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3. Isatuximab plus atezolizumab in patients with advanced solid tumors: results from a phase I/II, open-label, multicenter study

Author

Simonelli, M., Garralda, E., Eskens, F., Gil-Martin, M., Yen, C.-J., Obermannova, R., Chao, Y., Lonardi, S., Melichar, B., Moreno, V., Yu, M.-L., Bongiovanni, A., Calvo, E., Rottey, S., Machiels, J.-P., Gonzalez-Martin, A., Paz-Ares, L., Chang, C.-L., Mason, W., Lin, C.-C., Reardon, D.A., Vieito, M., Santoro, A., Meng, R., Abbadessa, G., Menas, F., Lee, H., Liu, Q., Combeau, C., Ternes, N., Ziti-Ljajic, S., and Massard, C.

Published
2022
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5. 6O Subcutaneous fat mass predicts progression-free survival in patients treated with antibody drug conjugates in early phase clinical trials

Author

Delaye, M., primary, Lawrance, L., additional, Belkouchi, Y., additional, Decazes, P., additional, Wirth, F., additional, Bône, A., additional, Ouali, K., additional, Hollebecque, A., additional, Smolenschi, C., additional, Champiat, S., additional, Danlos, F-X., additional, Beshiri, K., additional, Sakkal, M., additional, Massard, C., additional, Vera, P., additional, Marabelle, A., additional, Aix, S. Ponce, additional, Lassau, N., additional, Ammari, S., additional, and Baldini, C., additional

Published
2024
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6. Erdafitinib in patients with advanced solid tumours with FGFR alterations (RAGNAR): an international, single-arm, phase 2 study

