Difference between revisions of "Uveal melanoma"
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{{#lst:Section editor transclusions|mel}} | {{#lst:Section editor transclusions|mel}} | ||
<big>'''Note: this page is for regimens specific to uveal melanoma; see the [[Melanoma|main melanoma page]] for other regimens.</big> | <big>'''Note: this page is for regimens specific to uveal melanoma; see the [[Melanoma|main melanoma page]] for other regimens.</big> | ||
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{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
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=Guidelines= | =Guidelines= | ||
==[https://www.nccn.org/ NCCN]== | ==[https://www.nccn.org/ NCCN]== | ||
*[https://www.nccn.org/professionals/physician_gls/pdf/uveal.pdf NCCN Guidelines - Uveal Melanoma] | *[https://www.nccn.org/professionals/physician_gls/pdf/uveal.pdf NCCN Guidelines - Uveal Melanoma] | ||
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=Metastatic or unresectable disease= | =Metastatic or unresectable disease= | ||
==Dacarbazine monotherapy {{#subobject:d3599b|Regimen=1}}== | ==Dacarbazine monotherapy {{#subobject:d3599b|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:bede4c|Variant=1}}=== | ===Regimen {{#subobject:bede4c|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Dacarbazine (DTIC)]] 1000 mg/m<sup>2</sup> IV once on day 1 | *[[Dacarbazine (DTIC)]] 1000 mg/m<sup>2</sup> IV once on day 1 | ||
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'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===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. [https://jamanetwork.com/journals/jama/fullarticle/1881312 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4249701/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24938562 PubMed] NCT01143402 | # '''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. [https://jamanetwork.com/journals/jama/fullarticle/1881312 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4249701/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24938562 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. [https://doi.org/10.1200/JCO.2017.74.1090 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29528792 PubMed] NCT01974752 | # '''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. [https://doi.org/10.1200/JCO.2017.74.1090 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29528792 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. [https://doi.org/10.1056/nejmoa2103485 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34551229/ PubMed] NCT03070392 | # '''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. [https://doi.org/10.1056/nejmoa2103485 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34551229/ PubMed] NCT03070392 | ||
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==Fotemustine monotherapy {{#subobject:92d0c6|Regimen=1}}== | ==Fotemustine monotherapy {{#subobject:92d0c6|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:ff4f50|Variant=1}}=== | ===Regimen {{#subobject:ff4f50|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Fotemustine (Muphoran)]] as follows: | *[[Fotemustine (Muphoran)]] as follows: | ||
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**Weeks 4 to 8: no treatment | **Weeks 4 to 8: no treatment | ||
**Week 9 onwards: 100 mg/m<sup>2</sup> IV once on day 1, every 3 weeks | **Week 9 onwards: 100 mg/m<sup>2</sup> IV once on day 1, every 3 weeks | ||
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'''8-week induction cycle, then 21-day cycles''' | '''8-week induction cycle, then 21-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===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. [https://doi.org/10.1093/annonc/mdt585 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4433517/ link to PMC article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/24510314 PubMed] NCT00110123 | # '''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. [https://doi.org/10.1093/annonc/mdt585 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4433517/ link to PMC article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/24510314 PubMed] NCT00110123 | ||
