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2. A randomized, double-blind, placebo-controlled phase 1b/2 study of ralimetinib, a p38 MAPK inhibitor, plus gemcitabine and carboplatin versus gemcitabine and carboplatin for women with recurrent platinum-sensitive ovarian cancer

Author

Vergote, Ignace, Heitz, Florian, Buderath, Paul, Powell, Matthew, Sehouli, Jalid, Lee, Christine M., Hamilton, Anne, Fiorica, James, Moore, Kathleen N., Teneriello, Michael, Golden, Lisa, Zhang, Wei, Pitou, Celine, Bell, Robert, Campbell, Robert, Farrington, Daphne L., Bell-McGuinn, Katherine, and Wenham, Robert M.

Published
2020
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3. Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial

Author

Vergote, Ignace, Scambia, Giovanni, Park, Sang Yoon, Song, Yong Sang, Makarova, Yulia, Trinidad, Joshua, Ngan, Hextan Yuen Sheung, Bamias, Aristotelis, Aravantinos, Gerasimos, Nam, Joo-Hyun, Gorbunova, Vera, Krikunova, Ludmila, Bae, Duk-Soo, Arija, Jose Angel Arranz, Mirza, Mansoor Raza, Zamagni, Claudio, Papandreou, Christos, Raspagliesi, Francesco, Lisyanskaya, Alla, Benzaquen, Ana Oaknin, Tognon, Germana, Ortega, Eugenia, Herraez, Antonio Casado, Buscema, Joseph, Green, Andrew, Burger, Robert, Sakaeva, Dina, Sanchez, Andres Redondo, Ghamande, Sharad, King, Laurel, Petru, Edgar, Peen, Ulla, Takeuchi, Satoshi, Ushijima, Kimio, Martin, Antonio Gonzalez, Kamelle, Scott, Carney, Michael, Marth, Christian, Forget, Frédéric, Bentley, James, Sehouli, Jalid, Colombo, Nicoletta, Zola, Paolo, Kato, Hidenori, Fadeeva, Natalya, Gotovkin, Evgeny, Vladimirov, Vladimir, Marin, Margarita Romeo, Alia, Eva Guerra, Shahin, Mark, Bhoola, Snehalkumar, Tewari, Krishnansu, Anderson, Daniel, Honhon, Brigitte, Pelgrims, Joseph (Gino), Oza, Amit, Jimenez, Jesus Garcia-Donas, Hansen, Vincent, O'Malley, David, Benjamin, Ivor, Renard, Vincent, Van den Bulck, Heidi, Meier, Werner, Haenle, Claudia, Koumakis, Georgios, Yokota, Harushige, Popov, Vadim, Bradley, William, Wenham, Robert, Reid, Robert, McNamara, Donna, Friedman, Richard, Barlin, Joyce, Spirtos, Nicola, Chapman, Julia, Sevelda, Paul, Huizing, Manon, Lamot, Caroline, Goffin, Frédéric, Hondt, Lionel D, Covens, Allan, Spadafora, Silvana, Rautenberg, Beate, Reimer, Toralf, Möbus, Volker, Hilpert, Felix, Gropp-Meier, Martina, Savarese, Antonella, Pignata, Sandro, Verderame, Francesco, Mizuno, Mika, Takano, Hirokuni, Ottevanger, Petronella, Velasco, Andres Poveda, Palacio-Vazquez, Isabel, Law, Amy, McIntyre, Kristi, Teneriello, Michael, Fields, Abbie, Lentz, Samuel, Street, Daron, Schwartz, Benjamin, Mannel, Robert, Lim, Peter, Pulaski, Heather, Janni, Wolfgang, Zorr, Andreas, Karck, Ulrich, Cheng, Ashley Chi Kin, Sorio, Roberto, Gridelli, Cesare, Aoki, Daisuke, Oishi, Tetsuro, Hirashima, Yasuyuki, Boere, Ingrid, Ferrer, Esther Falco, Braly, Patricia, Wilks, Sharon, Lee, Christine, Schilder, Jeanne, Veljovich, Dan, Secord, Angeles, Davis, Kevin, Rojas-Espaillat, Luis, Lele, Shashikant, DePasquale, Stephen, Squatrito, Robert, Schauer, Christian, Dirix, Luc, Vuylsteke, Peter, Joosens, Eric, Provencher, Diane, Lueck, Hans-Joachim, Hein, Alexander, Burges, Alexander, Canzler, Ulrich, Park-Simon, Tjoung-Won, Griesinger, Frank, Gadducci, Angiolo, Alabiso, Oscar, Okamoto, Aikou, Sawasaki, Takashi, Saito, Toshiaki, Ibañez, Ana