Table 1. Open in new tab Characteristics...

Reference	Trial name	Phase	NCT number	Cancer type	Study type	QOL measure	Follow-up	Intervention arm	Comparison arm
Ascierto et al. 2017 (22)	Not reported	III	NCT01515189	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Ipilimumab 10 mg/kg Q3W	365	Ipilimumab 3 mg/kg Q3W	362
Barlesi et al. 2019 (11)	KEYNOTE-010	II/III	NCT01905657	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 2 mg/kg Q3W	344	Docetaxel 75 mg/m² Q3W	343
Pembrolizumab 10 mg/kg Q3W	346
Bordoni et al. 2017 (23)	OAK	III	NCT02008227	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 15	Atezolizumab 1200 mg Q3W	425	Docetaxel 75 mg/m² Q3W	425
Brahmer et al. 2017 (24)	KEYNOTE-024	III	NCT02142738	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 15	Pembrolizumab 200 mg/kg Q3W	151	Investigator-choice platinum-doublet chemotherapy Q3W	148
Cella et al. 2016 (25)	CheckMate 025	III	NCT01668784	Renal cell carcinoma	Randomized trial	EQ-5D	Week 12	Nivolumab 3 mg/kg Q2W	362	Everolimus 10 mg daily	344
Coens et al. 2017 (26)	EORTC 18071	III	NCT00636168	High-risk stage III melanoma	Randomized trial	EORTC QLQ-C30	Week 24	Ipilimumab 10 mg/kg 4x Q3W	475	Placebo 10 mg/kg 4x Q3W	476
El-Khoueiry et al. 2017 (27)	CheckMate 040	I/II	NCT01658878	Hepatocellular carcinoma	Single group trial	EQ-5D	Week 25	Nivolumab (dose-expansion phase)	214	NA
Harrington et al. 2017 (28)	CheckMate 141	III	NCT02105636	Squamous head and neck	Randomized trial	EORTC QLQ-C30	Week 15	Nivolumab 3 mg/kg Q2W	240	Chemotherapy (methotrexate, docetaxel, or cetuximab)	121
Hui et al. 2019 (29)	PACIFIC	III	NCT02125461	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 52	Durvalumab 10 mg/kg Q2W	476	Placebo 10 mg/kg 2 W	237
Kaufman et al. 2017 (30)	JAVELIN Merkel 200	II	NCT02155647	Merkel cell carcinoma	Single group trial	EQ-5D	Week 13	Avelumab 10 mg/kg Q2W	72	NA
Larkin et al. 2018 (31)	CheckMate 037	III	NCT01721746	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Nivolumab 3 mg/kg Q2W	272	Investigator’s choice (Dacarbazine 1000 mg/m² or Carboplatin AUC 6 + Paclitaxel 175 mg/m²) Q3W	133
Long et al. 2016 (32)	CheckMate 066	III	NCT01721772	Melanoma	Randomized trial	EORTC QLQ-C30	Weeks 61	Nivolumab 3 mg/kg Q2W	210	Dacarbazine 1000 mg/m² Q3W	208
Mathias et al. 2015 (33)^a	IMAGE	N/A	NCT01511913	Advanced cutaneous melanoma	Observational	EORTC QLQ-C30	Week 26	Ipilimumab	196	Non-ipilimumab–treated cohort	100
Mazieres et al. 2018 (34)^a	KEYNOTE-407	III	NCT02775435	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 18	Pembrolizumab 200 mg + Investigator’s Choice (Pacitaxel 200 mg/m² on Day 1 or NAB-Paclitaxel 100 mg/m² on Days 1, 8, 15) + Carboplatin AUC6 Day 1, Q3W	254	Placebo 200 mg + investigator’s choice (Pacitaxel 200 mg/m² on day 1 or NAB-Paclitaxel 100 mg/m² on days 1, 8, 15) + Carboplatin AUC6 day 1, Q3W	264
O’Donnell et al. 2018 (35)^a	MEDI4736	I/II	NCT01693562	Urothelial carcinoma	Single group trial	EORTC QLQ-C30	Week 16	Durvalumab, 10 mg/kg Q2W	182	NA
Perol et al. 2019 (36)^a	EVIDENS	N/A	NCT03382496	Non-small cell lung cancer	Observational	EQ-5D	Week 36	Nivolumab	1394	NA
Petrella et al. 2017 (12)	KEYNOTE-006	III	NCT01866319	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 10 mg/kg Q2W	270	Ipilimumab 3 mg/kg Q3W	240
Pembrolizumab 10 mg/kg Q3W	266
Powles et al. 2018 (37)	IMvigor211	III	NCT02302807	Urothelial carcinoma	Randomized trial	EORTC QLQ-C30	Week 12	Atezolizumab 1200 mg Q3W	467	Investigator’s choice: Docetaxel 75 mg/m² or Paclitaxel 175 mg/m² or Vinflunine 320 mg/m² Q3W	464
Reck et al. 2018 (38)	CheckMate 017	III	NCT01642004	Non-small cell lung cancer	Randomized trial	EQ-5D	Week 66	Nivolumab 3 mg/kg Q2W	135	Docetaxel 75 mg/m² Q3W	137
Revicki et al. 2012 (13)	MDX010-20	III	NCT00094653	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Ipilimumab (3 mg/kg) + gp 100 (1 mg) Q3W	403	gp100 (1 mg) + placebo Q3W	136
Ipilimumab (3 mg/kg) + placebo Q3W	137
Schadendorf et al. 2016 (14)	KEYNOTE-002	II	NCT01704287	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 2 mg/kg Q3W	180	Investigator’s choice: carboplatin + paclitaxel, paclitaxel, dacarbazine, or temozolomide	179
Pembrolizumab 10 mg/kg Q3W	181
Schadendorf et al. 2017 (15)	CheckMate 067	III	NCT01844505	Melanoma	Randomized trial	EORTC QLQ-C30	Week 55	Nivolumab 3 mg/kg Q2W + placebo for ipilimumab W 1 and W 4+ placebo for nivolumab W 4	270	Ipilimumab 3 mg/kg Q3W + placebo matching with nivolumab W 3, 5	259
Nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W	274
Sharma et al. 2017 (39)	CheckMate 275	II	NCT02387996	Bladder cancer	Single group trial	EORTC QLQ-C30	Week 17	Nivolumab 3 mg/kg Q2W	270	NA
Vaughn et al. 2018 (40)	KEYNOTE-045	III	NCT02256436	Urothelial carcinoma	Randomized trial	EORTC QLQ-C30	Week 15	Pembrolizumab 200 mg Q3W	266	Paclitaxel 175 mg/m² IV or Docetaxel 75 mg/m² IV or Vinflunine 320 mg/m² IV, Q3W	253
Weber et al. 2017 (16)	CheckMate 238	III	NCT02388906	Melanoma	Randomized trial	EORTC QLQ-C30	Week 17	Nivolumab and placebo matching ipilimumab 3 mg/kg Q2W	453	Ipilimumab and placebo matching nivolumab 10 mg/kg Q3W	453
Younes et al. 2016 (41)	CheckMate 205	II	NCT02181738	Hodgkin lymphoma	Clinical trial	EORTC QLQ-C30	Week 17	Nivolumab 3 mg/kg Q2W	80	NA

