Uveal melanoma

Section editor
	Elizabeth Buchbinder, MD Dana-Farber Cancer Institute Boston, MA LinkedIn

Note: this page is for regimens specific to uveal melanoma; see the main melanoma page for other regimens.

13 regimens on this page 13 variants on this page

Guidelines

NCCN

• NCCN Guidelines - Uveal Melanoma

Metastatic or unresectable disease

Dacarbazine monotherapy

back to top

Regimen

Study	Years of enrollment	Evidence	Comparator	Comparative Efficacy
Carvajal et al. 2014 (MSK 10-053)	2010-2013	Randomized Phase II (C)	Selumetinib	Might have inferior OS
Carvajal et al. 2018 (SUMIT)	2014-2015	Phase III (C)	Dacarbazine & Selumetinib	Did not meet primary endpoint of PFS

Chemotherapy

• Dacarbazine (DTIC) 1000 mg/m² IV once on day 1

21-day cycles

References

1. MSK 10-053: Carvajal RD, Sosman JA, Quevedo JF, Milhem MM, Joshua AM, Kudchadkar RR, Linette GP, Gajewski TF, Lutzky J, Lawson DH, Lao CD, Flynn PJ, Albertini MR, Sato T, Lewis K, Doyle A, Ancell K, Panageas KS, Bluth M, Hedvat C, Erinjeri J, Ambrosini G, Marr B, Abramson DH, Dickson MA, Wolchok JD, Chapman PB, Schwartz GK. Effect of selumetinib vs chemotherapy on progression-free survival in uveal melanoma: a randomized clinical trial. JAMA. 2014 Jun 18;311(23):2397-405. link to original article link to PMC article PubMed NCT01143402
2. SUMIT: Carvajal RD, Piperno-Neumann S, Kapiteijn E, Chapman PB, Frank S, Joshua AM, Piulats JM, Wolter P, Cocquyt V, Chmielowski B, Evans TRJ, Gastaud L, Linette G, Berking C, Schachter J, Rodrigues MJ, Shoushtari AN, Clemett D, Ghiorghiu D, Mariani G, Spratt S, Lovick S, Barker P, Kilgour E, Lai Z, Schwartz GK, Nathan P. Selumetinib in combination with dacarbazine in patients with metastatic uveal melanoma: a phase III, multicenter, randomized trial (SUMIT). J Clin Oncol. 2018 Apr 20;36(12):1232-1239. Epub 2018 Mar 12. link to original article contains verified protocol PubMed NCT01974752

Fotemustine monotherapy

back to top

Regimen

Study	Years of enrollment	Evidence	Comparator	Comparative Efficacy
Leyvraz et al. 2014 (EORTC 18021)	2005-2011	Phase III (C)	Fotemustine; HAI	Did not meet primary endpoint of OS

Chemotherapy

• Fotemustine (Muphoran) as follows:
  • Weeks 1 to 3: 100 mg/m² IV once per day on days 1, 8, 15
  • Weeks 4 to 8: no treatment
  • Week 9 onwards: 100 mg/m² IV once on day 1, every 3 weeks

8-week induction cycle, then 21-day cycles

References

1. EORTC 18021: Leyvraz S, Piperno-Neumann S, Suciu S, Baurain JF, Zdzienicki M, Testori A, Marshall E, Scheulen M, Jouary T, Negrier S, Vermorken JB, Kaempgen E, Durando X, Schadendorf D, Gurunath RK, Keilholz U. Hepatic intra-arterial versus intravenous fotemustine in patients with liver metastases from uveal melanoma (EORTC 18021): a multicentric randomized trial. Ann Oncol. 2014 Mar;25(3):742-6. Epub 2014 Feb 7. link to original article link to PMC article contains protocol PubMed NCT00110123

TACE monotherapy

back to top

TACE: Trans-Arterial Chemo-Embolization

Regimen

Study	Evidence
Mavligit et al. 1988	Non-randomized

Chemotherapy

• TACE

1 or more treatments

References

1. Mavligit GM, Charnsangavej C, Carrasco CH, Patt YZ, Benjamin RS, Wallace S. Regression of ocular melanoma metastatic to the liver after hepatic arterial chemoembolization with cisplatin and polyvinyl sponge. JAMA. 1988 Aug 19;260(7):974-6. link to original article PubMed

Selumetinib monotherapy

back to top

Regimen

Study	Years of enrollment	Evidence	Comparator	Comparative Efficacy
Carvajal et al. 2014 (MSK 10-053)	2010-2013	Randomized Phase II (E-switch-ooc)	1. Dacarbazine 2. Temozolomide	Might have superior OS

Targeted therapy

• Selumetinib (Koselugo) 75 mg PO twice per day

Continued indefinitely

References

1. MSK 10-053: Carvajal RD, Sosman JA, Quevedo JF, Milhem MM, Joshua AM, Kudchadkar RR, Linette GP, Gajewski TF, Lutzky J, Lawson DH, Lao CD, Flynn PJ, Albertini MR, Sato T, Lewis K, Doyle A, Ancell K, Panageas KS, Bluth M, Hedvat C, Erinjeri J, Ambrosini G, Marr B, Abramson DH, Dickson MA, Wolchok JD, Chapman PB, Schwartz GK. Effect of selumetinib vs chemotherapy on progression-free survival in uveal melanoma: a randomized clinical trial. JAMA. 2014 Jun 18;311(23):2397-405. link to original article link to PMC article contains verified protocol PubMed NCT01143402

Temozolomide monotherapy

back to top

Regimen

Study	Years of enrollment	Evidence	Comparator	Comparative Efficacy
Carvajal et al. 2014 (MSK 10-053)	2010-2013	Randomized Phase II (C)	Selumetinib	Might have inferior OS

Chemotherapy

• Temozolomide (Temodar) 150 mg/m² PO once per day on days 1 to 5

28-day cycles

References

1. MSK 10-053: Carvajal RD, Sosman JA, Quevedo JF, Milhem MM, Joshua AM, Kudchadkar RR, Linette GP, Gajewski TF, Lutzky J, Lawson DH, Lao CD, Flynn PJ, Albertini MR, Sato T, Lewis K, Doyle A, Ancell K, Panageas KS, Bluth M, Hedvat C, Erinjeri J, Ambrosini G, Marr B, Abramson DH, Dickson MA, Wolchok JD, Chapman PB, Schwartz GK. Effect of selumetinib vs chemotherapy on progression-free survival in uveal melanoma: a randomized clinical trial. JAMA. 2014 Jun 18;311(23):2397-405. link to original article link to PMC article contains protocol PubMed NCT01143402

TILs

back to top

TILs: Tumor Ifiltrating Lymphocytes

Regimen

Study	Evidence
Chandran et al. 2017 (NCI 13-C-0093)	Phase II

Preceding treatment

• FC lymphodepletion

Immunotherapy

• Autologous TILs

References

1. NCI 13-C-0093: Chandran SS, Somerville RPT, Yang JC, Sherry RM, Klebanoff CA, Goff SL, Wunderlich JR, Danforth DN, Zlott D, Paria BC, Sabesan AC, Srivastava AK, Xi L, Pham TH, Raffeld M, White DE, Toomey MA, Rosenberg SA, Kammula US. Treatment of metastatic uveal melanoma with adoptive transfer of tumour-infiltrating lymphocytes: a single-centre, two-stage, single-arm, phase 2 study. Lancet Oncol. 2017 Jun;18(6):792-802. Epub 2017 Apr 7. link to original article link to PMC article PubMed NCT01814046