Table Info

Table 1.

Clinical trials in CC

Author	Trial/Phase	Setting	Pts N	Treatment	Results	Grade 3–4 AEs Pts N (%)
Lheureux et al., 2015 [25]	NCT01693783 Phase I-II	Metastatic, recurrent	42	Ipilimumab 10 mg/kg q3w for 4 cycles If CR/PR/SD 4 → cycles ipilimumab 10 mg/kg q12w every 12 weeks	ORR 8.8%	-diarrhea n = 4 (9.5) -colitis n = 3 (7.1)
Chung et al., 2019 [11]	KEYNOTE-158 Phase II	PD-L1 positive advanced	98 (82, PDL1 CPS ≥ 1)	Pembrolizumab 200 mg q3w	ORR 12.2% 14.6% in PD-L1 positive Total population: Median PFS 2.1 Mo. Estimated PFS rate at 6 Mo. 25.0% Median OS 9.4 Mo. 6-month estimates OS 75.2% 12-month estimates OS 41.4% PD-L1 positive: Median PFS 2.1 Mo. Median OS 11 Mo. 6-month estimates OS 80.2% 12-month estimates OS 47.3%	Treatment related: -increased ALT n = 3 (3.1) -increased AST n = 2 (2.0) Immune-mediated: -hepatitis n = 2 (2.0) -severe skin reactions n = 2 (2) -adrenal insufficiency n = 1 (1)
Wendel Naumann et al., 2019 [12]	CheckMate 358 Phase I-II	HPV-associated tumors, recurrent or metastatic cervical, vaginal, vulvar cancers	24 (19 cervical, 5 vaginal-vulvar cancer)	Nivolumab 240 mg q2w	ORR: 26.3% (cervical) 20.0% (vaginal-vulvar) DCR: 68.4% (cervical) 80.0% (vaginal-vulvar) Median PFS 5.1 Mo. 26.3% progression free patients at 12 Mo. In cervical cohort: Median OS 21.9 Mo., 12-month OS rate 77.5% 24-month OS rate 49.8%	Cervical cohort: -diarrhea n = 1 (5.3) -hepatocellular injury n = 1 (5.3) -pneumonitis n = 1 (5.3) Vaginal/vulvar cohort: none

Author

Trial/Phase

Setting

Pts N

Treatment

Results

Grade 3–4 AEs Pts N (%)

Lheureux et al., 2015 [25]

NCT01693783 Phase I-II

Metastatic, recurrent

Ipilimumab 10 mg/kg q3w for 4 cycles

If CR/PR/SD 4 → cycles ipilimumab 10 mg/kg q12w every 12 weeks

ORR 8.8%

-diarrhea n = 4 (9.5)
-colitis n = 3 (7.1)

Chung et al., 2019 [11]

KEYNOTE-158 Phase II

PD-L1 positive advanced

98 (82, PDL1 CPS ≥ 1)

Pembrolizumab 200 mg q3w

ORR 12.2%

14.6% in PD-L1 positive

Total population:

Median PFS 2.1 Mo.
Estimated PFS rate at 6 Mo. 25.0%
Median OS 9.4 Mo.
6-month estimates OS 75.2%
12-month estimates OS 41.4%

PD-L1 positive:

Median PFS 2.1 Mo.
Median OS 11 Mo.
6-month estimates OS 80.2%
12-month estimates OS 47.3%

Treatment related:

-increased ALT n = 3 (3.1)
-increased AST n = 2 (2.0)

Immune-mediated:

-hepatitis n = 2 (2.0)
-severe skin reactions n = 2 (2)
-adrenal insufficiency n = 1 (1)

Wendel Naumann et al., 2019 [12]

CheckMate 358
Phase I-II

HPV-associated tumors, recurrent or metastatic cervical, vaginal, vulvar cancers

24 (19 cervical, 5 vaginal-vulvar cancer)

Nivolumab 240 mg q2w

ORR:

26.3% (cervical)
20.0% (vaginal-vulvar)

DCR:

68.4% (cervical)
80.0% (vaginal-vulvar)

Median PFS 5.1 Mo.
26.3% progression free patients at 12 Mo.

In cervical cohort:

Median OS 21.9 Mo.,
12-month OS rate 77.5%
24-month OS rate 49.8%

Cervical cohort:

-diarrhea n = 1 (5.3)
-hepatocellular injury n = 1 (5.3)
-pneumonitis n = 1 (5.3)

Vaginal/vulvar cohort:
none

Pts N: patient number; PFS: progression free survival; Mo.: month

Declarations

Author contributions

DL contributed to conception and design of the study; VC wrote the first draft of the manuscript; GD, AP, VS, MM, CN, FC, GS wrote sections of the manuscript. All authors contributed to manuscript revision, read and approved the submitted version.

Conflicts of interest

VC, MM, CN, FC declare that they have no conflicts of interest. Outside the submitted work:

DL has served on advisory boards for Clovis Oncology, AstraZeneca, Genmab/Seattle Genetics, MSD, ImmunoGen, PharmaMar, Roche, and Tesaro/GSK, received support for travel or accommodation from AstraZeneca, GSK and Roche and institutional research funding from Merck, GSK, Clovis, Pharmamar.

GD has served on advisory board of Beigene and received support for travel and accomodation from Roche.

VS has served on advisory board of Roche, Astra Zeneca, MSD, GSK and Clovis and received support for travel and accomodation from Pharmamar, GSK, Roche.

AP worked at Astra Zeneca Medical Affair Division until Dec 2018.

GS has served on advisory boards for TESARO Bio Italy S.r.l, Johnson & Johnson, Clovis Oncology Italy S.r.l. He received support for travel or accommodation from MSD Italy S.r.l and Clovis Oncology Italy S.r.l, and institutional research funding from MSD Italy S.r.l.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

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