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==Ipilimumab monotherapy {{#subobject:dga21b|Regimen=1}}== | ==Ipilimumab monotherapy {{#subobject:dga21b|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:ance4c|Variant=1}}=== | ===Regimen {{#subobject:ance4c|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
*[[Ipilimumab (Yervoy)]] 3 mg/kg IV once on day 1 | *[[Ipilimumab (Yervoy)]] 3 mg/kg IV once on day 1 | ||
− | |||
'''21-day cycle for up to 4 cycles''' | '''21-day cycle for up to 4 cycles''' | ||
− | + | </div></div> | |
===References=== | ===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. [https://doi.org/10.1056/nejmoa2103485 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34551229/ PubMed] NCT03070392 | # '''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. [https://doi.org/10.1056/nejmoa2103485 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34551229/ PubMed] NCT03070392 | ||
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==Ipilimumab & Nivolumab {{#subobject:51gu10|Regimen=1}}== | ==Ipilimumab & Nivolumab {{#subobject:51gu10|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen variant #1, "NIVO1+IPI3", flat-dose maintenance {{#subobject:3a481c|Variant=1}}=== | ===Regimen variant #1, "NIVO1+IPI3", flat-dose maintenance {{#subobject:3a481c|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
Line 121: | Line 115: | ||
|- | |- | ||
|} | |} | ||
− | + | <div class="toccolours" style="background-color:#b3e2cd"> | |
====Immunotherapy==== | ====Immunotherapy==== | ||
− | |||
*[[Ipilimumab (Yervoy)]] as follows: | *[[Ipilimumab (Yervoy)]] as follows: | ||
**Cycles 1 to 4: 3 mg/kg IV once on day 1 | **Cycles 1 to 4: 3 mg/kg IV once on day 1 | ||
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**Cycles 1 to 4: 1 mg/kg IV once on day 1 | **Cycles 1 to 4: 1 mg/kg IV once on day 1 | ||
**Cycle 5 onwards: 3 mg/kg IV once on day 1 | **Cycle 5 onwards: 3 mg/kg IV once on day 1 | ||
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'''21-day cycle for 4 cycles, then 14-day cycles''' | '''21-day cycle for 4 cycles, then 14-day cycles''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, "NIVO3+IPI1", flat-dose maintenance {{#subobject:3a48jc|Variant=1}}=== | ===Regimen variant #2, "NIVO3+IPI1", flat-dose maintenance {{#subobject:3a48jc|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
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!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
− | |[https:// | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8257877/ Pelster et al. 2020 (MDACC 2011-0919)] |
| style="background-color:#91cf61" |Phase 2 | | style="background-color:#91cf61" |Phase 2 | ||
|- | |- | ||
|} | |} | ||
− | + | <div class="toccolours" style="background-color:#b3e2cd"> | |
====Immunotherapy==== | ====Immunotherapy==== | ||
− | |||
*[[Ipilimumab (Yervoy)]] as follows: | *[[Ipilimumab (Yervoy)]] as follows: | ||
**Cycles 1 to 4: 1 mg/kg IV once on day 1 | **Cycles 1 to 4: 1 mg/kg IV once on day 1 | ||
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**Cycles 1 to 4: 3 mg/kg IV once on day 1 | **Cycles 1 to 4: 3 mg/kg IV once on day 1 | ||
**Cycle 5 onwards: 480 mg IV once on day 1 | **Cycle 5 onwards: 480 mg IV once on day 1 | ||
− | |||
'''21-day cycle for 4 cycles, then 28-day cycles''' | '''21-day cycle for 4 cycles, then 28-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
# '''GEM-1402:''' Piulats JM, Espinosa E, de la Cruz Merino L, Varela M, Alonso Carrión L, Martín-Algarra S, López Castro R, Curiel T, Rodríguez-Abreu D, Redrado M, Gomà M, Rullán AJ, Calvo González A, Berrocal-Jaime A. Nivolumab Plus Ipilimumab for Treatment-Naïve Metastatic Uveal Melanoma: An Open-Label, Multicenter, Phase II Trial by the Spanish Multidisciplinary Melanoma Group (GEM-1402). J Clin Oncol. 2021 Feb 20;39(6):586-598. [https://doi.org/10.1200/JCO.20.00550 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33417511/ PubMed] NCT02626962 | # '''GEM-1402:''' Piulats JM, Espinosa E, de la Cruz Merino L, Varela M, Alonso Carrión L, Martín-Algarra S, López Castro R, Curiel T, Rodríguez-Abreu D, Redrado M, Gomà M, Rullán AJ, Calvo González A, Berrocal-Jaime A. Nivolumab Plus Ipilimumab for Treatment-Naïve Metastatic Uveal Melanoma: An Open-Label, Multicenter, Phase II Trial by the Spanish Multidisciplinary Melanoma Group (GEM-1402). J Clin Oncol. 