Ipilimumab in all diseases
Melanoma
Source: Ipilimumab (Yervoy) for melanoma, adjuvant
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Example orders
Regimen variant #1, 1 year
| Study | Evidence | Comparator | Efficacy | 12-month recurrence-free survival (RFS) | Comparator RFS |
|---|---|---|---|---|---|
| Weber et al. 2017 (Checkmate 238) | Phase III (C) | Nivolumab | Inferior RFS | 61% overall Stage IIIB or IIIC: 62% (95% CI: 56-66.5) Stage IV: 57.5% (95% CI: 46-67) |
70.5% overall Stage IIIB or IIIC: 72% (95% CI, 67-77) Stage IV: 63% (95% CI, 52-72.5) |
Preceding treatment
- Complete resection of stage IIIB, IIIC, or IV melanoma
Immunotherapy
- Ipilimumab (Yervoy) as follows:
- Weeks 1, 4, 7, 10: 10 mg/kg IV once on day 1 (every 21 days)
- Weeks 22, 34, 48: Ipilimumab (Yervoy) 10 mg/kg IV once on day 1 (every 12 weeks)
12-month course, unless disease recurrence or unacceptable toxicity
Regimen variant #2, 3 years
| FDA-recommended dose |
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy | Comparative Toxicity |
|---|---|---|---|---|---|
| Eggermont et al. 2015 (EORTC 18071) | 2008-2011 | Phase III (E-RT-esc) | Placebo | Superior OS (*) | Similar HRQoL |
Efficacy is based on the 2016 update. While there was a statistically significant difference in EORTC QLC-C30 scores in EORTC 18071 (in favor of placebo), this difference did not meet the pre-determined threshold for clinically relevance.
Preceding treatment
- Complete resection of stage III cutaneous melanoma
Immunotherapy
- Ipilimumab (Yervoy) 10 mg/kg IV over 90 minutes once on day 1
21-day cycle for 4 cycles, then 12-week cycle for 12 cycles (3 years)
References
- EORTC 18071: Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbé C, Ferraresi V, Smylie M, Weber JS, Maio M, Konto C, Hoos A, de Pril V, Gurunath RK, de Schaetzen G, Suciu S, Testori A. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015 May;16(5):522-30. Erratum: Lancet Oncol. 2015 Jun;16(6):e262. Epub 2015 May 27. link to original article contains verified protocol PubMed
- Update: Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbé C, Ferraresi V, Smylie M, Weber JS, Maio M, Bastholt L, Mortier L, Thomas L, Tahir S, Hauschild A, Hassel JC, Hodi FS, Taitt C, de Pril V, de Schaetzen G, Suciu S, Testori A. Prolonged survival in stage III melanoma with ipilimumab adjuvant therapy. N Engl J Med. 2016 Nov 10;375(19):1845-1855. Epub 2016 Oct 7. link to original article contains verified protocol PubMed
- HRQoL analysis: Coens C, Suciu S, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbé C, Ferraresi V, Smylie M, Weber JS, Maio M, Bottomley A, Kotapati S, de Pril V, Testori A, Eggermont AM. Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): secondary outcomes of a multinational, randomised, double-blind, phase 3 trial. Lancet Oncol. 2017 Mar;18(3):393-403. Epub 2017 Feb 3. link to PMC article PubMed
- CheckMate 238: Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbé C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA1; CheckMate 238 Collaborators. Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma. N Engl J Med. 2017 Nov 9;377(19):1824-1835. Epub 2017 Sep 10. link to original article contains verified protocol PubMed
