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140 results on '"van den Berg, J. H."'

3. MART-1 TCR gene-modified peripheral blood T cells for the treatment of metastatic melanoma: a phase I/IIa clinical trial

Author

Rohaan, M. W., Gomez-Eerland, R., van den Berg, J. H., Geukes Foppen, M. H., van Zon, M., Raud, B., Jedema, I., Scheij, S., de Boer, R., Bakker, N. A. M., van den Broek, D., Pronk, L. M., Grijpink-Ongering, L. G., Sari, A., Kessels, R., van den Haak, M., Mallo, H. A., Karger, M., van de Wiel, B. A., Zuur, C. L., Duinkerken, C. W., Lalezari, F., van Thienen, J. V., Wilgenhof, S., Blank, C. U., Beijnen, J. H., Nuijen, B., Schumacher, T. N., Haanen, J. B. A. G., Graduate School, Tytgat Institute for Liver and Intestinal Research, Amsterdam Gastroenterology Endocrinology Metabolism, and Oral and Maxillofacial Surgery

Subjects
uveal, Oncology, MART-1, melanoma, Immunology and Allergy, adoptive cell therapy, T-cell receptor gene therapy, immunotherapy
Abstract

Background: Adoptive cell therapy with peripheral blood T cells expressing transgenic T-cell receptors (TCRs) is an innovative therapeutic approach for solid malignancies. We investigated the safety and feasibility of adoptive transfer of autologous T cells expressing melanoma antigen recognized by T cells 1 (MART-1)-specific TCR, cultured to have less differentiated phenotypes, in patients with metastatic melanoma. Materials and methods: In this phase I/IIa trial, peripheral blood T cells from HLA-A2∗02:01-positive patients with unresectable stage IIIC/IV melanoma expressing MART-1 were selected and stimulated with anti-CD3/CD28 beads, transduced with a modified MART-1(26-35)-specific 1D3 TCR (1D3HMCys) and expanded in interleukin (IL)-7 and IL-15. Patients received a single infusion of transgenic T cells in a dose-escalating manner. Feasibility, safety and objective response rate were assessed. Results: Twelve pretreated metastatic cutaneous (n = 7) and uveal (n = 5) melanoma patients were included. Patient 1 received 4.6 × 109 1D3HMCys T cells and experienced grade 5 toxicity after 9 days. Subsequent patients received 5.0 × 107 [n = 3; cohort (c) 2], 2.5 × 108 (n = 2; c3) and 1.0 × 108 (n = 6; c4) 1D3HMCys T cells. The study was prematurely terminated because of dose-dependent toxicity, concerning skin (10/12), eyes (3/12), ears (4/12) and cytokine release syndrome (5/12), with 7 patients experiencing grade 3-5 toxicity. Partial responses were seen in 2/11 (18%) assessable patients and persistence of 1D3HMCys T cells corresponded to infused cell dose. Conclusions: Production of TCR-modified cells as described leads to highly potent T cells. Partial responses were seen in 18% of patients with dose-dependent ‘on-target, off-tumor’ toxicity and a maximum tolerated dose of 1.0 × 108 cells.

Published
2022

20. On-site screening for syphilis at an antenatal clinic

Author

Delport, S D and van den Berg, J H Y

Abstract

Objective. To determine the validity, predictive value and accuracy of the rapid plasma reagin card test performed on site to diagnose active syphilis in pregnant women so that immediate treatment can be offered to prevent congenital syphilis.Design. Open, descriptive study.Setting. Antenatal clinic, Mamelodi Hospital, Pretoria.Patients. Four hundred and seventy-four pregnant women attending the antenatal clinic for the first time were entered into the study.Methods. A rapid plasma reagin test was performed on site with no specialised equipment and the results were compared with those of the reference laboratory.Results. In the event of rapid plasma reagin titres of 1:8 and higher, indicative of active syphilis, the on-site rapid plasma reagin test had a sensitivity of 90.5%. The test had a sensitivity of 100% if the rapid plasma reagin titres were 1:16 and higher.Conclusion. The on-site rapid plasma reagin test identified all women with rapid plasma reagin titres higher than 1:8. This implies that all women whose fetuses were in danger of acquiring congenital syphilis were identified at the clinic and could be treated immediately.