Author

Pant, S, Schuler, M, Iyer, G, Witt, O, Doi, T, Qin, S, Tabernero, J, Reardon, D, Massard, C, Minchom, A, Lugowska, I, Carranza, O, Arnold, D, Gutierrez, M, Winter, H, Stuyckens, K, Crow, L, Najmi, S, Hammond, C, Thomas, S, Santiago-Walker, A, Triantos, S, Sweiti, H, Loriot, Y, Greco, M, Coward, J, Joshua, A, Karapetis, C, Hart, C, Zhang, A, Prenen, H, Goeminne, J, Machiels, J, Rottey, S, Corassa, M, Molin, G, Tiscoski, K, Jardim, D, Mak, M, Fu, W, Yao, H, Huang, J, Jiang, H, Chen, B, Yan, D, Yang, Y, Le Tourneau, C, Penel, N, Salas, S, Blay, J, Brachet, P, Durando, X, Emambux, S, Ravaud, A, Folprecht, G, Ahrens, M, Golf, A, Haag, G, Lordick, F, Desuki, A, Cazzaniga, M, Ciardiello, F, Milella, M, Koyama, T, Hirooka, Y, Okamoto, W, Aogi, K, Kuboki, Y, Lee, J, Kim, S, Ahn, M, Chang, J, Kim, Y, Nam, D, Park, J, Paz-Ares, L, Moreno, V, Cervantes, A, Calvo, M, Falcon, A, Gonzalez, A, Martinez Bueno, A, Garcia-Corbacho, J, Longo, F, Yen, C, Chen, J, Hou, M, Chao, Y, Rau, K, Chiu, T, Feng, Y, Hsu, C, Huang, W, Lai, K, Yeh, S, Palmer, D, Welsh, L, Plummer, R, Bilen, M, Arrowsmith, E, Spigel, D, Zandberg, D, Doroshow, D, Lu-Emerson, C, Moezi, M, Paulson, S, Ward, P, Chaves, J, Grigg, C, Hussein, A, Manda, S, Monticelli, M, Qamar, R, Richey, S, Tamura, D, Wilks, S, Pant S., Schuler M., Iyer G., Witt O., Doi T., Qin S., Tabernero J., Reardon D. A., Massard C., Minchom A., Lugowska I., Carranza O., Arnold D., Gutierrez M., Winter H., Stuyckens K., Crow L., Najmi S., Hammond C., Thomas S., Santiago-Walker A., Triantos S., Sweiti H., Loriot Y., Greco M. A., Coward J., Joshua A., Karapetis C., Hart C., Zhang A., Prenen H., Goeminne J. -C., Machiels J. -P., Rottey S., Corassa M., Molin G. Z. D., Tiscoski K., Jardim D. L. F., Mak M., Fu W., Yao H., Huang J., Jiang H., Chen B., Yan D., Yang Y., Le Tourneau C., Penel N., Salas S., Blay J. -Y., Brachet P. -E., Durando X., Emambux S., Ravaud A., Folprecht G., Ahrens M., Golf A., Haag G. M., Lordick F., Desuki A., Cazzaniga M., Ciardiello F., Milella M., Koyama T., Hirooka Y., Okamoto W., Aogi K., Kuboki Y., Lee J., Kim S. -B., Ahn M. -J., Chang J. H., Kim Y. -M., Nam D. -H., Park J. -S., Paz-Ares L., Moreno V., Cervantes A., Calvo M., Falcon A., Gonzalez A., Martinez Bueno A., Garcia-Corbacho J., Longo F., Yen C. -J., Chen J. -S., Hou M. -F., Chao Y., Rau K. -M., Chiu T. -J., Feng Y. -H., Hsu C. -H., Huang W. -T., Lai K. -M., Yeh S. -P., Palmer D., Welsh L., Plummer R., Bilen M., Arrowsmith E., Spigel D. R., Zandberg D. P., Doroshow D., Lu-Emerson C., Moezi M., Paulson S., Reardon D., Ward P., Chaves J., Grigg C., Hussein A., Manda S., Monticelli M., Qamar R., Richey S. L., Tamura D., Wilks S., Pant, S, Schuler, M, Iyer, G, Witt, O, Doi, T, Qin, S, Tabernero, J, Reardon, D, Massard, C, Minchom, A, Lugowska, I, Carranza, O, Arnold, D, Gutierrez, M, Winter, H, Stuyckens, K, Crow, L, Najmi, S, Hammond, C, Thomas, S, Santiago-Walker, A, Triantos, S, Sweiti, H, Loriot, Y, Greco, M, Coward, J, Joshua, A, Karapetis, C, Hart, C, Zhang, A, Prenen, H, Goeminne, J, Machiels, J, Rottey, S, Corassa, M, Molin, G, Tiscoski, K, Jardim, D, Mak, M, Fu, W, Yao, H, Huang, J, Jiang, H, Chen, B, Yan, D, Yang, Y, Le Tourneau, C, Penel, N, Salas, S, Blay, J, Brachet, P, Durando, X, Emambux, S, Ravaud, A, Folprecht, G, Ahrens, M, Golf, A, Haag, G, Lordick, F, Desuki, A, Cazzaniga, M, Ciardiello, F, Milella, M, Koyama, T, Hirooka, Y, Okamoto, W, Aogi, K, Kuboki, Y, Lee, J, Kim, S, Ahn, M, Chang, J, Kim, Y, Nam, D, Park, J, Paz-Ares, L, Moreno, V, Cervantes, A, Calvo, M, Falcon, A, Gonzalez, A, Martinez Bueno, A, Garcia-Corbacho, J, Longo, F, Yen, C, Chen, J, Hou, M, Chao, Y, Rau, K, Chiu, T, Feng, Y, Hsu, C, Huang, W, Lai, K, Yeh, S, Palmer, D, Welsh, L, Plummer, R, Bilen, M, Arrowsmith, E, Spigel, D, Zandberg, D, Doroshow, D, Lu-Emerson, C, Moezi, M, Paulson, S, Ward, P, Chaves, J, Grigg, C, Hussein, A, Manda, S, Monticelli, M, Qamar, R, Richey, S, Tamura, D, Wilks, S, Pant S., Schuler M., Iyer G., Witt O., Doi T., Qin S., Tabernero J., Reardon D. A., Massard C., Minchom A., Lugowska I., Carranza O., Arnold D., Gutierrez M., Winter H., Stuyckens K., Crow L., Najmi S., Hammond C., Thomas S., Santiago-Walker A., Triantos S., Sweiti H., Loriot Y., Greco M. A., Coward J., Joshua A., Karapetis C., Hart C., Zhang A., Prenen H., Goeminne J. -C., Machiels J. -P., Rottey S., Corassa M., Molin G. Z. D., Tiscoski K., Jardim D. L. F., Mak M., Fu W., Yao H., Huang J., Jiang H., Chen B., Yan D., Yang Y., Le Tourneau C., Penel N., Salas S., Blay J. -Y., Brachet P. -E., Durando X., Emambux S., Ravaud A., Folprecht G., Ahrens M., Golf A., Haag G. M., Lordick F., Desuki A., Cazzaniga M., Ciardiello F., Milella M., Koyama T., Hirooka Y., Okamoto W., Aogi K., Kuboki Y., Lee J., Kim S. -B., Ahn M. -J., Chang J. H., Kim Y. -M., Nam D. -H., Park J. -S., Paz-Ares L., Moreno V., Cervantes A., Calvo M., Falcon A., Gonzalez A., Martinez Bueno A., Garcia-Corbacho J., Longo F., Yen C. -J., Chen J. -S., Hou M. -F., Chao Y., Rau K. -M., Chiu T. -J., Feng Y. -H., Hsu C. -H., Huang W. -T., Lai K. -M., Yeh S. -P., Palmer D., Welsh L., Plummer R., Bilen M., Arrowsmith E., Spigel D. R., Zandberg D. P., Doroshow D., Lu-Emerson C., Moezi M., Paulson S., Reardon D., Ward P., Chaves J., Grigg C., Hussein A., Manda S., Monticelli M., Qamar R., Richey S. L., Tamura D., and Wilks S.