Reference

Trial name

Phase

NCT number

Cancer type

Study type

QOL measure

Follow-up

Intervention arm

Comparison arm

Description

No.

Description

No.

Ascierto et al. 2017 (22)

Not reported

III

NCT01515189

Melanoma

Randomized trial

EORTC QLQ-C30

Week 12

Ipilimumab 10 mg/kg Q3W

365

Ipilimumab 3 mg/kg Q3W

362

Barlesi et al. 2019 (11)

KEYNOTE-010

II/III

NCT01905657

Non-small cell lung cancer

Randomized trial

EORTC QLQ-C30

Week 12

Pembrolizumab 2 mg/kg Q3W

344

Docetaxel 75 mg/m² Q3W

343

Pembrolizumab 10 mg/kg Q3W

346

Bordoni et al. 2017 (23)

OAK

III

NCT02008227

Non-small cell lung cancer

Randomized trial

EORTC QLQ-C30

Week 15

Atezolizumab 1200 mg Q3W

425

Docetaxel 75 mg/m² Q3W

425

Brahmer et al. 2017 (24)

KEYNOTE-024

III

NCT02142738

Non-small cell lung cancer

Randomized trial

EORTC QLQ-C30

Week 15

Pembrolizumab 200 mg/kg Q3W

151

Investigator-choice platinum-doublet chemotherapy Q3W

148

Cella et al. 2016 (25)

CheckMate 025

III

NCT01668784

Renal cell carcinoma

Randomized trial

EQ-5D

Week 12

Nivolumab 3 mg/kg Q2W

362

Everolimus 10 mg daily

344

Coens et al. 2017 (26)

EORTC 18071

III

NCT00636168

High-risk stage III melanoma

Randomized trial

EORTC QLQ-C30

Week 24

Ipilimumab 10 mg/kg 4x Q3W

475

Placebo 10 mg/kg 4x Q3W

476

El-Khoueiry et al. 2017 (27)

CheckMate 040

I/II

NCT01658878

Hepatocellular carcinoma

Single group trial

EQ-5D

Week 25

Nivolumab (dose-expansion phase)

214

Harrington et al. 2017 (28)

CheckMate 141

III

NCT02105636

Squamous head and neck

Randomized trial

EORTC QLQ-C30

Week 15

Nivolumab 3 mg/kg Q2W

240

Chemotherapy (methotrexate, docetaxel, or cetuximab)

121

Hui et al. 2019 (29)

PACIFIC

III

NCT02125461

Non-small cell lung cancer

Randomized trial

EORTC QLQ-C30

Week 52

Durvalumab 10 mg/kg Q2W

476

Placebo 10 mg/kg 2 W

237

Kaufman et al. 2017 (30)

JAVELIN Merkel 200

NCT02155647

Merkel cell carcinoma

Single group trial

EQ-5D

Week 13

Avelumab 10 mg/kg Q2W

Larkin et al. 2018 (31)

CheckMate 037

III

NCT01721746

Melanoma

Randomized trial

EORTC QLQ-C30

Week 12

Nivolumab 3 mg/kg Q2W

272

Investigator’s choice (Dacarbazine 1000 mg/m² or Carboplatin AUC 6 + Paclitaxel 175 mg/m²) Q3W

133

Long et al. 2016 (32)

CheckMate 066

III

NCT01721772

Melanoma

Randomized trial

EORTC QLQ-C30

Weeks 61

Nivolumab 3 mg/kg Q2W

210

Dacarbazine 1000 mg/m² Q3W

208

Mathias et al. 2015 (33)^a

IMAGE

N/A

NCT01511913

Advanced cutaneous melanoma

Observational

EORTC QLQ-C30

Week 26

Ipilimumab

196

Non-ipilimumab–treated cohort

100

Mazieres et al. 2018 (34)^a

KEYNOTE-407

III

NCT02775435

Non-small cell lung cancer

Randomized trial

EORTC QLQ-C30

Week 18

Pembrolizumab 200 mg + Investigator’s Choice (Pacitaxel 200 mg/m² on Day 1 or NAB-Paclitaxel 100 mg/m² on Days 1, 8, 15) + Carboplatin AUC6 Day 1, Q3W

254

Placebo 200 mg + investigator’s choice (Pacitaxel 200 mg/m² on day 1 or NAB-Paclitaxel 100 mg/m² on days 1, 8, 15) + Carboplatin AUC6 day 1, Q3W