Published
2016

21. Abstracts of papers symposium disposition and delivery of peptide drugs

Author

Barnard, M., Beijnen, J. H., Lubbers, S. C. M., van der Houwen, O. A. G. J., Lobbezoo, M. W., Underberg, W. J. M., Cachet, Th., Roets, E., Hoogmartens, J., Vanderhaeghe, H., de Bree, H., van der Stel, D. J. K., Brockhoff, O. A. M., van Berkel, M. P., Sierat, K., de Groot, G., Tepas, B. C. A., de Noord, O. E., Hempenius, J., Coenegracht, P. M. J., Jonkman, J. H. G., Doornbos, D. A., De Schutter, J. A., De Moerloose, P., Delbressine, L. P. C. P., Kaspersen, F. M., Blokland, A., Duchateau, A. L. L., Verstappen, T. A., Hendricks, P. J. H., Elferink, F., Leeuwenkamp, O. R., Pinedo, H. M., vd Vijh, W. J. F., Ensing, K., Bloemhof, D. A., in 't Hout, W. G., de Zeeuw, R. A., Feitsma, Karla G., Drenth, Ben F. H., de Zeeuw, Rokus A., Gerding, T. K., Drenth, B. F. H., de Zeeuw, R. A., Horn, A. S., Groen, C. P., Tipker, J., van den Bergh-Swart, J. K., Spruit, F. J., van den Berg, J. H. N., Bramel, E. H. Groot, Beijnen, J. H., Beckers, O., Otagiri, M., Underberg, W. J. M., Janssen, P. S. L., v. Nispen, J. W., Melgers, P. A. T. A., v. Zeeland, M. J. M., Hanmelinck, R. L. A. E., Goverde, B. C., v. Aalst, G. W. M., Kootstra, P. R., van den Broek, H. H., Hogendoorn, E. A., Goewie, C. E., Kwakman, P. J. M., Brinkman, U. A. Th., Frei, R. W., de Jong, G. J., Spruit, F. J., Lammers, N. G. F. M., van den Berg, J. H. M., Lammers, N., Groen, C. P., Ruijten, H. M., Maessen, P. A., Mross, K. B., Pinedo, H. M., van der Vijgh, W. J. F., Khan, Naeem Hasan, Hoogmartens, J., Roets, E., Vanderhaeghe, H., Rose, S. V., Lammerts van Bueren, L. G. D., van Beek, H., Baars, A. J., van Ginkel, L. A., Steinbuch, H. M., van Rossum, H. J., van Blitterswijk, H., Zoontjes, P. W., v.d. Heeft, E., de Jong, A. J. P. M., Stephany, R. W., van Gijn, R., de Clippeleir, J. J. M., Beijnen, J. H., Underberg, W. J. M., Verweij, S. L., Paalman, A. C. A., van Opstal, M. A. J., Krabbenborg, P., Holthuis, J. J. M., van Bennekom, W. P., Bult, A., van de Water, C., Haagsma, N., van der Stel, D. J. K., de Bree, H., Brockhoff, O. A. M., Vendrig, D. E. M. M., Mekking, A., Teeuwsen, J., and Holthuis, J. J. M.

Published
1988
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22. Deep sub-wavelength metrology for advanced defect classification

Author

van der Walle, P., additional, Kramer, E., additional, van der Donck, J. C. J., additional, Mulckhuyse, W., additional, Nijsten, L., additional, Bernal Arango, F. A., additional, de Jong, A., additional, van Zeijl, E., additional, Spruit, H. E. T., additional, van den Berg, J. H., additional, Nanda, G., additional, van Langen-Suurling, A. K., additional, Alkemade, P. F. A., additional, Pereira, S. F., additional, and Maas, D. J., additional

Published
2017
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23. Fluvial to tidal transition zone facies in the McMurray Formation (Christina River, Alberta, Canada), with emphasis on the reflection of flow intensity in bottomset architecture