Abstract

Background: FGFR alterations are reported across various malignancies and might act as oncogenic drivers in multiple histologies. Erdafitinib is an oral, selective pan-FGFR tyrosine kinase inhibitor with activity in FGFR-altered advanced urothelial carcinoma. We aimed to evaluate the safety and activity of erdafitinib in previously treated patients with FGFR-altered advanced solid tumours. Methods: The single-arm, phase 2 RAGNAR study was conducted at 156 investigative centres (hospitals or oncology practices that are qualified oncology study centres) across 15 countries. The study consisted of four cohorts based on tumour histology and patient age; the results reported in this Article are for the primary cohort of the study, defined as the Broad Panel Cohort, which was histology-agnostic. We recruited patients aged 12 years or older with advanced or metastatic tumours of any histology (except urothelial cancer) with predefined FGFR1–4 alterations (mutations or fusions according to local or central testing). Eligible patients had disease progression on at least one previous line of systemic therapy and no alternative standard therapy available to them, and an Eastern Cooperative Oncology Group performance status of 0–1 (or equivalent for adolescents aged 12–17 years). Patients received once-daily oral erdafitinib (8 mg/day with provision for pharmacodynamically guided up-titration to 9 mg/day) on a continuous 21-day cycle until disease progression or intolerable toxicity. The primary endpoint was objective response rate by independent review committee according to Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1, or Response Assessment In Neuro-Oncology (RANO). The primary analysis was conducted on the treated population of the Broad Panel Cohort. This ongoing study is registered with ClinicalTrials.gov, number NCT04083976. Findings: Patients were recruited between Dec 5, 2019, and Feb 15, 2022. Of 217 patients treated with erdafitinib, 97 (45%) pa

Published
2023

8. ANTIBODY DRUG CONJUGATES IN OLDER PATIENTS: STATE OF THE ART

Author

Rached, L, primary, Geraud, A, additional, Frelaut, M, additional, Thomas, Z ap, additional, Goldschmidt, V, additional, Beraud-Chaulet, G, additional, Nagera-Lazarovici, C, additional, Danlos, FX, additional, Henon, C, additional, Parisi, C, additional, Gazzah, A, additional, Bahleda, R, additional, Postel Vinay, S, additional, Smolenschi, C, additional, Hollebecque, A, additional, Michot, JM, additional, Ribrag, V, additional, Loriot, Y, additional, Champiat, S, additional, Ouali, K, additional, Massard, C, additional, Ponce Aix, S, additional, Bringuier, M, additional, and Baldini, C, additional

Published
2023
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9. First-In-Human Phase I Study Of A Dual mTOR Kinase And DNA-PK Inhibitor (CC-115) In Advanced Malignancy

Author

Munster P, Mita M, Mahipal A, Nemunaitis J, Massard C, Mikkelsen T, Cruz C, Paz-Ares L, Hidalgo M, Rathkopf D, Blumenschein Jr G, Smith DC, Eichhorst B, Cloughesy T, Filvaroff EH, Li S, Raymon H, de Haan H, Hege K, and Bendell JC