264

O’Donnell et al. 2018 (35)^a

MEDI4736

I/II

NCT01693562

Urothelial carcinoma

Single group trial

EORTC QLQ-C30

Week 16

Durvalumab, 10 mg/kg Q2W

182

Perol et al. 2019 (36)^a

EVIDENS

N/A

NCT03382496

Non-small cell lung cancer

Observational

EQ-5D

Week 36

Nivolumab

1394

Petrella et al. 2017 (12)

KEYNOTE-006

III

NCT01866319

Melanoma

Randomized trial

EORTC QLQ-C30

Week 12

Pembrolizumab 10 mg/kg Q2W

270

Ipilimumab 3 mg/kg Q3W

240

Pembrolizumab 10 mg/kg Q3W

266

Powles et al. 2018 (37)

IMvigor211

III

NCT02302807

Urothelial carcinoma

Randomized trial

EORTC QLQ-C30

Week 12

Atezolizumab 1200 mg Q3W

467

Investigator’s choice: Docetaxel 75 mg/m² or Paclitaxel 175 mg/m² or Vinflunine 320 mg/m² Q3W

464

Reck et al. 2018 (38)

CheckMate 017

III

NCT01642004

Non-small cell lung cancer

Randomized trial

EQ-5D

Week 66

Nivolumab 3 mg/kg Q2W

135

Docetaxel 75 mg/m² Q3W

137

Revicki et al. 2012 (13)

MDX010-20

III

NCT00094653

Melanoma

Randomized trial

EORTC QLQ-C30

Week 12

Ipilimumab (3 mg/kg) + gp 100 (1 mg) Q3W

403

gp100 (1 mg) + placebo Q3W

136

Ipilimumab (3 mg/kg) + placebo Q3W

137

Schadendorf et al. 2016 (14)

KEYNOTE-002

NCT01704287

Melanoma

Randomized trial

EORTC QLQ-C30

Week 12

Pembrolizumab 2 mg/kg Q3W

180

Investigator’s choice: carboplatin + paclitaxel, paclitaxel, dacarbazine, or temozolomide

179

Pembrolizumab 10 mg/kg Q3W

181

Schadendorf et al. 2017 (15)

CheckMate 067

III

NCT01844505

Melanoma

Randomized trial

EORTC QLQ-C30

Week 55

Nivolumab 3 mg/kg Q2W + placebo for ipilimumab W 1 and W 4+ placebo for nivolumab W 4

270

Ipilimumab 3 mg/kg Q3W + placebo matching with nivolumab W 3, 5

259

Nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W

274

Sharma et al. 2017 (39)

CheckMate 275

NCT02387996

Bladder cancer

Single group trial

EORTC QLQ-C30

Week 17

Nivolumab 3 mg/kg Q2W

270

Vaughn et al. 2018 (40)

KEYNOTE-045

III

NCT02256436

Urothelial carcinoma

Randomized trial

EORTC QLQ-C30

Week 15

Pembrolizumab 200 mg Q3W

266

Paclitaxel 175 mg/m² IV or Docetaxel 75 mg/m² IV or Vinflunine 320 mg/m² IV, Q3W

253

Weber et al. 2017 (16)

CheckMate 238

III

NCT02388906

Melanoma

Randomized trial

EORTC QLQ-C30

Week 17

Nivolumab and placebo matching ipilimumab 3 mg/kg Q2W

453

Ipilimumab and placebo matching nivolumab 10 mg/kg Q3W

453

Younes et al. 2016 (41)