Herrero, Calomeni, Coralia, Spillman, Monique, Choksi, Janak, Taylor, Nicholas, Muller, Carolyn, Moore, David, DiSilvestro, Paul, Cunningham, Mary, Rose, Peter, Oppelt, Peter, Verhoeven, Didier, Graas, Marie-Pascale, Ghatage, Prafull, Tonkin, Katia, Kurzeder, Christian, Schnappauf, Benjamin, Müller, Volkmar, Schmalzrie, Hannah, Kalofonos, Haralambos, Bruzzone, Milena, Kroep, Judith, Diaz, Cristina Caballero, Garcia, Jeronimo Martinez, Polo, Susana Hernando, Garrison, Mitchell, Rocconi, Rodney, Andrews, Stephen, Bristow, Robert, McHale, Michael, Basil, Jack, Houck III, William, Bell, Maria, Cosin, Jonathan, Modesitt, Susan, Kendrick, James, Wade III, James, Wong, Cheung, Evans, Anthony, Buekers, Thomas, Vanderkwaak, Timothy, Ferriss, James, Darus, Christopher, DAndre, Stacy, Higgins, Robert, Monk, Bradley, Bakkum-Gamez, Jamie, DeMars, Leslie, Van Le, Linda, Puls, Larry, Trehan, Shruti, LaPolla, James, Michelson, Elizabeth Dickson, Merchant, Joseph, Peterson, Christopher, Reid, Gary, Seago, Donald, Zweizig, Susan, Gajewski, Walter, Panwalkar, Amit, Leikermoser, Rudolf, Bogner, Gerhard, Debruyne, Philip, D'hondt, Randal, Berteloot, Patrick, Kerger, Joseph, Biagi, James, Castonguay, Vincent, Welch, Stephen, Muhic, Aida, Heubner, Martin, Grischke, Eva-Maria, Rack, Brigitte, Fleisch, Markus, Lordick, Florian, Pectasides, Dimitrios, Ho, Wing Ming, Selvaggi, Luigi, Vasquez, Flavia Morales, Villanueva, William Orlando Brito, Alavez, Alejandro Molina, Kessels, Lonneke, Bertran, Ana Santaballa, Fernandez, Cesar Mendiola, Fabregat, Miguel Beltran, Del Prete, Salvatore, Elkas, John, Cecchi, Gary, Kumar, Pallavi, Huh, Warner, Messing, Mark, Karimi, Misagh, Kelley, Ann, Edraki, Babak, Mutch, David, Leiserowitz, Gary, Anderson, Jeanne, Lentz, Scott, Chambers, Setsuko, Morris, Robert, Waggoner, Steven, Gordon, Alan, Method, Michael, Johnson, Peter, Lord, Raymond, Drake, Janet, Sivarajan, Kulumani, Midathada, Madhu, Rice, Kristen, Wadsworth, Troy, Pavelka, James, Edwards, Robert, Miller, David Scott, Ford, Patricia Locantore, Hurteau, Jean, Bender, David, Schimp, Veronica, Creasman, William, Lerner, Rachel, Chamberlain, Donald, Kueck, Angela, McDonald, John, Malad, Salman, Robinson-Bennett, Bernice, Davidson, Susan, Krivak, Thomas, Lestingi, Timothy, Arango, Hector, Berard, Paul, Finkelstein, Karen, Gaur, Rakesh, Krasner, Carolyn, Ueland, Frederick, Talmage, Lance, Yamada, Seiko, Sutton, Gregory, Potkul, Ronald, Prasad-Hayes, Monica, Osborne, Janet, Celano, Paul, Thigpen, James, Sharma, Sudarshan, Schilder, Russell, Tammela, Jonathan, Kemeny, Mary, Brown, Amy, Eisenhauer, Eric, Williams, James, Rowland, Kendrith, Nahum, Kenneth, Burke, James, Dar, Zahid, Fleming, Nicole, Gibb, Randall, Guirguis, Alfred, Herzog, Thomas, John, Veena, Kumar, Santhosh, Kamat, Aparna, Kassar, Mohamad, Leitao, Mario, Levine, Lyuba, Mendez, Luis, Patel, Dhimant, Berry, Emily, Warshal, David, Wolf, Judith, Zarwan, Corrine, Collins, Yvonne, Spitzer, Gary, Miller, Brigitte, Einstein, Mark, O'Malley, David M, Van Calster, Ben, Park, Sang-Yoon, del Campo, Josep M, Wenham, Robert M, Covens, Al, Raza Mirza, Mansoor, Kroep, Judith R, Ma, Haijun, Pickett, Cheryl A, and Monk, Bradley J

