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1. Pembrolizumab for the First-Line Treatment of Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma: Results from the Single-Arm, Open-Label, Phase III KEYNOTE-913 Study

Author

Mortier, Laurent, Villabona, Lisa, Lawrence, Ben, Arance, Ana, Butler, Marcus O., Beylot-Barry, Marie, Saiag, Philippe, Samimi, Mahtab, Ascierto, Paolo A., Spada, Francesca, De Pontville, Michel, Maio, Michele, Berrocal, Alfonso, Espinosa, Enrique, Capdevila, Jaume, Levin, Max, Das, Debasmita, Krepler, Clemens, Grebennik, Dmitri, and Chiarion-Sileni, Vanna

Published
2024
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2. Efficacy and Safety of the Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter Phase 3 Study

Author

Zager, Jonathan S., Orloff, Marlana, Ferrucci, Pier Francesco, Choi, Junsung, Eschelman, David J., Glazer, Evan S., Ejaz, Aslam, Howard, J. Harrison, Richtig, Erika, Ochsenreither, Sebastian, Reddy, Sunil A., Lowe, Michael C., Beasley, Georgia M., Gesierich, Anja, Bender, Armin, Gschnell, Martin, Dummer, Reinhard, Rivoire, Michel, Arance, Ana, Fenwick, Stephen William, Sacco, Joseph J., Haferkamp, Sebastian, Weishaupt, Carsten, John, Johnny, Wheater, Matthew, and Ottensmeier, Christian H.

Published
2024
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3. Correction: Efficacy and Safety of the Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter Phase 3 Study

Author

Zager, Jonathan S., Orloff, Marlana, Ferrucci, Pier Francesco, Choi, Junsung, Eschelman, David J., Glazer, Evan S., Ejaz, Aslam, Howard, J. Harrison, Richtig, Erika, Ochsenreither, Sebastian, Reddy, Sunil A., Lowe, Michael C., Beasley, Georgia M., Gesierich, Anja, Bender, Armin, Gschnell, Martin, Dummer, Reinhard, Rivoire, Michel, Arance, Ana, Fenwick, Stephen William, Sacco, Joseph J., Haferkamp, Sebastian, Weishaupt, Carsten, John, Johnny, Wheater, Matthew, and Ottensmeier, Christian H.

Published
2024
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4. Sequential immunotherapy and targeted therapy for metastatic BRAF V600 mutated melanoma: 4-year survival and biomarkers evaluation from the phase II SECOMBIT trial

Author

Ascierto, Paolo A., Casula, Milena, Bulgarelli, Jenny, Pisano, Marina, Piccinini, Claudia, Piccin, Luisa, Cossu, Antonio, Mandalà, Mario, Ferrucci, Pier Francesco, Guidoboni, Massimo, Rutkowski, Piotr, Ferraresi, Virginia, Arance, Ana, Guida, Michele, Maiello, Evaristo, Gogas, Helen, Richtig, Erika, Fierro, Maria Teresa, Lebbe, Celeste, Helgadottir, Hildur, Queirolo, Paola, Spagnolo, Francesco, Tucci, Marco, Del Vecchio, Michele, Cao, Maria Gonzales, Minisini, Alessandro Marco, De Placido, Sabino, Sanmamed, Miguel F., Mallardo, Domenico, Paone, Miriam, Vitale, Maria Grazia, Melero, Ignacio, Grimaldi, Antonio M., Giannarelli, Diana, Dummer, Reinhard, Sileni, Vanna Chiarion, and Palmieri, Giuseppe

Published
2024
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5. ASO Visual Abstract: Efficacy and Safety of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter, Phase 3 Study

Author

Zager, Jonathan S., Orloff, Marlana, Ferrucci, Pier Francesco, Choi, Junsung, Eschelman, David J., Glazer, Evan S., Ejaz, Aslam, Howard, J. Harrison, Richtig, Erika, Ochsenreither, Sebastian, Reddy, Sunil A., Lowe, Michael C., Beasley, Georgia M., Gesierich, Anja, Bender, Armin, Gschnell, Martin, Dummer, Reinhard, Rivoire, Michel, Arance, Ana, Fenwick, Stephen William, Sacco, Joseph J., Haferkamp, Sebastian, Weishaupt, Carsten, John, Johnny, Wheater, Matthew, and Ottensmeier, Christian H.

Published
2024
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6. Health-Related Quality of Life with Pembrolizumab in Patients with Locally Advanced or Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: KEYNOTE-629

Author

Bratland, Åse, Munoz-Couselo, Eva, Mortier, Laurent, Roshdy, Osama, González, Rene, Schachter, Jacob, Arance, Ana M., Grange, Florent, Meyer, Nicolas, Joshi, Abhishek Jagdish, Billan, Salem, Hughes, Brett G. M., Grob, Jean-Jacques, Ramakrishnan, Karthik, Ge, Joy, Gumuscu, Burak, Swaby, Ramona F., and Gutzmer, Ralf

Published
2023
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7. Nature and management of melanoma recurrences following adjuvant anti-PD-1 based therapy

Author

Woodford, Rachel, McKeown, Janet, Hoeijmakers, Lotte L., Mangana, Johanna, Dimitriou, Florentia, Allayous, Clara, Zaman, Farzana, Aya, Francisco, Marsiglio, John, Goodman, Rachel, Rayson, Victoria, Placzke, Joanna, Kessels, Jolien, Ramalyte, Egle, Haque, Waqas, Wilson, Isabella, Trojaniello, Claudia, Benannoune, Naima, Roberts-Thomson, Rachel, Robert, Caroline, Blank, Christian U., Dummer, Reinhard, Lebbe, Celeste, Haydon, Andrew, Arance, Ana, Hu-Lieskovan, Siwen, Johnson, Douglas B., Mcarthur, Grant A., Rutkowski, Piotr, Neyns, Bart, Sullivan, Ryan J., Weber, Jeffrey, Carlino, Matteo S., Ascierto, Paolo A., Lo, Serigne, Long, Georgina V., and Menzies, Alexander M.

Published
2024
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8. Anti-PD-1 alone or in combination with anti-CTLA-4 for advanced melanoma patients with liver metastases

Author

Pires da Silva, Ines, Li, Isabel, Ugurel, Selma, Serra-Bellver, Patricio, Andhale, Avanti, Burnette, Hannah, Aya, Francisco, Conway, Jordan W., Braden, Jorja, Carlino, Matteo S., Menzies, Alexander M., Weichenthal, Michael, Mohr, Peter, Gutzmer, Ralf, Arance, Ana M., Johnson, Douglas B., Lorigan, Paul, Schadendorf, Dirk, Lo, Serigne N., and Long, Georgina V.

Published
2024
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9. COLUMBUS 7-year update: A randomized, open-label, phase III trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF V600E/K-mutant melanoma

Author

Schadendorf, Dirk, Dummer, Reinhard, Flaherty, Keith T., Robert, Caroline, Arance, Ana, de Groot, Jan Willem B., Garbe, Claus, Gogas, Helen J., Gutzmer, Ralf, Krajsová, Ivana, Liszkay, Gabriella, Loquai, Carmen, Mandalà, Mario, Yamazaki, Naoya, Queirolo, Paola, Guenzel, Carolin, Polli, Anna, Thakur, Mahgull, di Pietro, Alessandra, and Ascierto, Paolo A.