CheckMate 205

NCT02181738

Hodgkin lymphoma

Clinical trial

EORTC QLQ-C30

Week 17

Nivolumab 3 mg/kg Q2W

Reference	Trial name	Phase	NCT number	Cancer type	Study type	QOL measure	Follow-up	Intervention arm	Comparison arm
Ascierto et al. 2017 (22)	Not reported	III	NCT01515189	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Ipilimumab 10 mg/kg Q3W	365	Ipilimumab 3 mg/kg Q3W	362
Barlesi et al. 2019 (11)	KEYNOTE-010	II/III	NCT01905657	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 2 mg/kg Q3W	344	Docetaxel 75 mg/m² Q3W	343
Pembrolizumab 10 mg/kg Q3W	346
Bordoni et al. 2017 (23)	OAK	III	NCT02008227	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 15	Atezolizumab 1200 mg Q3W	425	Docetaxel 75 mg/m² Q3W	425
Brahmer et al. 2017 (24)	KEYNOTE-024	III	NCT02142738	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 15	Pembrolizumab 200 mg/kg Q3W	151	Investigator-choice platinum-doublet chemotherapy Q3W	148
Cella et al. 2016 (25)	CheckMate 025	III	NCT01668784	Renal cell carcinoma	Randomized trial	EQ-5D	Week 12	Nivolumab 3 mg/kg Q2W	362	Everolimus 10 mg daily	344
Coens et al. 2017 (26)	EORTC 18071	III	NCT00636168	High-risk stage III melanoma	Randomized trial	EORTC QLQ-C30	Week 24	Ipilimumab 10 mg/kg 4x Q3W	475	Placebo 10 mg/kg 4x Q3W	476
El-Khoueiry et al. 2017 (27)	CheckMate 040	I/II	NCT01658878	Hepatocellular carcinoma	Single group trial	EQ-5D	Week 25	Nivolumab (dose-expansion phase)	214	NA
Harrington et al. 2017 (28)	CheckMate 141	III	NCT02105636	Squamous head and neck	Randomized trial	EORTC QLQ-C30	Week 15	Nivolumab 3 mg/kg Q2W	240	Chemotherapy (methotrexate, docetaxel, or cetuximab)	121
Hui et al. 2019 (29)	PACIFIC	III	NCT02125461	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 52	Durvalumab 10 mg/kg Q2W	476	Placebo 10 mg/kg 2 W	237
Kaufman et al. 2017 (30)	JAVELIN Merkel 200	II	NCT02155647	Merkel cell carcinoma	Single group trial	EQ-5D	Week 13	Avelumab 10 mg/kg Q2W	72	NA
Larkin et al. 2018 (31)	CheckMate 037	III	NCT01721746	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Nivolumab 3 mg/kg Q2W	272	Investigator’s choice (Dacarbazine 1000 mg/m² or Carboplatin AUC 6 + Paclitaxel 175 mg/m²) Q3W	133
Long et al. 2016 (32)	CheckMate 066	III	NCT01721772	Melanoma	Randomized trial	EORTC QLQ-C30	Weeks 61	Nivolumab 3 mg/kg Q2W	210	Dacarbazine 1000 mg/m² Q3W	208
Mathias et al. 2015 (33)^a	IMAGE	N/A	NCT01511913	Advanced cutaneous melanoma	Observational	EORTC QLQ-C30	Week 26	Ipilimumab	196	Non-ipilimumab–treated cohort	100
Mazieres et al. 2018 (34)^a	KEYNOTE-407	III	NCT02775435	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 18	Pembrolizumab 200 mg + Investigator’s Choice (Pacitaxel 200 mg/m² on Day 1 or NAB-Paclitaxel 100 mg/m² on Days 1, 8, 15) + Carboplatin AUC6 Day 1, Q3W	254	Placebo 200 mg + investigator’s choice (Pacitaxel 200 mg/m² on day 1 or NAB-Paclitaxel 100 mg/m² on days 1, 8, 15) + Carboplatin AUC6 day 1, Q3W	264
O’Donnell et al. 2018 (35)^a	MEDI4736	I/II	NCT01693562	Urothelial carcinoma	Single group trial	EORTC QLQ-C30	Week 16	Durvalumab, 10 mg/kg Q2W	182	NA
Perol et al. 2019 (36)^a	EVIDENS	N/A	NCT03382496	Non-small cell lung cancer	Observational	EQ-5D	Week 36	Nivolumab	1394	NA
Petrella et al. 2017 (12)	KEYNOTE-006	III	NCT01866319	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 10 mg/kg Q2W	270	Ipilimumab 3 mg/kg Q3W	240
Pembrolizumab 10 mg/kg Q3W	266
Powles et al. 2018 (37)	IMvigor211	III	NCT02302807	Urothelial carcinoma	Randomized trial	EORTC QLQ-C30	Week 12	Atezolizumab 1200 mg Q3W	467	Investigator’s choice: Docetaxel 75 mg/m² or Paclitaxel 175 mg/m² or Vinflunine 320 mg/m² Q3W	464
Reck et al. 2018 (38)	CheckMate 017	III	NCT01642004	Non-small cell lung cancer	Randomized trial	EQ-5D	Week 66	Nivolumab 3 mg/kg Q2W	135	Docetaxel 75 mg/m² Q3W	137
Revicki et al. 2012 (13)	MDX010-20	III	NCT00094653	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Ipilimumab (3 mg/kg) + gp 100 (1 mg) Q3W	403	gp100 (1 mg) + placebo Q3W	136
Ipilimumab (3 mg/kg) + placebo Q3W	137
Schadendorf et al. 2016 (14)	KEYNOTE-002	II	NCT01704287	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 2 mg/kg Q3W	180	Investigator’s choice: carboplatin + paclitaxel, paclitaxel, dacarbazine, or temozolomide	179
Pembrolizumab 10 mg/kg Q3W	181
Schadendorf et al. 2017 (15)	CheckMate 067	III	NCT01844505	Melanoma	Randomized trial	EORTC QLQ-C30	Week 55	Nivolumab 3 mg/kg Q2W + placebo for ipilimumab W 1 and W 4+ placebo for nivolumab W 4	270	Ipilimumab 3 mg/kg Q3W + placebo matching with nivolumab W 3, 5	259
Nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W	274
Sharma et al. 2017 (39)	CheckMate 275	II	NCT02387996	Bladder cancer	Single group trial	EORTC QLQ-C30	Week 17	Nivolumab 3 mg/kg Q2W	270	NA
Vaughn et al. 2018 (40)	KEYNOTE-045	III	NCT02256436	Urothelial carcinoma	Randomized trial	EORTC QLQ-C30	Week 15	Pembrolizumab 200 mg Q3W	266	Paclitaxel 175 mg/m² IV or Docetaxel 75 mg/m² IV or Vinflunine 320 mg/m² IV, Q3W	253
Weber et al. 2017 (16)	CheckMate 238	III	NCT02388906	Melanoma	Randomized trial	EORTC QLQ-C30	Week 17	Nivolumab and placebo matching ipilimumab 3 mg/kg Q2W	453	Ipilimumab and placebo matching nivolumab 10 mg/kg Q3W	453
Younes et al. 2016 (41)	CheckMate 205	II	NCT02181738	Hodgkin lymphoma	Clinical trial	EORTC QLQ-C30	Week 17	Nivolumab 3 mg/kg Q2W	80	NA

Reference

Trial name

Phase

NCT number

Cancer type

Study type

QOL measure

Follow-up

Intervention arm

Comparison arm

Description

No.

Description

No.