Published
2019
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4. Safety of dostarlimab in combination with chemotherapy in patients with primary advanced or recurrent endometrial cancer in a phase III, randomized, placebo-controlled trial (ENGOT-EN6-NSGO/GOG-3031/RUBY).

Author

Auranen, Annika, Powell, Matthew A., Sukhin, Vladyslav, Landrum, Lisa M., Ronzino, Graziana, Buscema, Joseph, Bauerschlag, Dirk, Lalisang, Roy, Bender, David, Gilbert, Lucy, Armstrong, Amy, Safra, Tamar, Nevadunsky, Nicole, Sebastianelli, Alexandra, Slomovitz, Brian, Ring, Kari, Coleman, Robert, Podzielinski, Iwona, Stuckey, Ashley, and Teneriello, Michael

Abstract

Background: In Part 1 of the phase III RUBY trial (NCT03981796) in patients with primary advanced or recurrent endometrial cancer (EC), dostarlimab plus carboplatin–paclitaxel (CP) significantly improved progression-free survival and overall survival compared with CP alone. Limited safety data have been reported for the combination of immunotherapies plus chemotherapy in this setting. Objectives: The objective of this analysis was to identify the occurrence of treatment-related adverse events (TRAEs) and immune-related adverse events (irAEs) and to describe irAE management in Part 1 of the RUBY trial. Design: RUBY is a phase III, randomized, double-blind, multicenter study of dostarlimab plus CP compared with CP alone in patients with primary advanced or recurrent EC. Methods: Patients were randomized 1:1 to dostarlimab 500 mg, or placebo, plus CP every 3 weeks for 6 cycles, followed by dostarlimab 1000 mg, or placebo, every 6 weeks for up to 3 years. Adverse events (AEs) were assessed according to Common Terminology Criteria for Adverse Events, version 4.03. Results: The safety population included 487 patients who received ⩾1 dose of treatment (241 dostarlimab plus CP; 246 placebo plus CP). Treatment-emergent AEs were experienced by 100% of patients in both arms. TRAEs occurred in 97.9% of the dostarlimab arm and 98.8% of the placebo arm. The most common TRAEs occurred at similar rates between arms and were mostly low grade. IrAEs occurred in 58.5% of patients in the dostarlimab arm and 37.0% of patients in the placebo arm. Dostarlimab- or placebo-related irAEs were reported in 40.7% of patients in the dostarlimab arm and 16.3% of the placebo arm. Conclusion: The safety profile of dostarlimab plus CP was generally consistent with that of the individual components. Dostarlimab plus CP has a favorable benefit–risk profile and is a new standard of care for patients with primary advanced or recurrent EC. Trial registration: NCT03981796. Plain language summary: Safety of dostarlimab plus carboplatin-paclitaxel compared with carboplatin-paclitaxel in primary advanced or recurrent endometrial cancer For many years, patients with primary advanced or recurrent endometrial cancer were treated with chemotherapy, specifically with a combination of carboplatin and paclitaxel. Recently, new treatments called immune checkpoint inhibitors have been used to treat endometrial cancer. Dostarlimab, an immune checkpoint inhibitor, is being tested to treat many types of cancer, including endometrial cancer. In the RUBY trial, a combination of dostarlimab plus chemotherapy was compared with chemotherapy alone as treatment for primary advanced or recurrent endometrial cancer. Results showed that patients treated with dostarlimab plus chemotherapy had a lower risk of their cancer becoming worse and a lower risk of dying. Results in this article describe the safety of dostarlimab plus chemotherapy compared with chemotherapy alone. All patients in the RUBY trial experienced at least one adverse event (an undesired effect that happens while receiving treatment or shortly after stopping treatment); most were determined to be caused by the cancer treatments. No differences in the frequency of the overall cancer treatment-related adverse events were seen in patients who received dostarlimab plus chemotherapy compared with those patients who received chemotherapy alone. Some patients experienced an immune-related adverse event. These are a specific type of undesired effect that can occur when patients are treated with immune checkpoint inhibitors. Immune-related adverse events occurred more frequently in patients who received dostarlimab plus chemotherapy than in those who received chemotherapy alone. Physicians were generally able to treat the immune-related adverse events, and only a low percentage of patients discontinued treatment because they experienced an immune-related adverse event. The types of adverse events seen were similar to a combination of those seen in patients who received dostarlimab alone or patients who received chemotherapy alone as treatment for endometrial cancer. Dostarlimab plus chemotherapy is a new standard of care for patients with primary advanced or recurrent endometrial cancer. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Patient-reported outcomes (PROs) in patients (pts) with primary advanced or recurrent endometrial cancer (pA/rEC) treated with dostarlimab (D) plus carboplatin/paclitaxel (CP) compared with CP in the ENGOT-EN6/GOG3031/RUBY trial.

