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1. Phase 1 trial of navitoclax and sorafenib in patients with relapsed or refractory solid tumors with hepatocellular carcinoma expansion cohort

Author

Emiloju, Oluwadunni E., Yin, Jun, Koubek, Emily, Reid, Joel M., Borad, Mitesh J., Lou, Yanyan, Seetharam, Mahesh, Edelman, Martin J., Sausville, Edward A., Jiang, Yixing, Kaseb, Ahmed O., Posey, James A., Davis, Sarah L., Gores, Gregory J., Roberts, Lewis R., Takebe, Naoko, Schwartz, Gary K., Hendrickson, Andrea E. Wahner, Kaufmann, Scott H., Adjei, Alex A., Hubbard, Joleen M., and Costello, Brian A.

Published
2024
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2. Randomized trial of anetumab ravtansine and pembrolizumab compared to pembrolizumab for mesothelioma

Author

Mansfield, Aaron S., Vivien Yin, Jun, Bradbury, Penelope, Kwiatkowski, David J., Patel, Shiven, Bazhenova, Lyudmila A., Forde, Patrick, Lou, Yanyan, Dizona, Paul, Villaruz, Liza C., Arnold, Susanne M., Khalil, Maya, Kindler, Hedy L., Koczywas, Marianna, Pacheco, Jose, Rolfo, Christian, Xia, Bing, Mikula, Elizabeth, Chen, Li, Patel, Kashish, Smith, Katherine E.R., Cao, Liang, Shapiro, Geoffrey, Costello, Brian A., Adjei, Alex, Sharon, Elad, Moscow, Jeffrey A., Zamboni, William, and Hassan, Raffit

Published
2024
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3. Bintrafusp Alfa With CCRT Followed by Bintrafusp Alfa Versus Placebo With CCRT Followed by Durvalumab in Patients With Unresectable Stage III NSCLC: A Phase 2 Randomized Study

Author

Vokes, Everett E., Mornex, Francoise, Sezer, Ahmet, Cheng, Ying, Fang, Jian, Baz, David Vicente, Cil, Timucin, Adjei, Alex A., Ahn, Myung-Ju, Barlesi, Fabrice, Felip, Enriqueta, Garon, Edward B., Audhuy, Francois, Ito, Rena, Sato, Masashi, Eggleton, S. Peter, Martin, Claudio Marcelo, Reck, Martin, Robinson, Clifford G., and Paz-Ares, Luis

Published
2024
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4. Bintrafusp Alfa Versus Pembrolizumab in Patients With Treatment-Naive, Programmed Death-Ligand 1–High Advanced NSCLC: A Randomized, Open-Label, Phase 3 Trial

Author

Cho, Byoung Chul, Lee, Jong Seok, Wu, Yi-Long, Cicin, Irfan, Dols, Manuel Cobo, Ahn, Myung-Ju, Cuppens, Kristof, Veillon, Rémi, Nadal, Ernest, Dias, Josiane Mourão, Martin, Claudio, Reck, Martin, Garon, Edward B., Felip, Enriqueta, Paz-Ares, Luis, Mornex, Francoise, Vokes, Everett E., Adjei, Alex A., Robinson, Clifford, Sato, Masashi, Vugmeyster, Yulia, Machl, Andreas, Audhuy, Francois, Chaudhary, Surendra, and Barlesi, Fabrice

Published
2023
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5. Time from immune checkpoint inhibitor to sotorasib use correlates with risk of hepatotoxicity in non-small cell lung cancer: A brief report

Author

Desai, Aakash, Rakshit, Sagar, Bansal, Radhika, Ashara, Yash, Potter, Ashley, Manochakian, Rami, Lou, Yanyan, Zhao, Yujie, Ernani, Vinicius, Savvides, Panos, Schwecke, Anna, Moffett, Nicole, Hocum, Craig, Leventakos, Konstantinos, Adjei, Alex, Marks, Randolph, Molina, Julian, Mansfield, Aaron S., Chen, Zong-Ming, and Dimou, Anastasios

Published
2023
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9. Development of MK-8353, an orally administered ERK1/2 inhibitor, in patients with advanced solid tumors