Ascierto et al. 2017 (22)

Not reported

III

NCT01515189

Melanoma

Randomized trial

EORTC QLQ-C30

Week 12

Ipilimumab 10 mg/kg Q3W

365

Ipilimumab 3 mg/kg Q3W

362

Barlesi et al. 2019 (11)

KEYNOTE-010

II/III

NCT01905657

Non-small cell lung cancer

Randomized trial

EORTC QLQ-C30

Week 12

Pembrolizumab 2 mg/kg Q3W

344

Docetaxel 75 mg/m² Q3W

343

Pembrolizumab 10 mg/kg Q3W

346

Bordoni et al. 2017 (23)

OAK

III

NCT02008227

Non-small cell lung cancer

Randomized trial

EORTC QLQ-C30

Week 15

Atezolizumab 1200 mg Q3W

425

Docetaxel 75 mg/m² Q3W

425

Brahmer et al. 2017 (24)

KEYNOTE-024

III

NCT02142738

Non-small cell lung cancer

Randomized trial

EORTC QLQ-C30

Week 15

Pembrolizumab 200 mg/kg Q3W

151

Investigator-choice platinum-doublet chemotherapy Q3W

148

Cella et al. 2016 (25)

CheckMate 025

III

NCT01668784

Renal cell carcinoma

Randomized trial

EQ-5D

Week 12

Nivolumab 3 mg/kg Q2W

362

Everolimus 10 mg daily

344

Coens et al. 2017 (26)

EORTC 18071

III

NCT00636168

High-risk stage III melanoma

Randomized trial

EORTC QLQ-C30

Week 24

Ipilimumab 10 mg/kg 4x Q3W

475

Placebo 10 mg/kg 4x Q3W

476

El-Khoueiry et al. 2017 (27)

CheckMate 040

I/II

NCT01658878

Hepatocellular carcinoma

Single group trial

EQ-5D

Week 25

Nivolumab (dose-expansion phase)

214

Harrington et al. 2017 (28)

CheckMate 141

III

NCT02105636

Squamous head and neck

Randomized trial

EORTC QLQ-C30

Week 15

Nivolumab 3 mg/kg Q2W

240

Chemotherapy (methotrexate, docetaxel, or cetuximab)

121

Hui et al. 2019 (29)

PACIFIC

III

NCT02125461

Non-small cell lung cancer

Randomized trial

EORTC QLQ-C30

Week 52

Durvalumab 10 mg/kg Q2W

476

Placebo 10 mg/kg 2 W

237

Kaufman et al. 2017 (30)

JAVELIN Merkel 200

NCT02155647

Merkel cell carcinoma

Single group trial

EQ-5D

Week 13

Avelumab 10 mg/kg Q2W

Larkin et al. 2018 (31)

CheckMate 037

III

NCT01721746

Melanoma

Randomized trial

EORTC QLQ-C30

Week 12

Nivolumab 3 mg/kg Q2W

272

Investigator’s choice (Dacarbazine 1000 mg/m² or Carboplatin AUC 6 + Paclitaxel 175 mg/m²) Q3W

133

Long et al. 2016 (32)

CheckMate 066

III

NCT01721772

Melanoma

Randomized trial

EORTC QLQ-C30

Weeks 61

Nivolumab 3 mg/kg Q2W

210

Dacarbazine 1000 mg/m² Q3W

208

Mathias et al. 2015 (33)^a

IMAGE

N/A

NCT01511913

Advanced cutaneous melanoma

Observational

EORTC QLQ-C30

Week 26

Ipilimumab

196

Non-ipilimumab–treated cohort

100

Mazieres et al. 2018 (34)^a

KEYNOTE-407

III

NCT02775435

Non-small cell lung cancer

Randomized trial

EORTC QLQ-C30

Week 18

Pembrolizumab 200 mg + Investigator’s Choice (Pacitaxel 200 mg/m² on Day 1 or NAB-Paclitaxel 100 mg/m² on Days 1, 8, 15) + Carboplatin AUC6 Day 1, Q3W

254

Placebo 200 mg + investigator’s choice (Pacitaxel 200 mg/m² on day 1 or NAB-Paclitaxel 100 mg/m² on days 1, 8, 15) + Carboplatin AUC6 day 1, Q3W

264

O’Donnell et al. 2018 (35)^a

MEDI4736

I/II

NCT01693562

Urothelial carcinoma

Single group trial

EORTC QLQ-C30

Week 16

Durvalumab, 10 mg/kg Q2W

182

Perol et al. 2019 (36)^a

EVIDENS

N/A

NCT03382496

Non-small cell lung cancer

Observational

EQ-5D

Week 36

Nivolumab

1394

Petrella et al. 2017 (12)

KEYNOTE-006

III

NCT01866319

Melanoma

Randomized trial

EORTC QLQ-C30

Week 12

Pembrolizumab 10 mg/kg Q2W

270

Ipilimumab 3 mg/kg Q3W

240

Pembrolizumab 10 mg/kg Q3W

266

Powles et al. 2018 (37)

IMvigor211

III

NCT02302807

Urothelial carcinoma

Randomized trial

EORTC QLQ-C30

Week 12

Atezolizumab 1200 mg Q3W

467

Investigator’s choice: Docetaxel 75 mg/m² or Paclitaxel 175 mg/m² or Vinflunine 320 mg/m² Q3W

464

Reck et al. 2018 (38)

CheckMate 017

III

NCT01642004

Non-small cell lung cancer

Randomized trial

EQ-5D

Week 66

Nivolumab 3 mg/kg Q2W

135

Docetaxel 75 mg/m² Q3W

137

Revicki et al. 2012 (13)

MDX010-20

III

NCT00094653

Melanoma

Randomized trial

EORTC QLQ-C30

Week 12

Ipilimumab (3 mg/kg) + gp 100 (1 mg) Q3W

403

gp100 (1 mg) + placebo Q3W

136

Ipilimumab (3 mg/kg) + placebo Q3W

137

Schadendorf et al. 2016 (14)

KEYNOTE-002

NCT01704287

Melanoma

Randomized trial

EORTC QLQ-C30

Week 12

Pembrolizumab 2 mg/kg Q3W

180

Investigator’s choice: carboplatin + paclitaxel, paclitaxel, dacarbazine, or temozolomide

179

Pembrolizumab 10 mg/kg Q3W

181

Schadendorf et al. 2017 (15)

CheckMate 067

III

NCT01844505

Melanoma

Randomized trial

EORTC QLQ-C30

Week 55

Nivolumab 3 mg/kg Q2W + placebo for ipilimumab W 1 and W 4+ placebo for nivolumab W 4