Author

Mirza, Mansoor Raza, primary, Shahin, Mark S., additional, Powell, Matthew A., additional, Lundgren, Caroline, additional, Sukhin, Vladyslav, additional, Pothuri, Bhavana, additional, Gilbert, Lucy, additional, Gill, Sarah, additional, Ronzino, Graziana, additional, Nevadunsky, Nicole Suzanne, additional, Kommoss, Stefan, additional, Willmott, Lyndsay, additional, Boere, Ingrid, additional, Mathews, Cara Amanda, additional, Buscema, Joseph, additional, Teneriello, Michael, additional, Meyers, Oren, additional, Garside, Jamie, additional, Coleman, Robert L., additional, and Slomovitz, Brian M., additional

Published
2023
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6. #267 Quality-adjusted time without symptoms of disease or toxicity in patients with primary advanced or recurrent endometrial cancer treated with dostarlimab plus carboplatin-paclitaxel versus carboplatin-paclitaxel in the ENGOT-EN6/GOG-3031/RUBY trial

Author

Chase, Dana, primary, Bjørge, Line, additional, Coleman, Robert L, additional, Zub, Oleksandr, additional, Miller, Eirwen, additional, Angioli, Roberto, additional, Mathews, Cara, additional, Hanker, Lars C, additional, Teneriello, Michael G, additional, Reyners, Anna, additional, Powell, Matthew, additional, Gilbert, Lucy, additional, Cloven, Noelle, additional, Gill, Sarah, additional, Monk, Bradley J, additional, Pothuri, Bhavana, additional, Garside, Jamie, additional, Allonby, Odette, additional, Mccourt, Carolyn, additional, and Mirza, Mansoor Raza, additional

Published
2023
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9. A randomized, double-blind, placebo-controlled phase Ib/II study of ralimetinib, a p38 MAPK inhibitor, plus gemcitabine (G) and carboplatin (C) versus GC for women with recurrent platinum-sensitive ovarian cancer.

Author

Vergote, Ignace, primary, Heitz, Florian, additional, Buderath, Paul, additional, Powell, Matthew A., additional, Sehouli, Jalid, additional, Lee, Christine M., additional, Hamilton, Anne L., additional, Fiorica, James, additional, Moore, Kathleen N., additional, Teneriello, Michael, additional, Golden, Lisa, additional, Zhang, Wei, additional, Pitou, Celine, additional, Farrington, Daphne L., additional, Bell-McGuinn, Katherine M, additional, and Wenham, Robert Michael, additional

Published
2019
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12. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer

