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2. Avelumab as second-line or later treatment in patients with metastatic Merkel cell carcinoma: Analysis of real-world outcomes in France using the CARADERM database linked to the French national healthcare database

Author

Mortier, Laurent, Blom, Astrid, van Hille, Benoît, Samimi, Mahtab, Luciani, Laura, Cahuzac, Capucine, Robert, Caroline, Quereux, Gaelle, Maubec, Eve, Miotti, Hakima, Maillard, Cathy, Aubin, François, Lenormand, Cédric, Solbes, Marie-Noëlle, Joly, Pascal, Kachaner, Isabelle, Lebbé, Céleste, Dutriaux, Caroline, and Saiag, Philippe

Published
2024
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5. Skin cancers are the most frequent cancers in fair-skinned populations, but we can prevent them.

Author

Garbe, Claus, Forsea, Ana-Maria, Amaral, Teresa, Arenberger, Petr, Autier, Philippe, Berwick, Marianne, Boonen, Brigitta, Bylaite, Matilda, del Marmol, Veronique, Dreno, Brigitte, Fargnoli, Maria Concetta, Geller, Alan C., Green, Adele C., Greinert, Rüdiger, Hauschild, Axel, Harwood, Catherine A., Hoorens, Isabelle, Kandolf, Lidija, Kaufmann, Roland, Kelleners-Smeets, Nicole, Lallas, Aimilios, Lebbé, Celeste, Leiter, Ulrike, Lim, Henry W., Longo, Caterina, Malvehy, Joseph, Moreno, David, Pellacani, Giovanni, Peris, Ketty, Robert, Caroline, Saiag, Philippe, Schadendorf, Dirk, Peter Soyer, H., Stockfleth, Eggert, Stratigos, Alex, Uhara, Hisashi, Vieira, Ricardo, Volkmer, Beate, Weinstock, Martin A., Whitaker, Dagmar, Zalaudek, Iris, Whiteman, David C., and Brochez, Lieve

Published
2024
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6. Efficacy and safety of ‘Second Adjuvant’ therapy with BRAF/MEK inhibitors after local therapy for recurrent melanoma following adjuvant PD-1 based immunotherapy

Author

Taylor, Amelia M., McKeown, Janet, Dimitriou, Florentia, Jacques, Sarah K., Zimmer, Lisa, Allayous, Clara, Yeoh, Hui-Ling, Haydon, Andrew, Ressler, Julia M., Galea, Claire, Woodford, Rachel, Kahler, Katharina, Hauschild, Axel, Festino, Lucia, Hoeller, Christoph, Schwarze, Julia K., Neyns, Bart, Wicky, Alexandre, Michielin, Olivier, Placzke, Joanna, Rutkowski, Piotr, Johnson, Douglas B., Lebbe, Celeste, Dummer, Reinhard, Ascierto, Paolo A., Lo, Serigne, Long, Georgina V., Carlino, Matteo S., and Menzies, Alexander M.

Published
2024
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7. Outcomes of patients with resected stage III/IV acral or mucosal melanoma, treated with adjuvant anti-PD-1 based therapy

Author

Jacques, Sarah K., McKeown, Janet, Grover, Piyush, Johnson, Douglas B., Zaremba, Anne, Dimitriou, Florentia, Weiser, Roi, Farid, Mohamad, Namikawa, Kenjiro, Sullivan, Ryan J., Rutkowski, Piotr, Lebbe, Celeste, Hamid, Omid, Zager, Jonathan S., Michielin, Olivier, Neyns, Bart, Nakamura, Yasuhiro, Robert, Caroline, Mehnert, Janice, Ascierto, Paolo A., Bhave, Prachi, Park, Benjamin, Zimmer, Lisa, Mangana, Joanna, Mooradian, Megan, Placzke, Joanna, Allayous, Clare, Glitza Oliva, Isabella C., Mehmi, Inderjit, Depalo, Danielle, Wicky, Alexandre, Schwarze, Julia K., Roy, Severine, Boatwright, Christina, Vanella, Vito, Long, Georgina V., Menzies, Alexander M., Lo, Serigne N., and Carlino, Matteo S.

Published
2024
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8. The side effect registry immuno-oncology (SERIO) – A tool for systematic analysis of immunotherapy-induced side effects

Author

Ertl, Carolin, Ruf, Theresa, Mentzer, Dirk, Kong, Mingzi, Kramer, Rafaela, Bergwelt-Baildon, Michael von, Subklewe, Marion, Tomsitz, Dirk, Ascierto, Paolo A., Dummer, Reinhard, Gogas, Helen, Lebbé, Celeste, Long, Georgina V., McArthur, Grant, Neilan, Tomas G., Ribas, Antoni, Robert, Caroline, Schadendorf, Dirk, Zimmer, Lisa, Eigentler, Thomas, Grabbe, Stephan, Forschner, Andrea, Kähler, Katharina C., Milani, Valeria, Pföhler, Claudia, Hassel, Jessica, Gutzmer, Ralf, Loquai, Carmen, Routy, Bertrand, Furness, Andrew J.S., Blank, Christian, Wolchok, Jedd D., French, Lars E., Hauschild, Axel, and Heinzerling, Lucie