2021 Feb 20;39(6):586-598. [https://doi.org/10.1200/JCO.20.00550 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33417511/ PubMed] NCT02626962 | ||
− | # '''MDACC 2011-0919:''' Pelster MS, Gruschkus SK, Bassett R, Gombos DS, Shephard M, Posada L, Glover MS, Simien R, Diab A, Hwu P, Carter BW, Patel SP. Nivolumab and Ipilimumab in Metastatic Uveal Melanoma: Results From a Single-Arm Phase II Study. J Clin Oncol. 2021 Feb 20;39(6):599-607. Epub 2020 Oct 30. [https://doi.org/10.1200/JCO.20.00605 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33125309/ PubMed] NCT01585194 | + | # '''MDACC 2011-0919:''' Pelster MS, Gruschkus SK, Bassett R, Gombos DS, Shephard M, Posada L, Glover MS, Simien R, Diab A, Hwu P, Carter BW, Patel SP. Nivolumab and Ipilimumab in Metastatic Uveal Melanoma: Results From a Single-Arm Phase II Study. J Clin Oncol. 2021 Feb 20;39(6):599-607. Epub 2020 Oct 30. [https://doi.org/10.1200/JCO.20.00605 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8257877/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33125309/ PubMed] NCT01585194 |
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==Pembrolizumab monotherapy {{#subobject:dhuahb|Regimen=1}}== | ==Pembrolizumab monotherapy {{#subobject:dhuahb|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen variant #1, weight-based {{#subobject:bed6av|Variant=1}}=== | ===Regimen variant #1, weight-based {{#subobject:bed6av|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
*[[Pembrolizumab (Keytruda)]] 2 mg/kg (maximum dose of 200 mg) IV once on day 1 | *[[Pembrolizumab (Keytruda)]] 2 mg/kg (maximum dose of 200 mg) IV once on day 1 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, flat dosing {{#subobject:b7d6av|Variant=1}}=== | ===Regimen variant #2, flat dosing {{#subobject:b7d6av|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 193: | Line 184: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
*[[Pembrolizumab (Keytruda)]] 200 mg IV once on day 1 | *[[Pembrolizumab (Keytruda)]] 200 mg IV once on day 1 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===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. [https://doi.org/10.1056/nejmoa2103485 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34551229/ PubMed] NCT03070392 | # '''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. [https://doi.org/10.1056/nejmoa2103485 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34551229/ PubMed] NCT03070392 | ||
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==TACE monotherapy {{#subobject:f96a1b|Regimen=1}}== | ==TACE monotherapy {{#subobject:f96a1b|Regimen=1}}== | ||
− | |||
TACE: '''<u>T</u>'''rans-'''<u>A</u>'''rterial '''<u>C</u>'''hemo-'''<u>E</u>'''mbolization | TACE: '''<u>T</u>'''rans-'''<u>A</u>'''rterial '''<u>C</u>'''hemo-'''<u>E</u>'''mbolization | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:93050b|Variant=1}}=== | ===Regimen {{#subobject:93050b|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Local therapy==== | ====Local therapy==== | ||
*[[TACE]] | *[[TACE]] | ||
− | |||
'''1 or more treatments''' | '''1 or more treatments''' | ||
− | + | </div></div> | |
===References=== | ===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. [https://jamanetwork.com/journals/jama/article-abstract/373516 link to original article] [https://pubmed.ncbi.nlm.nih.gov/3398202 PubMed] | # 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. [https://jamanetwork.com/journals/jama/article-abstract/373516 link to original article] [https://pubmed.ncbi.nlm.nih.gov/3398202 PubMed] | ||
− | |||
==Selumetinib monotherapy {{#subobject:4e8yua|Regimen=1}}== | ==Selumetinib monotherapy {{#subobject:4e8yua|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:6e73a5|Variant=1}}=== | ===Regimen {{#subobject:6e73a5|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Selumetinib (Koselugo)]] 75 mg PO twice per day | *[[Selumetinib (Koselugo)]] 75 mg PO twice per day | ||
− | |||
'''Continued indefinitely''' | '''Continued indefinitely''' | ||
− | + | </div></div> | |