Subjects
cc-115, mtorc1/mtorc2, mtor inhibitor, dna-pk inhibitor, phase i study, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Pamela Munster,1 Monica Mita,2 Amit Mahipal,3 John Nemunaitis,4 Christophe Massard,5 Tom Mikkelsen,6 Cristina Cruz,7 Luis Paz-Ares,8 Manuel Hidalgo,9 Dana Rathkopf,10 George Blumenschein Jr,11 David C Smith,12 Barbara Eichhorst,13 Tim Cloughesy,14 Ellen H Filvaroff,15 Shaoyi Li,16 Heather Raymon,17 Hans de Haan,15 Kristen Hege,15 Johanna C Bendell18 1UCSF Helen Diller Family Comprehensive Cancer Center, Department of Medicine, San Francisco, CA, USA; 2Samuel Oschin Comprehensive Cancer Institute, Internal Medicine Medical Oncology Department, Los Angeles, CA, USA; 3Mayo Clinic, Medical Oncology Department, Rochester, MN, USA; 4University of Toledo College of Medicine and Life Sciences, Hematology/Oncology Department, Toledo, OH, USA; 5Institut Gustave Roussy, Drug Development Department, Paris, France; 6Henry Ford Health System, Neurology Department, Detroit, MI, USA; 7Vall d’Hebron University Hospital, Medical Oncology Department, Barcelona, Spain; 8University Hospital 12 de Octubre, CNIO, Universidad Complutense & Ciberonc, Medical Oncology Department, Madrid, Spain; 9Centro Integral Oncológico Clara Campal, Oncology Department, Madrid, Spain; 10Memorial Sloan Kettering Cancer Center, Department of Medicine, New York, NY, USA; 11The University of Texas MD Anderson Cancer Center, Department of Thoracic/Head and Neck Medical Oncology, Houston, TX, USA; 12University of Michigan, Urology Oncology, Ann Arbor, MI, USA; 13University Hospital of Cologne, Department I for Internal Medicine, Cologne, Germany; 14David Geffen School of Medicine, Neurology Department, UCLA, Los Angeles, CA, USA; 15Celgene Corporation, Translational Development Department, San Francisco, CA, USA; 16Celgene Corporation, Department of Statistics, Summit, NJ, USA; 17Celgene Corporation, Department of Pharmacology, San Diego, CA, USA; 18Sarah Cannon Research Institute, Drug Development Unit, Tennessee Oncology, Nashville, TN, USACorrespondence: Johanna C BendellSarah Cannon Research Institute, Drug Development Unit, Tennessee Oncology, 250 25th Ave North, Suite 110, Nashville, TN 37203, USATel +1 615 329 7274Email jbendell@tnonc.comPurpose: This first-in-human Phase I study investigated the safety, pharmacokinetics (PK), pharmacodynamic profile, and preliminary efficacy of CC-115, a dual inhibitor of mammalian target of rapamycin (mTOR) kinase and DNA-dependent protein kinase.Patients and Methods: Patients with advanced solid or hematologic malignancies were enrolled in dose-finding and cohort expansion phases. In dose-finding, once-daily or twice-daily (BID) ascending oral doses of CC-115 (range: 0.5–40 mg/day) in 28-day continuous cycles identified the maximum-tolerated dose for cohort expansion in 5 specified tumor types. Twelve additional patients with mixed solid tumors participated in a bioavailability substudy.Results: Forty-four patients were enrolled in the dose-finding cohort. Dose-limiting toxicity included thrombocytopenia, stomatitis, hyperglycemia, asthenia/fatigue, and increased transaminases. CC-115 10 mg BID was selected for cohort expansion (n=74) in which fatigue, nausea, and decreased appetite were the most frequent toxicities. Dose-proportional PK was found. CC-115 distributed to glioblastoma tissue (mean tumor/plasma concentration ratio: 0.713). Total exposure of CC-115 was similar under fasting and fed conditions. A patient with endometrial carcinoma remained in complete remission >4 years. Partial response (PR; n=2) and stable disease (SD; n=4) were reported in the bioavailability substudy; SD was reached in 53%, 22%, 21%, and 64% of patients with head and neck squamous cell carcinoma, Ewing sarcoma, glioblastoma multiforme, and castration-resistant prostate cancer, respectively. Chronic lymphocytic leukemia/small lymphocytic lymphoma showed 38% PR and 25% SD.Conclusion: CC-115 was well-tolerated, with toxicities consistent with mTOR inhibitors. Together with biomarker inhibition and preliminary efficacy, oral CC-115 10 mg BID is a promising novel anticancer treatment.Clinical trial registration: NCT01353625.Keywords: CC-115, mTORC1/mTORC2, mTOR inhibitor, DNA-PK inhibitor, Phase I study

Published
2019

11. Outcomes of long-term responders to anti-programmed death 1 and anti-programmed death ligand 1 when being rechallenged with the same anti-programmed death 1 and anti-programmed death ligand 1 at progression

Author

Bernard-Tessier, A., Baldini, C., Martin, Patricia, Champiat, Stéphane, Hollebecque, Antoine, Postel-Vinay, Sophie, Varga, Andrea, Bahleda, Rastilav, Gazzah, Anas, Michot, Jean-Marie, Ribrag, Vincent, Armand, Jean-Pierre, Marabelle, Aurélien, Soria, Jean-Charles, and Massard, C.

