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1. 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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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., 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

4. 748P Real-world-data (RWD) on platinum (Pt)-based chemotherapy (CT) after PARP inhibitors (PARPi) in high-grade serous (or endometrioid) ovarian cancer (HGSEOC)

Author

Romeo Marin, M., primary, Gil-Martin, M., additional, Gaba Garcia, L., additional, Fina, C., additional, Taus, Á., additional, Murata, P., additional, Masvidal, M., additional, Martinez, A., additional, Fernández-Plana, J., additional, García, Y., additional, Pérez, C., additional, Cros Costa, S., additional, Rodriguez, V., additional, Zanui, M., additional, Catot, S., additional, Plaja, A., additional, Teruel, I., additional, Pardo Búrdalo, B., additional, Barretina-Ginesta, M-P., additional, and Esteve, A.M., additional

Published
2021
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5. LBA-5 Phase Ib study of the anti-TIGIT antibody tiragolumab in combination with atezolizumab in patients with metastatic esophageal cancer

Author

Wainberg, Z., primary, Matos, I., additional, Delord, J., additional, Cassier, P., additional, Gil-Martin, M., additional, Kim, T., additional, LoRusso, P., additional, Bahleda, R., additional, Italiano, A., additional, Mendus, D., additional, Hoang, T., additional, Xue, C., additional, Wen, X., additional, Carvalho, O., additional, Pham, T., additional, Patil, N., additional, Meng, R., additional, Bendell, J., additional, Cervantes, A., additional, and Cho, B., additional

Published
2021
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6. LBA41 Durvalumab (durva) plus carboplatin/paclitaxel (CP) followed by maintenance (mtx) durva ± olaparib (ola) as a first-line (1L) treatment for newly diagnosed advanced or recurrent endometrial cancer (EC): Results from the phase III DUO-E/GOG-3041/ENGOT-EN10 trial

Author

Westin, S.N., Moore, K.N., Chon, H.S., Lee, J-Y., Thomes Pepin, J., Sundborg, M., de la Garza, J., Nishio, S., Wang, K., Mcintyre, K., Tillmanns, T., Contreras Mejia, F., de Melo, A.C., Klasa-Mazurkiewicz, D., Papadimitriou, C.A., Gil Martín, M., Brasiuniene, B., Donnelly, C., Liu, X., and Van Nieuwenhuysen, E.

Published
2023
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7. 1712P Implementation of a molecular pre-screening program (MPP) in a network of public cancer centres for phase I clinical trial (Ph1-CT) candidates: The PREICO program

Author

Soto Castillo, J.J., Notario Rincon, L., Azuara, D., Ruffinelli, J.C., Stradella, A., Oliva Bernal, M., Calvo Campos, M., Jové, M., Llop Serna, S., Villanueva Vazquez, R., Cuadra Amor, C., Bergamino, M.A., Teixidor Vilà, E., Villatoro Gómez, S., González Acosta, M., Fina Planas, C., Hierro, C., Gil Martín, M., Lazaro, C., and Martin-Liberal, J.

Published
2023
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8. 761P A phase II trial of avelumab in combination with pegylated liposomal doxorubicin in recurrent/metastatic endometrial cancer (GEICO 70-E): analysis according to molecular classification

Author

Piulats Rodriguez, J.M., Palacio Vazquez, I., Alarcon, J.D., Gatius, S., Marin Jimenez, J.A., Gil Martín, M., Márquez Aragonés, A., Santacana, M., Manso Sanchez, L.M., Hernando Polo, S., Ruiz, N., Matias-Guiu, X., Romeo Marin, M., Navarro Garces, V., and Barbarroja, P.

Published
2023
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9. A randomised double-blind placebo-controlled phase II trial of palbociclib combined with letrozole (L) in patients (pts) with oestrogen receptor-positive (ER plus ) advanced/recurrent endometrial cancer (EC): NSGO-PALEO / ENGOT-EN3 trial

Author

Mirza, M. R., Bjorge, L., Marme, F., Christensen, R. DePont, Gil-Martin, M., Auranen, A., Ataseven, B., Rubio, M. J., Salutari, V., Lund, B., Runnebaum, I., Redondo, A., Lindemann, K., Trillsch, F., Barretina Ginesta, M. P., Roed, H., Lohndorf, J., Nyvang, G-B., and Sehouli, J.