Published
2024
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9. The features and management of acquired resistance to PD1-based therapy in metastatic melanoma

Author

Hepner, Adriana, Versluis, Judith M., Wallace, Roslyn, Allayous, Clara, Brown, Lauren Julia, Trojaniello, Claudia, Gerard, Camille Lea, Jansen, Yanina JL, Bhave, Prachi, Neyns, Bart, Haydon, Andrew, Michielin, Olivier, Mangana, Joanna, Klein, Oliver, Shoushtari, Alexander N., Warner, Allison Betof, Ascierto, Paolo Antonio, McQuade, Jennifer Leigh, Carlino, Matteo S., Zimmer, Lisa, Lebbe, Celeste, Johnson, Douglas B., Sandhu, Shahneen, Atkinson, Victoria, Blank, Christian U., Lo, Serigne N., Long, Georgina V., and Menzies, Alexander M.

Published
2024
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10. European consensus-based interdisciplinary guideline for invasive cutaneous squamous cell carcinoma: Part 2. Treatment–Update 2023

Author

Stratigos, Alexander J., Garbe, Claus, Dessinioti, Clio, Lebbe, Celeste, van Akkooi, Alexander, Bataille, Veronique, Bastholt, Lars, Dreno, Brigitte, Dummer, Reinhard, Fargnoli, Maria Concetta, Forsea, Ana Maria, Harwood, Catherine A., Hauschild, Axel, Hoeller, Christoph, Kandolf-Sekulovic, Lidija, Kaufmann, Roland, Kelleners-Smeets, Nicole WJ, Lallas, Aimilios, Leiter, Ulrike, Malvehy, Josep, del Marmol, Veronique, Moreno-Ramirez, David, Pellacani, Giovanni, Peris, Ketty, Saiag, Philippe, Tagliaferri, Luca, Trakatelli, Myrto, Ioannides, Dimitrios, Vieira, Ricardo, Zalaudek, Iris, Arenberger, Petr, Eggermont, Alexander M.M., Röcken, Martin, Grob, Jean-Jacques, and Lorigan, Paul

Published
2023
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12. European consensus-based interdisciplinary guideline for invasive cutaneous squamous cell carcinoma. Part 1: Diagnostics and prevention–Update 2023

Author

Stratigos, Alexander J., Garbe, Claus, Dessinioti, Clio, Lebbe, Celeste, van Akkooi, Alexander, Bataille, Veronique, Bastholt, Lars, Dreno, Brigitte, Dummer, Reinhard, Fargnoli, Maria Concetta, Forsea, Ana Maria, Harwood, Catherine A., Hauschild, Axel, Hoeller, Christoph, Kandolf-Sekulovic, Lidija, Kaufmann, Roland, Kelleners-Smeets, Nicole WJ, Lallas, Aimilios, Leiter, Ulrike, Malvehy, Josep, del Marmol, Veronique, Moreno-Ramirez, David, Pellacani, Giovanni, Peris, Ketty, Saiag, Philippe, Tagliaferri, Luca, Trakatelli, Myrto, Ioannides, Dimitrios, Vieira, Ricardo, Zalaudek, Iris, Arenberger, Petr, Eggermont, Alexander M.M., Röcken, Martin, Grob, Jean-Jacques, and Lorigan, Paul

Published
2023
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15. Characteristics of circulating KSHV-infected viroblasts during active KSHV+ multicentric Castleman disease

Author

Martin de Frémont, Gregoire, Vanjak, Anthony, Sbihi, Zineb, Knapp, Silene, Garzaro, Margaux, Chbihi, Marwa, Fournier, Benjamin, Poirot, Justine, Dossier, Antoine, Silvestrini, Marc-Antoine, Villemonteix, Juliette, Meignin, Véronique, Galicier, Lionel, Bertinchamp, Rémi, Le Goff, Jerome, Salmona, Maud, Flamarion, Edouard, Cassius, Charles, Lebbé, Celeste, Ronchetti, Anne Marie, Latour, Sylvain, Oksenhendler, Eric, Carcelain, Guislaine, and Boutboul, David

Published
2023
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17. Immune-related generalised oedema – A new category of adverse events with immune checkpoint inhibitors

Author

Velev, Maud, Baroudjian, Barouyr, Pruvost, Roxane, De Martin, Eleonora, Laparra, Ariane, Babai, Samy, Teysseire, Sandra, Danlos, François-Xavier, Albiges, Laurence, Bernigaud, Charlotte, Benderra, Marc-Antoine, Pradère, Pauline, Zaidan, Mohamad, Decroisette, Chantal, Fallah, Fatma, Matergia, Gaelle, Lavaud, Pernelle, Jantzem, Hélène, Atzenhoffer, Marina, Buyse, Véronique, Ammari, Samy, Robert, Caroline, Champiat, Stéphane, Messayke, Sabine, Marabelle, Aurélien, Guettier, Catherine, Lebbe, Céleste, Lambotte, Olivier, and Michot, Jean-Marie

Published
2023
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18. CLAUDIUS Study: Risk of materno-fetal transmission of melanoma cells in pregnant women with high grade melanoma – A retrospective multicenter study and literature review

