Uveal melanoma
Revision as of 22:37, 27 January 2022 by Jwarner (talk | contribs) (→Metastatic or unresectable disease)
Section editor transclusions 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
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Guidelines
NCCN
Metastatic or unresectable disease
Dacarbazine monotherapy
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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 |
Nathan et al. 2021 (IMCgp100-202) | 2017-2020 | Phase III (C) | Tebentafusp | Inferior OS |
Chemotherapy
- Dacarbazine (DTIC) 1000 mg/m2 IV once on day 1
21-day cycles
References
- 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
- 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
- IMCgp100-202: Nathan P, Hassel JC, Rutkowski P, Baurain JF, Butler MO, Schlaak M, Sullivan RJ, Ochsenreither S, Dummer R, Kirkwood JM, Joshua AM, Sacco JJ, Shoushtari AN, Orloff M, Piulats JM, Milhem M, Salama AKS, Curti B, Demidov L, Gastaud L, Mauch C, Yushak M, Carvajal RD, Hamid O, Abdullah SE, Holland C, Goodall H, Piperno-Neumann S; IMCgp100-202 Investigators. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2021 Sep 23;385(13):1196-1206. link to original article contains verified protocol PubMed NCT03070392
Fotemustine monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Leyvraz et al. 2014 (EORTC 18021) | 2005-2011 | Phase 3 (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
- 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, Karra Gurunath R, 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
Ipilimumab monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Nathan et al. 2021 (IMCgp100-202) | 2017-2020 | Phase III (C) | Tebentafusp | Inferior OS |
Immunotherapy
- Ipilimumab (Yervoy) 3 mg/kg IV once on day 1
21-day cycle for up to 4 cycles
References
- IMCgp100-202: Nathan P, Hassel JC, Rutkowski P, Baurain JF, Butler MO, Schlaak M, Sullivan RJ, Ochsenreither S, Dummer R, Kirkwood JM, Joshua AM, Sacco JJ, Shoushtari AN, Orloff M, Piulats JM, Milhem M, Salama AKS, Curti B, Demidov L, Gastaud L, Mauch C, Yushak M, Carvajal RD, Hamid O, Abdullah SE, Holland C, Goodall H, Piperno-Neumann S; IMCgp100-202 Investigators. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2021 Sep 23;385(13):1196-1206. link to original article contains verified protocol PubMed NCT03070392
Pembrolizumab monotherapy
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Regimen variant #1, weight-based
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Nathan et al. 2021 (IMCgp100-202) | 2017-2020 | Phase III (C) | Tebentafusp | Inferior OS |
Immunotherapy
- Pembrolizumab (Keytruda) 2 mg/kg (maximum dose of 200 mg) IV once on day 1
21-day cycles
Regimen variant #2, flat dosing
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Nathan et al. 2021 (IMCgp100-202) | 2017-2020 | Phase III (C) | Tebentafusp | Inferior OS |
Immunotherapy
- Pembrolizumab (Keytruda) 200 mg IV once on day 1
21-day cycles
References
- IMCgp100-202: Nathan P, Hassel JC, Rutkowski P, Baurain JF, Butler MO, Schlaak M, Sullivan RJ, Ochsenreither S, Dummer R, Kirkwood JM, Joshua AM, Sacco JJ, Shoushtari AN, Orloff M, Piulats JM, Milhem M, Salama AKS, Curti B, Demidov L, Gastaud L, Mauch C, Yushak M, Carvajal RD, Hamid O, Abdullah SE, Holland C, Goodall H, Piperno-Neumann S; IMCgp100-202 Investigators. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2021 Sep 23;385(13):1196-1206. link to original article contains verified protocol PubMed NCT03070392
TACE monotherapy
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TACE: Trans-Arterial Chemo-Embolization
Regimen
Study | Evidence |
---|---|
Mavligit et al. 1988 | Non-randomized |
Chemotherapy
1 or more treatments
References
- 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
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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
- 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
Tebentafusp monotherapy
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Regimen
FDA-recommended dose |
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Nathan et al. 2021 (IMCgp100-202) | 2017-2020 | Phase 3 (E-RT-switch-ooc) | Investigator's choice of: 1. Dacarbazine 2. Ipilimumab 3. Pembrolizumab |
Superior OS OS12: 73% vs 59% (HR 0.51, 95% CI 0.37-0.71) |
Immunotherapy
- Tebentafusp (Kimmtrak) as follows:
- Cycle 1: 20 mcg IV once on day 1
- Cycle 2: 30 mcg IV once on day 1
- Cycle 3 onwards: 68 mcg IV once on day 1
7-day cycles
References
- IMCgp100-202: Nathan P, Hassel JC, Rutkowski P, Baurain JF, Butler MO, Schlaak M, Sullivan RJ, Ochsenreither S, Dummer R, Kirkwood JM, Joshua AM, Sacco JJ, Shoushtari AN, Orloff M, Piulats JM, Milhem M, Salama AKS, Curti B, Demidov L, Gastaud L, Mauch C, Yushak M, Carvajal RD, Hamid O, Abdullah SE, Holland C, Goodall H, Piperno-Neumann S; IMCgp100-202 Investigators. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2021 Sep 23;385(13):1196-1206. link to original article contains verified protocol PubMed NCT03070392
Temozolomide monotherapy
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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
- 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
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TILs: Tumor Ifiltrating Lymphocytes
Regimen
Study | Evidence |
---|---|
Chandran et al. 2017 (NCI 13-C-0093) | Phase II |
Preceding treatment
- FC lymphodepletion
Immunotherapy
References
- 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