Author

Moschos, Stergios J, Sullivan, Ryan J, Hwu, Wen-Jen, Ramanathan, Ramesh K, Adjei, Alex A, Fong, Peter C, Shapira-Frommer, Ronnie, Tawbi, Hussein A, Rubino, Joseph, Rush, Thomas S, Zhang, Da, Miselis, Nathan R, Samatar, Ahmed A, Chun, Patrick, Rubin, Eric H, Schiller, James, Long, Brian J, Dayananth, Priya, Carr, Donna, Kirschmeier, Paul, Bishop, W Robert, Deng, Yongqi, Cooper, Alan, Shipps, Gerald W, Moreno, Blanca Homet, Robert, Lidia, Ribas, Antoni, and Flaherty, Keith T

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Cancer, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Administration, Oral, Adult, Animals, Biological Availability, Cell Line, Tumor, Diarrhea, Dogs, Dose-Response Relationship, Drug, Drug Eruptions, Drug Evaluation, Preclinical, Fatigue, Female, Humans, Indazoles, MAP Kinase Signaling System, Male, Maximum Tolerated Dose, Mice, Middle Aged, Mitogen-Activated Protein Kinase 1, Mitogen-Activated Protein Kinase 3, Nausea, Neoplasm Staging, Neoplasms, Protein Kinase Inhibitors, Pyridines, Pyrrolidines, Rats, Triazoles, Xenograft Model Antitumor Assays, Young Adult, Clinical Trials, Melanoma, Oncology, Signal transduction, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundConstitutive activation of ERK1/2 occurs in various cancers, and its reactivation is a well-described resistance mechanism to MAPK inhibitors. ERK inhibitors may overcome the limitations of MAPK inhibitor blockade. The dual mechanism inhibitor SCH772984 has shown promising preclinical activity across various BRAFV600/RAS-mutant cancer cell lines and human cancer xenografts.MethodsWe have developed an orally bioavailable ERK inhibitor, MK-8353; conducted preclinical studies to demonstrate activity, pharmacodynamic endpoints, dosing, and schedule; completed a study in healthy volunteers (P07652); and subsequently performed a phase I clinical trial in patients with advanced solid tumors (MK-8353-001). In the P07652 study, MK-8353 was administered as a single dose in 10- to 400-mg dose cohorts, whereas in the MK-8353-001 study, MK-8353 was administered in 100- to 800-mg dose cohorts orally twice daily. Safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity were analyzed.ResultsMK-8353 exhibited comparable potency with SCH772984 across various preclinical cancer models. Forty-eight patients were enrolled in the P07652 study, and twenty-six patients were enrolled in the MK-8353-001 study. Adverse events included diarrhea (44%), fatigue (40%), nausea (32%), and rash (28%). Dose-limiting toxicity was observed in the 400-mg and 800-mg dose cohorts. Sufficient exposure to MK-8353 was noted that correlated with biological activity in preclinical data. Three of fifteen patients evaluable for treatment response in the MK-8353-001 study had partial response, all with BRAFV600-mutant melanomas.ConclusionMK-8353 was well tolerated up to 400 mg twice daily and exhibited antitumor activity in patients with BRAFV600-mutant melanoma. However, antitumor activity was not particularly correlated with pharmacodynamic parameters.Trial registrationClinicalTrials.gov NCT01358331.FundingMerck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., and NIH (P01 CA168585 and R35 CA197633).

Published
2018

10. Molecular Characterization and Therapeutic Opportunities in KRAS Wildtype Pancreatic Ductal Adenocarcinoma

Author

Desai, Aakash, primary, Xiao, Alexander H., additional, Choi, Daheui, additional, Toruner, Merih D., additional, Walden, Daniel, additional, Halfdanarson, Thorvardur R., additional, Alberts, Steven, additional, McWilliams, Robert R., additional, Mahipal, Amit, additional, Ahn, Daniel, additional, Babiker, Hani, additional, Stybayeva, Gulnaz, additional, Revzin, Alexander, additional, Kizilbash, Sani, additional, Adjei, Alex, additional, Bekaii-Saab, Tanios, additional, Mansfield, Aaron S., additional, Carr, Ryan M., additional, and Ma, Wen Wee, additional

