Treatment of metastatic uveal melanoma with adoptive transfer of tumour-infiltrating lymphocytes: a single-centre, two-stage, single-arm, phase 2 study

The Lancet Oncology

Volumn 18, Issue 6, 2017, Pages 792-802

  Chandran, Smita S ^a   Somerville, Robert P T ^a   Yang, James C ^a   Sherry, Richard M ^a   Klebanoff, Christopher A ^a   Goff, Stephanie L ^a   Wunderlich, John R ^a   Danforth, David N ^a   Zlott, Daniel ^a   Paria, Biman C ^a   Sabesan, Arvind C ^a   Srivastava, Abhishek K ^a   Xi, Liqiang ^a   Pham, Trinh H ^a   Raffeld, Mark ^a   White, Donald E ^a   Toomey, Mary Ann ^a   Rosenberg, Steven A ^a   Kammula, Udai S ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CYCLOPHOSPHAMIDE; FLUDARABINE; INTERLEUKIN 2; GNA11 PROTEIN, HUMAN; GNAQ PROTEIN, HUMAN; GUANINE NUCLEOTIDE BINDING PROTEIN ALPHA SUBUNIT;

ADOPTIVE TRANSFER; ADULT; ADVERSE OUTCOME; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLURRED VISION; BRAIN ISCHEMIA; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER REGRESSION; CANCER TISSUE; CELL EXPANSION; CLINICAL ARTICLE; CONTROLLED STUDY; COUGHING; DEATH; DESQUAMATION; DRUG MEGADOSE; DYSPNEA; EDEMA; EMBOLISM; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HEART ARRHYTHMIA; HISTOLOGY; HUMAN; HUMAN CELL CULTURE; HUMAN TISSUE; HYPERBILIRUBINEMIA; HYPOALBUMINEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; HYPOPIGMENTATION; HYPOTENSION; HYPOXIA; IN VIVO STUDY; INFECTION; KIDNEY FAILURE; KIDNEY FUNCTION; LIVER FUNCTION; LIVER METASTASIS; LYMPHOCYTOPENIA; MALE; METASTASIS RESECTION; METASTATIC UVEA MELANOMA; MIDDLE AGED; MOTOR NEUROPATHY; MULTIPLE ORGAN FAILURE; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; SEPSIS; SIDE EFFECT; THROMBOCYTOPENIA; THROMBOSIS; THROMBUS; TREATMENT OUTCOME; TREATMENT RESPONSE; TUMOR ASSOCIATED LEUKOCYTE; ADOPTIVE IMMUNOTHERAPY; ADVERSE EFFECTS; AUTOTRANSPLANTATION; CHEMICALLY INDUCED; CLINICAL TRIAL; EYE ENUCLEATION; GENETICS; MELANOMA; PATHOLOGY; RADIOTHERAPY; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; SECONDARY; TRANSPLANTATION; TRANSPLANTATION CONDITIONING; UVEAL NEOPLASMS;

ADULT; ANEMIA; EYE ENUCLEATION; FEMALE; GTP-BINDING PROTEIN ALPHA SUBUNITS; GTP-BINDING PROTEIN ALPHA SUBUNITS, GQ-G11; HUMANS; IMMUNOTHERAPY, ADOPTIVE; INFECTION; LYMPHOCYTES, TUMOR-INFILTRATING; LYMPHOPENIA; MALE; MELANOMA; METASTASECTOMY; MIDDLE AGED; NEUTROPENIA; RADIOTHERAPY; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; THROMBOCYTOPENIA; TRANSPLANTATION CONDITIONING; TRANSPLANTATION, AUTOLOGOUS; UVEAL NEOPLASMS;

EID: 85017152791     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(17)30251-6     Document Type: Article

References (34)

