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A phase Ib randomiz...
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Bagge, R. OlofssonUniv Gothenburg, Inst Clin Sci, Sahlgrenska Acad, Dept Surg, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Surg, Gothenburg 41345, Sweden.;Univ Gothenburg, Wallenberg Ctr Mol & Translat Med, Gothenburg, Sweden.
(författare)
A phase Ib randomized multicenter trial of isolated hepatic perfusion in combination with ipilimumab and nivolumab for uveal melanoma metastases (SCANDIUM II trial)
- Artikel/kapitelEngelska2024
Förlag, utgivningsår, omfång ...
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Elsevier,2024
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electronicrdacarrier
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LIBRIS-ID:oai:DiVA.org:uu-535797
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-535797URI
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https://doi.org/10.1016/j.esmoop.2024.103623DOI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:ref swepub-contenttype
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Ämneskategori:art swepub-publicationtype
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Background:Uveal melanoma (UM) is a rare malignancy where 50% of patients develop metastatic disease primarily affecting the liver. Approximately 40% of patients with metastatic UM respond to one-time isolated hepatic perfusion (IHP) with high -dose melphalan. This phase I trial investigates the safety and clinical ef fi cacy of IHP combined with ipilimumab (IPI) and nivolumab (NIVO).Patients and methods:Immunotherapy-na & iuml;ve patients were randomized in this phase I trial to receive either IHP followed by IPI 3 mg/kg and NIVO 1 mg/kg (IPI3/NIVO1) for four cycles (post -operative arm), or one cycle of preoperative IPI3/NIVO1, IHP and then three cycles of IPI3/NIVO1 (pre-post-operative arm), followed by maintenance therapy with NIVO 480 mg for 1 year.Results:Eighteen patients were enrolled and randomized. Three patients did not undergo IHP as planned. In total, 11/ 18 patients (6 in the post -operative arm and 5 in the pre-post-operative arm) did not complete the planned four cycles of IPI3/NIVO1. Toxicity to IHP was similar in both groups, but the number of immune-related adverse events (AEs) was higher in the pre-post-operative arm. Among assessable patients, overall response rate was 57% in the post -operative arm (4/7) and 22% in the pre-post-operative arm (2/9).Conclusions:Combination therapy with IHP and IPI3/NIVO1 was associated with severe AEs. The efficacy of this combination is encouraging with high response rates. One cycle of preoperative IPI/NIVO before IHP did not show potential benefits in terms of safety or efficacy.
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Nelson, A.Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Clin Sci, Dept Oncol,Sahlgrenska Acad, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Oncol, Gothenburg, Sweden.
(författare)
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Shafazand, A.Univ Gothenburg, Inst Clin Sci, Sahlgrenska Acad, Dept Surg, Gothenburg, Sweden.;Univ Gothenburg, Wallenberg Ctr Mol & Translat Med, Gothenburg, Sweden.
(författare)
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Cahlin, C.Univ Gothenburg, Sahlgrenska Univ Hosp, Transplant Inst, Inst Clin Sci,Sahlgrenska Acad, Gothenburg, Sweden.
(författare)
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Carneiro, A.Skane Univ Hosp, Dept Haematol Oncol & Radiat Phys, Comprehens Canc Ctr, Lund, Sweden.
(författare)
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Helgadottir, H.Karolinska Univ Hosp, Dept Oncol, Stockholm, Sweden.
(författare)
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Levin, M.Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Clin Sci, Dept Oncol,Sahlgrenska Acad, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Oncol, Gothenburg, Sweden.
(författare)
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Rizell, M.Univ Gothenburg, Sahlgrenska Univ Hosp, Transplant Inst, Inst Clin Sci,Sahlgrenska Acad, Gothenburg, Sweden.
(författare)
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Ullenhag, GustavUppsala universitet,Cancerimmunterapi(Swepub:uu)gustulle
(författare)
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Wiren, S.Univ Gothenburg, Inst Clin Sci, Sahlgrenska Acad, Dept Surg, Gothenburg, Sweden.;Umeå Univ Hosp, Dept Radiat Sci, Umeå, Sweden.
(författare)
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Lindner, P.Univ Gothenburg, Sahlgrenska Univ Hosp, Transplant Inst, Inst Clin Sci,Sahlgrenska Acad, Gothenburg, Sweden.
(författare)
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Nilsson, J. A.Univ Gothenburg, Inst Clin Sci, Sahlgrenska Acad, Dept Surg, Gothenburg, Sweden.;Univ Western Australia, Harry Perkins Inst Med Res, Perth, Australia.
(författare)
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Ny, L.Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Clin Sci, Dept Oncol,Sahlgrenska Acad, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Oncol, Gothenburg, Sweden.
(författare)
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Univ Gothenburg, Inst Clin Sci, Sahlgrenska Acad, Dept Surg, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Surg, Gothenburg 41345, Sweden.;Univ Gothenburg, Wallenberg Ctr Mol & Translat Med, Gothenburg, Sweden.Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Clin Sci, Dept Oncol,Sahlgrenska Acad, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Oncol, Gothenburg, Sweden.
(creator_code:org_t)
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Ingår i:ESMO Open: Elsevier9:72059-7029
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Bagge, R. Olofss ...
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Nelson, A.
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Shafazand, A.
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Cahlin, C.
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Carneiro, A.
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Helgadottir, H.
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Levin, M.
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Rizell, M.
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Ullenhag, Gustav
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Wiren, S.
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Lindner, P.
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Nilsson, J. A.
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Ny, L.
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