Published
2018
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17. 86P Validation of the Gustave Roussy Immune (GRIm) score in patients treated with bispecific CD3 T cell engagers in phase I clinical trials

Author

Herbel, N., primary, Goldschmidt, V., additional, Michot, J-M., additional, Laparra, A., additional, Géraud, A., additional, Ouali, K., additional, Danlos, F-X., additional, Martin Romano, P., additional, Vuagnat, P., additional, Bernard-Tessier, A., additional, Gazzah, A., additional, Bahleda, R., additional, Hollebecque, A., additional, Marabelle, A., additional, Postel-Vinay, S., additional, Massard, C., additional, Ribrag, V., additional, Ponce Aix, S., additional, Champiat, S., additional, and Baldini, C., additional

Published
2023
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19. Photoactive TiO2 antibacterial coating on surgical external fixation pins for clinical application

Author

Villatte G, Massard C, Descamps S, Sibaud Y, Forestier C, and Awitor KO

Subjects
Medicine (General), R5-920
Abstract

Guillaume Villatte,1,2 Christophe Massard,1 Stéphane Descamps,1,2 Yves Sibaud,1 Christiane Forestier,3 Komla-Oscar Awitor1 1Laboratory C-Biosenss EA 4676, Clermont-Ferrand University, Université d’Auvergne, Clermont-Ferrand, France; 2Department of Orthopedics, Clermont-Ferrand University Hospital (CHU), Clermont-Ferrand, France; 3Laboratory Microorganism UMR 6023, Clermont-Ferrand University, Université d’Auvergne, Clermont-Ferrand, France Abstract: External fixation is a method of osteosynthesis currently used in traumatology and orthopedic surgery. Pin tract infection is a common problem in clinical practice. Infection occurs after bacterial colonization of the pin due to its contact with skin and the local environment. One way to prevent such local contamination is to create a specific coating that could be applied in the medical field. In this work, we developed a surface coating for external fixator pins based on the photocatalytic properties of titanium dioxide, producing a bactericidal effect with sufficient mechanical strength to be compatible with surgical use. The morphology and structure of the sol-gel coating layers were characterized using, respectively, scanning electron microscopy and X-ray diffraction. The resistance properties of the coating were investigated by mechanical testing. Photodegradation of acid orange 7 in aqueous solution was used as a probe to assess the photocatalytic activity of the titanium dioxide layers under ultraviolet irradiation. The bactericidal effect induced by the process was evaluated against two strains, ie, Staphylococcus aureus and multiresistant Staphylococcus epidermidis. The coated pins showed good mechanical strength and an efficient antibacterial effect after 1 hour of ultraviolet irradiation. Keywords: hybrid sol-gel, external pin fixation, titanium dioxide, antibacterial effect, mechanical strength, ultraviolet photoactivity

Published
2015

20. Essais précoces pour les patients porteurs de corticosurrénalomes avancés : étude rétrospective au sein du réseau endocan-comete

Author

Hescot, S., primary, Debien, V., additional, Libe, R., additional, Drui, D., additional, Haissaguerre, M., additional, De La Fouchardiere, C., additional, Sajous, C., additional, Vezzosi, D., additional, Laboureau, S., additional, Do Cao, C., additional, Decoudier, B., additional, Florence, E., additional, Sylvie, Z., additional, Raingeard, I., additional, Le Tourneau, C., additional, Baudin, E., additional, Massard, C., additional, and Du Rusquec, P., additional

Published
2022
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21. Use of the Geriatric Core Dataset for older patients included in early phase trials

Author

Seknazi, L., primary, Goldschmidt, V., additional, Champiat, S., additional, Hollebecque, A., additional, Martin-Romano, P., additional, Bahleda, R., additional, Gazzah, A., additional, Michot, J.M., additional, Sarkozy, C., additional, Vuagnat, P., additional, Ouali, K., additional, Bayle, A., additional, Danlos, F.X., additional, Mahjoubi, L., additional, Massard, C., additional, Ponce Aix, S., additional, Paillaud, E., additional, and Baldini, C., additional

Published
2022
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23. Prognostic impact of progression to induction chemotherapy and prior paclitaxel therapy in patients with germ cell tumors receiving salvage high-dose chemotherapy in the last 10 years: a study of the European Society for Blood and Marrow Transplantation Solid Tumors Working Party