1. McLaughlin, CC, Wu, XC, Jemal, A, Martin, HJ, Roche, LM, Chen, VW, Incidence of noncutaneous melanomas in the US. Cancer 103 (2005), 1000–1007.
2. Harbour, JW, The genetics of uveal melanoma: an emerging framework for targeted therapy. Pigment Cell Melanoma Res 25 (2012), 171–181.
3. Van Raamsdonk, CD, Bezrookove, V, Green, G, et al. Frequent somatic mutations of GNAQ in uveal melanoma and blue naevi. Nature 457 (2009), 599–602.
4. Van Raamsdonk, CD, Griewank, KG, Crosby, MB, et al. Mutations in GNA11 in uveal melanoma. N Engl J Med 363 (2010), 2191–2199.
5. Collaborative Ocular Melanoma Study Group. Assessment of metastatic disease status at death in 435 patients with large choroidal melanoma in the Collaborative Ocular Melanoma Study (COMS): COMS report no. 15. Arch Ophthalmol 119 (2001), 670–676.
6. Atkins, MB, Lotze, MT, Dutcher, JP, et al. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol 17 (1999), 2105–2116.
7. Hodi, FS, O'Day, SJ, McDermott, DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 363 (2010), 711–723.
8. Rosenberg, SA, Yang, JC, Sherry, RM, et al. Durable complete responses in heavily pretreated patients with metastatic melanoma using T-cell transfer immunotherapy. Clin Cancer Res 17 (2011), 4550–4557.
9. Hamid, O, Robert, C, Daud, A, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med 369 (2013), 134–144.
10. Larkin, J, Chiarion-Sileni, V, Gonzalez, R, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 373 (2015), 23–34.
11. Dorval, T, Fridman, WH, Mathiot, C, Pouillart, P, Interleukin-2 therapy for metastatic uveal melanoma. Eur J Cancer, 28A, 1992, 2087.
12. Danielli, R, Ridolfi, R, Chiarion-Sileni, V, et al. Ipilimumab in pretreated patients with metastatic uveal melanoma: safety and clinical efficacy. Cancer Immunol Immunother 61 (2012), 41–48.
13. Tarhini, AA, Cherian, J, Moschos, SJ, et al. Safety and efficacy of combination immunotherapy with interferon alfa-2b and tremelimumab in patients with stage IV melanoma. J Clin Oncol 30 (2012), 322–328.
14. Luke, JJ, Callahan, MK, Postow, MA, et al. Clinical activity of ipilimumab for metastatic uveal melanoma: a retrospective review of the Dana-Farber Cancer Institute, Massachusetts General Hospital, Memorial Sloan-Kettering Cancer Center, and University Hospital of Lausanne experience. Cancer 119 (2013), 3687–3695.
15. Kelderman, S, van der Kooij, MK, van den Eertwegh, AJ, et al. Ipilimumab in pretreated metastastic uveal melanoma patients. Results of the Dutch Working group on Immunotherapy of Oncology (WIN-O). Acta Oncol 52 (2013), 1786–1788.
16. Khattak, MA, Fisher, R, Hughes, P, Gore, M, Larkin, J, Ipilimumab activity in advanced uveal melanoma. Melanoma Res 23 (2013), 79–81.
17. Maio, M, Danielli, R, Chiarion-Sileni, V, et al. Efficacy and safety of ipilimumab in patients with pre-treated, uveal melanoma. Ann Oncol 24 (2013), 2911–2915.
18. Herbst, RS, Soria, JC, Kowanetz, M, et al. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature 515 (2014), 563–567.
19. Joshua, AM, Monzon, JG, Mihalcioiu, C, Hogg, D, Smylie, M, Cheng, T, A phase 2 study of tremelimumab in patients with advanced uveal melanoma. Melanoma Res 25 (2015), 342–347.
20. Zimmer, L, Vaubel, J, Mohr, P, et al. Phase II DeCOG-study of ipilimumab in pretreated and treatment-naive patients with metastatic uveal melanoma. PLoS One, 10, 2015, e0118564.
21. Niederkorn, JY, Ocular immune privilege and ocular melanoma: parallel universes or immunological plagiarism?. Front Immunol, 3, 2012, 148.
22. Rothermel, LD, Sabesan, A, Stephens, DJ, et al. Identification of an immunogenic subset of metastatic uveal melanoma. Clin Cancer Res 22 (2016), 2237–2249.
23. Tran, E, Turcotte, S, Gros, A, et al. Cancer immunotherapy based on mutation-specific CD4+ T cells in a patient with epithelial cancer. Science 344 (2014), 641–645.
24. Stevanovic, S, Draper, LM, Langhan, MM, et al. Complete regression of metastatic cervical cancer after treatment with human papillomavirus-targeted tumor-infiltrating T cells. J Clin Oncol 33 (2015), 1543–1550.
25. Harbour, JW, Onken, MD, Roberson, ED, et al. Frequent mutation of BAP1 in metastasizing uveal melanomas. Science 330 (2010), 1410–1413.
26. Harbour, JW, Roberson, ED, Anbunathan, H, Onken, MD, Worley, LA, Bowcock, AM, Recurrent mutations at codon 625 of the splicing factor SF3B1 in uveal melanoma. Nat Genet 45 (2013), 133–135.
27. Kish, JA, Kopecky, K, Samson, MK, et al. Evaluation of fludarabine phosphate in malignant melanoma. A Southwest Oncology Group study. Invest New Drugs 9 (1991), 105–108.
28. Presant, CA, Bartolucci, AA, Balch, C, Troner, M, A randomized comparison of cyclophosphamide, DTIC with or without piperazinedione in metastatic malignant melanoma. Cancer 49 (1982), 1355–1357.
29. Buder, K, Gesierich, A, Gelbrich, G, Goebeler, M, Systemic treatment of metastatic uveal melanoma: review of literature and future perspectives. Cancer Med 2 (2013), 674–686.
30. Carvajal, RD, Sosman, JA, Quevedo, J, Effect of selumetinib vs chemotherapy on progression-free survival in uveal melanoma: a randomized clinical trial. JAMA 311 (2014), 2397–2405.
31. Robbins, PF, Dudley, ME, Wunderlich, J, et al. Cutting edge: persistence of transferred lymphocyte clonotypes correlates with cancer regression in patients receiving cell transfer therapy. J Immunol 173 (2004), 7125–7130.
32. Dudley, ME, Gross, CA, Somerville, RP, et al. Randomized selection design trial evaluating CD8+-enriched versus unselected tumor-infiltrating lymphocytes for adoptive cell therapy for patients with melanoma. J Clin Oncol 31 (2013), 2152–2159.
33. Robbins, PF, Lu, YC, El-Gamil, M, et al. Mining exomic sequencing data to identify mutated antigens recognized by adoptively transferred tumor-reactive T cells. Nat Med 19 (2013), 747–752.
34. Lu, YC, Yao, X, Crystal, JS, et al. Efficient identification of mutated cancer antigens recognized by T cells associated with durable tumor regressions. Clin Cancer Res 20 (2014), 3401–3410.