Author

Mirza, Mansoor R, Monk, Bradley J, Herrstedt, Jørn, Oza, Amit M, Mahner, Sven, Redondo, Andrés, Fabbro, Michel, Ledermann, Jonathan A, Lorusso, Domenica, Vergote, Ignace, Ben-Baruch, Noa E, Marth, Christian, Madry, Radoslaw, Christensen, René D, Berek, Jonathan S, Dørum, Anne, Tinker, Anna V, du Bois, Andreas, González-Martín, Antonio, Follana, Philippe, Benigno, Benedict, Rosenberg, Per, Gilbert, Lucy, Rimel, Bobbie J, Buscema, Joseph, Balser, John P, Agarwal, Shefali, Matulonis, Ursula A, Lund, Bente, Malander, Susanne, Woie, Kathrine, Hellman, Kristina, Nøttrup, Trine Juhler, Havsteen, Hanne, Sehouli, Jalid, Harter, Philipp, Canzler, Ulrich, Lück, Hans-Joachim, Wölber, Linn, Marmé, Frederik, Meier, Werner, Heubner, Martin, Hilpert, Felix, Emons, Günter, Burges, Alexander, Bover Barcelo, Isabel Maria, Gil Martín, Marta, Palacio Vázquez, Isabel, Casado Herráez, Antonio, Maria del Campo, José, Lesoin, Anne, Berton-Rigaud, Dominique, N'Guyen, Thierry, Hardy-Bessard, Anne-Claire, Banerjee, Susana, Lord, Rosemary, Waters, Justin, Montes, Ana, Chan, Stephen, Williams, Sarah J, Barlow, Claire, Mullard, Anna, Colombo, Nicoletta, Scambia, Giovanni, Tognon, Germana, Scollo, Paolo, Kridelka, Frédéric, Leroy, Chantal, Debruyne, Philip, Huizing, Manon, Rosengarten, Ora, Levy, Talia, Frommer, Ronnie Shapira, Fishman, Ami, Edelman, David, Safra, Tamar, Amit, Amnon, Pikiel, Joanna, Suzin, Jacek, Mackowiak-Matejczyk, Beata, Reinthaller, Alexander, Petru, Edgar, Csoszi, Tibor, Bessette, Paul, Provencher, Diane, Lau, Susie, Ellard, Susan, Ghatage, Prafull, Moore, Kathleen, Wenham, Robert, Pineda, Mario, Azodi, Masoud, Mantia-Smaldone, Gina, Cloven, Noelle, Bailey, Cheryl, Lee, Christine, Secord, Angeles, Patel, Manish, Method, Michael, Callahan, Michael, Veena, John, Chan, John, Zarwan, Corrine, DiSilvestro, Paul, Teneriello, Michael, Gupta, Divya, Geller, Melissa, Burris, Howard, Slomovitz, Brian, Hendrickson, Andrea Wahner, McCormick, Colleen, Hanjani, Parviz, Blank, Stephanie, Haluska, Paul, Matei, Daniela, Vasilev, Stephen, Neidhart, Jeffrey, Boente, Matthew, Tchabo, Nana, Miller, David, and Targeted Gynaecologic Oncology (TARGON)

Subjects
0301 basic medicine, Oncology, Medizin, Genes, BRCA1, Platinum Compounds, POLY(ADP-RIBOSE) POLYMERASE, Kaplan-Meier Estimate, 030226 pharmacology & pharmacy, chemistry.chemical_compound, 0302 clinical medicine, Piperidines, Maintenance therapy, Bone Marrow, Medicine, Merck Sharp & Dohme, Homologous Recombination, Indazoles/adverse effects, Ovarian Neoplasms, Aged, 80 and over, Platinum compounds, OLAPARIB, Ovarian Neoplasms/drug therapy, Obstetrics and Gynecology, Bone Marrow/drug effects, General Medicine, Middle Aged, SOLID TUMORS, BRCA MUTATION CARRIERS, 030220 oncology & carcinogenesis, TRIAL, Female, Platinum sensitive, Adult, Piperidines/adverse effects, medicine.medical_specialty, Indazoles, Adolescent, Antineoplastic Agents, Disease-Free Survival, Olaparib, Maintenance Chemotherapy, Young Adult, 03 medical and health sciences, Platinum Compounds/therapeutic use, Double-Blind Method, Internal medicine, Humans, Rucaparib, Germ-Line Mutation, Aged, Neoplasm Staging, Cancer och onkologi, business.industry, Antineoplastic Agents/adverse effects, NEGATIVE BREAST-CANCER, 030104 developmental biology, chemistry, Recurrent Ovarian Cancer, Cancer and Oncology, Johnson Johnson, business
Abstract

