From:  Immunotherapy in gynecological cancers

Clinical trials in CC

AuthorTrial/PhaseSettingPts NTreatmentResultsGrade 3–4 AEs Pts N (%)
Lheureux et al., 2015 [25]NCT01693783 Phase I-IIMetastatic, recurrent42Ipilimumab 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 IIPD-L1 positive advanced98 (82, PDL1 CPS ≥ 1)Pembrolizumab 200 mg q3wORR 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 cancers24 (19 cervical, 5 vaginal-vulvar cancer)Nivolumab 240 mg q2wORR:

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