Author

Martinius, A. W., Jablonski, B. V J, Fustic, M., Strobl, R., Van den Berg, J. H., Ashworth, Philip J., Best, James L., Parsons, Daniel R., Universiteit Utrecht, and Coastal dynamics, Fluvial systems and Global change

Subjects
Bottomset, Fluvial to tidal transition zone, McMurray Formation, Outcrop, Trough (geology), Fluvial, Geology, Point bar, Oceanography, Sedimentary depositional environment, Reactivation surfaces, Flow retardation, Aggradation, Facies, Transition zone, Cyclicity, Geomorphology, Backflow ripples
Abstract

An outcrop of the McMurray Formation along the Christina River (Alberta, Canada) has been investigated to better understand depositional processes and setting. The succession is formed by large-scale tabular sets of unidirectional trough cross-stratification. Many of these sets are characterized by profusely ripple-laminated and thick, laterally persistent bottomset intervals at their base. Additionally, reactivation surfaces and infrequent set climbers occur in the foresets. The bottomsets almost entirely consist of backflow cross-lamination. Available knowledge indicates that this points to a rather strong vortex circulation and related strong and persistent main flow velocity. The observed bottomset succession is discussed within the range of variation in bottomset architecture that results from the structure and strength of the flow in the wake behind dunes and related strength of the main flow. Sets descend along a gentle slope, suggesting that dunes filled a preexisting depression, thus representing conditions of a vertically expanding and decelerating flow. This means that aggradation rate was high, which is in accordance with the thickness of the preserved sets. Systematic changes in flow strength are documented by downstream cyclic variations in organic debris, bottomset thickness, and foreset dip. The periodic increase of flow velocity is interpreted as being produced by the increased strength of the river flow during the ebbing tide on the days around spring tide. Apart from these subtle variations, the area experienced large changes in flow strength due to seasonal differences in fluvial discharge. The turbidity maximum zone was located downstream of the study site since thick slackwater mud drapes that characterize the seaward part of the fluvial to tidal transition zone are not present; only a few thin mud drapes are found at the study locality. Therefore, it is concluded that deposition took place in the most landward part of this zone. This new interpretation of this facies in the Christina River area is in line with the inferred depositional setting of the transition to the overlying thick point bar units formed by inclined heterolithic stratification.

Published
2015

24. Fluvial to tidal transition zone facies in the McMurray Formation (Christina River, Alberta, Canada), with emphasis on the reflection of flow intensity in bottomset architecture

Author

Universiteit Utrecht, Coastal dynamics, Fluvial systems and Global change, Martinius, A. W., Jablonski, B. V J, Fustic, M., Strobl, R., Van den Berg, J. H., Ashworth, Philip J., Best , James L., Parsons, Daniel R., Universiteit Utrecht, Coastal dynamics, Fluvial systems and Global change, Martinius, A. W., Jablonski, B. V J, Fustic, M., Strobl, R., Van den Berg, J. H., Ashworth, Philip J., Best , James L., and Parsons, Daniel R.