Published
2024
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10. Randomized Phase III Trial Evaluating Spartalizumab Plus Dabrafenib and Trametinib for BRAF V600–Mutant Unresectable or Metastatic Melanoma

Author

Dummer, Reinhard, Long, Georgina V, Robert, Caroline, Tawbi, Hussein A, Flaherty, Keith T, Ascierto, Paolo A, Nathan, Paul D, Rutkowski, Piotr, Leonov, Oleg, Dutriaux, Caroline, Mandalà, Mario, Lorigan, Paul, Ferrucci, Pier Francesco, Grob, Jean Jacques, Meyer, Nicolas, Gogas, Helen, Stroyakovskiy, Daniil, Arance, Ana, Brase, Jan C, Green, Steven, Haas, Tomas, Masood, Aisha, Gasal, Eduard, Ribas, Antoni, and Schadendorf, Dirk

Subjects
Clinical Research, Genetics, Cancer, Clinical Trials and Supportive Activities, Human Genome, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adolescent, Adult, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Humans, Imidazoles, Melanoma, Mutation, Neoplasms, Second Primary, Oximes, Proto-Oncogene Proteins B-raf, Pyridones, Pyrimidinones, Receptors, Death Domain, Skin Neoplasms, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposePreclinical data suggest the combination of an anti-programmed death receptor 1 antibody plus dabrafenib and trametinib to have superior antitumor activity compared with dabrafenib plus trametinib alone. These observations are supported by translational evidence suggesting that immune checkpoint inhibitors plus targeted therapy may improve treatment outcomes in patients with BRAF V600-mutant metastatic melanoma. COMBI-i is a phase III trial evaluating spartalizumab, an anti-programmed death receptor 1 antibody, in combination with dabrafenib and trametinib (sparta-DabTram), versus placebo plus dabrafenib and trametinib (placebo-DabTram) in patients with BRAF V600-mutant unresectable or metastatic melanoma.MethodsPatients received spartalizumab 400 mg intravenously every 4 weeks plus dabrafenib 150 mg orally twice daily and trametinib 2 mg orally once daily or placebo-DabTram. Participants were age ≥ 18 years with unresectable or metastatic BRAF V600-mutant melanoma. The primary end point was investigator-assessed progression-free survival. Overall survival was a key secondary end point (ClinicalTrials.gov identifier: NCT02967692).ResultsAt data cutoff (July 1, 2020), the median progression-free survival was 16.2 months (95% CI, 12.7 to 23.9 months) in the sparta-DabTram arm versus 12.0 months (95% CI, 10.2 to 15.4 months) in the placebo-DabTram arm (hazard ratio, 0.82 [95% CI, 0.66 to 1.03]; P = .042 [one-sided; nonsignificant]). The objective response rates were 69% (183 of 267 patients) versus 64% (170 of 265 patients), respectively. Grade ≥ 3 treatment-related adverse events occurred in 55% (146 of 267) of patients in the sparta-DabTram arm and 33% (88 of 264) in the placebo-DabTram arm.ConclusionThe study did not meet its primary end point; broad first-line use of sparta-DabTram is not supported by these results. Further biomarker-driven investigation may identify patient subpopulations who could benefit from checkpoint inhibitor plus targeted therapy combinations.

Published
2022

11. Combined immunotherapy in melanoma patients with brain metastases: A multicenter international study

Author

Mandalà, Mario, Lorigan, Paul, Sergi, Maria Chiara, Benannoune, Naima, Serra, Patricio, Vitale, Maria Grazia, Giannarelli, Diana, Arance, Ana Maria, Couselo, Eva Munoz, Neyns, Bart, Tucci, Marco, Guida, Michele, Spagnolo, Francesco, Rossi, Ernesto, Occelli, Marcella, Queirolo, Paola, Quaglino, Pietro, Depenni, Roberta, Merelli, Barbara, Placzke, Joanna, Di Giacomo, Anna Maria, del Vecchio, Michele, Indini, Alice, da Silva, Ines Pires, Menzies, Alexander M., Long, Georgina V., Robert, Caroline, Rutkowski, Piotr, and Ascierto, Paolo A.

Published
2024
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12. Long-term outcomes in patients with advanced melanoma who had initial stable disease with pembrolizumab in KEYNOTE-001 and KEYNOTE-006.

Author

Hamid, Omid, Robert, Caroline, Daud, Adil, Carlino, Matteo S, Mitchell, Tara C, Hersey, Peter, Schachter, Jacob, Long, Georgina V, Hodi, F Stephen, Wolchok, Jedd D, Arance, Ana, Grob, Jean Jacques, Joshua, Anthony M, Weber, Jeffrey S, Mortier, Laurent, Jensen, Erin, Diede, Scott J, Moreno, Blanca Homet, and Ribas, Antoni

Subjects
Humans, Melanoma, Skin Neoplasms, Disease Progression, Neoplasm Staging, Prognosis, Drug Administration Schedule, Survival Rate, Patient Selection, Aged, Middle Aged, Female, Male, Antibodies, Monoclonal, Humanized, Clinical Decision-Making, Progression-Free Survival, Immune Checkpoint Inhibitors, PD-1, Pembrolizumab, Programmed death 1, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Cancer, Oncology and Carcinogenesis, Public Health and Health Services, Oncology & Carcinogenesis
Abstract

ObjectivePatients with melanoma and early stable disease (SD) with pembrolizumab have unclear prognosis. We present post hoc analyses of long-term outcomes for patients with early SD, partial response (PR) or complete response (CR) with pembrolizumab.Patients and methodsPatients who received pembrolizumab in the KEYNOTE-001 and KEYNOTE-006 studies and had SD, PR or CR at weeks 12 or 24 were included.ResultsOf 294 patients in the week 12 analysis, 107 (36.4%) had SD at week 12, of whom 7 (6.5%) had a best overall response of CR, 43 (40.2%) had PR and 57 (53.3%) had SD. Forty-eight-month overall survival (OS) rates were 95.2%, 73.0% and 47.7%, respectively, for patients with CR, PR and SD at week 12. Similar results were observed in the 241 patients in the week 24 analysis. Forty-eight-month OS rates were 72.1% for patients with SD at week 12 followed by subsequent response and 75.0% for patients with PR at week 12 followed by no change in response or progression. Thirty-six-month and 48-month OS rates were 11.6% and not reached, respectively, for patients with SD at week 12 followed by progression before week 24.ConclusionsA substantial proportion of patients (46.7%) with early (week 12) SD with pembrolizumab achieved subsequent PR or CR. Patients with SD at week 12 and subsequent CR/PR had similar survival to those who maintained PR. In contrast, patients with SD at week 12 and subsequent progression had poor survival outcomes. These findings may guide treatment decisions for patients achieving early SD.Trial registrationClinicaltrials.gov: NCT01295827 (KEYNOTE-001); NCT01866319 (KEYNOTE-006).