Author

Necchi, A, Miceli, R, Bregni, M, Bokemeyer, C, Berger, L A, Oechsle, K, Schumacher, K, Kanfer, E, Bourhis, J H, Massard, C, Laszlo, D, Montoro, J, Flechon, A, Arpaci, F, Secondino, S, Wuchter, P, Dreger, P, Crysandt, M, Worel, N, Kruger, W, Ringhoffer, M, Unal, A, Nagler, A, Campos, A, Wahlin, A, Michieli, M, Sucak, G, Donnini, I, Schots, R, Ifrah, N, Badoglio, M, Martino, M, Raggi, D, Giannatempo, P, Rosti, G, Pedrazzoli, P, and Lanza, F

Published
2016
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24. 1405P Circulating tumor DNA in advanced prostate cancer: Focus on high blood tumor mutational burden (h-bTMB)

Author

Guillaume, Z., primary, Bayle, A., additional, Pobel, C., additional, Lacroix, L., additional, Vasseur, D., additional, Albiges, L., additional, Colomba, E., additional, Flippot, R., additional, Naoun, N., additional, Patrikidou, A., additional, Goldschmidt, V., additional, Vuagnat, P., additional, Massard, C., additional, Ponce, S., additional, Fizazi, K., additional, Loriot, Y., additional, Baldini, C., additional, Italiano, A., additional, and Bernard-Tessier, A., additional

Published
2022
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25. P1.16-02 Clinical Utility of ctDNA in Advanced NSCLC at Diagnosis or Where Insufficient Tissue Was Available, Based on the ESMO ESCAT Scale

Author

Mezquita, L., primary, Riudavets, M., additional, Garcia de Herreros, M., additional, Auclin, E., additional, Dorta, M., additional, Albarran, V., additional, Aldea, M., additional, Naltet, C., additional, Grecea, M., additional, Martin-Romano, P., additional, Lacroix, L.L., additional, Nicotra, C., additional, Arcocha, A., additional, Gazzah, A., additional, Pipinikas, C., additional, Morris, C., additional, Howarth, K., additional, Teixidó, C., additional, Reyes, R., additional, Viñolas, N., additional, Massard, C., additional, Barlesi, F., additional, Planchard, D., additional, and Besse, B., additional

Published
2022
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26. 1661MO Genomic somatic copy number alterations drive adaptive tumor immune suppression and primary resistance to anti-PD1 + anti-angiogenics in pleural mesothelioma

Author

Danlos, F-X, primary, Baldini, C., additional, Texier, M., additional, Varga, A., additional, Mouraud, S., additional, Job, B., additional, Letourneur, D., additional, Cassard, L., additional, Bredel, D., additional, Laghouati, S., additional, Adam, J., additional, Droin, N., additional, Parpaleix, A., additional, Chaput-Gras, N., additional, Rabeau, A., additional, Massard, C., additional, Soria, J-C., additional, Zalcman, G., additional, Planchard, D., additional, and Marabelle, A., additional

Published
2022
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27. Isatuximab plus atezolizumab in patients with advanced solid tumors:results from a phase I/II, open-label, multicenter study

Author

Simonelli, M., Garralda, E., Eskens, F., Gil-Martin, M., Yen, C. J., Obermannova, R., Chao, Y., Lonardi, S., Melichar, B., Moreno, V., Yu, M. L., Bongiovanni, A., Calvo, E., Rottey, S., Machiels, J. P., Gonzalez-Martin, A., Paz-Ares, L., Chang, C. L., Mason, W., Lin, C. C., Reardon, D. A., Vieito, M., Santoro, A., Meng, R., Abbadessa, G., Menas, F., Lee, H., Liu, Q., Combeau, C., Ternes, N., Ziti-Ljajic, S., Massard, C., Simonelli, M., Garralda, E., Eskens, F., Gil-Martin, M., Yen, C. J., Obermannova, R., Chao, Y., Lonardi, S., Melichar, B., Moreno, V., Yu, M. L., Bongiovanni, A., Calvo, E., Rottey, S., Machiels, J. P., Gonzalez-Martin, A., Paz-Ares, L., Chang, C. L., Mason, W., Lin, C. C., Reardon, D. A., Vieito, M., Santoro, A., Meng, R., Abbadessa, G., Menas, F., Lee, H., Liu, Q., Combeau, C., Ternes, N., Ziti-Ljajic, S., and Massard, C.

