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A phase Ib randomized multicenter trial of isolated hepatic perfusion in combination with ipilimumab and nivolumab for uveal melanoma
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- Olofsson Bagge, Roger, 1978 (författare)
- Gothenburg University,Göteborgs universitet,Wallenberg Centre for Molecular and Translational Medicine,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery,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.
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- Nelson, Axel, 1981 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Clin Sci, Dept Oncol,Sahlgrenska Acad, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Oncol, Gothenburg, Sweden.,Univ Gothenburg, Inst Clin Sci, Sahlgrenska Acad, Dept Surg, Gothenburg, Sweden.;Univ Western Australia, Harry Perkins Inst Med Res, Perth, Australia.,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery
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- Shafazand, A. (författare)
- Univ Gothenburg, Inst Clin Sci, Sahlgrenska Acad, Dept Surg, Gothenburg, Sweden.;Univ Gothenburg, Wallenberg Ctr Mol & Translat Med, Gothenburg, Sweden.
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- Elsevier, 2024
- 2024
- Engelska.
- Ingår i: ESMO OPEN. - : Elsevier. - 2059-7029. ; 9:7
- Tidskriftsartikel (refereegranskat)
Abstract
Ämnesord
Stäng
- 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 ef fi cacy of this combination is encouraging with high response rates. One cycle of preoperative IPI/NIVO before IHP did not show potential bene fi ts in terms of safety or ef fi cacy.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Nyckelord
- isolated hepatic perfusion
- immune checkpoint inhibitor
- PD-1
- CTLA-4
- liver metastases
- uveal melanoma
- isolated hepatic perfusion
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- ref (ämneskategori)
- art (ämneskategori)
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- Levin, Max, 1969
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- Ny, Lars, 1967
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