Published
2021

13. Efficacy and safety of immune checkpoint inhibitors in young adults with metastatic melanoma

Author

Wong, Selina K., Blum, Steven M., Sun, Xiaopeng, Da Silva, Inês P., Zubiri, Leyre, Ye, Fei, Bai, Kun, Zhang, Kevin, Ugurel, Selma, Zimmer, Lisa, Livingstone, Elisabeth, Schadendorf, Dirk, Serra-Bellver, Patricio, Muñoz-Couselo, Eva, Ortiz, Carolina, Lostes, Julia, Huertas, Roberto M., Arance, Ana, Pickering, Lisa, Long, Georgina V., Carlino, Matteo S., Buchbinder, Elizabeth I., Vázquez-Cortés, Leticia, Jara-Casas, Diego, Márquez-Rodas, Iván, González-Espinoza, Iván R., Balko, Justin M., Menzies, Alexander M., Sullivan, Ryan J., and Johnson, Douglas B.

Published
2023
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14. Real-world outcomes with ipilimumab and nivolumab in advanced melanoma: a multicentre retrospective study

Author

Serra-Bellver, Patricio, Versluis, Judith M., Oberoi, Honey K., Zhou, Cong, Slattery, Timothy D., Khan, Yasir, Patrinely, James R., Pires da Silva, Inês, Martínez-Vila, C., Cook, Natalie, Graham, Donna M., Carlino, Matteo S., Menzies, Alexander M., Arance, Ana M., Johnson, Douglas B., Long, Georgina V., Pickering, Lisa, Larkin, James M.G., Blank, Christian U., and Lorigan, Paul

Published
2022
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16. Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria

Author

Larkin, James, Weber, Jeffrey, Del Vecchio, Michele, Gogas, Helen, Arance, Ana M., Dalle, Stephane, Cowey, C. Lance, Schenker, Michael, Grob, Jean-Jacques, Chiarion-Sileni, Vanna, Márquez-Rodas, Iván, Butler, Marcus O., Di Giacomo, Anna Marie, Middleton, Mark R., De la Cruz-Merino, Luis, Arenberger, Petr, Atkinson, Victoria, Hill, Andrew, Fecher, Leslie A., Millward, Michael, Khushalani, Nikhil I., Queirolo, Paola, Long, Georgina V., Lobo, Maurice, Askelson, Margarita, Ascierto, Paolo A., and Mandalá, Mario

Published
2022
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17. Pembrolizumab 400 mg every 6 weeks as first-line therapy for advanced melanoma (KEYNOTE-555): Results from cohort B of an open-label, phase 1 study.

Author

Cohen, Graham, Rapoport, Bernardo, Chan, Sze W., Ruff, Paul, Arance, Ana, Mujika Eizmendi, Karmele, Houghton, Baerin, Brown, Michael P., Zielinski, Robert M., Muñoz Couselo, Eva, Lyle, Megan, Anderson, James R., Jain, Lokesh, de Alwis, Dinesh, Lala, Mallika, Akala, Omobolaji, Chartash, Elliot, and Jacobs, Conrad

Subjects
ADVERSE health care events, PROGRESSION-free survival, PEMBROLIZUMAB, PHARMACOKINETICS, MELANOMA
Abstract

Intravenous pembrolizumab 400 mg every 6 weeks was approved across tumor types based on pharmacokinetic modeling, which showed exposures consistent with previous standard dosing of 200 mg or 2 mg/kg every 3 weeks, and early results of cohort B of the phase 1 KEYNOTE-555 study. Results after ≥1 year of potential follow-up for all patients in cohort B of KEYNOTE-555 are presented. Patients aged ≥18 years with previously untreated stage III/IV melanoma received pembrolizumab 400 mg every 6 weeks for ≤18 cycles. The primary endpoint was objective response rate per RECIST v1.1 by blinded independent central review. Secondary endpoints included duration of response, progression-free survival, pharmacokinetics, and safety. Overall, 101 patients received pembrolizumab. Median projected follow-up was 21.9 months (range, 17.0–25.7). The objective response rate was 50.5% (95% CI: 40.4–60.6; 19 complete responses, 32 partial responses). Median duration of response was not reached (NR; range, 2.4+ to 21.0+ months). Median progression-free survival was 13.8 months (95% CI: 4.1–NR). Observed pharmacokinetic exposures were consistent with model predictions for pembrolizumab 400 mg every 6 weeks and other approved and tested schedules (2 mg/kg or 200 mg every 3 weeks). Grade 3–4 treatment-related adverse events occurred in 13 patients (12.9%). No deaths were considered treatment related. These results support the pharmacokinetic modeling and demonstrate that the benefit-risk profile of pembrolizumab 400 mg Q6W is consistent with that of 200 mg or 2 mg/kg every 3 weeks. Clinically meaningful objective response rate and durable progression-free survival within the expected range for first-line pembrolizumab were observed. Clinical trial registry: ClinicalTrials.gov, NCT03665597. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Encorafenib and binimetinib followed by radiotherapy for patients with BRAFV600-mutant melanoma and brain metastases (E-BRAIN/GEM1802 phase II study).

Author

Márquez-Rodas, Iván, Álvarez, Ana, Arance, Ana, Valduvieco, Izaskun, Berciano-Guerrero, Miguel-Ángel, Delgado, Raquel, Soria, Ainara, Campos, Fernándo Lopez, Sánchez, Pedro, Romero, Jose Luis, Martin-Liberal, Juan, Lucas, Anna, Díaz-Beveridge, Roberto, Conde-Moreno, Antonio-José, Gala, Maria del Carmen Álamo de la, García-Castaño, Almudena, Prada, Pedro José, Cao, María González, Puertas, Enrique, and Vidal, Joana

Published
2024
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19. Lymphocyte T Subsets and Outcome of Immune Checkpoint Inhibitors in Melanoma Patients: An Oncologist's Perspective on Current Knowledge.

Author

Martínez-Vila, Clara, González-Navarro, Europa Azucena, Teixido, Cristina, Martin, Roberto, Aya, Francisco, Juan, Manel, and Arance, Ana

Subjects
LYMPHOCYTE subsets, PATIENTS' attitudes, IMMUNE checkpoint inhibitors, T cells, SKIN cancer, BRAF genes
Abstract

Melanoma is the most aggressive and deadly form of skin cancer, and its incidence has been steadily increasing over the past few decades, particularly in the Caucasian population. Immune checkpoint inhibitors (ICI), anti-PD-1 monotherapy or in combination with anti-CTLA-4, and more recently, anti-PD-1 plus anti-LAG-3 have changed the clinical evolution of this disease. However, a significant percentage of patients do not benefit from these therapies. Therefore, to improve patient selection, it is imperative to look for novel biomarkers. Immune subsets, particularly the quantification of lymphocyte T populations, could contribute to the identification of ICI responders. The main purpose of this review is to thoroughly examine significant published data on the potential role of lymphocyte T subset distribution in peripheral blood (PB) or intratumorally as prognostic and predictive of response biomarkers in advanced melanoma patients treated with ICI regardless of BRAFV600 mutational status. [ABSTRACT FROM AUTHOR]

Published
2024
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20. Antitumour activity of pembrolizumab in advanced mucosal melanoma: a post-hoc analysis of KEYNOTE-001, 002, 006.