270

Ipilimumab 3 mg/kg Q3W + placebo matching with nivolumab W 3, 5

259

Nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W

274

Sharma et al. 2017 (39)

CheckMate 275

NCT02387996

Bladder cancer

Single group trial

EORTC QLQ-C30

Week 17

Nivolumab 3 mg/kg Q2W

270

Vaughn et al. 2018 (40)

KEYNOTE-045

III

NCT02256436

Urothelial carcinoma

Randomized trial

EORTC QLQ-C30

Week 15

Pembrolizumab 200 mg Q3W

266

Paclitaxel 175 mg/m² IV or Docetaxel 75 mg/m² IV or Vinflunine 320 mg/m² IV, Q3W

253

Weber et al. 2017 (16)

CheckMate 238

III

NCT02388906

Melanoma

Randomized trial

EORTC QLQ-C30

Week 17

Nivolumab and placebo matching ipilimumab 3 mg/kg Q2W

453

Ipilimumab and placebo matching nivolumab 10 mg/kg Q3W

453

Younes et al. 2016 (41)

CheckMate 205

NCT02181738

Hodgkin lymphoma

Clinical trial

EORTC QLQ-C30

Week 17

Nivolumab 3 mg/kg Q2W

Table 1.

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Characteristics of included studies

Reference	Trial name	Phase	NCT number	Cancer type	Study type	QOL measure	Follow-up	Intervention arm		Comparison arm
Reference	Trial name	Phase	NCT number	Cancer type	Study type	QOL measure	Follow-up	Description	No.	Description	No.
Ascierto et al. 2017 (22)	Not reported	III	NCT01515189	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Ipilimumab 10 mg/kg Q3W	365	Ipilimumab 3 mg/kg Q3W	362
Barlesi et al. 2019 (11)	KEYNOTE-010	II/III	NCT01905657	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 2 mg/kg Q3W	344	Docetaxel 75 mg/m² Q3W	343
Barlesi et al. 2019 (11)	KEYNOTE-010	II/III	NCT01905657	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 10 mg/kg Q3W	346	Docetaxel 75 mg/m² Q3W	343
Bordoni et al. 2017 (23)	OAK	III	NCT02008227	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 15	Atezolizumab 1200 mg Q3W	425	Docetaxel 75 mg/m² Q3W	425
Brahmer et al. 2017 (24)	KEYNOTE-024	III	NCT02142738	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 15	Pembrolizumab 200 mg/kg Q3W	151	Investigator-choice platinum-doublet chemotherapy Q3W	148
Cella et al. 2016 (25)	CheckMate 025	III	NCT01668784	Renal cell carcinoma	Randomized trial	EQ-5D	Week 12	Nivolumab 3 mg/kg Q2W	362	Everolimus 10 mg daily	344
Coens et al. 2017 (26)	EORTC 18071	III	NCT00636168	High-risk stage III melanoma	Randomized trial	EORTC QLQ-C30	Week 24	Ipilimumab 10 mg/kg 4x Q3W	475	Placebo 10 mg/kg 4x Q3W	476
El-Khoueiry et al. 2017 (27)	CheckMate 040	I/II	NCT01658878	Hepatocellular carcinoma	Single group trial	EQ-5D	Week 25	Nivolumab (dose-expansion phase)	214	NA
Harrington et al. 2017 (28)	CheckMate 141	III	NCT02105636	Squamous head and neck	Randomized trial	EORTC QLQ-C30	Week 15	Nivolumab 3 mg/kg Q2W	240	Chemotherapy (methotrexate, docetaxel, or cetuximab)	121
Hui et al. 2019 (29)	PACIFIC	III	NCT02125461	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 52	Durvalumab 10 mg/kg Q2W	476	Placebo 10 mg/kg 2 W	237
Kaufman et al. 2017 (30)	JAVELIN Merkel 200	II	NCT02155647	Merkel cell carcinoma	Single group trial	EQ-5D	Week 13	Avelumab 10 mg/kg Q2W	72	NA
Larkin et al. 2018 (31)	CheckMate 037	III	NCT01721746	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Nivolumab 3 mg/kg Q2W	272	Investigator’s choice (Dacarbazine 1000 mg/m² or Carboplatin AUC 6 + Paclitaxel 175 mg/m²) Q3W	133
Long et al. 2016 (32)	CheckMate 066	III	NCT01721772	Melanoma	Randomized trial	EORTC QLQ-C30	Weeks 61	Nivolumab 3 mg/kg Q2W	210	Dacarbazine 1000 mg/m² Q3W	208