Published
2020
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11. PD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical cancer

Author

Rischin, D, Gil-Martin, M, Gonzalez-Martin, A, Brana, I, Hou, JY, Cho, D, Falchook, GS, Formenti, S, Jabbour, S, Moore, K, Naing, A, Papadopoulos, KP, Baranda, J, Fury, W, Feng, M, Stankevich, E, Li, J, Yama-Dang, NA, Yoo, S-Y, Lowy, I, Mathias, M, Fury, MG, Rischin, D, Gil-Martin, M, Gonzalez-Martin, A, Brana, I, Hou, JY, Cho, D, Falchook, GS, Formenti, S, Jabbour, S, Moore, K, Naing, A, Papadopoulos, KP, Baranda, J, Fury, W, Feng, M, Stankevich, E, Li, J, Yama-Dang, NA, Yoo, S-Y, Lowy, I, Mathias, M, and Fury, MG

Abstract

OBJECTIVES: To characterize the safety, tolerability, and anti-tumor activity of cemiplimab as monotherapy or in combination with hypofractionated radiation therapy (hfRT) in patients with recurrent or metastatic cervical cancer. To determine the association between histology and programmed death-ligand 1 (PD-L1) expression. METHODS: In non-randomized phase I expansion cohorts, patients (squamous or non-squamous histology) received cemiplimab 3 mg/kg intravenously every 2 weeks for 48 weeks, either alone (monotherapy cohort) or with hfRT during week 2 (combination cohort). Due to insufficient tissue material, PD-L1 protein expression was evaluated in commercially purchased samples and mRNA expression levels were analyzed from The Cancer Genome Atlas (TCGA). RESULTS: Twenty patients enrolled in both cohorts in total; 10 had squamous histology. The most common adverse events of any grade were diarrhea, fatigue, and hypokalemia, occurring in 35%, 25%, and 25%, respectively. Objective response rate was 10% in each cohort; responders had squamous histology. Duration of response was 11.2 months and 6.4 months for the responder in the monotherapy and combination cohort, respectively. Irradiated lesions were not included in the response assessments. In separate archived specimens (N = 155), PD-L1 protein expression in tumor and immune cells was negative (<1%) more commonly in adenocarcinoma than in squamous tumors. PD-L1 mRNA levels were lower in adenocarcinoma than squamous cell tumors (1.2 vs 5.0 mean transcripts per million, respectively) in TCGA. CONCLUSIONS: Cemiplimab has activity in cervical squamous cell carcinoma. The phase I results, combined with results from other anti-PD-1 trials in cervical cancer and our biomarker analyses have informed the design of the ongoing phase III trial, with the primary overall survival hierarchical analyses being done first in patients with squamous histology.

Published
2020

12. 864P Phase II of ABTL0812, a pro-autophagic drug, in combination with paclitaxel and carboplatin (P/C) as first-line treatment in advanced/recurrent endometrial cancer

Author

Leary, A., primary, Estévez-García, P., additional, Sabatier, R., additional, Fariñas-Madrid, L., additional, Pérez-Fidalgo, J.A., additional, Romeo, M., additional, Barretina Ginesta, M.P., additional, Gil-Martin, M., additional, Garralda, E., additional, Rodon, J., additional, Lizcano, J.M., additional, Muñoz Guardiola, P., additional, Pérez-Montoyo, H., additional, Yeste-Velasco, M., additional, Cortal, M., additional, Domènech, C., additional, Alfon, J., additional, Ray-Coquard, I.L., additional, and Oaknin, A., additional

Published
2020
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13. LBA28 A randomised double-blind placebo-controlled phase II trial of palbociclib combined with letrozole (L) in patients (pts) with oestrogen receptor-positive (ER+) advanced/recurrent endometrial cancer (EC): NSGO-PALEO / ENGOT-EN3 trial