Author

Hamid, Omid, Robert, Caroline, Ribas, Antoni, Hodi, F Stephen, Walpole, Euan, Daud, Adil, Arance, Ana S, Brown, Ewan, Hoeller, Christoph, Mortier, Laurent, Schachter, Jacob, Long, Jianmin, Ebbinghaus, Scot, Ibrahim, Nageatte, and Butler, Marcus

Subjects
Humans, Melanoma, Treatment Outcome, Drug Administration Schedule, Survival Analysis, Adolescent, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Young Adult, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Immunological, Ipilimumab, and over, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Immunological, Oncology and Carcinogenesis, Public Health and Health Services, Oncology & Carcinogenesis
Abstract

BackgroundMucosal melanoma is an aggressive melanoma with poor prognosis. We assessed efficacy of pembrolizumab in patients with advanced mucosal melanoma in KEYNOTE-001 (NCT01295827), -002 (NCT01704287), and -006 (NCT01866319).MethodsPatients received pembrolizumab 2 mg/kg every 3 weeks (Q3W) or 10 mg/kg Q2W or Q3W. Response was assessed by independent central review per RECIST v1.1.Results1567 patients were treated and 84 (5%) had mucosal melanoma. Fifty-one of 84 were ipilimumab-naive. In patients with mucosal melanoma, the objective response rate (ORR) was 19% (95% CI 11-29%), with median duration of response (DOR) of 27.6 months (range 1.1 + to 27.6). Median progression-free survival (PFS) was 2.8 months (95% CI 2.7-2.8), with median overall survival (OS) of 11.3 months (7.7-16.6). ORR was 22% (95% CI 11-35%) and 15% (95% CI 5-32%) in ipilimumab-naive and ipilimumab-treated patients.ConclusionPembrolizumab provides durable antitumour activity in patients with advanced mucosal melanoma regardless of prior ipilimumab.

Published
2018

21. Anti-PD-1 alone or in combination with anti-CTLA-4 for advanced melanoma patients with liver metastases.

Author

da Silva, Ines Pires, primary, Li, Isabel, additional, Ugurel, Selma, additional, Serra-Bellver, Patricio, additional, Andhale, Avanti, additional, Burnette, Hannah, additional, Aya, Francisco, additional, Conway, Jordan W., additional, Braden, Jorja, additional, Carlino, Matteo S., additional, Menzies, Alexander M., additional, Weichenthal, Michael, additional, Mohr, Peter, additional, Gutzmer, Ralf, additional, Arance, Ana M., additional, Johnson, Douglas B., additional, Lorigan, Paul, additional, Schadendorf, Dirk, additional, Lo, Serigne N, additional, and Long, Georgina V., additional

Published
2024
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23. Sequential immunotherapy and targeted therapy for metastatic BRAF V600 mutated melanoma: 4-year survival and biomarkers evaluation from the phase II SECOMBIT trial

Author

Ascierto, Paolo A; https://orcid.org/0000-0002-8322-475X, Casula, Milena, Bulgarelli, Jenny; https://orcid.org/0000-0002-6551-0189, Pisano, Marina, Piccinini, Claudia, Piccin, Luisa, Cossu, Antonio, Mandalà, Mario; https://orcid.org/0000-0001-8846-8959, Ferrucci, Pier Francesco; https://orcid.org/0000-0001-6255-5851, Guidoboni, Massimo; https://orcid.org/0000-0001-7703-790X, Rutkowski, Piotr; https://orcid.org/0000-0002-8920-5429, Ferraresi, Virginia, Arance, Ana; https://orcid.org/0000-0003-2896-1957, Guida, Michele, Maiello, Evaristo, Gogas, Helen; https://orcid.org/0000-0002-0451-2885, Richtig, Erika; https://orcid.org/0000-0002-5505-6103, Fierro, Maria Teresa, Lebbe, Celeste; https://orcid.org/0000-0002-5854-7290, Helgadottir, Hildur, Queirolo, Paola, Spagnolo, Francesco, Tucci, Marco, Del Vecchio, Michele, Cao, Maria Gonzales; https://orcid.org/0000-0003-3791-540X, Minisini, Alessandro Marco, De Placido, Sabino, Sanmamed, Miguel F; https://orcid.org/0000-0002-7295-6074, Mallardo, Domenico; https://orcid.org/0000-0002-1081-5313, Dummer, Reinhard; https://orcid.org/0000-0002-2279-6906, et al, Ascierto, Paolo A; https://orcid.org/0000-0002-8322-475X, Casula, Milena, Bulgarelli, Jenny; https://orcid.org/0000-0002-6551-0189, Pisano, Marina, Piccinini, Claudia, Piccin, Luisa, Cossu, Antonio, Mandalà, Mario; https://orcid.org/0000-0001-8846-8959, Ferrucci, Pier Francesco; https://orcid.org/0000-0001-6255-5851, Guidoboni, Massimo; https://orcid.org/0000-0001-7703-790X, Rutkowski, Piotr; https://orcid.org/0000-0002-8920-5429, Ferraresi, Virginia, Arance, Ana; https://orcid.org/0000-0003-2896-1957, Guida, Michele, Maiello, Evaristo, Gogas, Helen; https://orcid.org/0000-0002-0451-2885, Richtig, Erika; https://orcid.org/0000-0002-5505-6103, Fierro, Maria Teresa, Lebbe, Celeste; https://orcid.org/0000-0002-5854-7290, Helgadottir, Hildur, Queirolo, Paola, Spagnolo, Francesco, Tucci, Marco, Del Vecchio, Michele, Cao, Maria Gonzales; https://orcid.org/0000-0003-3791-540X, Minisini, Alessandro Marco, De Placido, Sabino, Sanmamed, Miguel F; https://orcid.org/0000-0002-7295-6074, Mallardo, Domenico; https://orcid.org/0000-0002-1081-5313, Dummer, Reinhard; https://orcid.org/0000-0002-2279-6906, and et al

Abstract

No prospective data were available prior to 2021 to inform selection between combination BRAF and MEK inhibition versus dual blockade of programmed cell death protein-1 (PD-1) and cytotoxic T lymphocyte antigen-4 (CTLA-4) as first-line treatment options for BRAFV600-mutant melanoma. SECOMBIT (NCT02631447) was a randomized, three-arm, noncomparative phase II trial in which patients were randomized to one of two sequences with immunotherapy or targeted therapy first, with a third arm in which an 8-week induction course of targeted therapy followed by a planned switch to immunotherapy was the first treatment. BRAF/MEK inhibitors were encorafenib plus binimetinib and checkpoint inhibitors ipilimumab plus nivolumab. Primary outcome of overall survival was previously reported, demonstrating improved survival with immunotherapy administered until progression and followed by BRAF/MEK inhibition. Here we report 4-year survival outcomes, confirming long-term benefit with first-line immunotherapy. We also describe preliminary results of predefined biomarkers analyses that identify a trend toward improved 4-year overall survival and total progression-free survival in patients with loss-of-function mutations affecting JAK or low baseline levels of serum interferon gamma (IFNy). These long-term survival outcomes confirm immunotherapy as the preferred first-line treatment approach for most patients with BRAFV600-mutant metastatic melanoma, and the biomarker analyses are hypothesis-generating for future investigations of predictors of durable benefit with dual checkpoint blockade and targeted therapy.