Author

Wiedemann, Svenja Vanessa, Müller, Verena, Toth, Bettina, Erdmann, Michael, Bühler, Bodo, Dugas-Breit, Susanne, Schatton, Kerstin, Reinhardt, Lydia, Meissner, Markus, Mickler, Marion, Pföhler, Claudia, Weishaupt, Carsten, Herbst, Rudolf, Debus, Dirk, Susok, Laura, Tietze, Julia Katharina, Welzel, Julia, Arnold, Andreas, Dabrowski, Evelyn, Forschner, Andrea, Goetze, Steven, Hayani, Kinan, Lebbe, Céleste, Löhr, Florian, Mengoni, Miriam, Hermes, Barbara, Peitsch, Wiebke Katharina, Poch, Gabriela, Sachse, Michael Max, Sindrilaru, Anca, Wenk, Saskia, Ziemer, Mirjana, Kaune, Kjell, Meier-Naust, Lisette, Nikolakis, Georgios, Oberndörfer, Florian, Wesselmann, Ulrich, Utikal, Jochen Sven, and Gaiser, Maria Rita

Published
2023
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20. Safety and efficacy of nivolumab, an anti-PD1 immunotherapy, in patients with advanced basal cell carcinoma, after failure or intolerance to sonic Hedgehog inhibitors: UNICANCER AcSé NIVOLUMAB trial

Author

Véron, Marie, Chevret, Sylvie, Grob, Jean-Jacques, Beylot-Barry, Marie, Saiag, Philippe, Fléchon, Aude, You, Benoit, Maubec, Eve, Jouary, Thomas, Toulemonde, Elise, Jamme, Philippe, Gambotti, Laëtitia, Lamrani-Ghaouti, Assia, Dupuy, Alain, Lebbe, Céleste, Seguin, Nicole Basset, Houede, Nadine, Leccia, Marie-Thérèse, Le Du, Fanny, de Pontville, Michel, Gaudy-Marquestre, Caroline, Guillot, Bernard, Simon, Clotilde, Marabelle, Aurélien, and Mortier, Laurent

Published
2022
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22. Randomized, Open-Label Phase II Study Evaluating the Efficacy and Safety of Talimogene Laherparepvec in Combination With Ipilimumab Versus Ipilimumab Alone in Patients With Advanced, Unresectable Melanoma

Author

Chesney, Jason, Puzanov, Igor, Collichio, Frances, Singh, Parminder, Milhem, Mohammed M, Glaspy, John, Hamid, Omid, Ross, Merrick, Friedlander, Philip, Garbe, Claus, Logan, Theodore F, Hauschild, Axel, Lebbé, Celeste, Chen, Lisa, Kim, Jenny J, Gansert, Jennifer, Andtbacka, Robert HI, and Kaufman, Howard L

Subjects
Clinical Research, Cancer, Clinical Trials and Supportive Activities, Genetics, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Biological Products, Female, Herpesvirus 1, Human, Humans, Ipilimumab, Male, Melanoma, Middle Aged, Neoplasm Staging, Progression-Free Survival, Proto-Oncogene Proteins B-raf, Skin Neoplasms, Young Adult, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

Purpose We evaluated the combination of talimogene laherparepvec plus ipilimumab versus ipilimumab alone in patients with advanced melanoma in a phase II study. To our knowledge, this was the first randomized trial to evaluate addition of an oncolytic virus to a checkpoint inhibitor. Methods Patients with unresectable stages IIIB to IV melanoma, with no more than one prior therapy if BRAF wild-type, no more than two prior therapies if BRAF mutant, measurable/injectable disease, and without symptomatic autoimmunity or clinically significant immunosuppression were randomly assigned 1:1 to receive talimogene laherparepvec plus ipilimumab or ipilimumab alone. Talimogene laherparepvec treatment began in week 1 (first dose, ≤ 4 mL × 106 plaque-forming units/mL; after 3 weeks, ≤ 4 mL × 108 plaque-forming units/mL every 2 weeks). Ipilimumab (3 mg/kg every 3 weeks; up to four doses) began week 1 in the ipilimumab alone arm and week 6 in the combination arm. The primary end point was objective response rate evaluated by investigators per immune-related response criteria. Results One hundred ninety-eight patients were randomly assigned to talimogene laherparepvec plus ipilimumab (n = 98), or ipilimumab alone (n = 100). Thirty-eight patients (39%) in the combination arm and 18 patients (18%) in the ipilimumab arm had an objective response (odds ratio, 2.9; 95% CI, 1.5 to 5.5; P = .002). Responses were not limited to injected lesions; visceral lesion decreases were observed in 52% of patients in the combination arm and 23% of patients in the ipilimumab arm. Frequently occurring adverse events (AEs) included fatigue (combination, 59%; ipilimumab alone, 42%), chills (combination, 53%; ipilimumab alone, 3%), and diarrhea (combination, 42%; ipilimumab alone, 35%). Incidence of grade ≥ 3 AEs was 45% and 35%, respectively. Three patients in the combination arm had fatal AEs; none were treatment related. Conclusion The study met its primary end point; the objective response rate was significantly higher with talimogene laherparepvec plus ipilimumab versus ipilimumab alone. These data indicate that the combination has greater antitumor activity without additional safety concerns versus ipilimumab.