BACKGROUND Niraparib is an oral poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) 1/2 inhibitor that has shown clinical activity in patients with ovarian cancer. We sought to evaluate the efficacy of niraparib versus placebo as maintenance treatment for patients with platinum-sensitive, recurrent ovarian cancer. METHODS In this randomized, double-blind, phase 3 trial, patients were categorized according to the presence or absence of a germline BRCA mutation (gBRCA cohort and non-gBRCA cohort) and the type of non-gBRCA mutation and were randomly assigned in a 2: 1 ratio to receive niraparib (300 mg) or placebo once daily. The primary end point was progression-free survival. RESULTS Of 553 enrolled patients, 203 were in the gBRCA cohort (with 138 assigned to niraparib and 65 to placebo), and 350 patients were in the non-gBRCA cohort (with 234 assigned to niraparib and 116 to placebo). Patients in the niraparib group had a significantly longer median duration of progression-free survival than did those in the placebo group, including 21.0 vs. 5.5 months in the gBRCA cohort (hazard ratio, 0.27; 95% confidence interval [CI], 0.17 to 0.41), as compared with 12.9 months vs. 3.8 months in the non-gBRCA cohort for patients who had tumors with homologous recombination deficiency (HRD) (hazard ratio, 0.38; 95% CI, 0.24 to 0.59) and 9.3 months vs. 3.9 months in the overall non-gBRCA cohort (hazard ratio, 0.45; 95% CI, 0.34 to 0.61; P amp;lt; 0.001 for all three comparisons). The most common grade 3 or 4 adverse events that were reported in the niraparib group were thrombocytopenia (in 33.8%), anemia (in 25.3%), and neutropenia (in 19.6%), which were managed with dose modifications. CONCLUSIONS Among patients with platinum-sensitive, recurrent ovarian cancer, the median duration of progression-free survival was significantly longer among those receiving niraparib than among those receiving placebo, regardless of the presence or absence of gBRCA mutations or HRD status, with moderate bone marrow toxicity. (Funded by Tesaro; ClinicalTrials.gov number, NCT01847274.) Funding Agencies|Tesaro; Amgen; Genentech; Roche; AstraZeneca; Myriad Genetics; Merck; Gradalis; Cerulean; Vermillion; ImmunoGen; Pfizer; Bayer; Nu-Cana BioMed; INSYS Therapeutics; GlaxoSmithKline; Verastem; Mateon Therapeutics; Pharmaceutical Product Development; Clovis Oncology; Janssen/Johnson Johnson; Eli Lilly; Merck Sharp Dohme

Published
2016
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13. A Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess Efficacy and Safety of Weekly Farletuzumab in Combination With Carboplatin and Taxane in Patients With Ovarian Cancer in First Platinum-Sensitive Relapse

Author

Vergote, Ignace, primary, Armstrong, Deborah, additional, Scambia, Giovanni, additional, Teneriello, Michael, additional, Sehouli, Jalid, additional, Schweizer, Charles, additional, Weil, Susan C., additional, Bamias, Aristotelis, additional, Fujiwara, Keiichi, additional, Ochiai, Kazunori, additional, Poole, Christopher, additional, Gorbunova, Vera, additional, Wang, Wenquan, additional, O’Shannessy, Daniel, additional, and Herzog, Thomas J., additional

Published
2016
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14. Abstract A02: Biomarkers of drug response to buparlisib: Results of next-generation sequencing in a phase II trial of advanced endometrial carcinoma

Author

Solovieff, Nadia, primary, Singh, Angad Pal, additional, Bitter, Hans, additional, Riester, Markus, additional, Teneriello, Michael, additional, Oza, Amit, additional, Monk, Bradley, additional, Robinson, Douglas, additional, Trandafir, Lucia, additional, Massacesi, Cristian, additional, Tomaso, Emmanuelle di, additional, and Naumann, R. Wendel, additional

Published
2015
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15. Patient-reported outcomes (PROs) in primary advanced or recurrent endometrial cancer (pA/rEC) for patients (pts) treated with dostarlimab plus carboplatin/paclitaxel (CP) as compared to CP in the ENGOT-EN6/GOG3031/RUBY trial.