Published
2015

31. Abstracts of papers Pharmaceutical and biomedical analysis meeting

Author

Bandhoe, A. U., Paalman, A. C. A., Underberg, W. J. M., Beijnen, J. H., Bekers, O., Otagiri, M., Bult, A., Beuman, Gert, van der Heijden, Jacques, Janss, Jenny, Ceelen, P. R. J., Feenstra-Bielders, G. G. L. M., Groeneveld, D. J., de Boer, D., Rutten, M. J. A., de Jong, E. G., Maes, R. A. A., van Rossum, J. M., de Groot, G., Kopps, R., Savelkoul, T. J. F., van Vloten, P., de Jonag, E. G., van Ooyen, R., Kiffers, J., de Kroon, I. F. I., Langendijk, P. N. J., de Goede, P. N. F. C., De Smet, M., Musch, C., Peeters, A., Buydens, L., Massart, D. L., De Turck, K., Cachet, Th., Hoogmartens, J., Delrue, M., Lannoo, P., Drenth, B. F. H., Beckeringh, F. J., Bosman, J., Feitsma, K. G., van Nijhuisvan Dam, A., Driebergen, R. J., van Gorp, J. A., Ensing, K., Farlam, A., de Jong, G. J., Frel, R. W., Brinkman, U. A. Th., Gerding, T. K., van de Grampel, V. J. M., Niemeijer, N. R., de Zeeuw, R. A., Tepper, P. G., Horn, A. S., Halvax, J. J., Wiese, G., van Bennekom, W. P., Hindriks, Rik, Buydens, Lutgarde, Peeters, Anne, de Smet, Marina, Massart, Luc, Blokland, Aric, Vink, Jan, Keizers, S., de Jong, E. G., Niessen, W. M. A., Verhey, E. R., LaVos, G. F., Tjaden, U. R., van der Greef, J., Ooms, J. A., Haak, G. S. J., Grooten, G., Pattyn, G., Sandra, P., David, F., van Oosterom, A. T., de Bruijn, E. A., Pouwelse, A. V., de Jong, D., Lammers, N. G. F. M., van den Berg, J. H. M., Quintens, I., Roets, E., Reeuwijk, H. J. E. M., Lingeman, H., Keizer, H. J., Rosing, H., Elferink, F., van de Vaart, F. J., Kloeg, P. H. A. M., Sauter, André, Stegehuis, D. S., Reinhoud, N. J., Steijger, O. M., Hilhorst, J. J. L., Holthuis, J. J. M., Underberg-Chitoe, U. K., Meenhorst, P. L., Van den Mooter, G., Hauchecorne, R., Vinckier, C., van der Horst, A., Martens, H. J. M., van der Horst, F. A. L., Post, M. H., van Ginkel, L. A., Zoontjes, P. W., van Blitterswijk, H., Stephany, R. W., van Gijn, R., Bakker, C. H., Koks, C. H. W., Rodenhuis, S., van Opstal, M. A. J., van den Horst, F. A. L., Krabbenborg, P., van Tellingen, O., Woude, H. R. v. d., van Beers, C. J. T., Nooyen, W. J., Varossieau, F. J., Los, G., Nagel, J. D., McVie, J. G., Veen, R. N., Land, J. T. Op 't, Vendrig, D. E. M. M., Teeuwsen, J., Verlaar, F. C. A. M., Trum, T. J. H. M., de Kleijn, J. P., Vervoort, R., Vrieling, M., Maris, F., Hindriks, H., Walhagen, A., Edholm, L. -E., Heeremans, C. E. M., and van der Hoeven, R. A. M.

Published
1989
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32. Abstracts of Dutch doctoral theses