Published
2018

24. Efficacy, safety and factors associated with disease progression in patients with unresectable (stage III) or distant metastatic (stage IV) BRAF V600-mutant melanoma: An open label, non-randomized, phase IIIb study of trametinib in combination with dabrafenib

Author

Saiag, Philippe, Robert, Caroline, Grob, Jean-Jacques, Mortier, Laurent, Dereure, Olivier, Lebbe, Céleste, Mansard, Sandrine, Grange, Florent, Neidhardt, Eve-Marie, Lesimple, Thierry, Machet, Laurent, Bedane, Christophe, Maillard, Hervé, Dalac-Rat, Sophie, Nardin, Charlée, Szenik, Alexandra, Denden, Amine, and Dutriaux, Caroline

Published
2021
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26. Ipilimumab alone or ipilimumab plus anti-PD-1 therapy in patients with metastatic melanoma resistant to anti-PD-(L)1 monotherapy: a multicentre, retrospective, cohort study

Author

Pires da Silva, Ines, Ahmed, Tasnia, Reijers, Irene L M, Weppler, Alison M, Betof Warner, Allison, Patrinely, James Randall, Serra-Bellver, Patricio, Allayous, Clara, Mangana, Joanna, Nguyen, Khang, Zimmer, Lisa, Trojaniello, Claudia, Stout, Dan, Lyle, Megan, Klein, Oliver, Gerard, Camille L, Michielin, Olivier, Haydon, Andrew, Ascierto, Paolo A, Carlino, Matteo S, Lebbe, Celeste, Lorigan, Paul, Johnson, Douglas B, Sandhu, Shahneen, Lo, Serigne N, Blank, Christian U, Menzies, Alexander M, and Long, Georgina V

Published
2021
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27. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial

Author

Lesimple, Thierry, Maio, Michele, Linette, Gerald, Mortier, Laurent, Svane, Inge Marie, Schachter, Jacob, Brown, Michael, Hersey, Peter, Barrow, Catherine, Kudchadkar, Ragini, Dutriaux, Caroline, Song, Xinni, Quaglino, Pietro, Queirolo, Paola, Meier, Friedegund, Stroyakovskiy, Daniil, Guillot, Bernard, Romero, Pablo Luis Ortiz, Bastholt, Lars, Garbe, Claus, Grange, Florent, Mohr, Peter, Algazi, Alain, Bechter, Oliver, Hernberg, Micaela, Loquai, Carmen, Meiss, Frank, Chiarion Sileni, Vanna, Bar-Sela, Gil, Fitzharris, Bernard, Saiag, Philippe, Arnault, Jean-Philippe, Simon, Jan-Christoph, Stephens, Rosalie, Baurain, Jean-Francois, Lebbe, Célèste, Combemale, Patrick, Dummer, Reinhard, Hauschild, Axel, Parente, Phillip, Yamazaki, Naoya, Milhem, Mohammed, Leccia, Marie-Thérèse, Geoffrois, Lionel, Kretschmer, Lutz, Dunwoodie, Elaine, Walker, John, Lotem, Michal, Hendler, Daniel, Mackiewicz, Andrzej, Sekulovic, Lidija, Dzienis, Marcin, Hospers, Geke A.P., Siano, Marco, Hassel, Jessica, Corrie, Philippa, Passos, Maria-Jose, Levin, Max, Hoeller, Christoph, Machet, Laurent, Hallmeyer, Sigrun, Waterston, Ashita, Descamps, Vincent, Kiecker, Felix, Aarts, Maureen, Schmidt, Henrik, Raimundo, Ana, Nyakas, Marta, Lacour, Jean-Philippe, Berking, Carola, Ferrucci, Pier Francesco, Jameson, Michael, Kim, Kevin, Yokota, Kenji, Kerger, Joseph, Aubin, François, Groenewegen, Gerard, Kapiteijn, Helena, Boehncke, Wolf-Henning, Utikal, Jochen, Casasola, Richard, Marshall, Ernest, Ferraresi, Virginia, Richtig, Erika, Matkovic, Suzana, Inozume, Takashi, Crook, Timothy, McNeil, Catriona, Kiyohara, Yoshio, Avril, Marie-Francoise, Hein, Rüdiger, Terheyden, Patrick, Nathan, Paul, Aoi, Jun, Skytta, Tanja, Jouary, Thomas, Takenouchi, Tatsuya, Straume, Oddbjorn, Martins, César, Mukhametshina, Guzel, Bottomley, Andrew, Coens, Corneel, Mierzynska, Justyna, Blank, Christian U, Mandalà, Mario, Long, Georgina V, Atkinson, Victoria G, Dalle, Stéphane, Haydon, Andrew M, Meshcheryakov, Andrey, Khattak, Adnan, Carlino, Matteo S, Sandhu, Shahneen, Puig, Susana, Ascierto, Paolo A, Larkin, James, Lorigan, Paul C, Rutkowski, Piotr, Schadendorf, Dirk, Koornstra, Rutger, Hernandez-Aya, Leonel, Di Giacomo, Anna Maria, van den Eertwegh, Alfonsus J M, Grob, Jean-Jacques, Gutzmer, Ralf, Jamal, Rahima, van Akkooi, Alexander C J, Krepler, Clemens, Ibrahim, Nageatte, Marreaud, Sandrine, Kicinski, Michal, Suciu, Stefan, Robert, Caroline, and Eggermont, Alexander M M