Published
2024
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11. A Phase I Study of sequences of the CDK4/6 Inhibitor, Ribociclib Combined with Gemcitabine in Patients with Advanced Solid Tumors

Author

Seetharam, Mahesh, primary, Norman, Aurora, additional, Allred, Jacob, additional, Kong, Jianping, additional, Opyrchal, Mateusz, additional, Ma, Wen Wee, additional, Lou, Yanyan, additional, Dy, Grace K, additional, Mahipal, Amit, additional, Weroha, John, additional, Wahner-Hendrickson, Andrea, additional, Reid, Joel M., additional, and Adjei, Alex A., additional

Published
2024
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14. Adjuvant chemotherapy with or without bevacizumab in patients with resected non-small-cell lung cancer (E1505): an open-label, multicentre, randomised, phase 3 trial

Author

Wakelee, Heather A, Dahlberg, Suzanne E, Keller, Steven M, Tester, William J, Gandara, David R, Graziano, Stephen L, Adjei, Alex A, Leighl, Natasha B, Aisner, Seena C, Rothman, Jan M, Patel, Jyoti D, Sborov, Mark D, McDermott, Sean R, Perez-Soler, Roman, Traynor, Anne M, Butts, Charles, Evans, Tracey, Shafqat, Atif, Chapman, Andrew E, Kasbari, Samer S, Horn, Leora, Ramalingam, Suresh S, Schiller, Joan H, and ECOG-ACRIN

Subjects
Clinical Research, Lung Cancer, Lung, Clinical Trials and Supportive Activities, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Antineoplastic Agents, Immunological, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Carcinoma, Non-Small-Cell Lung, Chemotherapy, Adjuvant, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Lung Neoplasms, Male, Middle Aged, Patient Selection, Pneumonectomy, Survival Analysis, Treatment Outcome, ECOG-ACRIN, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundAdjuvant chemotherapy for resected early-stage non-small-cell lung cancer (NSCLC) provides a modest survival benefit. Bevacizumab, a monoclonal antibody directed against VEGF, improves outcomes when added to platinum-based chemotherapy in advanced-stage non-squamous NSCLC. We aimed to evaluate the addition of bevacizumab to adjuvant chemotherapy in early-stage resected NSCLC.MethodsWe did an open-label, randomised, phase 3 trial of adult patients (aged ≥18 years) with an Eastern Cooperative Oncology Group performance status of 0 or 1 and who had completely resected stage IB (≥4 cm) to IIIA (defined by the American Joint Committee on Cancer 6th edition) NSCLC. We enrolled patients from across the US National Clinical Trials Network, including patients from the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) affiliates in Europe and from the Canadian Cancer Trials Group, within 6-12 weeks of surgery. The chemotherapy regimen for each patient was selected before randomisation and administered intravenously; it consisted of four 21-day cycles of cisplatin (75 mg/m2 on day 1 in all regimens) in combination with investigator's choice of vinorelbine (30 mg/m2 on days 1 and 8), docetaxel (75 mg/m2 on day 1), gemcitabine (1200 mg/m2 on days 1 and 8), or pemetrexed (500 mg/m2 on day 1). Patients in the bevacizumab group received bevacizumab 15 mg/kg intravenously every 21 days starting with cycle 1 of chemotherapy and continuing for 1 year. We randomly allocated patients (1:1) to group A (chemotherapy alone) or group B (chemotherapy plus bevacizumab), centrally, using permuted blocks sizes and stratified by chemotherapy regimen, stage of disease, histology, and sex. No one was masked to treatment assignment, except the Data Safety and Monitoring Committee. The primary endpoint was overall survival, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00324805.FindingsBetween June 1, 2007, and Sept 20, 2013, 1501 patients were enrolled and randomly assigned to the two treatment groups: 749 to group A (chemotherapy alone) and 752 to group B (chemotherapy plus bevacizumab). 383 (26%) of 1458 patients (with complete staging information) had stage IB, 636 (44%) had stage II, and 439 (30%) had stage IIIA disease (stage of disease data were missing for 43 patients). Squamous cell histology was reported for 422 (28%) of 1501 patients. All four cisplatin-based chemotherapy regimens were used: 377 (25%) patients received vinorelbine, 343 (23%) received docetaxel, 283 (19%) received gemcitabine, and 497 (33%) received pemetrexed. At a median follow-up of 50·3 months (IQR 32·9-68·0), the estimated median overall survival in group A has not been reached, and in group B was 85·8 months (95% CI 74·9 to not reached); hazard ratio (group B vs group A) 0·99 (95% CI 0·82-1·19; p=0·90). Grade 3-5 toxicities of note (all attributions) that were reported more frequently in group B (the bevacizumab group) than in group A (chemotherapy alone) were overall worst grade (ie, all grade 3-5 toxicities; 496 [67%] of 738 in group A vs 610 [83%] of 735 in group B), hypertension (60 [8%] vs 219 [30%]), and neutropenia (241 [33%] vs 275 [37%]). The number of deaths on treatment did not differ between the groups (15 deaths in group A vs 19 in group B). Of these deaths, three in group A and ten in group B were considered at least possibly related to treatment.InterpretationAddition of bevacizumab to adjuvant chemotherapy did not improve overall survival for patients with surgically resected early-stage NSCLC. Bevacizumab does not have a role in this setting and should not be considered as an adjuvant therapy for patients with resected early-stage NSCLC.FundingNational Cancer Institute of the National Institutes of Health.