Author

Navis, G. J., Sterk, G. J., van Nispen, J. W., Hichens, M., Sauter, A., Lingeman, H., van den Beld, C. M. B., Tjaden, U. R., van der Greef, J., Desiderio, D. M., Cubbins, D. C., McMartin, C., Webb, R. L., Wennogle, L. P., Wysowskyi, H. E., Zimmerman, M. B., Lee, V. H. L., Sandow, J., Seidel, H., Schmiedel, R., Keller, Bradley T., Smith, Kevin R., Borchardt, Ronald T., Banks, W. A., Kastin, A. J., de Wied, D., DeLuca, P. P., Robinson, J. R., Lundin, S., Vilhardt, H., Saffran, M., Kumar, G. S., Neckers, D. G., Williams, F., Field, J. B., Jones, R. H., Panepinto, L., Harris, A. S., Moses, Alan C., Muranishi, S., Boddé, H. E., Ponec, M., Verhoef, J., Liversidge, Gary G., Boer, G. J., Kruisbrink, J., de Nijs, H., Bouwman, T. R. M., Eenink, M. J. D., Patel, Harish M., Bundgaard, H., Larsen, J. D., Nielsen, M. N., Buur, A., Tjadeh, U. R., Lemaire, M., Andres, H., Marbach, P., Widlund, L., Guilbaud, O., Wilton, P., van Bree, J. B. M. M., Audus, K. L., Deinum, Johanna, Norén, Karin, Sohtell, Morgan, Weström, B. R., Folkesson, H. G., Karlsson, B. W., Damge, C., Michel, C., Aprahamian, M., Couvreur, P., Puisieux, F., Touitou, E., Alhaique, F., Fisher, P., Memoli, A., Riccieri, F. M., Santucci, E., Hermens, W. A. J. J., Romei jn, S. G., Merkus, F. W. H. H., Schneider, C., Smith, T. W., Bremecker, K. -D., Hungerer, K. -D., Tabata, Y., Ikada, Y., Uno, K., Muramatsu, S., Bruning, J. W., Claas, F. H. J., Kardol, M. J., van Ree, J. M., Rust, C. J. J., Verduyn, W., Wiegant, V. M., Wolterink, G., van Hoogdalem, E. J., Heijligers-Feijen, C. D., de Boer, A. G., Breimer, D. D., Lambalk, C. B., van Kessel, H., de Koning, J., van Dieten, J. A. M. J., van Rees, G. P., Schoemaker, J., Devissaguet J. -Ph., Orieu K., Dray F., Ezan E., Devissaguet J. Ph., Drieu K., Dray P., Ezah E., Barnfield, D. J., Barker, Y. K., Knott, S., Miles, G. S., Warrander, A., Adam, H. K., Barker, Y., Hutchinson, F. G., Milsted, R. A. V., Moore, R. H., Swaisland, A. J., Barke, Y., Porter, E. T., Holmes, B., Barnard, M., Beijnen, J. H., Lubbers, S. C. H., van der Houwen, O. A. G. J., Lobbezoo, M. W., Underberg, W. J. M., Cachet, Th., Roets, E., Hoogmartens, J., Vanderhaeghe, H., de Bree, H., van der Stel, D. J. K., Brockhoff, O. A. M., van Berkel, M. P., Sierat, K., de Groot, G., Tepas, B. C. A., de Noord, O. E., Hempenius, J., Coenegracht, P. M. J., Jonkman, J. H. G., Doornbos, D. A., De Schutter, J. A., De Moerloose, P., Delbressine, L. P. C., Kaspersen, F. M., Blokland, A., Duchateau, A. L. L., Verstappen, T. A., Hendricks, P. J. H., Elferink, F, Leeuwenkamp, O R, Pinedo, H M, vd Vijgh, W J F, Ensing, K., Bloemhof, D. A., In 't Hout, W. G., de Zeeuw, R. A., Feitsma, Karla G., Drenth, Ben F. H., de Zeeuw, Rokus A., Gerding, T. K., Drenth, B. F. H., Horn, A. S., Groen, C. P., Tipker, J., van den Bergh-Swart, J. K., Spruit, F. J., van den Berg, J. H. M., Bramel, E. H. Groot, Bekers, O., Otagiri, M., Janssen, P. S. L., Nispen, J. W. v., Melgers, P. A. T. A., Zeeland, M. J. M. v., Hamelinck, R. L. A. E., Goverde, B. C., Aalst, G. W. M. v., Kootstra, P. R., van den Broek, H. H., Hogendoorn, E. A., Goewie, C. E., Kwakman, P. J. M., Brinkman, U. A. Th., Frei, R. W., de Jong, G. J., Lammers, N. G. F. M., Lammers, N., Ruijten, H. M., de Jong, J., Maessen, P. A., Mross, K. B., Plnedo, H. M., van der Vljgh, W. J. F., Khan, Naeem Hasan, Hoogmartens, J., Rose, S. V., van Bueren, L. G. D. Lammerts, van Amsterdam, P. H., van Beek, H., Baars, A. J., van Ginkel, L. A., Steinbuch, H. M., van Rossum, H. J., van Blitterswijk, H., Zoontjes, P. W., Heeft, E. v. d., de Jong, A. J. P. M., Stephany, R. W., van Gijn, R., de Clippeleir, J. J. M., Verweij, S. L., Paalman, A. C. A., van Opstal, M. A. J., Krabbenborg, P., Holthuis, J. J. M., van Bennekom, W. P., Bult, A., Redegeld, F. A. M., Houdkamp, E., van de Water, C., Haagsma, N., van der Stel, D. J. K., Vendrig, D. E. M. M., Mekking, A., and Teeuwsen, J.

