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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

4336 - Randomized phase III study comparing a non-myeloablative lymphocyte depleting regimen of chemotherapy followed by infusion of tumor infiltrating lymphocytes and interleukine-2 to standard ipilimumab treatment in metastatic melanoma

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Presenters

Maartje Rohaan

Citation

Annals of Oncology (2018) 29 (suppl_8): viii442-viii466. 10.1093/annonc/mdy289

Authors

M.W. Rohaan1, T.H. Borch2, J.H. van den Berg3, M.H. Geukes Foppen1, M. Donia2, Ö. Met4, B. Nuijen5, M. van Zon3, E.A.M. Bakker3, R. de Boer3, L.M. Pronk6, S. Wilgenhof1, C.U. Blank7, J.V. van Thienen1, A.C.J. van Akkooi8, I. Svane2, J.B.A.G. Haanen7

Author affiliations

  • 1 Medical Oncology, Het Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI-AVL), 1006 BE - Amsterdam/NL
  • 2 Department Of Oncology, Herlev and Gentofte Hospital, 2730 - Herlev/DK
  • 3 Biotherapeutics Unit, Netherlands Cancer Institute, 1066CX - Amsterdam/NL
  • 4 Center For Cancer Immunotherapy And Department Of Oncology, Herlev and Gentofte Hospital, 2730 - Herlev/DK
  • 5 Department Of Pharmacy & Pharmacology, The Netherlands Cancer Institute and MC Slotervaart, 1066CX - Amsterdam/NL
  • 6 Biometrics, Het Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI-AVL), 1006 BE - Amsterdam/NL
  • 7 Medical Oncology, The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, 1066 CX - Amsterdam/NL
  • 8 Surgical oncology, The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, 1066 CX - Amsterdam/NL
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Resources

Abstract 4336

Background

Less than a decade ago, the prognosis of advanced melanoma was extremely poor, with a 5-year overall survival (OS) of only 9-28%. Introduction of targeted therapies and immunotherapies have significantly improved the outcome of these patients. Ipilimumab, an anti-CTLA-4 antibody, was the first to show clinical benefit in advanced melanoma patients and 20% achieved long-term survival. The PD-1-blocking agents pembrolizumab and nivolumab further increased objective response rates (ORR) up to 40% and are now often used as first-line therapy. However, a large group of patients still does not benefit from this treatment. Adoptive cell therapy with tumor infiltrating lymphocytes (TIL) has shown promising clinical ORR of 40-70% in patients with advanced melanoma in several phase I/II trials, with durable responses in a substantial group of patients. TIL treatment consists of infusion of ex vivo expanded tumor resident T cells following non-myeloablative (NMA) chemotherapy and subsequent high-dose interleukine-2 (HD IL-2).

Trial design

In this international, multicenter, open-label phase III trial, 168 patients with irresectable stage IIIc or IV melanoma, between 18 and 75 years of age, with resectable metastatic lesion(s) of at least 2-3 cm diameter and sufficient organ function, will be randomized 1:1 to either ipilimumab or TIL treatment. Patients will be stratified for BRAFV600 mutation status, treatment line (1st or 2nd) and treatment center. Patients randomized to ipilimumab (3 mg/kg i.v.) receive this once every 3 weeks, maximum of 4 doses. Patients randomized to TIL will undergo resection of a metastatic lesion for the outgrowth of TIL. Subsequently, NMA chemotherapy with cyclophosphamide (60 mg/kg/day for 2 days i.v.) and fludarabine (25 mg/m2/day for 5 days i.v.) is administered prior to infusion of > 5x109 TIL followed by HD IL-2 (600.000 IU/kg/dose every 8 hours, maximum of 15 doses). The primary endpoint is progression free survival at 6 months. Secondary endpoints are ORR, complete response rate, OS and safety. Enrollment started in September 2014.

Clinical trial identification

NCT02278887.

Legal entity responsible for the study

Netherlands Cancer Institute, Amsterdam, The Netherlands.

Funding

The Dutch Cancer Association, the Netherlands Organisation for Health Research and Development, the Dutch Ministry of Health, the Danish Cancer Society and Capital Region of Denmark Research Foundation.

Editorial Acknowledgement

Disclosure

T.H. Borch: Travel support: Roche; Travel support, Speaker’s fee: Bristol-Myers Squibb. J.H. van den Berg: Grants: Neon therapeutics, BMS, Medimmune. E.A.M. Bakker: Research funding: Neon therapeutics. C.U. Blank: Personal fees, Advisory role: MSD, BMS, Roche, GSK, Novartis, Pfizer, Lilly; Grants: BMS, Novartis. J.V. van Thienen: Travel support: Roche. A.C.J. van Akkooi: Grants and personal fees: Amgen, Novartis, Personal fees: MSD-Merck, Bristol-Myers Squibb. J.B.A.G. Haanen: Compensation to NKI for Advisory roles: BMS, Merck, Roche, Neon Therapeutics, Pfizer, Ipsen; Grants to NKI: BMS, Merck, Novartis, Neon Therapeutics. All other authors have declared no conflicts of interest.

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