Abstract

Background: The anti-CD38 antibody isatuximab is approved for the treatment of relapsed/refractory multiple myeloma, but there are no data on its efficacy in solid tumors. This phase I/II study (NCT03637764) assessed the safety and activity of isatuximab plus atezolizumab (Isa + Atezo), an anti-programmed death-ligand 1 (PD-L1) antibody, in patients with immunotherapy-naive solid tumors: epithelial ovarian cancer (EOC), glioblastoma (GBM), hepatocellular carcinoma (HCC), and squamous cell carcinoma of the head and neck (SCCHN). Patients and methods: Phase I assessed safety, tolerability, pharmacokinetics, pharmacodynamics, and the recommended phase II dose (RP2D) of isatuximab 10 mg/kg intravenously (i.v.) every week for 3 weeks followed by once every 3 weeks + atezolizumab 1200 mg i.v. every 3 weeks. Phase II used a Simon's two-stage design to assess the overall response rate or progression-free survival rate at 6 months (GBM cohort). Interim analysis was carried out at 6 months following first dose of the last enrolled patient in each cohort. Pharmacodynamic biomarkers were tested for CD38, PD-L1, tumor-infiltrating immune cells, and FOXP3+ regulatory T cells (Tregs) in the tumor microenvironment (TME). Results: Overall, 107 patients were treated (EOC, n = 18; GBM, n = 33; HCC, n = 27; SCCHN, n = 29). In phase I, Isa + Atezo showed an acceptable safety profile, no dose-limiting toxicities were observed, and RP2D was confirmed. Most patients experienced ≥1 treatment-emergent adverse event (TEAE), with ≤48.5% being grade ≥3. The most frequent TEAE was infusion reactions. The study did not continue to stage 2 based on prespecified targets. Tumor-infiltrating CD38+ immune cells were reduced and almost cleared after treatment. Isa + Atezo did not significantly modulate Tregs or PD-L1 expression in the TME. Conclusions: Isa + Atezo had acceptable safety and tolerability. Clinical pharmacodynamic evaluation revealed efficient target engagement of isatuximab via treatm

Published
2022

29. Early phase trials in soft-tissue sarcomas: clinical benefit of inclusion in early lines of treatment, molecular screening, and histology-driven trials

Author

Nassif, E.F., primary, Blay, J.-Y., additional, Massard, C., additional, Dufresne, A., additional, Brahmi, M., additional, Cassier, P., additional, Ray-Coquard, I., additional, Pautier, P., additional, Leary, A., additional, Sunyach, M.-P., additional, Bahleda, R., additional, Levy, A., additional, Le Pechoux, C., additional, Honoré, C., additional, Mir, O., additional, and Le Cesne, A., additional

Published
2022
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30. Entitäten-unabhängige Sicherheit und Wirksamkeit von Erdafitinib bei Patienten mit fortgeschrittenen soliden Tumoren mit präspezifizierten genomischen FGFR- Aberrationen (RAGNAR Interimanalyse)

Author

Schuler, Martin, Loriot, Y., Iyer, G., Witt, O., Doi, T., Qin, S., Tabernero, J., Reardon, D. A., Massard, C., Palmer, D. H., Lugowska, I., Coward, J., Corassa, M., Stuyckens, K., Liao, H., Najmi, S., Hammond, C., Santiago-Walker, A. E., Sweiti, H., and Pant, S.

Subjects
Medizin
Published
2022

33. 15P STELLAR-001: A phase I study of the anti-C5aR avdoralimab in combination with the anti-PD-L1 durvalumab in advanced solid tumors

Author

Bennouna, J., primary, Touchefeu, Y., additional, Ghiringhelli, F., additional, Isambert, N., additional, Barlesi, F., additional, Tomasini, P., additional, Cassier, P., additional, Edeline, J., additional, Le Sourd, S.M., additional, Tosi, D., additional, Tolcher, A.W., additional, Marron, T., additional, Marie, D.B., additional, Viotti, J., additional, Boyer Chammard, A., additional, Martin Romano, P., additional, and Massard, C., additional

Published
2022
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44. 83P Association of lung immune prognostic index (LIPI) with progression-free survival (PFS) in soft-tissue sarcoma (STS) patients treated with immunotherapy (IO) in early phase trials

Author

Nassif, E., primary, Le Cesne, A., additional, Massard, C., additional, Mezquita, L., additional, Roulleaux Dugage, M., additional, Bahleda, R., additional, Dufresne, A., additional, Brahmi, M., additional, Ray-Coquard, I., additional, Pautier, P., additional, Leary, A., additional, Levy, A., additional, Le Pechoux, C., additional, Honoré, C., additional, Mir, O., additional, Besse, B., additional, Blay, J-Y., additional, and Auclin, E., additional