Mathias et al. 2015 (33)^a	IMAGE	N/A	NCT01511913	Advanced cutaneous melanoma	Observational	EORTC QLQ-C30	Week 26	Ipilimumab	196	Non-ipilimumab–treated cohort	100
Mazieres et al. 2018 (34)^a	KEYNOTE-407	III	NCT02775435	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 18	Pembrolizumab 200 mg + Investigator’s Choice (Pacitaxel 200 mg/m² on Day 1 or NAB-Paclitaxel 100 mg/m² on Days 1, 8, 15) + Carboplatin AUC6 Day 1, Q3W	254	Placebo 200 mg + investigator’s choice (Pacitaxel 200 mg/m² on day 1 or NAB-Paclitaxel 100 mg/m² on days 1, 8, 15) + Carboplatin AUC6 day 1, Q3W	264
O’Donnell et al. 2018 (35)^a	MEDI4736	I/II	NCT01693562	Urothelial carcinoma	Single group trial	EORTC QLQ-C30	Week 16	Durvalumab, 10 mg/kg Q2W	182	NA
Perol et al. 2019 (36)^a	EVIDENS	N/A	NCT03382496	Non-small cell lung cancer	Observational	EQ-5D	Week 36	Nivolumab	1394	NA
Petrella et al. 2017 (12)	KEYNOTE-006	III	NCT01866319	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 10 mg/kg Q2W	270	Ipilimumab 3 mg/kg Q3W	240
Petrella et al. 2017 (12)	KEYNOTE-006	III	NCT01866319	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 10 mg/kg Q3W	266	Ipilimumab 3 mg/kg Q3W	240
Powles et al. 2018 (37)	IMvigor211	III	NCT02302807	Urothelial carcinoma	Randomized trial	EORTC QLQ-C30	Week 12	Atezolizumab 1200 mg Q3W	467	Investigator’s choice: Docetaxel 75 mg/m² or Paclitaxel 175 mg/m² or Vinflunine 320 mg/m² Q3W	464
Reck et al. 2018 (38)	CheckMate 017	III	NCT01642004	Non-small cell lung cancer	Randomized trial	EQ-5D	Week 66	Nivolumab 3 mg/kg Q2W	135	Docetaxel 75 mg/m² Q3W	137
Revicki et al. 2012 (13)	MDX010-20	III	NCT00094653	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Ipilimumab (3 mg/kg) + gp 100 (1 mg) Q3W	403	gp100 (1 mg) + placebo Q3W	136
Revicki et al. 2012 (13)	MDX010-20	III	NCT00094653	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Ipilimumab (3 mg/kg) + placebo Q3W	137	gp100 (1 mg) + placebo Q3W	136
Schadendorf et al. 2016 (14)	KEYNOTE-002	II	NCT01704287	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 2 mg/kg Q3W	180	Investigator’s choice: carboplatin + paclitaxel, paclitaxel, dacarbazine, or temozolomide	179
Schadendorf et al. 2016 (14)	KEYNOTE-002	II	NCT01704287	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 10 mg/kg Q3W	181		179
Schadendorf et al. 2017 (15)	CheckMate 067	III	NCT01844505	Melanoma	Randomized trial	EORTC QLQ-C30	Week 55	Nivolumab 3 mg/kg Q2W + placebo for ipilimumab W 1 and W 4+ placebo for nivolumab W 4	270	Ipilimumab 3 mg/kg Q3W + placebo matching with nivolumab W 3, 5	259
Schadendorf et al. 2017 (15)	CheckMate 067	III	NCT01844505	Melanoma	Randomized trial	EORTC QLQ-C30	Week 55	Nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W	274		259
Sharma et al. 2017 (39)	CheckMate 275	II	NCT02387996	Bladder cancer	Single group trial	EORTC QLQ-C30	Week 17	Nivolumab 3 mg/kg Q2W	270	NA
Vaughn et al. 2018 (40)	KEYNOTE-045	III	NCT02256436	Urothelial carcinoma	Randomized trial	EORTC QLQ-C30	Week 15	Pembrolizumab 200 mg Q3W	266	Paclitaxel 175 mg/m² IV or Docetaxel 75 mg/m² IV or Vinflunine 320 mg/m² IV, Q3W	253
Weber et al. 2017 (16)	CheckMate 238	III	NCT02388906	Melanoma	Randomized trial	EORTC QLQ-C30	Week 17	Nivolumab and placebo matching ipilimumab 3 mg/kg Q2W	453	Ipilimumab and placebo matching nivolumab 10 mg/kg Q3W	453
Younes et al. 2016 (41)	CheckMate 205	II	NCT02181738	Hodgkin lymphoma	Clinical trial	EORTC QLQ-C30	Week 17	Nivolumab 3 mg/kg Q2W	80	NA