Published
2021
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28. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): distant metastasis-free survival results from a double-blind, randomised, controlled, phase 3 trial

Author

Menzies, Alex, Lesimple, Thierry, Maio, Michele, Linette, Gerald, Brown, Michael, Hersey, Peter, Svane, Inge Marie, Mortier, Laurent, Schachter, Jacob, Barrow, Catherine, Kudchadkar, Ragini, Song, Xinni, Dutriaux, Caroline, Quaglino, Pietro, Meier, Friedegund, Queirolo, Paola, Stroyakovskiy, Daniil, Bastholt, Lars, Guillot, Bernard, Garbe, Claus, Ortiz Romero, Pablo Luis, Grange, Florent, Mohr, Peter, Algazi, Alain, Bechter, Oliver, Hernberg, Micaela, Arnault, Jean-Philippe, Saiag, Philippe, Loquai, Carmen, Meiss, Frank, Simon, Jan-Christoph, Bar-Sela, Gil, Chiarion Sileni, Vanna, Fitzharris, Bernard, McCrystal, Mike, Parente, Phillip, Baurain, Jean-Francois, Combemale, Patrick, Lebbe, Célèste, Hauschild, Axel, Yamazaki, Naoya, Dummer, Reinhard, Milhem, Mohammed, Dzienis, Marcin, Walker, John, Geoffrois, Lionel, Leccia, Marie-Thérèse, Kretschmer, Lutz, Hendler, Daniel, Lotem, Michal, Mackiewicz, Andrzej, Sekulovic, Lidija, Dunwoodie, Elaine, Hoeller, Christoph, Machet, Laurent, Hassel, Jessica, Hospers, Geke A.P., Passos, Maria-Jose, Levin, Max, Fehr, Martin, Corrie, Philippa, Waterston, Ashita, Hallmeyer, Sigrun, Schmidt, Henrik, Descamps, Vincent, Lacour, Jean-Philippe, Berking, Carola, Kiecker, Felix, Ferrucci, Pier Francesco, Yokota, Kenji, Aarts, Maureen, Jameson, Michael, Winge-Main, Anna Katharina, Ferreira, Paula, Kim, Kevin, McNeil, Catriona, Hofmann-Wellenhof, Reiner, Kerger, Joseph, Aubin, François, Utikal, Jochen, Ferraresi, Virginia, Inozume, Takashi, Kiyohara, Yoshio, Groenewegen, Gerard, Kapiteijn, Helena, Matkovic, Suzana, Boehncke, Wolf-Henning, Casasola, Richard, Crook, Timothy, Marshall, Ernest, Skytta, Tanja, Avril, Marie-Francoise, Jouary, Thomas, Hein, Rüdiger, Terheyden, Patrick, Aoi, Jun, Takenouchi, Tatsuya, Straume, Oddbjorn, Martins, César, Mukhametshina, Guzel, Nathan, Paul, Eggermont, Alexander M M, Blank, Christian U, Mandalà, Mario, Long, Georgina V, Atkinson, Victoria G, Dalle, Stéphane, Haydon, Andrew M, Meshcheryakov, Andrey, Khattak, Adnan, Carlino, Matteo S, Sandhu, Shahneen, Larkin, James, Puig, Susana, Ascierto, Paolo A, Rutkowski, Piotr, Schadendorf, Dirk, Koornstra, Rutger, Hernandez-Aya, Leonel, Di Giacomo, Anna Maria, van den Eertwegh, Alfonsus J M, Grob, Jean-Jacques, Gutzmer, Ralf, Jamal, Rahima, Lorigan, Paul C, van Akkooi, Alexander C J, Krepler, Clemens, Ibrahim, Nageatte, Marreaud, Sandrine, Kicinski, Michal, Suciu, Stefan, and Robert, Caroline

Published
2021
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30. Combined PD-1, BRAF and MEK inhibition in advanced BRAF-mutant melanoma: safety run-in and biomarker cohorts of COMBI-i

Author

Dummer, Reinhard, Lebbé, Celeste, Atkinson, Victoria, Mandalà, Mario, Nathan, Paul D., Arance, Ana, and Richtig, Erika

Subjects
Mutation (Biology) -- Health aspects, Immunotherapy -- Methods, Melanoma -- Genetic aspects -- Care and treatment, Biological sciences, Health
Abstract