Published
2024

24. Predictive and Prognostic Factors in Melanoma Central Nervous System Metastases—A Cohort Study.

Author

Serra, Estefania, Abarzua-Araya, Álvaro, Arance, Ana, Martin-Huertas, Roberto, Aya, Francisco, Olondo, María Lourdes, Rizo-Potau, Daniel, Malvehy, Josep, Puig, Susana, Carrera, Cristina, and Podlipnik, Sebastian

Subjects
BRAIN tumor risk factors, RISK assessment, CANCER treatment, PREDICTION models, RESEARCH funding, CANCER invasiveness, MULTIPLE regression analysis, TUMOR markers, DESCRIPTIVE statistics, AGE distribution, LACTATE dehydrogenase, MENINGEAL cancer, CANCER patients, METASTASIS, LONGITUDINAL method, KAPLAN-Meier estimator, SURVIVAL analysis (Biometry), TORSO, CUTANEOUS malignant melanoma, BRAIN tumors, SPECIALTY hospitals, REGRESSION analysis, PROPORTIONAL hazards models, SKIN ulcers, DISEASE risk factors, DISEASE complications
Abstract

Simple Summary: We conducted a study at the Melanoma Unit of the Hospital Clinic of Barcelona to investigate brain metastases in patients with cutaneous melanoma. We collected data from patients diagnosed between January 1998 and September 2023. Patients with melanoma in situ or those with prior lung or breast cancer were excluded. Our aim was to identify factors associated with the development and survival outcomes of brain metastases. We analyzed patient demographics, tumor characteristics, and survival data. The diagnosis of brain metastases was confirmed using imaging techniques, and biopsies were performed when feasible. Our study followed strict guidelines for reporting observational studies. We found that younger age and larger primary tumor thickness increased the risk of developing brain metastases. Additionally, the presence of ulceration and microscopic satellitosis in the primary tumor were associated with a higher risk. Melanomas located on the trunk had a higher risk compared to those on the extremities. Patients with brain metastases had a median survival of around six months. Neurological symptoms and leptomeningeal involvement were associated with poorer survival outcomes. Higher number of brain lesions and elevated levels of lactate dehydrogenase (LDH) also predicted worse survival. Our findings highlight the importance of early detection and monitoring of melanoma patients, especially those at higher risk of brain metastases. Understanding these factors can aid in personalized treatment approaches and improving patient outcomes. Background: Melanoma is the cancer with the highest risk of dissemination to the central nervous system (CNS), one of the leading causes of mortality from this cancer. Objective: To identify patients at higher risk of developing CNS metastases and to evaluate associated prognostic factors. Methods: A cohort study (1998–2023) assessed patients who developed CNS melanoma metastases. Multivariate logistic regression was used to identify predictive factors at melanoma diagnosis for CNS metastasis. Cox regression analysis evaluated the CNS-independent metastasis-related variables impacting survival. Results: Out of 4718 patients, 380 (8.05%) developed CNS metastases. Multivariate logistic regression showed that a higher Breslow index, mitotic rate ≥ 1 mm2, ulceration, and microscopic satellitosis were significant risk factors for CNS metastasis development. Higher patient age and the location of the primary tumor in the upper or lower extremities were protective factors. In survival analysis, post-CNS metastasis, symptomatic disease, prior non-CNS metastases, CNS debut with multiple metastases, elevated LDH levels, and leptomeningeal involvement correlated with poorer survival. Conclusion: Predictive factors in the primary tumor independently associated with brain metastases include microscopic satellitosis, ulceration, higher Breslow index, and trunk location. Prognostic factors for lower survival in CNS disease include symptomatic disease, multiple CNS metastases, and previous metastases from different sites. [ABSTRACT FROM AUTHOR]

Published
2024
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25. Combination of encorafenib and binimetinib followed by ipilimumab and nivolumab versus ipilimumab and nivolumab in patients with advanced BRAF -V600E/K-mutated melanoma: The primary analysis of an EORTC randomized phase II study (EBIN).

Author

Robert, Caroline, Dutriaux, Caroline, Oppong, Felix Boakye, Kicinski, Michal, Routier, Emilie, Neidhardt, Eve-Marie, Durando, Xavier, Baroudjian, Barouyr, Saiag, Philippe, Gaudy-Marqueste, Caroline, Ascierto, Paolo Antonio, Arance, Ana Maria, Russillo, Michelangelo, Perrot, Jean-Luc, Govaerts, Anne-sophie, Bührer, Emanuel, Schilling, Bastian, Mandala, Mario, Lorigan, Paul, and van Akkooi, Alexander Christopher Jonathan

Published
2024
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26. Adjuvant nivolumab versus ipilimumab in resected stage IIIB–C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial

Author

Ascierto, Paolo A, Del Vecchio, Michele, Mandalá, Mario, Gogas, Helen, Arance, Ana M, Dalle, Stephane, Cowey, C Lance, Schenker, Michael, Grob, Jean-Jacques, Chiarion-Sileni, Vanna, Márquez-Rodas, Iván, Butler, Marcus O, Maio, Michele, Middleton, Mark R, de la Cruz-Merino, Luis, Arenberger, Petr, Atkinson, Victoria, Hill, Andrew, Fecher, Leslie A, Millward, Michael, Khushalani, Nikhil I, Queirolo, Paola, Lobo, Maurice, de Pril, Veerle, Loffredo, John, Larkin, James, and Weber, Jeffrey

Published
2020
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27. Trial Protocol 1 from A Phase II Trial of the CD40 Agonistic Antibody Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Confirmed Disease Progression on Anti-PD-1 Therapy

Author

Weiss, Sarah A., primary, Sznol, Mario, primary, Shaheen, Montaser, primary, Berciano-Guerrero, Miguel-Ángel, primary, Couselo, Eva Muñoz, primary, Rodríguez-Abreu, Delvys, primary, Boni, Valentina, primary, Schuchter, Lynn M., primary, Gonzalez-Cao, Maria, primary, Arance, Ana, primary, Wei, Wei, primary, Ganti, Apar Kishor, primary, Hauke, Ralph J., primary, Berrocal, Alfonso, primary, Iannotti, Nicholas O., primary, Hsu, Frank J., primary, and Kluger, Harriet M., primary

Published
2024
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28. Supplementary Data 1 from A Phase II Trial of the CD40 Agonistic Antibody Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Confirmed Disease Progression on Anti-PD-1 Therapy

Author

Weiss, Sarah A., primary, Sznol, Mario, primary, Shaheen, Montaser, primary, Berciano-Guerrero, Miguel-Ángel, primary, Couselo, Eva Muñoz, primary, Rodríguez-Abreu, Delvys, primary, Boni, Valentina, primary, Schuchter, Lynn M., primary, Gonzalez-Cao, Maria, primary, Arance, Ana, primary, Wei, Wei, primary, Ganti, Apar Kishor, primary, Hauke, Ralph J., primary, Berrocal, Alfonso, primary, Iannotti, Nicholas O., primary, Hsu, Frank J., primary, and Kluger, Harriet M., primary