Author

Mirza, M.R., primary, Bjørge, L., additional, Marmé, F., additional, DePont Christensen, R., additional, Gil-Martin, M., additional, Auranen, A., additional, Ataseven, B., additional, Rubio, M.J., additional, Salutari, V., additional, Lund, B., additional, Runnebaum, I., additional, Redondo, A., additional, Lindemann, K., additional, Trillsch, F., additional, Barretina Ginesta, M.P., additional, Roed, H., additional, Løhndorf, J., additional, Nyvang, G-B., additional, and Sehouli, J., additional

Published
2020
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14. 477P Genomically-matched therapy in refractory CRC according to ESCAT

Author

Margalef, N. Mulet, primary, Castillo, C., additional, Mosteiro, M., additional, Martinez, J. Perez, additional, PAdrol, I., additional, Aguilar, S., additional, Villacampa, M. Martinez, additional, Rodriguez, J.C. Ruffinelli, additional, Losa, F., additional, Vega, A. Teulé, additional, Soler, G., additional, Castany, R., additional, Capdevila, F., additional, Gil-Martin, M., additional, Cuadra, C., additional, Elez, E., additional, Garralda, E., additional, Salazar, R., additional, Dienstmann, R., additional, and Santos, C., additional

Published
2020
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15. 824P Real-world-data (RWD) on platinum (Pt) outcomes after PARP inhibitors (PARPi) progression in high grade serous ovarian cancer (HGSOC) patients (p)

Author

Plaja Salarich, A., primary, Teruel García, I., additional, Pardo Burdalo, B., additional, Gil-Martin, M., additional, Piulats, J.M., additional, Fina Planas, C., additional, Barretina Ginesta, M.P., additional, Ferrando Diez, A., additional, Notario Rincon, L., additional, Pous Badia, A., additional, Gonzalez Valencia, A., additional, Esteve Gomez, A., additional, and Romeo Marin, M., additional

Published
2020
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16. A phase 1 dose-escalation with expansion study of the antibody-drug conjugate trastuzumab duocarmazine (SYD985) in locally advanced and metastatic solid tumours and HER2-expressing breast cancer

Author

Banerji, U, Van Herpen, C, Saura, C, Thistlethwaite, F, Lord, S, Moreno, V, Macpherson, I, Boni, V, Rolfo, C, De Vries, E, Rottey, S, Geenen, J, Eskens, F, Gil-Martin, M, Mommers, E, Koper, N, Aftimos, P, and Cox, A

Abstract

Background: Trastuzumab duocarmazine is a novel HER2-targeting antibody-drug conjugate comprised of trastuzumab covalently bound to a linker-drug containing duocarmycin. Preclinical studies showed impressive antitumour activity in various models. In this first-in-human study we evaluated the safety and activity in patients with solid tumours. Methods: In the dose-escalation part, patients aged 18 years or older with locally advanced or metastatic solid tumours with variable HER2 status and refractory to standard therapy were enrolled. The expansion cohorts included patients with breast, gastric, urothelial, or endometrial cancer with at least HER2 immunohistochemistry 1+ expression and measurable disease according to RECIST. Trastuzumab duocarmazine was administered intravenously on day 1 of each 3-week cycle at doses of 0·3 to 2·4 mg/kg until disease progression or unacceptable toxicity. A 3+3 design was used in the dose-escalation part and the primary endpoint was to evaluate safety and determine the recommended phase 2 dose. The primary endpoint of the expansion part was the proportion of patients who achieved an objective response. This ongoing study is registered with ClinicalTrials.gov, number NCT02277717, and is fully recruited. Findings: Between October 30, 2014 and April 2, 2018, 39 patients were enrolled and treated in the dose-escalation part and 146 patients in the expansion part of the study. One dose-limiting toxicity (fatal pneumonitis) occurred at the highest administered dose. Grade ≥ 3 treatment-related adverse events reported more than once were keratitis (three patients) and fatigue (two patients). Based on all available data, the recommended phase 2 dose was set at 1·2 mg/kg. In de expansion part of the study, treatment-related serious adverse events were reported in 16 (11%) of 146 patients. The most common treatment-related adverse events were fatigue (48 [33%] of 146 patients), conjunctivitis (45 [31%]), and dry eye (45 [31%]). The majority of patients had one or more ocular adverse events, with grade 3 events in 10 (7%) of 146 patients. In the breast cancer expansion cohorts, 16 (33%, 95% CI 20·4-48·4) of 48 evaluable patients with HER2-positive breast cancer achieved an objective response. The proportion of patients with HER2-low, HR-positive breast cancer who achieved an objective response was 28% (95% CI 13·8-46·8; nine of 32 patients) and for patients with HER2-low, HR-negative breast cancer 40% (95% CI 16·3-67·6; six of 15 patients). Responses were also observed in one (6%; 95% CI 0·2-30·2) of 16 gastric cancer, four (25%; 95% CI 7·3-52·4) of 16 urothelial cancer, and five (39%; 95% CI 13·9-68·4) of 13 endometrial cancer patients. Interpretation: Trastuzumab duocarmazine has shown important clinical activity in heavily pretreated patients with HER2-expressing metastatic cancer, including HER2-positive trastuzumab emtansine-resistant and HER2-low breast cancer, with a manageable safety profile.