Immune and targeted therapies achieve long-term survival in metastatic melanoma; however, new treatment strategies are needed to improve patients' outcomes.sup.1,2. We report on the efficacy, safety and biomarker analysis from the single-arm safety run-in (part 1; n = 9) and biomarker (part 2; n = 27) cohorts of the randomized, placebo-controlled, phase 3 COMBI-i trial ((https://clinicaltrials.gov/ct2/show/NCT02967692)) of the anti-PD-1 antibody spartalizumab, in combination with the BRAF inhibitor dabrafenib and MEK inhibitor trametinib. Patients (n = 36) had previously untreated BRAF V600-mutant unresectable or metastatic melanoma. In part 1, the recommended phase 3 regimen was identified based on the incidence of dose-limiting toxicities (DLTs; primary endpoint): 400 mg of spartalizumab every 4 weeks plus 150 mg of dabrafenib twice daily plus 2 mg of trametinib once daily. Part 2 characterized changes in PD-L1 levels and CD8.sup.+ cells following treatment (primary endpoint), and analyzed additional biomarkers. Assessments of efficacy and safety were key secondary endpoints (median follow-up, 24.3 months). Spartalizumab plus dabrafenib and trametinib led to an objective response rate (ORR) of 78%, including 44% complete responses (CRs). Grade [greater than or equal to]3 treatment-related adverse events (TRAEs) were experienced by 72% of patients. All patients had temporary dose modifications, and 17% permanently discontinued all three study drugs due to TRAEs. Early progression-free survival (PFS) events were associated with low tumor mutational burden/T cell-inflamed gene expression signature (GES) or high immunosuppressive tumor microenvironment (TME) GES levels at baseline; an immunosuppressive TME may also preclude CR. Overall, the efficacy, safety and on-treatment biomarker modulations associated with spartalizumab plus dabrafenib and trametinib are promising, and biomarkers that may predict long-term benefit were identified. Clinical activity and biomarker analysis from the COMBI-i trial evaluating PD-1, BRAF and MEK inhibition in patients with metastatic melanoma demonstrate high response rates and uncover molecular correlates of long-term treatment benefit., Author(s): Reinhard Dummer [sup.1] , Celeste Lebbé [sup.2] , Victoria Atkinson [sup.3] , Mario Mandalà [sup.4] , Paul D. Nathan [sup.5] , Ana Arance [sup.6] , Erika Richtig [sup.7] , [...]

Published
2020
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32. Pazopanib or methotrexate–vinblastine combination chemotherapy in adult patients with progressive desmoid tumours (DESMOPAZ): a non-comparative, randomised, open-label, multicentre, phase 2 study

Author

Toulmonde, Maud, Pulido, Marina, Ray-Coquard, Isabelle, Andre, Thierry, Isambert, Nicolas, Chevreau, Christine, Penel, Nicolas, Bompas, Emmanuelle, Saada, Esma, Bertucci, François, Lebbe, Celeste, Le Cesne, Axel, Soulie, Patrick, Piperno-Neumann, Sophie, Sweet, Stephen, Cecchi, Fabiola, Hembrough, Todd, Bellera, Carine, Kind, Michèle, Crombe, Amandine, Lucchesi, Carlo, Le Loarer, François, Blay, Jean-Yves, and Italiano, Antoine

Published
2019
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33. Neoadjuvant systemic therapy in melanoma: recommendations of the International Neoadjuvant Melanoma Consortium

Author

Andrews, Miles C, Berry, Donald A, Block, Matthew S, Boland, Genevieve M, Bollin, Kathryn B, Carlino, Matteo S, Carvajal, Richard D, Cohen, Jonathan, Davar, Diwakar, Delman, Keith A, Dummer, Reinhard, Farwell, Michael D, Fisher, David E, Fusi, Alberto, Glitza, Isabella C, de Gruijl, Tanja D, Gyorki, David E, Hauschild, Axel, Hieken, Tina J, Larkin, James, Lawson, David H, Lebbe, Celeste, Lee, Jeffrey E, Lowe, Michael C, Luke, Jason J, McArthur, Grant A, McDermott, David F, McQuade, Jennifer L, Mitchell, Tara C, Petrella, Teresa M, Prieto, Peter A, Puzanov, Igor, Robert, Caroline, Salama, April K, Sandhu, Shaneen, Schadendorf, Dirk, Shoushtari, Alexander N, Sosman, Jeffrey A, Swetter, Susan M, Tanabe, Ken K, Turajlic, Samra, Tyler, Douglas S, Woodman, Scott E, Wright, Frances C, Zager, Jonathan S, Amaria, Rodabe N, Menzies, Alexander M, Burton, Elizabeth M, Scolyer, Richard A, Tetzlaff, Michael T, Antdbacka, Robert, Ariyan, Charlotte, Bassett, Roland, Carter, Brett, Daud, Adil, Faries, Mark, Fecher, Leslie A, Flaherty, Keith T, Gershenwald, Jeffrey E, Hamid, Omid, Hong, Angela, Kirkwood, John M, Lo, Serigne, Margolin, Kim, Messina, Jane, Postow, Michael A, Rizos, Helen, Ross, Merrick I, Rozeman, Elisa A, Saw, Robyn P M, Sondak, Vernon, Sullivan, Ryan J, Taube, Janis M, Thompson, John F, van de Wiel, Bart A, Eggermont, Alexander M, Davies, Michael A, Ascierto, Paolo A, Spillane, Andrew J, van Akkooi, Alexander C J, Wargo, Jennifer A, Blank, Christian U, Tawbi, Hussein A, and Long, Georgina V

Published
2019
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35. Safety and efficacy of vemurafenib in BRAF V600E and BRAF V600K mutation-positive melanoma (BRIM-3): extended follow-up of a phase 3, randomised, open-label study