===References=== | ===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. [https://jamanetwork.com/journals/jama/fullarticle/1881312 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4249701/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24938562 PubMed] NCT01143402 | # '''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. [https://jamanetwork.com/journals/jama/fullarticle/1881312 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4249701/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24938562 PubMed] NCT01143402 | ||
− | |||
==Tebentafusp monotherapy {{#subobject:4ugh17|Regimen=1}}== | ==Tebentafusp monotherapy {{#subobject:4ugh17|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:6eug88|Variant=1}}=== | ===Regimen {{#subobject:6eug88|Variant=1}}=== | ||
{| class="wikitable" style="color:white; background-color:#404040" | {| class="wikitable" style="color:white; background-color:#404040" | ||
Line 267: | Line 255: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
*[[Tebentafusp (Kimmtrak)]] as follows: | *[[Tebentafusp (Kimmtrak)]] as follows: | ||
Line 272: | Line 261: | ||
**Cycle 2: 30 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 | **Cycle 3 onwards: 68 mcg IV once on day 1 | ||
− | |||
'''7-day cycles''' | '''7-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===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. [https://doi.org/10.1056/nejmoa2103485 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34551229/ PubMed] NCT03070392 | # '''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. [https://doi.org/10.1056/nejmoa2103485 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34551229/ PubMed] NCT03070392 | ||
− | |||
==Temozolomide monotherapy {{#subobject:4e2652|Regimen=1}}== | ==Temozolomide monotherapy {{#subobject:4e2652|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:6e73a5|Variant=1}}=== | ===Regimen {{#subobject:6e73a5|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 295: | Line 282: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Temozolomide (Temodar)]] 150 mg/m<sup>2</sup> PO once per day on days 1 to 5 | *[[Temozolomide (Temodar)]] 150 mg/m<sup>2</sup> PO once per day on days 1 to 5 | ||
− | |||
'''28-day cycles''' | '''28-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===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. [https://jamanetwork.com/journals/jama/fullarticle/1881312 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4249701/ link to PMC article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/24938562 PubMed] NCT01143402 | # '''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. [https://jamanetwork.com/journals/jama/fullarticle/1881312 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4249701/ link to PMC article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/24938562 PubMed] NCT01143402 | ||
− | |||
==TILs {{#subobject:f33e1b|Regimen=1}}== | ==TILs {{#subobject:f33e1b|Regimen=1}}== | ||
− | |||
TILs: '''<u>T</u>'''umor '''<u>I</u>'''filtrating '''<u>L</u>'''ymphocyte'''<u>s</u>''' | TILs: '''<u>T</u>'''umor '''<u>I</u>'''filtrating '''<u>L</u>'''ymphocyte'''<u>s</u>''' | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:12350b|Variant=1}}=== | ===Regimen {{#subobject:12350b|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
Line 315: | Line 301: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
*[[Autologous_HSCT#FC|FC]] lymphodepletion | *[[Autologous_HSCT#FC|FC]] lymphodepletion | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
*[[Autologous TILs]] | *[[Autologous TILs]] | ||
− | + | </div></div> | |
===References=== | ===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. [https://doi.org/10.1016/S1470-2045(17)30251-6 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5490083/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28395880 PubMed] NCT01814046 | # '''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. [https://doi.org/10.1016/S1470-2045(17)30251-6 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5490083/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28395880 PubMed] NCT01814046 | ||
− | |||
[[Category:Uveal melanoma regimens]] | [[Category:Uveal melanoma regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Skin cancers]] | [[Category:Skin cancers]] |