Published
1988
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33. Commercial SOI sensor technology

Author

van Zeijl, E., Schmits, R., van den Berg, J. H., Harmsma, P. J., Westerveld, W.J., Lagioia, M., Bodis, P., Ebeling, R. P., Nieuwland, R. A., and Yang, S.

Abstract

We present a platform for the deployment of SOI based sensors in commercialapplications. The platform is designed from a systems perspective and includes allaspects of a SOI sensor system, including sensor head itself, the communicationsinfrastructure and a customized interrogation system.

Published
2010

37. Commercial SOI sensor technology

Author

van Zeijl, E. (author), Schmits, R. (author), van den Berg, J. H. (author), Harmsma, P. J. (author), Westerveld, W.J. (author), Lagioia, M. (author), Bodis, P. (author), Ebeling, R. P. (author), Nieuwland, R. A. (author), Yang, S. (author), van Zeijl, E. (author), Schmits, R. (author), van den Berg, J. H. (author), Harmsma, P. J. (author), Westerveld, W.J. (author), Lagioia, M. (author), Bodis, P. (author), Ebeling, R. P. (author), Nieuwland, R. A. (author), and Yang, S. (author)

Abstract

We present a platform for the deployment of SOI based sensors in commercial applications. The platform is designed from a systems perspective and includes all aspects of a SOI sensor system, including sensor head itself, the communications infrastructure and a customized interrogation system., Dynamics of Micro and Nano Systems

Published
2010

38. Erosion of Sediments between Groynes in the River Waal as a Result of Navigation Traffic

Author

Ten Brinke, W. B.M., Kruyt, N. M., Kroon, A., Van Den Berg, J. H., Ten Brinke, W. B.M., Kruyt, N. M., Kroon, A., and Van Den Berg, J. H.

Abstract

The River Waal is the largest river in The Netherlands, and its shipping density is among the highest of all the inland waterways of the world. The river bed sediments of the Waal are mainly sandy. To protect the river banks from erosion, groynes have been built all along the river. The groynes are submerged at high discharges only, and it is hypothesized that the sandy beaches between the groynes are the result of a balance between sand deposition at high discharges and sand erosion by currents induced by navigation traffic at moderate and low discharges. In the summer of 1996, currents and sediment resuspension resulting from navigation traffic were measured between the groynes. The largest vessels had the strongest impact, typically creating a water-level depression of 15-20 cm and currents of 30-40 cm s-1 at 10 cm above the bed. Scaling sand transport from groyne fields up to the entire river and a time-scale of 1 yr results in overestimates of sand losses from the groyne fields, suggesting that more measurements in groyne fields with different orientations and at different discharge conditions have to be carried out. Models in the literature that relate vessel characteristics to currents induced near the bank do not seem to serve for the conditions of the navigation traffic in the River Waal.

Published
2009

39. Deep sub-wavelength metrology for advanced defect classification

Author

Lehmann, Peter, Osten, Wolfgang, Albertazzi Gonçalves, Armando, van der Walle, P., Kramer, E., van der Donck, J. C. J., Mulckhuyse, W., Nijsten, L., Bernal Arango, F. A., de Jong, A., van Zeijl, E., Spruit, H. E. T., van den Berg, J. H., Nanda, G., van Langen-Suurling, A. K., Alkemade, P. F. A., Pereira, S. F., and Maas, D. J.

Published
2017
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41. Succession and rejuvenation in floodplains along the river Allier (France).

Author

Martens, K., van der Velde, G., Breedveld, M., Liefhebber, D., Geerling, G. W., Smits, A. J. M., Ragas, A. M. J., Leuven, R. S. E. W., and van den Berg, J. H.