Author

McArthur, Grant A, Chapman, Paul B, Robert, Caroline, Larkin, James, Haanen, John B, Dummer, Reinhard, Ribas, Antoni, Hogg, David, Hamid, Omid, Ascierto, Paolo A, Garbe, Claus, Testori, Alessandro, Maio, Michele, Lorigan, Paul, Lebbé, Celeste, Jouary, Thomas, Schadendorf, Dirk, O'Day, Stephen J, Kirkwood, John M, Eggermont, Alexander M, Dréno, Brigitte, Sosman, Jeffrey A, Flaherty, Keith T, Yin, Ming, Caro, Ivor, Cheng, Suzanne, Trunzer, Kerstin, and Hauschild, Axel

Subjects
Genetics, Cancer, Clinical Trials and Supportive Activities, Clinical Research, Prevention, Good Health and Well Being, Adult, Aged, Dacarbazine, Disease-Free Survival, Female, Follow-Up Studies, Humans, Indoles, Male, Melanoma, Middle Aged, Mutation, Protein Kinase Inhibitors, Proto-Oncogene Proteins B-raf, Sulfonamides, Vemurafenib, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundIn the BRIM-3 trial, vemurafenib was associated with risk reduction versus dacarbazine of both death and progression in patients with advanced BRAF(V600) mutation-positive melanoma. We present an extended follow-up analysis of the total population and in the BRAF(V600E) and BRAF(V600K) mutation subgroups.MethodsPatients older than 18 years, with treatment-naive metastatic melanoma and whose tumour tissue was positive for BRAF(V600) mutations were eligible. Patients also had to have a life expectancy of at least 3 months, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate haematological, hepatic, and renal function. Patients were randomly assigned by interactive voice recognition system to receive either vemurafenib (960 mg orally twice daily) or dacarbazine (1000 mg/m(2) of body surface area intravenously every 3 weeks). Coprimary endpoints were overall survival and progression-free survival, analysed in the intention-to-treat population (n=675), with data censored at crossover. A sensitivity analysis was done. This trial is registered with ClinicalTrials.gov, NCT01006980.Findings675 eligible patients were enrolled from 104 centres in 12 countries between Jan 4, 2010, and Dec 16, 2010. 337 patients were randomly assigned to receive vemurafenib and 338 to receive dacarbazine. Median follow-up was 12·5 months (IQR 7·7-16·0) on vemurafenib and 9·5 months (3·1-14·7) on dacarbazine. 83 (25%) of the 338 patients initially randomly assigned to dacarbazine crossed over from dacarbazine to vemurafenib. Median overall survival was significantly longer in the vemurafenib group than in the dacarbazine group (13·6 months [95% CI 12·0-15·2] vs 9·7 months [7·9-12·8]; hazard ratio [HR] 0·70 [95% CI 0·57-0·87]; p=0·0008), as was median progression-free survival (6·9 months [95% CI 6·1-7·0] vs 1·6 months [1·6-2·1]; HR 0·38 [95% CI 0·32-0·46]; p

Published
2014

36. PROM2 overexpression induces metastatic potential through epithelial‐to‐mesenchymal transition and ferroptosis resistance in human cancers.

Author

Paris, Justine, Wilhelm, Claire, Lebbé, Celeste, Elmallah, Mohammed, Pamoukdjian, Frédéric, Héraud, Audrey, Gapihan, Guillaume, Walle, Aurore Van De, Tran, Van Nhan, Hamdan, Diaddin, Allayous, Clara, Battistella, Maxime, Van Glabeke, Emmanuel, Lim, Kah Wai, Leboeuf, Christophe, Roger, Sébastien, Falgarone, Géraldine, Phan, Anh Tuan, and Bousquet, Guilhem

Subjects
EPITHELIAL-mesenchymal transition, TRIPLE-negative breast cancer, RENAL cell carcinoma, METASTASIS, GENETIC overexpression
Abstract

Introduction: Despite considerable therapeutic advances in the last 20 years, metastatic cancers remain a major cause of death. We previously identified prominin‐2 (PROM2) as a biomarker predictive of distant metastases and decreased survival, thus providing a promising bio‐target. In this translational study, we set out to decipher the biological roles of PROM2 during the metastatic process and resistance to cell death, in particular for metastatic melanoma. Methods and results: Methods and results: We demonstrated that PROM2 overexpression was closely linked to an increased metastatic potential through the increase of epithelial‐to‐mesenchymal transition (EMT) marker expression and ferroptosis resistance. This was also found in renal cell carcinoma and triple negative breast cancer patient‐derived xenograft models. Using an oligonucleotide anti‐sense anti‐PROM2, we efficaciously decreased PROM2 expression and prevented metastases in melanoma xenografts. We also demonstrated that PROM2 was implicated in an aggravation loop, contributing to increase the metastatic burden both in murine metastatic models and in patients with metastatic melanoma. The metastatic burden is closely linked to PROM2 expression through the expression of EMT markers and ferroptosis cell death resistance in a deterioration loop. Conclusion: Our results open the way for further studies using PROM2 as a bio‐target in resort situations in human metastatic melanoma and also in other cancer types. [ABSTRACT FROM AUTHOR]

Published
2024
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38. French dermatologists' opinions and practices with regard to adjuvant therapy in stage III melanoma