Published
2019

17. Efficacy and safety results from GEICO 1205, a randomized phase II trial of neoadjuvant chemotherapy with or without bevacizumab for advanced epithelial ovarian cancer

Author

Garcia, YG, Ferre, AD, Mendiola, C, Barretina-Ginesta, MP, Garcia, LG, Bertran, AS, Barcelo, IB, Gil-Martin, M, Manzano, A, Perez, MJR, Marin, MR, Nunez, CA, Garcia-Martinez, E, and Martin, AG

Subjects
ovarian cancer, interval debulking surgery, bevacizumab, complete macroscopic response rate, neoadjuvant chemotherapy
Abstract

Background Bevacizumab is an approved treatment after primary debulking surgery for ovarian cancer. However, there is limited information on bevacizumab added to neoadjuvant chemotherapy before interval debulking surgery. Objective To evaluate neoadjuvant bevacizumab in a randomized phase II trial. Methods Patients with newly diagnosed stage III/IV high-grade serous/endometrioid ovarian cancer were randomized to receive four cycles of neoadjuvant chemotherapy with or without >= 3 cycles of bevacizumab 15 mg/kg every 3 weeks. After interval debulking surgery, all patients received post-operative chemotherapy (three cycles) and bevacizumab for 15 months. The primary end point was complete macroscopic response rate at interval debulking surgery. Results Of 68 patients randomized, 64 completed four neoadjuvant cycles; 22 of 33 (67%) in the chemotherapy-alone arm and 31 of 35 (89%) in the bevacizumab arm (p=0.029) underwent surgery. The complete macroscopic response rate did not differ between treatment arms in either the intention-to-treat population of 68 patients (6.1% vs 5.7%, respectively; p=0.25) or the 55 patients who underwent surgery (8.3% vs 6.5%; p=1.00). There was no difference in complete cytoreduction rate or progression-free survival between the treatment arms. During neoadjuvant therapy, grade >= 3 adverse events were more common with chemotherapy alone than with bevacizumab (61% vs 29%, respectively; p=0.008). Intestinal (sub)occlusion, fatigue/asthenia, abdominal infection, and thrombocytopenia were less frequent with bevacizumab. The incidence of grade >= 3 adverse events was 9% in the control arm versus 16% in the experimental arm in the month after surgery. Conclusions Adding three to four pre-operative cycles of bevacizumab to neoadjuvant chemotherapy for unresectable disease did not improve the complete macroscopic response rate or surgical outcome, but improved surgical operability without increasing toxicity. These results support the early integration of bevacizumab in carefully selected high-risk patients requiring neoadjuvant chemotherapy for initially unresectable ovarian cancer.

Published
2019

18. 583P Aurora kinase overexpression may play a role in PARPi resistance in tumor samples of patients with high grade ovarian cancer and its inhibition with alisertib overcomes resistance to olaparib in a PARPi-resistant cell line model

Author

Perez Fidalgo, J.A., Martinez Pretel, J.J., Heredia, V., Romeo Marin, M., Mendiola, M., Hochstadt, J., Bernat, A., Sanchez-Serrano, P., Redondo Sanchez, A., Gil Martín, M., Guerra Ojeda, S., Teruel, I., Burgués, O., Cervantes, A., and Pineda Merlo, B.

