 21;S1470-2045(20)30541-6. NCT02516241	RCT	mUC - L1 - PDL1 positive	durvalumab plus tremelimumab	platine based chemotherpy (SOC)	first line in Patients with Stage IV Urothelial Cancer with PDL1 high expression level	205 / 207	some concern	suggested	suggested 26 % decrease in deaths (OS)
mUC - L2 - all population metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - all population
versus Standard of Care (SoC)
	atezolizumab alone
	IMvigor-211 (all population), 2018 Lancet 2018;391:748-757 Eur Urol 2021 Apr 23;S0302-2838(21)00230-X. NCT02302807	RCT	mUC - L2 - all population	atezolizumab	chemotherapy	patients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen patients had received no more than two previous lines of therapy and had progressed during or following one or more platinum-containing regimens for metastatic urothelial carcinoma (or neoadjuvant or adjuvant therapy with progression)	467 / 464	some concern	suggested	suggested 15 % decrease in deaths (OS) (PE) suggested 18 % decrease in deaths (OS) (extension)
	pembrolizumab alone
	KEYNOTE-045 (all population), 2017 N Engl J Med 2017;376:1015-1026 Urologe A 2015; 54:1287-90 Int. J. Clin. Oncol. 2020; 25:165-174 Ann. Oncol. 2019; 30:970-976 J Clin Oncol 2018 Jun 1;36(16):1579-1587. NCT02256436	RCT	mUC - L2 - all population	pembrolizumab	chemotherapy (ICC) : paclitaxel, docetaxel, or vinflunine	patients with advanced urothelial carcinoma that progressed during or after the receipt of platinumbased chemotherapy treated as second-line therapy	270 / 272	some concern	conclusif	demonstrated 27 % decrease in deaths (OS) (PE) inconclusive 2 % decrease in progression or deaths (PFS) (PE) suggested 30 % decrease in deaths (OS) (extension) demonstrated 1.1-fold increase in objective responses (ORR) (PE) more...
mUC - L2 - PDL1 positive metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - PDL1 positive
versus Standard of Care (SoC)
	atezolizumab alone
	IMvigor-211 (PDL1>5%), 2018 Lancet 2018;391:748-757 Eur Urol 2021 Apr 23;S0302-2838(21)00230-X. NCT02302807	RCT	mUC - L2 - PDL1 positive	atezolizumab	chemotherapy	patients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen patients had received no more than two previous lines of therapy and had progressed during or following one or more platinum-containing regimens for metastatic urothelial carcinoma (or neoadjuvant or adjuvant therapy with progression)	116 / 118	some concern	inconclusive	inconclusive 13 % decrease in deaths (OS) (PE)
	IMvigor-211 (PDL1>1%), 2018 Lancet 2018;391:748-757 Eur Urol 2021 Apr 23;S0302-2838(21)00230-X. NCT02302807	RCT	mUC - L2 - PDL1 positive	atezolizumab	chemotherapy	patients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen patients had received no more than two previous lines of therapy and had progressed during or following one or more platinum-containing regimens for metastatic urothelial carcinoma (or neoadjuvant or adjuvant therapy with progression	316 / 309	some concern	suggested	inconclusive 13 % decrease in deaths (OS) (PE)
	pembrolizumab alone
	KEYNOTE-045 (PDL1 CPS >10%), 2017 N Engl J Med 2017;376:1015-1026 Urologe A 2015; 54:1287-90 Int. J. Clin. Oncol. 2020; 25:165-174 Ann. Oncol. 2019; 30:970-976 NCT02256436	RCT	mUC - L2 - PDL1 positive	pembrolizumab	chemotherapy (ICC)	as second-line therapy in patients with advanced urothelial carcinoma that progressed during or after the receipt of platinumbased chemotherapy.=> only PDL1 CPS >10%	74 / 90	some concern	conclusif	demonstrated 43 % decrease in deaths (OS) (PE) inconclusive 11 % decrease in progression or deaths (PFS) (PE)
mUC - M - all population metastatic/advanced UC (mUC) - maintenance (M) mUC - M - all population
versus BSC
	avelumab alone