Abstract

The spatio-temporal heterogeneity of a meandering part of the Allier river was studied by analysing ecotope composition and dynamics using a series of aerial images covering a period of 46 years (1954-2000). The ecotope dynamics was exemplified by two time series showing rejuvenating hydro-geomorphological processes, i.e., meander progression, meander cut-off and channel shift. The mean rejuvenation rate was 33.8 ha per 5 years for the 5.5 km long study area. The ecotope transition rates varied from 18% surface area change per 5 years to 58.7% surface area change per 5 years for pioneer vegetation. The combination of hydro-geomorphological processes and ecological succession resulted in a temporal diversity of the riparian area. In the year 2000 half of the total riparian landscape was 14 years or younger and 23% was not rejuvenated in 46 years. Eighty percent of the pioneer vegetation was found on young soils (<14 years) while more than 50% of the surface area of low dynamic ecotopes like bush and side channels was located on parts, which were stable for more than 46 years. Examining the relation between river stretch size and ecotope diversity showed that the ecotope diversity remained stable above a stretch size of 1.5 meander lengths for the years 1978, 1985 and 2000. The spatial and temporal analysis of the study area showed evidence supporting the steady state or meta-climax hypotheses, but influences of long-term processes on landscape composition were also found. Some implications for floodplain management are discussed. [ABSTRACT FROM AUTHOR]

Published
2006
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48. Tumor-Infiltrating Lymphocyte Therapy or Ipilimumab in Advanced Melanoma.

Author

Rohaan, M. W., Borch, T. H., van den Berg, J. H., Met, Ö., Kessels, R., Geukes Foppen, M. H., Stoltenborg Granhgj, J., Nuilen, B., Nijenhuis, C., Jedema, I., van Zon, M., Scheij, S., Beijnen, J. H., Hansen, M., Voermans, C., Noringrils, I. M., Monberg, T. J., Holmstroem, R. B., Wever, L. D. V., and van Dijk, M.

Subjects
*IPILIMUMAB, *MELANOMA, *TUMOR-infiltrating immune cells, *CLINICAL trials, *IMMUNE checkpoint inhibitors, *ADVERSE health care events, *PROGRESSION-free survival
Abstract

BACKGROUND Immune checkpoint inhibitors and targeted therapies have dramatically improved outcomes in patients with advanced melanoma, but approximately half these patients will not have a durable benefit. Phase 1–2 trials of adoptive cell therapy with tumor-infiltrating lymphocytes (TILs) have shown promising responses, but data from phase 3 trials are lacking to determine the role of TILs in treating advanced melanoma.METHODSIn this phase 3, multicenter, open-label trial, we randomly assigned patients with unresectable stage IIIC or IV melanoma in a 1:1 ratio to receive TIL or anti–cytotoxic T-lymphocyte antigen 4 therapy (ipilimumab at 3 mg per kilogram of body weight). Infusion of at least 5×109 TILs was preceded by nonmyeloablative, lymphodepleting chemotherapy (cyclophosphamide plus fludarabine) and followed by high-dose interleukin-2. The primary end point was progression-free survival. RESULTS A total of 168 patients (86% with disease refractory to anti–programmed death 1 treatment) were assigned to receive TILs (84 patients) or ipilimumab (84 patients). In the intention-to-treat population, median progression-free survival was 7.2 months (95% confidence interval [CI], 4.2 to 13.1) in the TIL group and 3.1 months (95% CI, 3.0 to 4.3) in the ipilimumab group (hazard ratio for progression or death, 0.50; 95% CI, 0.35 to 0.72; P<0.001); 49% (95% CI, 38 to 60) and 21% (95% CI, 13 to 32) of the patients, respectively, had an objective response. Median overall survival was 25.8 months (95% CI, 18.2 to not reached) in the TIL group and 18.9 months (95% CI, 13.8 to 32.6) in the ipilimumab group. Treatment-related adverse events of grade 3 or higher occurred in all patients who received TILs and in 57% of those who received ipilimumab; in the TIL group, these events were mainly chemotherapy-related myelosuppression. CONCLUSIONSIn patients with advanced melanoma, progression-free survival was significantly longer among those who received TIL therapy than among those who received ipilimumab. [ABSTRACT FROM AUTHOR]

Published
2022
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