Published
2022
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20. Abstract PD1-02: Withdrawn

Author

Cortes, J, primary, Martin, M, additional, Pernas, S, additional, Gomez Pardo, P, additional, Lopez-Tarruella, S, additional, Gil-Martin, M, additional, Manso, L, additional, Ciruelos, E, additional, Perez-Fidalgo, JA, additional, Hernando, C, additional, Ademuyiwa, FO, additional, Weilbaecher, K, additional, Mayer, I, additional, Pluard, TJ, additional, Martinez Garcia, M, additional, Vahdat, L, additional, Wach, A, additional, Barker, D, additional, Romagnoli, B, additional, and Kaufman, PA, additional

Published
2019
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21. Cemiplimab, a human PD-1 monoclonal antibody, in patients (pts) with recurrent or metastatic cervical cancer: Interim data from phase I cohorts

Author

Rischin, D., primary, Gil-Martin, M., additional, González-Martin, A., additional, Brana, I., additional, Hou, J.Y., additional, Cho, D., additional, Falchook, G., additional, Formenti, S., additional, Jabbour, S., additional, Moore, K., additional, Naing, A., additional, Papadopoulos, K.P., additional, Baranda, J., additional, Weise, A., additional, Fury, M.G., additional, Feng, M., additional, Li, J., additional, Lowy, I., additional, and Mathias, M., additional

Published
2018
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22. Cemiplimab, a human monoclonal anti-PD-1, plus radiotherapy (RT) in advanced non-small cell lung cancer (NSCLC): Results from a phase I expansion cohort (EC 2)

Author

Moreno, V., primary, Gil-Martin, M., additional, Johnson, M.L., additional, Aljumaily, R., additional, Lopez Criado, P., additional, Northfelt, D.W., additional, Crittenden, M., additional, Jabbour, S., additional, Rosen, L., additional, Garrido, P., additional, Hervás Morón, A., additional, Rietschel, P., additional, Mohan, K.K., additional, Li, J., additional, Stankevich, E., additional, Feng, M., additional, Lowy, I., additional, and Fury, M.G., additional

Published
2018
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23. Cemiplimab, a human monoclonal anti-PD-1, in patients (pts) with advanced or metastatic hepatocellular carcinoma (HCC): Data from an expansion cohort (EC) in a phase I study

Author

He, A.R., primary, Weiss, G.J., additional, Falchook, G., additional, Yee, N.S., additional, Gil-Martin, M., additional, Shahda, S., additional, Moreno, V., additional, Brana, I., additional, Crittenden, M., additional, Formenti, S., additional, Al-Rajabi, R., additional, Papadopoulos, K.P., additional, Pishvaian, M.J., additional, Stankevich, E., additional, Feng, M., additional, Li, J., additional, Mathias, M., additional, Kroog, G., additional, Lowy, I., additional, and Fury, M.G., additional

Published
2018
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25. MA04.01 Cemiplimab, a Human Monoclonal Anti-PD-1, Alone or in Combination with Radiotherapy: Phase 1 NSCLC Expansion Cohorts

Author

Moreno, V., primary, Gil-Martin, M., additional, Johnson, M., additional, Aljumaily, R., additional, Lopez-Criado, M.P., additional, Northfelt, D., additional, Crittenden, M., additional, Jabbour, S., additional, Rosen, L., additional, Calvo, E., additional, Papadopoulos, K., additional, Garrido, P., additional, Hervás Morón, A., additional, Rietschel, P., additional, Mohan, K., additional, Li, J., additional, Stankevich, E., additional, Feng, M., additional, Lowy, I., additional, and Fury, M., additional

Published
2018
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26. Phase I study of cemiplimab, a human monoclonal anti-PD-1, in patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC): Longer follow-up efficacy and safety data

Author

Owonikoko, T.K., primary, Papadopoulos, K.P., additional, Gil-Martin, M., additional, Moreno, V., additional, Salama, A.K., additional, Calvo, E., additional, Safran, H., additional, González-Martín, A., additional, Aljumaily, R., additional, Mahadevan, D., additional, Niu, J., additional, Kal Mohan, K., additional, Li, J., additional, Stankevich, E., additional, Mathias, M., additional, Lowy, I., additional, Fury, M.G., additional, and Babiker, H.M., additional