Published
2024
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29. Data from A Phase II Trial of the CD40 Agonistic Antibody Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Confirmed Disease Progression on Anti-PD-1 Therapy

Author

Weiss, Sarah A., primary, Sznol, Mario, primary, Shaheen, Montaser, primary, Berciano-Guerrero, Miguel-Ángel, primary, Couselo, Eva Muñoz, primary, Rodríguez-Abreu, Delvys, primary, Boni, Valentina, primary, Schuchter, Lynn M., primary, Gonzalez-Cao, Maria, primary, Arance, Ana, primary, Wei, Wei, primary, Ganti, Apar Kishor, primary, Hauke, Ralph J., primary, Berrocal, Alfonso, primary, Iannotti, Nicholas O., primary, Hsu, Frank J., primary, and Kluger, Harriet M., primary

Published
2024
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30. Supplementary Figure 1 from A Phase II Trial of the CD40 Agonistic Antibody Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Confirmed Disease Progression on Anti-PD-1 Therapy

Author

Weiss, Sarah A., primary, Sznol, Mario, primary, Shaheen, Montaser, primary, Berciano-Guerrero, Miguel-Ángel, primary, Couselo, Eva Muñoz, primary, Rodríguez-Abreu, Delvys, primary, Boni, Valentina, primary, Schuchter, Lynn M., primary, Gonzalez-Cao, Maria, primary, Arance, Ana, primary, Wei, Wei, primary, Ganti, Apar Kishor, primary, Hauke, Ralph J., primary, Berrocal, Alfonso, primary, Iannotti, Nicholas O., primary, Hsu, Frank J., primary, and Kluger, Harriet M., primary

Published
2024
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31. Management of infliximab refractory immune checkpoint inhibitor gastrointestinal toxicity: a multicenter case series

Author

Harvey, Catriona, primary, Nahar, Kazi J, additional, McKeown, Janet, additional, Lo, Serigne N, additional, Farag, Sheima, additional, Yousaf, Nadia, additional, Young, Kate, additional, Tas, Liselotte, additional, Meerveld-Eggink, Aafke, additional, Blank, Christian, additional, Thomas, Austin, additional, McQuade, Jennifer, additional, Schilling, Bastian, additional, Johnson, Douglas B, additional, Huertas, Roberto Martín, additional, Arance, Ana, additional, Lee, Joanna, additional, Zimmer, Lisa, additional, Long, Georgina V, additional, Carlino, Matteo S, additional, Wang, Yinghong, additional, and Menzies, Alexander Maxwell, additional

Published
2024
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32. Intermittent BRAF inhibition in advanced BRAF mutated melanoma results of a phase II randomized trial

Author

Gonzalez-Cao, Maria, Mayo de las Casas, Clara, Oramas, Juana, Berciano-Guerrero, Miguel A., de la Cruz, Luis, Cerezuela, Pablo, Arance, Ana, Muñoz-Couselo, Eva, Espinosa, Enrique, Puertolas, Teresa, Diaz Beveridge, Roberto, Ochenduszko, Sebastian, Villanueva, Maria-Jose, Basterretxea, Laura, Bellido, Lorena, Rodriguez, Delvys, Campos, Begoña, Montagut, Clara, Drozdowskyj, Ana, Molina, Miguel A., Lopez-Martin, Jose Antonio, and Berrocal, Alfonso

Published
2021
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34. 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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35. Pembrolizumab versus ipilimumab in advanced melanoma (KEYNOTE-006): post-hoc 5-year results from an open-label, multicentre, randomised, controlled, phase 3 study

Author

Robert, Caroline, Ribas, Antoni, Schachter, Jacob, Arance, Ana, Grob, Jean-Jacques, Mortier, Laurent, Daud, Adil, Carlino, Matteo S, McNeil, Catriona M, Lotem, Michal, Larkin, James M G, Lorigan, Paul, Neyns, Bart, Blank, Christian U, Petrella, Teresa M, Hamid, Omid, Su, Shu-Chih, Krepler, Clemens, Ibrahim, Nageatte, and Long, Georgina V

Published
2019
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36. Epacadostat plus pembrolizumab versus placebo plus pembrolizumab in patients with unresectable or metastatic melanoma (ECHO-301/KEYNOTE-252): a phase 3, randomised, double-blind study

Author

Long, Georgina V, Dummer, Reinhard, Hamid, Omid, Gajewski, Thomas F, Caglevic, Christian, Dalle, Stephane, Arance, Ana, Carlino, Matteo S, Grob, Jean-Jacques, Kim, Tae Min, Demidov, Lev, Robert, Caroline, Larkin, James, Anderson, James R, Maleski, Janet, Jones, Mark, Diede, Scott J, and Mitchell, Tara C

Published
2019
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37. Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Author