Published
2021
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45. Detection of additional occult malignancy through profiling of ctDNA in late-stage cancer patients

Author

Aldea, M., primary, Cerbone, L., additional, Bayle, A., additional, Parisi, C., additional, Sarkozy, C., additional, Vasseur, D., additional, Verlingue, L., additional, Blanc-Durand, F., additional, Mosele, F., additional, Sakkal, M., additional, Ponce, S., additional, Lavaud, P., additional, Loriot, Y., additional, Hollebecque, A., additional, Massard, C., additional, Soria, J.-C., additional, Lacroix, L., additional, Rouleau, E., additional, and Italiano, A., additional

Published
2021
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46. Plasma proteomics identifies leukemia inhibitory factor (LIF) as a novel predictive biomarker of immune-checkpoint blockade resistance

Author

Loriot, Y., primary, Marabelle, A., additional, Guégan, J.P., additional, Danlos, F.X., additional, Besse, B., additional, Chaput, N., additional, Massard, C., additional, Planchard, D., additional, Robert, C., additional, Even, C., additional, Khettab, M., additional, Tselikas, L., additional, Friboulet, L., additional, André, F., additional, Nafia, I., additional, Le Loarer, F., additional, Soria, J.C., additional, Bessede, A., additional, and Italiano, A., additional

Published
2021
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48. Durvalumab for the management of urothelial carcinoma: a short review on the emerging data and therapeutic potential

Author

Baldini C, Champiat S, Vuagnat P, and Massard C

Subjects
Bladder cancer, Urothelial carcinoma, Immunotherapy, Durvalumab, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, PD-L1 inhibitor, lcsh:RC254-282
Abstract

Capucine Baldini, Stéphane Champiat, Perrine Vuagnat, Christophe Massard Drug Development Department, Gustave Roussy Cancer Campus, Université Paris-Saclay, Villejuif, France Abstract: Urothelial carcinoma (UC) is the second most frequent urogenital malignancy with high incidence in the United States and Europe. Despite poor prognosis, new treatments have emerged with great efficacy and safety such as immune checkpoint inhibitors. Durvalumab, an anti Programmed Death Ligand 1, has been given breakthrough in UC in 2017 in patients who have disease progression during or following platinum-containing chemotherapy or who have disease progression Keywords: immunotherapy, PD-L1 inhibitor, durvalumab, urothelial carcinoma, bladder cancer

Published
2019

49. Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project†

Author

Kramar, A., Negrier, S., Sylvester, R., Joniau, S., Mulders, P., Powles, T., Bex, A., Bonnetain, F., Bossi, A., Bracarda, S., Bukowski, R., Catto, J., Choueiri, T. K., Crabb, S., Eisen, T., El Demery, M., Fitzpatrick, J., Flamand, V., Goebell, P. J., Gravis, G., Houédé, N., Jacqmin, D., Kaplan, R., Malavaud, B., Massard, C., Melichar, B., Mourey, L., Nathan, P., Pasquier, D., Porta, C., Pouessel, D., Quinn, D., Ravaud, A., Rolland, F., Schmidinger, M., Tombal, B., Tosi, D., Vauleon, E., Volpe, A., Wolter, P., Escudier, B., Filleron, T., Kramar, Andrew, Sylvester, Richard, Filleron, Thomas, Negrier, Sylvie, Joniau, Steven, Mulders, Peter, Powles, Thomas, Escudier, Bernard, Bex, Axel, Bonnetain, Franck, Bossi, Alberto, Braccarda, Sergio, Bukowski, Ronald, Catto, James, Choueiri, Toni, Crabb, Simon, Eisen, Tim, El Demery, Mounira, Fitzpatrick, John, Flamand, Vincent, Goebell, Peter J., Gravis, Gwendael, Houédé, Nadine, Jacqmin, Didier, Kaplan, Richard, Malavaud, Bernard, Massard, Christophe, Melichar, Bohuslav, Mourey, Loïc, Nathan, Paul, Pasquier, David, Porta, Camillo, Pouessel, Damien, Quinn, David, Ravaud, Alain, Rolland, Frédéric, Schmidinger, Manuela, Tombal, Bertrand, Tosi, Diego, Vauleon, Elodie, Volpe, Alessandro, and Wolter, Pascal

Published
2015
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