Published
2018
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27. Cemiplimab, a human monoclonal anti-PD-1, in patients (pts) with advanced or metastatic hepatocellular carcinoma (HCC): Data from an expansion cohort in a phase I study

Author

Pishvaian, M.J., primary, Weiss, G.J., additional, Falchook, G.S., additional, Yee, N., additional, Gil-Martin, M., additional, Shahda, S., additional, Moreno, V., additional, Brana, I., additional, Crittenden, M., additional, Formenti, S., additional, Al-Rajabi, R., additional, Papadopoulos, K.P., additional, Stankevich, E., additional, Feng, M., additional, Li, J., additional, Mathias, M., additional, Kroog, G., additional, Lowy, I., additional, and Fury, M.G., additional

Published
2018
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28. Balixafortide (a novel CXCR4 inhibitor) and eribulin in HER2-neg metastatic breast cancer (MBC) patients (pts): A phase I trial

Author

Cortes Castan, J., primary, Martín, M., additional, Pernas Simon, S., additional, Gomez Pardo, P., additional, Lopez-Tarruella, S., additional, Gil Martin, M., additional, Manso, L.M., additional, Ciruelos, E.M., additional, Perez Fidalgo, J.A., additional, Hernando, C., additional, Ademuyiwa, F., additional, Weilbaecher, K., additional, Mayer, I.A., additional, Pluard, T., additional, Martinez Garcia, M., additional, Vahdat, L.T., additional, Wach, A., additional, Barker, D., additional, Romagnoli, B., additional, and Kaufman, P.A., additional

Published
2018
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29. PCN7 - A TIME WITHOUT SYMPTOMS OR TOXICITY ANALYSIS OF NIRAPARIB COMPARED WITH ROUTINE SURVEILLANCE IN THE MAINTENANCE TREATMENT OF PATIENTS WITH RECURRENT OVARIAN CANCER

Author

Mirza, M.R., primary, Walder, L., additional, Monk, B.J., additional, Tinker, A.V., additional, Mahner, S., additional, Gil-Martin, M., additional, Kalbacher, E., additional, Waters, J., additional, Wenham, R.M., additional, Malander, S., additional, Gilbert, L., additional, Sehouli, J., additional, Casado Herraez, A., additional, Hardy-Bessard, A., additional, Williams, S.J., additional, Rimel, B.J., additional, Lund, B., additional, Levy, T., additional, Guy, H., additional, and Matulonis, U.A., additional

Published
2018
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30. Impact of chemotherapy (CT) in heavily pretreated BRCA1/2 mutation carrier ovarian cancer (BMCOC) patients (pts)

Author

Rodriguez Freixinos, V., primary, Fariñas Madrid, L., additional, Gil Martin, M., additional, Barretina, P., additional, Romeo Marin, M., additional, Villacampa Javierre, G., additional, VIAPLANA, C., additional, Pardo, B., additional, Ahmed Ouahid, H., additional, Recalde, S., additional, Piulats Rodriguez, J.M., additional, Gomez, M.C., additional, Gil-Moreno, A., additional, Sala, E., additional, Martinez-Román, S., additional, Melendez, C., additional, Carballas, E., additional, Dienstmann, R., additional, and Oaknin, A., additional

Published
2017
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31. A phase II trial of dasatinib (D) in combination with trastuzumab (T) and paclitaxel (P) in the first line treatment of HER2 positive metastatic breast cancer (MBC) patients (pts): GEICAM/2010-04

Author

Ocana Fernandez, A., primary, Ruiz Borrego, M., additional, Gil Martin, M., additional, Antolin, S., additional, Atienza, M., additional, Montaño, A., additional, Ribelles, N., additional, Guerrero, A., additional, Muñoz, M., additional, Fernández-Pérez, I., additional, Urruticoechea, A., additional, Falcon Gonzalez, A., additional, Pernas Simon, S., additional, Prato Varela, J., additional, Escudero, M.J., additional, Benito, S., additional, Caballero, R., additional, Carrasco, E., additional, Rojo, F., additional, and Pandiella, A., additional