Bouzid, Kamel, Campone, Mario, Coudert, Bruno, Nowecki, Zbigniew, Errihani, Hassan, Dalenc, Florence, Ferreira, Ana, Mano, Max, Ricci, Francesco, Kalofonos, Haralabos, Andreetta, Claudia, Montemurro, Filippo, Barrett, Sophie, Zhang, Qingyuan, Mavroudis, Dimitris, Matus, Juan, Beato, Carlos, Hu, Xichun, Gaafar, Rabab, Abdel Azeem, Hamdy, Perrin, Christophe, Ettl, Johannes, Lang, Istvan, Verma, Sunil, Li, Huiping, Brain, Etienne, Hoffmann, Oliver, Cariello, Anna, Tondini, Carlo, Altwegeiri, Taher, Loman, Niklas, Lux, Michael, Frassoldati, Antonio, Aziz, Zeba, Salas, Fernando, Streb, Joanna, Wronski, Andrzej, Menjón Beltrán, Salomón, Cicin, Irfan, Schmid, Peter, Laing, Robert, Tong, Zhongsheng, Boer, Katalin, Juhasz, Balazs, Gianni, Luca, Curigliano, Giuseppe, Juarez, Alejandro, Susnjar, Snezana, Matos, Erika, Uslu, Ruchan, Wildiers, Hans, Cruz, Marcelo, Bourgeois, Hugues, von Schumann, Raquel, Stemmer, Salomón, Vásquez, Flavia Morales, Dominguez, Adriana, Wojtukiewicz, Marek, Trifunovic, Jasna, Illarramendi, Jose Juan, Garcia, Laura, Peron, Yann Izarzugaza, Echarri, Maria Jose, Voitko, Natliia, Wheatley, Duncan, Waters, Simon, De Boer, Richard, Jerusalem, Guy, Cocquyt, Véronique, Barrios, Carlos, Panasci, Lawrence, Mattson, Johanna, Tanner, Minna, Gozy, Michel, Vasilopoulos, Georgios, Revesz, Janos, Latini, Luciano, Gridelli, Cesare, Lazaro, Jesus, Gonzalez, Antonio, Barnadas Molins, Agusti, Martinez, Eduardo, Alarcón, Jesús, Arance, Ana, Klint, Leif, Kovalyov, Oleksiy, Baird, Richard, Yeo, Belinda, McCarthy, Nicole, Greil, Richard, Wang, Shusen, Artignan, Xavier, Augereau, Paule, Juhasz-Boess, Ingolf, Ngan, Roger, Goldberg, Hadassah, Di Costanzo, Francesco, Ferraù, Francesco, Aleknavicius, Eduardas, Rashid, Kamran, Costa, Luís, Angel Garcia, Jose, de la Cruz, Luis Ruiz, López López, Rafael, Del Val, Olga, Ozyilkan, Ozgur, Azribi, Fathi, Verrill, Mark, Turner, Nicholas, Beith, Jane, Petzer, Andreas, Andrade, Jurandyr, Bernstein, Vanessa, Rayson, Daniel, Saad Eldin, Ibtessam, Achille, Mihaëla, Mueller, Volkmar, Gennari, Alessandra, Cascinu, Stefano, Ghosn, Marwan, El-Saghir, Nagi, Van den Bosch, Joan, Oosterkamp, Rianne, Kukulska, Monika, Pelaez, Ignacio, Hernandez, Carolina, del Mar Gordon, Maria, Dalmau, Elsa, Alonso, Jose Luis, Aksoy, Sercan, Coskun, Hasan Senol, Shparyk, Yaroslav, Varughese, Mohini, Panwar, Udaiveer, Barraclough, Lisa, Levitt, Nicola, Hicks, Jonathan, Rigg, Anna, Allen, Mark, Castillo, Cecila, Fein, Luis Enrique, Stuart-Harris, Robin, Singer, Christian, Stoeger, Herbert, Smiljanic, Sasha, Feng, Jifeng, Cedeño, Miguel, Berdah, Jean Francois, Orfeuvre, Hubert, Goncalves, Anthony, Grischke, Eva-Maria, Simon, Eike, Wagner, Steffen, Efremidou, Anna, Papazisis, Konstantinos, Evron, Ella, Inbar, Moshe, Baruch, Noa Ben, Geffen, David, Karminsky, Natalya, Ruggeri, Enzo Maria, Luigi, Cavanna, Grasso, Donatella, Juozaityte, Elona, Rafael Rodriguez Cid, Jeronimo, Roerdink, Henk, Siddiqi, Neelum, Passos Coelho, José Luís, Garre, Elisa Garcia, Garcia, Andres, Martínez Jañez, Noelia, Lopez Ceballos, Maria Helena, Mele, Mireia, García, María, Arcediano, Alberto, McAdam, Karen, Perren, Timothy, Taylor, Wendy, Humphreys, Alison, Vera, Raul, Kaen, Luis Alberto, Steger, Günther, Andel, Johannes, de Grève, Jacques, Huizing, Manon, Hegg, Roberto, Joy, Anil, Sehdev, Sandeep, Kütner, Riina, Ruohola, Johanna, Dohollou, Nadine, Grosjean, Jessica, Laplaige, Philippe, Largillier, Rémy, Martin, Philippe, Pottier, Virginie, Alexandre, Jerome, Christensen, Bernd, Zahm, Dirk-Michael, Khandan, Fariba, Lueck, Hans-Joachim, Fountzilas, Georgios, Fried, Georgeta, Giacobino, Alice, Bonetti, Andrea, Guerra, Yanin Chavarri, Van Warmerdam, Laurens, Van der Velden, Annette, Vrijaldenhoven, Suzan, de Jongh, Felix, Cavero, Milagros, Andres Conejero, Raquel, Murias, Adolfo, Saura, Salvador, Oltra, Amparo, Redondo, Andres, Ribelles, Nuria, Bachmeier, Kilian, Joffe, Johnathan, Chakraborti, Prabir, Beresford, Mark, Butt, Mohammad, Poole, Christopher, Yordi, Gassan, Woodward, Natasha, Amorim, Gilberto, Califaretti, Nadia, Fox, Susan, Robidoux, Andre, Li, NanLi, Li, Nenxiao, Jiang, Jun, Soria, Tannia, Padrik, Peeter, Saarni, Outi, Genet, Dominique, Catala, Stéphanie, Barletta, Hugues, Teixeira, Luis, Facchini, Thomas, Hesse, Tobias, Kühn, Thorsten, Ober, Angelika, Repp, Roland, Schroeder, Willibald, Pectasides, Dimitrios, Bodoky, Gyorgy, Kahan, Zsuzsanna, Jiveliouk, Irina, Rosengarten, Ora, Alabiso, Oscar, Perez, Mario, Van de Wouw, Yes, Smok-Kalwat, Jolanta, Damasceno, Margarida, Sousa, Gabriela, Abulkhair, Omalkhair, Antón Torres, Antonio, Martinez, Maria Purificación, Garcia Mata, Jesús, Jesús Florián Jerico, Marta Santisteban, Llombart, Antonio, Sanchez, Rosa, Torrego, Juan Carlos, Garate, Clara Olier, Rodriguez, Cesar, Llorente, Rosa, de Prado, Diego Soto, Cortés, Javier, Llorca, Cristina, Galán, Antonio, Viñas Villaro, Gemma, Narbe, Ulrik, Bjömeklett, Helena Granstam, Westwell, Sarah, Newby, Jackie, Jafri, Mariam, Rodríguez, Robinson, Alonso, Isabel, Bachelot, T., Ciruelos, E., Schneeweiss, A., Puglisi, F., Peretz-Yablonski, T., Bondarenko, I., Paluch-Shimon, S., Wardley, A., Merot, J.-L., du Toit, Y., Easton, V., Lindegger, N., and Miles, D.

Published
2019
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38. 770 ADU-1604, a novel CTLA-4 blocking antibody modulates pharmacodynamic markers in PD1 relapse/refractory melanoma patients

Author

Oria de Rueda, Guillemo De Velasco, primary, Rutkowski, Piotr, additional, Maio, Michele, additional, Arance, Ana Maria, additional, Robert, Caroline, additional, Chiarion-Sileni, Vanna, additional, Marquez-Rodas, Ivan, additional, Kundapur, Jessica, additional, Villaudy, Julien, additional, Eenennaam, Hans Van, additional, Lassouw-Polman, Laura, additional, and Eggermont, Alexander, additional

Published
2023
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39. Rechallenge with BRAF-directed treatment in metastatic melanoma: A multi-institutional retrospective study

Author

Valpione, Sara, Carlino, Matteo S., Mangana, Johanna, Mooradian, Meghan J., McArthur, Grant, Schadendorf, Dirk, Hauschild, Axel, Menzies, Alexander M., Arance, Ana, Ascierto, Paolo A., Di Giacomo, AnnaMaria, de Rosa, Francesco, Larkin, James, Park, John J., Goldinger, Simone M., Sullivan, Ryan J., Xu, Wen, Livingstone, Elisabeth, Weichenthal, Michael, Rai, Rajat, Gaba, Lydia, Long, Georgina V., and Lorigan, Paul

Published
2018
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40. A Phase II Trial of the CD40 Agonistic Antibody Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Confirmed Disease Progression on Anti-PD-1 Therapy