Published
2017

15. A phase I dose-escalation study of TAK-733, an investigational oral MEK inhibitor, in patients with advanced solid tumors

Author

Adjei, Alex A, LoRusso, Patricia, Ribas, Antoni, Sosman, Jeffrey A, Pavlick, Anna, Dy, Grace K, Zhou, Xiaofei, Gangolli, Esha, Kneissl, Michelle, Faucette, Stephanie, Neuwirth, Rachel, and Bózon, Viviana

Subjects
Cancer, Clinical Research, Rare Diseases, Patient Safety, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Antineoplastic Agents, Colonic Neoplasms, Extracellular Signal-Regulated MAP Kinases, Female, Humans, MAP Kinase Kinase 1, MAP Kinase Kinase 2, Male, Maximum Tolerated Dose, Melanoma, Middle Aged, Phosphorylation, Protein Kinase Inhibitors, Pyridones, Pyrimidinones, Skin Neoplasms, Treatment Outcome, Uveal Neoplasms, Young Adult, MEK inhibition, Phase 1, Solid tumor, TAK-733, Pharmacology and Pharmaceutical Sciences, Oncology & Carcinogenesis
Abstract

Purpose TAK-733, an investigational, selective, allosteric MEK1/2 inhibitor, has demonstrated antitumor effects against multiple cancer cell lines and xenograft models. This first-in-human study investigated TAK-733 in patients with solid tumors. Methods Patients received oral TAK-733 once daily on days 1-21 in 28-day treatment cycles. Adverse events (AEs) were graded using the Common Terminology Criteria for AEs version 3.0. Response was assessed using RECIST v1.1. Blood samples for TAK-733 pharmacokinetics and pharmacodynamics (inhibition of ERK phosphorylation) were collected during cycle 1. Results Fifty-one patients received TAK-733 0.2-22 mg. Primary diagnoses included uveal melanoma (24 %), colon cancer (22 %), and cutaneous melanoma (10 %). Four patients had dose-limiting toxicities of dermatitis acneiform, plus fatigue and pustular rash in one patient, and stomatitis in one patient. The maximum tolerated dose was 16 mg. Common drug-related AEs included dermatitis acneiform (51 %), diarrhea (29 %), and increased blood creatine phosphokinase (20 %); grade ≥ 3 AEs were reported in 27 (53 %) patients. Median Tmax was 3 h; systemic exposure increased less than dose-proportionally over the dose range 0.2-22 mg. On day 21 maximum inhibition of ERK phosphorylation in peripheral blood mononuclear cells of 46-97 % was seen in patients receiving TAK-733 ≥ 8.4 mg. Among 41 response-evaluable patients, 2 (5 %) patients with cutaneous melanoma (one with BRAF L597R mutant melanoma) had partial responses. Conclusions TAK-733 had a generally manageable toxicity profile up to the maximum tolerated dose, and showed the anticipated pharmacodynamic effect of sustained inhibition of ERK phosphorylation. Limited antitumor activity was demonstrated. Further investigation is not currently planned.