Published
2017
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32. CA-170, a first in class oral small molecule dual inhibitor of immune checkpoints PD-L1 and VISTA, demonstrates tumor growth inhibition in pre-clinical models and promotes T cell activation in Phase 1 study

Author

Powderly, J., primary, Patel, M.R., additional, Lee, J.J., additional, Brody, J., additional, Meric-Bernstam, F., additional, Hamilton, E., additional, Ponce Aix, S., additional, Garcia-Corbacho, J., additional, Bang, Y-J., additional, Ahn, M-J., additional, Rha, S.Y., additional, Kim, K-P., additional, Gil Martin, M., additional, Wang, H., additional, Lazorchak, A., additional, Wyant, T., additional, Ma, A., additional, Agarwal, S., additional, Tuck, D., additional, and Daud, A., additional

Published
2017
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34. 710P - Systemic administration of the hyaluronidase-expressing oncolytic adenovirus VCN-01 in patients with advanced or metastatic pancreatic cancer: First-in-human clinical trial

Author

Garcia-Carbonero, R., Gil Martín, M., Alvarez Gallego, R., Macarulla Mercade, T., Riesco Martinez, M.C., Guillen-Ponce, C., Vidal, N., Real, F.X., Moreno, R., Maliandi, V., Mato-Berciano, A., Bazan-Peregrino, M., Capella, G., Alemany, R., Blasi, E., Blasco, C., Cascallo, M., and Salazar, R.

Published
2019
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38. 71P - Phase I study of cemiplimab, a human monoclonal anti-PD-1, in patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC): Longer follow-up efficacy and safety data

Author

Owonikoko, T.K., Papadopoulos, K.P., Johnson, M.L., Gil Martín, M., Moreno, V., Salama, A.K., Calvo, E., Yee, N.S., Safran, H., Aljumaily, R., Mahadevan, D., Niu, J., Kal Mohan, K., Li, J., Stankevich, E., Mathias, M., Lowy, I., Fury, M.G., and Babiker, H.M.

Published
2018
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39. 1292P - Phase I study of cemiplimab, a human monoclonal anti-PD-1, in patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC): Longer follow-up efficacy and safety data

Author

Owonikoko, T.K., Papadopoulos, K.P., Gil-Martin, M., Moreno, V., Salama, A.K., Calvo, E., Safran, H., González-Martín, A., Aljumaily, R., Mahadevan, D., Niu, J., Kal Mohan, K., Li, J., Stankevich, E., Mathias, M., Lowy, I., Fury, M.G., and Babiker, H.M.

Published
2018
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43. 285PD - Balixafortide (a novel CXCR4 inhibitor) and eribulin in HER2-neg metastatic breast cancer (MBC) patients (pts): A phase I trial

Author

Cortes Castan, J., Martín, M., Pernas Simon, S., Gomez Pardo, P., Lopez-Tarruella, S., Gil Martin, M., Manso, L.M., Ciruelos, E.M., Perez Fidalgo, J.A., Hernando, C., Ademuyiwa, F., Weilbaecher, K., Mayer, I.A., Pluard, T., Martinez Garcia, M., Vahdat, L.T., Wach, A., Barker, D., Romagnoli, B., and Kaufman, P.A.

Published
2018
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45. Phase I study and preclinical efficacy evaluation of the mTOR inhibitor sirolimus plus gemcitabine in patients with advanced solid tumours

Author

Martin-Liberal, J., Gil-Martin, M., Sainz-Jaspeado, Miguel, Gonzalo, N., Rigo, R., Colom, H., Munoz, C., Tirado, O. M., Garcia del Muro, X., Martin-Liberal, J., Gil-Martin, M., Sainz-Jaspeado, Miguel, Gonzalo, N., Rigo, R., Colom, H., Munoz, C., Tirado, O. M., and Garcia del Muro, X.