Author

Rolland, Marion, primary, Oger, Emmanuel, additional, Dinulescu, Monica, additional, Lesimple, Thierry, additional, Russo, David, additional, Pracht, Marc, additional, Porneuf, Marc, additional, Dalac, Sophie, additional, Giacchero, Damien, additional, Jouary, Thomas, additional, Lebbé, Celeste, additional, Leccia, Marie-Thérèse, additional, Maubec, Eve, additional, Meyer, Nicolas, additional, Mortier, Laurent, additional, and Dupuy, Alain, additional

Published
2023
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41. STAT3 Mediates Nilotinib Response in KIT-Altered Melanoma: A Phase II Multicenter Trial of the French Skin Cancer Network

Author

Delyon, Julie, Chevret, Sylvie, Jouary, Thomas, Dalac, Sophie, Dalle, Stephane, Guillot, Bernard, Arnault, Jean-Philippe, Avril, Marie-Françoise, Bedane, Christophe, Bens, Guido, Pham-Ledard, Anne, Mansard, Sandrine, Grange, Florent, Machet, Laurent, Meyer, Nicolas, Legoupil, Delphine, Saiag, Philippe, Idir, Zakia, Renault, Victor, Deleuze, Jean-François, Hindie, Elif, Battistella, Maxime, Dumaz, Nicolas, Mourah, Samia, and Lebbe, Celeste

Published
2018
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45. Talimogene laherparepvec in combination with ipilimumab versus ipilimumab alone for advanced melanoma: 5-year final analysis of a multicenter, randomized, open-label, phase II trial

Author

Chesney, Jason A, primary, Puzanov, Igor, additional, Collichio, Frances A, additional, Singh, Parminder, additional, Milhem, Mohammed M, additional, Glaspy, John, additional, Hamid, Omid, additional, Ross, Merrick, additional, Friedlander, Philip, additional, Garbe, Claus, additional, Logan, Theodore, additional, Hauschild, Axel, additional, Lebbé, Celeste, additional, Joshi, Harshada, additional, Snyder, Wendy, additional, and Mehnert, Janice M, additional

Published
2023
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46. Three-year pooled analysis of factors associated with clinical outcomes across dabrafenib and trametinib combination therapy phase 3 randomised trials

Author

Schadendorf, Dirk, Long, Georgina V., Stroiakovski, Daniil, Karaszewska, Boguslawa, Hauschild, Axel, Levchenko, Evgeny, Chiarion-Sileni, Vanna, Schachter, Jacob, Garbe, Claus, Dutriaux, Caroline, Gogas, Helen, Mandalà, Mario, Haanen, John B.A.G., Lebbé, Céleste, Mackiewicz, Andrzej, Rutkowski, Piotr, Grob, Jean-Jacques, Nathan, Paul, Ribas, Antoni, Davies, Michael A., Zhang, Ying, Kaper, Mathilde, Mookerjee, Bijoyesh, Legos, Jeffrey J., Flaherty, Keith T., and Robert, Caroline

Published
2017
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47. Dabrafenib plus trametinib in patients with BRAFV600-mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial

Author

Davies, Michael A, Saiag, Philippe, Robert, Caroline, Grob, Jean-Jacques, Flaherty, Keith T, Arance, Ana, Chiarion-Sileni, Vanna, Thomas, Luc, Lesimple, Thierry, Mortier, Laurent, Moschos, Stergios J, Hogg, David, Márquez-Rodas, Iván, Del Vecchio, Michele, Lebbé, Céleste, Meyer, Nicolas, Zhang, Ying, Huang, Yingjie, Mookerjee, Bijoyesh, and Long, Georgina V

Published
2017
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48. Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial

Author

Ascierto, Paolo A, Del Vecchio, Michele, Robert, Caroline, Mackiewicz, Andrzej, Chiarion-Sileni, Vanna, Arance, Ana, Lebbé, Céleste, Bastholt, Lars, Hamid, Omid, Rutkowski, Piotr, McNeil, Catriona, Garbe, Claus, Loquai, Carmen, Dreno, Brigitte, Thomas, Luc, Grob, Jean-Jacques, Liszkay, Gabriella, Nyakas, Marta, Gutzmer, Ralf, Pikiel, Joanna, Grange, Florent, Hoeller, Christoph, Ferraresi, Virginia, Smylie, Michael, Schadendorf, Dirk, Mortier, Laurent, Svane, Inge Marie, Hennicken, Delphine, Qureshi, Anila, and Maio, Michele

Published
2017
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49. Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): secondary outcomes of a multinational, randomised, double-blind, phase 3 trial

Author

Coens, Corneel, Suciu, Stefan, Chiarion-Sileni, Vanna, Grob, Jean-Jacques, Dummer, Reinhard, Wolchok, Jedd D, Schmidt, Henrik, Hamid, Omid, Robert, Caroline, Ascierto, Paolo A, Richards, Jon M, Lebbé, Celeste, Ferraresi, Virginia, Smylie, Michael, Weber, Jeffrey S, Maio, Michele, Bottomley, Andrew, Kotapati, Srividya, de Pril, Veerle, Testori, Alessandro, and Eggermont, Alexander M M

Published
2017
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