Author

Mirza, Mansoor Raza, Powell, Matthew A., Lundgren, Caroline, Sukhin, Vladyslav, Pothuri, Bhavana, Gilbert, Lucy, Gill, Sarah, Ronzino, Graziana, Nevadunsky, Nicole, Kommoss, Stefan, Willmott, Lyndsay, Boere, Ingrid, Mathews, Cara Amanda, Buscema, Joseph, Teneriello, Michael, Shahin, Mark S., Meyers, Oren, Garside, Jamie, Coleman, Robert L., and Slomovitz, Brian M.

Published
2023
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16. PRECEDENT: A Randomized Phase II Trial Comparing Vintafolide (EC145) and Pegylated Liposomal Doxorubicin (PLD) in Combination Versus PLD Alone in Patients With Platinum-Resistant Ovarian Cancer

Author

Naumann, R. Wendel, primary, Coleman, Robert L., additional, Burger, Robert A., additional, Sausville, Edward A., additional, Kutarska, Elzbieta, additional, Ghamande, Sharad A., additional, Gabrail, Nashat Y., additional, DePasquale, Stephen E., additional, Nowara, Elzbieta, additional, Gilbert, Lucy, additional, Gersh, Robert H., additional, Teneriello, Michael G., additional, Harb, Wael A., additional, Konstantinopoulos, Panagiotis A., additional, Penson, Richard T., additional, Symanowski, James T., additional, Lovejoy, Chandra D., additional, Leamon, Christopher P., additional, Morgenstern, David E., additional, and Messmann, Richard A., additional

Published
2013
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17. A phase II trial of lenvatinib in patients with advanced or recurrent endometrial cancer: Angiopoietin-2 as a predictive marker for clinical outcomes.

Author

Vergote, Ignace, primary, Teneriello, Michael, additional, Powell, Matthew A., additional, Miller, David S., additional, Garcia, Agustin A., additional, Mikheeva, Olga N., additional, Pinter, Tamas, additional, Bidzinski, Mariusz, additional, Cebotaru, Cristina Ligia, additional, Fan, Jean, additional, Ren, Min, additional, Meneses, Nicole, additional, Funahashi, Yasuhiro, additional, Kadowaki, Tadashi, additional, O'Brien, James P., additional, and Penson, Richard T., additional

Published
2013
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18. OCEANS: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Author

Aghajanian, Carol, primary, Blank, Stephanie V., additional, Goff, Barbara A., additional, Judson, Patricia L., additional, Teneriello, Michael G., additional, Husain, Amreen, additional, Sovak, Mika A., additional, Yi, Jing, additional, and Nycum, Lawrence R., additional

Published
2012
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20. Randomized Phase III Trial of Gemcitabine Compared With Pegylated Liposomal Doxorubicin in Patients With Platinum-Resistant Ovarian Cancer

Author

Mutch, David G., primary, Orlando, Mauro, additional, Goss, Tiana, additional, Teneriello, Michael G., additional, Gordon, Alan N., additional, McMeekin, Scott D., additional, Wang, Yanping, additional, Scribner, Dennis R., additional, Marciniack, Martin, additional, Naumann, R. Wendel, additional, and Secord, Angeles Alvarez, additional

Published
2007
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22. Adjuvant Chemotherapy versus Chemotherapy plus Pelvic Irradiation for High-Risk Cervical Cancer Patients after Radical Hysterectomy and Pelvic Lymphadenectomy (RH-PLND): A Randomized Phase III Trial

Author

Curtin, John P., primary, Hoskins, William J., additional, Venkatraman, Ennapadam S., additional, Almadrones, Lois, additional, Podratz, Karl C., additional, Long, Harry, additional, Teneriello, Michael, additional, Averette, Hervy, additional, and Sevin, Bernd-Uwe, additional

Published
1996
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