Reference	Trial name	Phase	NCT number	Cancer type	Study type	QOL measure	Follow-up	Intervention arm		Comparison arm
Reference	Trial name	Phase	NCT number	Cancer type	Study type	QOL measure	Follow-up	Description	No.	Description	No.
Ascierto et al. 2017 (22)	Not reported	III	NCT01515189	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Ipilimumab 10 mg/kg Q3W	365	Ipilimumab 3 mg/kg Q3W	362
Barlesi et al. 2019 (11)	KEYNOTE-010	II/III	NCT01905657	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 2 mg/kg Q3W	344	Docetaxel 75 mg/m² Q3W	343
Barlesi et al. 2019 (11)	KEYNOTE-010	II/III	NCT01905657	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 10 mg/kg Q3W	346	Docetaxel 75 mg/m² Q3W	343
Bordoni et al. 2017 (23)	OAK	III	NCT02008227	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 15	Atezolizumab 1200 mg Q3W	425	Docetaxel 75 mg/m² Q3W	425
Brahmer et al. 2017 (24)	KEYNOTE-024	III	NCT02142738	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 15	Pembrolizumab 200 mg/kg Q3W	151	Investigator-choice platinum-doublet chemotherapy Q3W	148
Cella et al. 2016 (25)	CheckMate 025	III	NCT01668784	Renal cell carcinoma	Randomized trial	EQ-5D	Week 12	Nivolumab 3 mg/kg Q2W	362	Everolimus 10 mg daily	344
Coens et al. 2017 (26)	EORTC 18071	III	NCT00636168	High-risk stage III melanoma	Randomized trial	EORTC QLQ-C30	Week 24	Ipilimumab 10 mg/kg 4x Q3W	475	Placebo 10 mg/kg 4x Q3W	476
El-Khoueiry et al. 2017 (27)	CheckMate 040	I/II	NCT01658878	Hepatocellular carcinoma	Single group trial	EQ-5D	Week 25	Nivolumab (dose-expansion phase)	214	NA
Harrington et al. 2017 (28)	CheckMate 141	III	NCT02105636	Squamous head and neck	Randomized trial	EORTC QLQ-C30	Week 15	Nivolumab 3 mg/kg Q2W	240	Chemotherapy (methotrexate, docetaxel, or cetuximab)	121
Hui et al. 2019 (29)	PACIFIC	III	NCT02125461	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 52	Durvalumab 10 mg/kg Q2W	476	Placebo 10 mg/kg 2 W	237
Kaufman et al. 2017 (30)	JAVELIN Merkel 200	II	NCT02155647	Merkel cell carcinoma	Single group trial	EQ-5D	Week 13	Avelumab 10 mg/kg Q2W	72	NA
Larkin et al. 2018 (31)	CheckMate 037	III	NCT01721746	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Nivolumab 3 mg/kg Q2W	272	Investigator’s choice (Dacarbazine 1000 mg/m² or Carboplatin AUC 6 + Paclitaxel 175 mg/m²) Q3W	133
Long et al. 2016 (32)	CheckMate 066	III	NCT01721772	Melanoma	Randomized trial	EORTC QLQ-C30	Weeks 61	Nivolumab 3 mg/kg Q2W	210	Dacarbazine 1000 mg/m² Q3W	208
Mathias et al. 2015 (33)^a	IMAGE	N/A	NCT01511913	Advanced cutaneous melanoma	Observational	EORTC QLQ-C30	Week 26	Ipilimumab	196	Non-ipilimumab–treated cohort	100
Mazieres et al. 2018 (34)^a	KEYNOTE-407	III	NCT02775435	Non-small cell lung cancer	Randomized trial	EORTC QLQ-C30	Week 18	Pembrolizumab 200 mg + Investigator’s Choice (Pacitaxel 200 mg/m² on Day 1 or NAB-Paclitaxel 100 mg/m² on Days 1, 8, 15) + Carboplatin AUC6 Day 1, Q3W	254	Placebo 200 mg + investigator’s choice (Pacitaxel 200 mg/m² on day 1 or NAB-Paclitaxel 100 mg/m² on days 1, 8, 15) + Carboplatin AUC6 day 1, Q3W	264
O’Donnell et al. 2018 (35)^a	MEDI4736	I/II	NCT01693562	Urothelial carcinoma	Single group trial	EORTC QLQ-C30	Week 16	Durvalumab, 10 mg/kg Q2W	182	NA
Perol et al. 2019 (36)^a	EVIDENS	N/A	NCT03382496	Non-small cell lung cancer	Observational	EQ-5D	Week 36	Nivolumab	1394	NA
Petrella et al. 2017 (12)	KEYNOTE-006	III	NCT01866319	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 10 mg/kg Q2W	270	Ipilimumab 3 mg/kg Q3W	240
Petrella et al. 2017 (12)	KEYNOTE-006	III	NCT01866319	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 10 mg/kg Q3W	266	Ipilimumab 3 mg/kg Q3W	240
Powles et al. 2018 (37)	IMvigor211	III	NCT02302807	Urothelial carcinoma	Randomized trial	EORTC QLQ-C30	Week 12	Atezolizumab 1200 mg Q3W	467	Investigator’s choice: Docetaxel 75 mg/m² or Paclitaxel 175 mg/m² or Vinflunine 320 mg/m² Q3W	464
Reck et al. 2018 (38)	CheckMate 017	III	NCT01642004	Non-small cell lung cancer	Randomized trial	EQ-5D	Week 66	Nivolumab 3 mg/kg Q2W	135	Docetaxel 75 mg/m² Q3W	137
Revicki et al. 2012 (13)	MDX010-20	III	NCT00094653	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Ipilimumab (3 mg/kg) + gp 100 (1 mg) Q3W	403	gp100 (1 mg) + placebo Q3W	136
Revicki et al. 2012 (13)	MDX010-20	III	NCT00094653	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Ipilimumab (3 mg/kg) + placebo Q3W	137	gp100 (1 mg) + placebo Q3W	136
Schadendorf et al. 2016 (14)	KEYNOTE-002	II	NCT01704287	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 2 mg/kg Q3W	180	Investigator’s choice: carboplatin + paclitaxel, paclitaxel, dacarbazine, or temozolomide	179
Schadendorf et al. 2016 (14)	KEYNOTE-002	II	NCT01704287	Melanoma	Randomized trial	EORTC QLQ-C30	Week 12	Pembrolizumab 10 mg/kg Q3W	181		179
Schadendorf et al. 2017 (15)	CheckMate 067	III	NCT01844505	Melanoma	Randomized trial	EORTC QLQ-C30	Week 55	Nivolumab 3 mg/kg Q2W + placebo for ipilimumab W 1 and W 4+ placebo for nivolumab W 4	270	Ipilimumab 3 mg/kg Q3W + placebo matching with nivolumab W 3, 5	259
Schadendorf et al. 2017 (15)	CheckMate 067	III	NCT01844505	Melanoma	Randomized trial	EORTC QLQ-C30	Week 55	Nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W	274		259
Sharma et al. 2017 (39)	CheckMate 275	II	NCT02387996	Bladder cancer	Single group trial	EORTC QLQ-C30	Week 17	Nivolumab 3 mg/kg Q2W	270	NA
Vaughn et al. 2018 (40)	KEYNOTE-045	III	NCT02256436	Urothelial carcinoma	Randomized trial	EORTC QLQ-C30	Week 15	Pembrolizumab 200 mg Q3W	266	Paclitaxel 175 mg/m² IV or Docetaxel 75 mg/m² IV or Vinflunine 320 mg/m² IV, Q3W	253
Weber et al. 2017 (16)	CheckMate 238	III	NCT02388906	Melanoma	Randomized trial	EORTC QLQ-C30	Week 17	Nivolumab and placebo matching ipilimumab 3 mg/kg Q2W	453	Ipilimumab and placebo matching nivolumab 10 mg/kg Q3W	453
Younes et al. 2016 (41)	CheckMate 205	II	NCT02181738	Hodgkin lymphoma	Clinical trial	EORTC QLQ-C30	Week 17	Nivolumab 3 mg/kg Q2W	80	NA

Published abstract. IV = intravenous; NA = not applicable; Q2W = every 2 weeks; Q3W = every 3 weeks; QOL = quality of life; NCT = ClinicalTrials.gov identifier.

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