Author

Weiss, Sarah A., primary, Sznol, Mario, additional, Shaheen, Montaser, additional, Berciano-Guerrero, Miguel-Ángel, additional, Couselo, Eva Muñoz, additional, Rodríguez-Abreu, Delvys, additional, Boni, Valentina, additional, Schuchter, Lynn M., additional, Gonzalez-Cao, Maria, additional, Arance, Ana, additional, Wei, Wei, additional, Ganti, Apar Kishor, additional, Hauke, Ralph J., additional, Berrocal, Alfonso, additional, Iannotti, Nicholas O., additional, Hsu, Frank J., additional, and Kluger, Harriet M., additional

Published
2023
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41. Pembrolizumab versus ipilimumab for advanced melanoma: final overall survival results of a multicentre, randomised, open-label phase 3 study (KEYNOTE-006)

Author

Schachter, Jacob, Ribas, Antoni, Long, Georgina V, Arance, Ana, Grob, Jean-Jacques, Mortier, Laurent, Daud, Adil, Carlino, Matteo S, McNeil, Catriona, Lotem, Michal, Larkin, James, Lorigan, Paul, Neyns, Bart, Blank, Christian, Petrella, Teresa M, Hamid, Omid, Zhou, Honghong, Ebbinghaus, Scot, Ibrahim, Nageatte, and Robert, Caroline

Published
2017
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42. Open-label, multicentre safety study of vemurafenib in 3219 patients with BRAFV600 mutation-positive metastatic melanoma: 2-year follow-up data and long-term responders' analysis

Author

Blank, Christian U., Larkin, James, Arance, Ana M., Hauschild, Axel, Queirolo, Paola, Del Vecchio, Michele, Ascierto, Paolo A., Krajsova, Ivana, Schachter, Jacob, Neyns, Bart, Garbe, Claus, Chiarion Sileni, Vanna, Mandalà, Mario, Gogas, Helen, Espinosa, Enrique, Hospers, Geke A.P., Miller, Wilson H., Jr., Robson, Susan, Makrutzki, Martina, Antic, Vladan, and Brown, Michael P.

Published
2017
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43. 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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44. 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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45. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial

Author

Dummer, Reinhard, Schadendorf, Dirk, Ascierto, Paolo A, Arance, Ana, Dutriaux, Caroline, Di Giacomo, Anna Maria, Rutkowski, Piotr, Del Vecchio, Michele, Gutzmer, Ralf, Mandala, Mario, Thomas, Luc, Demidov, Lev, Garbe, Claus, Hogg, David, Liszkay, Gabriella, Queirolo, Paola, Wasserman, Ernesto, Ford, James, Weill, Marine, Sirulnik, L Andres, Jehl, Valentine, Bozón, Viviana, Long, Georgina V, and Flaherty, Keith

Published
2017
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46. Abstract LB198: A first-in-human, open-label, multicenter study of intratumoral SAR441000 (mixture of cytokine encoding mRNAs), as monotherapy and in combination with cemiplimab in patients with advanced solid tumors

Author

Bechter, Oliver, primary, Loquai, Carmen, additional, Champiat, Stephane, additional, Baurain, Jean Francois, additional, Grob, Jean-Jacques, additional, Utikal, Jochen, additional, Rottey, Sylvie, additional, Berrocal, Alfonso, additional, Hassel, Jessica, additional, Arance, Ana, additional, Sanmamed, Miguel F., additional, Boers-Sonderen, Marye, additional, Gastman, Brian, additional, Gebhardt, Christoffer, additional, Delafontaine, Brant, additional, Sahin, Ugur, additional, Türeci, Özlem, additional, Abbadessa, Giovanni, additional, Genova, Gianfranco Di, additional, Brueck, Patrick, additional, Marpadga, Rahul, additional, Lee, Helen, additional, and Lebbe, Céleste, additional

Published
2023
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47. Figure S1 from Phase I Dose-Escalation and -Expansion Study of the BRAF Inhibitor Encorafenib (LGX818) in Metastatic BRAF-Mutant Melanoma

Author

Delord, Jean-Pierre, primary, Robert, Caroline, primary, Nyakas, Marta, primary, McArthur, Grant A., primary, Kudchakar, Ragini, primary, Mahipal, Amit, primary, Yamada, Yasuhide, primary, Sullivan, Ryan, primary, Arance, Ana, primary, Kefford, Richard F., primary, Carlino, Matteo S., primary, Hidalgo, Manuel, primary, Gomez-Roca, Carlos, primary, Michel, Daniela, primary, Seroutou, Abdelkader, primary, Aslanis, Vassilios, primary, Caponigro, Giordano, primary, Stuart, Darrin D., primary, Moutouh-de Parseval, Laure, primary, Demuth, Tim, primary, and Dummer, Reinhard, primary

Published
2023
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48. Table S3 from Phase I Dose-Escalation and -Expansion Study of the BRAF Inhibitor Encorafenib (LGX818) in Metastatic BRAF-Mutant Melanoma

Author

Delord, Jean-Pierre, primary, Robert, Caroline, primary, Nyakas, Marta, primary, McArthur, Grant A., primary, Kudchakar, Ragini, primary, Mahipal, Amit, primary, Yamada, Yasuhide, primary, Sullivan, Ryan, primary, Arance, Ana, primary, Kefford, Richard F., primary, Carlino, Matteo S., primary, Hidalgo, Manuel, primary, Gomez-Roca, Carlos, primary, Michel, Daniela, primary, Seroutou, Abdelkader, primary, Aslanis, Vassilios, primary, Caponigro, Giordano, primary, Stuart, Darrin D., primary, Moutouh-de Parseval, Laure, primary, Demuth, Tim, primary, and Dummer, Reinhard, primary

Published
2023
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49. Data from Immune-Related Gene Expression Profiling After PD-1 Blockade in Non–Small Cell Lung Carcinoma, Head and Neck Squamous Cell Carcinoma, and Melanoma

Author

Prat, Aleix, primary, Navarro, Alejandro, primary, Paré, Laia, primary, Reguart, Noemí, primary, Galván, Patricia, primary, Pascual, Tomás, primary, Martínez, Alex, primary, Nuciforo, Paolo, primary, Comerma, Laura, primary, Alos, Llucia, primary, Pardo, Nuria, primary, Cedrés, Susana, primary, Fan, Cheng, primary, Parker, Joel S., primary, Gaba, Lydia, primary, Victoria, Iván, primary, Viñolas, Nuria, primary, Vivancos, Ana, primary, Arance, Ana, primary, and Felip, Enriqueta, primary

Published
2023
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50. Table S2 from Immune-Related Gene Expression Profiling After PD-1 Blockade in Non–Small Cell Lung Carcinoma, Head and Neck Squamous Cell Carcinoma, and Melanoma

Author

Prat, Aleix, primary, Navarro, Alejandro, primary, Paré, Laia, primary, Reguart, Noemí, primary, Galván, Patricia, primary, Pascual, Tomás, primary, Martínez, Alex, primary, Nuciforo, Paolo, primary, Comerma, Laura, primary, Alos, Llucia, primary, Pardo, Nuria, primary, Cedrés, Susana, primary, Fan, Cheng, primary, Parker, Joel S., primary, Gaba, Lydia, primary, Victoria, Iván, primary, Viñolas, Nuria, primary, Vivancos, Ana, primary, Arance, Ana, primary, and Felip, Enriqueta, primary

Published
2023
Full Text
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