Revision as of 15:05, 26 February 2023
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
|
Guidelines
NCCN
Metastatic or unresectable disease
Dacarbazine monotherapy
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Carvajal et al. 2014 (MSK 10-053) | 2010-2013 | Randomized Phase 2 (C) | Selumetinib | Might have inferior OS |
Carvajal et al. 2018 (SUMIT) | 2014-2015 | Phase 3 (C) | Dacarbazine & Selumetinib | Did not meet primary endpoint of PFS |
Nathan et al. 2021 (IMCgp100-202) | 2017-2020 | Phase 3 (C) | Tebentafusp | Inferior OS |
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 dosing details in manuscript 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 dosing details in manuscript PubMed NCT03070392
Fotemustine monotherapy
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 dosing details in abstract PubMed NCT00110123
Ipilimumab monotherapy
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Nathan et al. 2021 (IMCgp100-202) | 2017-2020 | Phase 3 (C) | Tebentafusp | Inferior OS |
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 dosing details in manuscript PubMed NCT03070392
Ipilimumab & Nivolumab
Regimen variant #1, "NIVO1+IPI3", flat-dose maintenance
Study | Evidence |
---|---|
Piulats et al. 2021 (GEM-1402) | Phase 2 |
Immunotherapy
- Ipilimumab (Yervoy) as follows:
- Cycles 1 to 4: 3 mg/kg IV once on day 1
- Nivolumab (Opdivo) as follows:
- Cycles 1 to 4: 1 mg/kg IV once on day 1
- Cycle 5 onwards: 3 mg/kg IV once on day 1
21-day cycle for 4 cycles, then 14-day cycles
Regimen variant #2, "NIVO3+IPI1", flat-dose maintenance
Study | Evidence |
---|---|
Pelster et al. 2020 (MDACC 2011-0919) | Phase 2 |
Immunotherapy
- Ipilimumab (Yervoy) as follows:
- Cycles 1 to 4: 1 mg/kg IV once on day 1
- Nivolumab (Opdivo) as follows:
- Cycles 1 to 4: 3 mg/kg IV once on day 1
- Cycle 5 onwards: 480 mg IV once on day 1
21-day cycle for 4 cycles, then 28-day cycles
References
- GEM-1402: Piulats JM, Espinosa E, de la Cruz Merino L, Varela M, Alonso Carrión L, Martín-Algarra S, López Castro R, Curiel T, Rodríguez-Abreu D, Redrado M, Gomà M, Rullán AJ, Calvo González A, Berrocal-Jaime A. Nivolumab Plus Ipilimumab for Treatment-Naïve Metastatic Uveal Melanoma: An Open-Label, Multicenter, Phase II Trial by the Spanish Multidisciplinary Melanoma Group (GEM-1402). J Clin Oncol. 2021 Feb 20;39(6):586-598. link to original article PubMed NCT02626962
- MDACC 2011-0919: Pelster MS, Gruschkus SK, Bassett R, Gombos DS, Shephard M, Posada L, Glover MS, Simien R, Diab A, Hwu P, Carter BW, Patel SP. Nivolumab and Ipilimumab in Metastatic Uveal Melanoma: Results From a Single-Arm Phase II Study. J Clin Oncol. 2021 Feb 20;39(6):599-607. Epub 2020 Oct 30. link to original article link to PMC article PubMed NCT01585194
Pembrolizumab monotherapy
Regimen variant #1, weight-based
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Nathan et al. 2021 (IMCgp100-202) | 2017-2020 | Phase 3 (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 3 (C) | Tebentafusp | Inferior OS |
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 dosing details in manuscript PubMed NCT03070392
TACE monotherapy
TACE: Trans-Arterial Chemo-Embolization
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
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Carvajal et al. 2014 (MSK 10-053) | 2010-2013 | Randomized Phase 2 (E-switch-ooc) | 1. Dacarbazine 2. Temozolomide |
Might have superior OS |
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 dosing details in manuscript PubMed NCT01143402
Tebentafusp monotherapy
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: 1a. Dacarbazine 1b. Ipilimumab 1c. 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 dosing details in manuscript PubMed NCT03070392
Temozolomide monotherapy
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Carvajal et al. 2014 (MSK 10-053) | 2010-2013 | Randomized Phase 2 (C) | Selumetinib | Might have inferior OS |
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 dosing details in abstract PubMed NCT01143402
TILs
TILs: Tumor Ifiltrating Lymphocytes
Regimen
Study | Evidence |
---|---|
Chandran et al. 2017 (NCI 13-C-0093) | Phase 2 |
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