	JAVELIN Bladder 100 (all population), 2020 N Engl J Med 2020 Sep 24;383(13):1218-1230. International Journal of Clinical Oncology NCT02603432	RCT	mUC - M - all population	avelumab	BSC	as first line therapy, previously untreated locally advanced or metastatic urothelial carcinoma whose disease did not progress on induction chemotherapy	350 / 350	some concern	conclusif	demonstrated 31 % decrease in deaths (OS),deaths (OS) (PE) suggested 24 % decrease in deaths (OS) (extension),deaths (OS) (extension) suggested 46 % decrease in PFS (extension),PFS (extension) suggested 38 % decrease in progression or deaths (PFS),progression or deaths (PFS)
mUC - M - PDL1 positive metastatic/advanced UC (mUC) - maintenance (M) mUC - M - PDL1 positive
versus BSC
	avelumab alone
	JAVELIN Bladder 100 (PDL1>25%), 2020 N Engl J Med 2020 Sep 24;383(13):1218-1230. NCT02603432	RCT	mUC - M - PDL1 positive	avelumab	no treatment	previously untreated locally advanced or metastatic urothelial carcinoma whose disease did not progress on induction chemotherapy	189 / 169	some concern	conclusif	demonstrated 44 % decrease in deaths (OS),deaths (OS) (PE) suggested 31 % decrease in deaths (OS) (extension),deaths (OS) (extension) suggested 54 % decrease in PFS (extension),PFS (extension) suggested 44 % decrease in progression or deaths (PFS),progression or deaths (PFS)
MIBC - NA - all population muscular invasive bladder cancer (MIBC) MIBC - (neo)adjuvant (NA) MIBC - NA - all population
versus no additional treatment
	atezolizumab alone
	IMvigor-010, 2021 Urologe A 2016; 55:1491-1493 ESMO Immuno-Oncology Virtual Congress 2020 (9-12 December) Lancet Oncol 2021 Apr;22(4):525-537. The Lancet Oncology NCT02450331	RCT	MIBC - (neo)adjuvant (NA)	atezolizumab	observation	patients aged 18 years or older and had histologically confirmed muscle-invasiveurothelial carcinoma of either the bladder or the upper tract as Adjuvant Therapy (Participants With High-Risk Muscle-Invasive Urothelial Carcinoma)	406 / 403	some concern	inconclusive	inconclusive 11 % decrease in events or deaths (EFS),events or deaths (EFS) (PE)
versus placebo
	nivolumab alone
	CheckMate 274 (all population), 2017 Urologe A 2017; 56:1331-1332 Journal of Clinical Oncology 39, no. 6_suppl (February 20, 2021) 391-391. N Engl J Med 2021 Jun 3;384(22):2102-2114. NCT02632409	RCT	MIBC - NA - all population	nivolumab	placebo	adjuvant therapy patients with muscle-invasive high-risk urothelial carcinoma who had undergone radicalsurgery	353 / 356	low	conclusif	suggested 28 % decrease in RFS/DFS demonstrated 30 % decrease in events or deaths (EFS) (PE)
MIBC - NA - PDL1 positive muscular invasive bladder cancer (MIBC) MIBC - (neo)adjuvant (NA) MIBC - NA - PDL1 positive
versus placebo
	nivolumab alone
	CheckMate 274 (PDL1>1%), 2017 Urologe A 2017; 56:1331-1332 Journal of Clinical Oncology 39, no. 6_suppl (February 20, 2021) 391-391. N Engl J Med 2021 Jun 3;384(22):2102-2114. NCT02632409	RCT	MIBC - NA - PDL1 positive	nivolumab	placebo	adjuvant therapy patients with muscle-invasive high-risk urothelial carcinoma who had undergone radicalsurgery	140 / 142	low	conclusif	suggested 45 % decrease in RFS/DFS demonstrated 45 % decrease in events or deaths (EFS) (PE)

mUC - L1 - all population metastatic/advanced UC (mUC) - 1st Line (L1) mUC - L1 - all population

mUC - L1 - PDL1 positive metastatic/advanced UC (mUC) - 1st Line (L1) mUC - L1 - PDL1 positive

mUC - L2 - all population metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - all population

mUC - L2 - PDL1 positive metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - PDL1 positive

mUC - M - all population metastatic/advanced UC (mUC) - maintenance (M) mUC - M - all population

mUC - M - PDL1 positive metastatic/advanced UC (mUC) - maintenance (M) mUC - M - PDL1 positive

MIBC - NA - all population muscular invasive bladder cancer (MIBC) MIBC - (neo)adjuvant (NA) MIBC - NA - all population

MIBC - NA - PDL1 positive muscular invasive bladder cancer (MIBC) MIBC - (neo)adjuvant (NA) MIBC - NA - PDL1 positive