Difference between revisions of "Uveal melanoma"

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m (Text replacement - "style="background-color:#1a9851" |Phase III" to "style="background-color:#1a9851" |Phase 3")
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|Dacarbazine & Selumetinib
 
|Dacarbazine & Selumetinib
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
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|-
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|[https://doi.org/10.1056/nejmoa2103485 Nathan et al. 2021 (IMCgp100-202)]
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|2017-2020
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|style="background-color:#1a9851"|Phase III (C)
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|Tebentafusp
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| style="background-color:#d73027" |Inferior OS
 
|-
 
|-
 
|}
 
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# '''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 verified protocol''' [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 verified protocol''' [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 verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/34551229/ PubMed] NCT03070392
  
 
==Fotemustine monotherapy {{#subobject:92d0c6|Regimen=1}}==
 
==Fotemustine monotherapy {{#subobject:92d0c6|Regimen=1}}==
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===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 protocol''' [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 protocol''' [https://pubmed.ncbi.nlm.nih.gov/24510314 PubMed] NCT00110123
 +
 +
==Ipilimumab monotherapy {{#subobject:dga21b|Regimen=1}}==
 +
{| class="wikitable" style="float:right; margin-left: 5px;"
 +
|-
 +
|[[#top|back to top]]
 +
|}
 +
===Regimen {{#subobject:ance4c|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://doi.org/10.1056/nejmoa2103485 Nathan et al. 2021 (IMCgp100-202)]
 +
|2017-2020
 +
|style="background-color:#1a9851"|Phase III (C)
 +
|Tebentafusp
 +
| style="background-color:#d73027" |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. [https://doi.org/10.1056/nejmoa2103485 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/34551229/ PubMed] NCT03070392
 +
 +
==Pembrolizumab monotherapy {{#subobject:dhuahb|Regimen=1}}==
 +
{| class="wikitable" style="float:right; margin-left: 5px;"
 +
|-
 +
|[[#top|back to top]]
 +
|}
 +
===Regimen variant #1, weight-based {{#subobject:bed6av|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://doi.org/10.1056/nejmoa2103485 Nathan et al. 2021 (IMCgp100-202)]
 +
|2017-2020
 +
|style="background-color:#1a9851"|Phase III (C)
 +
|Tebentafusp
 +
| style="background-color:#d73027" |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 {{#subobject:b7d6av|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://doi.org/10.1056/nejmoa2103485 Nathan et al. 2021 (IMCgp100-202)]
 +
|2017-2020
 +
|style="background-color:#1a9851"|Phase III (C)
 +
|Tebentafusp
 +
| style="background-color:#d73027" |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. [https://doi.org/10.1056/nejmoa2103485 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/34551229/ PubMed] NCT03070392
  
 
==TACE monotherapy {{#subobject:f96a1b|Regimen=1}}==
 
==TACE monotherapy {{#subobject:f96a1b|Regimen=1}}==

Revision as of 16:09, 17 December 2021

Section editor
Bethbuchbinder.jpg
 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

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
Nathan et al. 2021 (IMCgp100-202) 2017-2020 Phase III (C) Tebentafusp Inferior OS

Chemotherapy

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
  3. 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

back to top

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

  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, 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

back to top

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Nathan et al. 2021 (IMCgp100-202) 2017-2020 Phase III (C) Tebentafusp Inferior OS

Immunotherapy

21-day cycle for up to 4 cycles

References

  1. 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

back to top

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

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

21-day cycles

References

  1. 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

back to top

TACE: Trans-Arterial Chemo-Embolization

Regimen

Study Evidence
Mavligit et al. 1988 Non-randomized

Chemotherapy

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

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

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

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
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