Abstract

Background: We conducted a phase I study in patients with advanced solid tumours to identify the recommended dose, assess pharmacokinetics (PK), pharmacodynamic activity and preclinical antitumour efficacy of the combination of sirolimus and gemcitabine. Methods: Nineteen patients were treated with sirolimus 2 or 5mg daily and gemcitabine 800 or 1000 mg m(-2) on days 1 and 8. Dose escalation depended on dose-limiting toxicity (DLT) rate during the first 3-week period. Paired skin biopsies were evaluated for phosphorylated S6 (pS6) as marker of mTOR (mammalian target of rapamycin) inhibition. Pharmacokinetics and preclinical evaluation of efficacy using two different sarcoma cell lines and leiomyosarcoma xenografts were also conducted. Results: Three DLTs were observed: grade 3 transaminitis, grade 3 thrombocytopenia and grade 4 thrombocytopenia. Common treatment-related adverse events included anaemia, neutropenia, thrombocytopenia and transaminitis. Pharmacodynamic analyses demonstrated mTOR inhibition with sirolimus 5mg and PK showed no influence of sirolimus concentrations on gemcitabine clearance. In vitro and in vivo studies suggested mTOR pathway hyperactivation by gemcitabine that was reversed by sirolimus. Tumour growth in leiomyosarcoma xenografts was dramatically inhibited by the treatment. Conclusions: Recommended dose was sirolimus 5mg per 24 h plus gemcitabine 800 mg m(-2). Antitumour activity in preclinical sarcoma models and mTOR signalling inhibition were observed. A phase II study is currently ongoing.

Published
2014
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46. 1141PD - CA-170, a first in class oral small molecule dual inhibitor of immune checkpoints PD-L1 and VISTA, demonstrates tumor growth inhibition in pre-clinical models and promotes T cell activation in Phase 1 study

Author

Powderly, J., Patel, M.R., Lee, J.J., Brody, J., Meric-Bernstam, F., Hamilton, E., Ponce Aix, S., Garcia-Corbacho, J., Bang, Y-J., Ahn, M-J., Rha, S.Y., Kim, K-P., Gil Martin, M., Wang, H., Lazorchak, A., Wyant, T., Ma, A., Agarwal, S., Tuck, D., and Daud, A.

Published
2017
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48. 239PD - A phase II trial of dasatinib (D) in combination with trastuzumab (T) and paclitaxel (P) in the first line treatment of HER2 positive metastatic breast cancer (MBC) patients (pts): GEICAM/2010-04

Author

Ocana Fernandez, A., Ruiz Borrego, M., Gil Martin, M., Antolin, S., Atienza, M., Montaño, A., Ribelles, N., Guerrero, A., Muñoz, M., Fernández-Pérez, I., Urruticoechea, A., Falcon Gonzalez, A., Pernas Simon, S., Prato Varela, J., Escudero, M.J., Benito, S., Caballero, R., Carrasco, E., Rojo, F., and Pandiella, A.

Published
2017
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49. Impact of Demographic Characteristics, Staging Methods and Treatment in a European Locally Advanced Cervical Cancer (Lacc) Population

Author

Sanz-Garcia, E., primary, Gil-Martin, M., additional, Linossi, C., additional, Perez-Martin, X., additional, Fariñas-Madrid, L., additional, Borras, S. Marin I, additional, Verges, R., additional, Gil, A., additional, Ponce Sebastia, J., additional, Rodriguez-Freixinos, V., additional, Del Campo, J.M., additional, Garcia Del Muro, X., additional, Pardo Burdalo, B., additional, and Oaknin, A., additional

Published
2014
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50. A Phase 1 Mechanism of Action Study of Intra-Tumoural (It) or Intravenous (Iv) Administration of Enadenotucirev, an Oncolytic Ad11/Ad3 Chimeric Group B Adenovirus in Colon Cancer Patients Undergoing Resection of Primary Tumour

Author

Boni, V., primary, De La Portilla, F., additional, Cubillo, A., additional, Gil-Martin, M., additional, Calvo, E., additional, Salazar, R., additional, Santos, C., additional, Sanchez-Gastaldo, A., additional, Prados, S., additional, Sanjuan, X., additional, Bozada, J.M., additional, Duran, H., additional, Jurado, M., additional, Ellis, C., additional, Alvis, S., additional, Beadle, J., additional, Fisher, K., additional, Blanc, C., additional, and Garcia-Carbonero, R., additional

Published
2014
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