Published
2017

16. A phase I pharmacokinetic and safety study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) alone and in combination with carboplatin in patients with advanced solid malignancies and biliary tract cancers

Author

Ma, Wen Wee, Zhu, Mojun, Lam, Elaine T., Diamond, Jennifer R., Dy, Grace K., Fisher, George A., Goff, Laura Williams, Alberts, Steven, Bui, Lynne A., Sanghal, Akhil, Kothekar, Mudgal, Khopade, Ajay, Chimote, Geetanjali, Faulkner, Robert, Eckhardt, S. Gail, Adjei, Alex A., and Jimeno, Antonio

Published
2021
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17. Lung Cancer in Ghana.

Author

Afriyie-Mensah, Jane S., Dadzie, Mary-Ann, Vanderpuye, Verna D.N.K., Calys-Tagoe, Benedict, Gbadamosi, Hafisatu, Akakpo, Patrick Kafui, Entsua-Mensah, Kow, Issaka, Adamu, and Adjei, Alex A.

Published
2024
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19. Targeting of the Hedgehog/GLI and mTOR pathways in advanced pancreatic cancer, a phase 1 trial of Vismodegib and Sirolimus combination

Author

Carr, Ryan M., Duma, Narjust, McCleary-Wheeler, Angela L., Almada, Luciana L., Marks, David L., Graham, Rondell P., Smyrk, Thomas C., Lowe, Val, Borad, Mitesh J., Kim, George, Johnson, Geoffrey B., Allred, Jacob B., Yin, Jun, Lim, Vun-Sin, Bekaii-Saab, Tanios, Ma, Wen We, Erlichman, Charles, Adjei, Alex A., and Fernandez-Zapico, Martin E.

Published
2020
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22. Treatment Guidance for Patients With Lung Cancer During the Coronavirus 2019 Pandemic

Author

Dingemans, Anne-Marie C., Soo, Ross A., Jazieh, Abdul Rahman, Rice, Shawn J., Kim, Young Tae, Teo, Lynette L.S., Warren, Graham W., Xiao, Shu-Yuan, Smit, Egbert F., Aerts, Joachim G., Yoon, Soon Ho, Veronesi, Giulia, De Cobelli, Francesco, Ramalingam, Suresh S., Garassino, Marina C., Wynes, Murry W., Behera, Madhusmita, Haanen, John, Lu, Shun, Peters, Solange, Ahn, Myung-Ju, Scagliotti, Giorgio V., Adjei, Alex A., and Belani, Chandra P.

Published
2020
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23. Immune Checkpoint Inhibitors in Thoracic Malignancies: Review of the Existing Evidence by an IASLC Expert Panel and Recommendations

Author

Remon, Jordi, Passiglia, Francesco, Ahn, Myung-Ju, Barlesi, Fabrice, Forde, Patrick M., Garon, Edward B., Gettinger, Scott, Goldberg, Sarah B., Herbst, Roy S., Horn, Leora, Kubota, Kaoru, Lu, Shun, Mezquita, Laura, Paz-Ares, Luis, Popat, Sanjay, Schalper, Kurt A., Skoulidis, Ferdinandos, Reck, Martin, Adjei, Alex A., and Scagliotti, Giorgio V.

Published
2020
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25. A Randomized Double-Blind Phase II Study of the Seneca Valley Virus (NTX-010) versus Placebo for Patients with Extensive-Stage SCLC (ES SCLC) Who Were Stable or Responding after at Least Four Cycles of Platinum-Based Chemotherapy: North Central Cancer Treatment Group (Alliance) N0923 Study

Author

Schenk, Erin L., Mandrekar, Sumithra J., Dy, Grace K., Aubry, Marie Christine, Tan, Angelina D., Dakhil, Shaker R., Sachs, Bradley A., Nieva, Jorge J., Bertino, Erin, Lee Hann, Christine, Schild, Steven E., Wadsworth, Troy W., Adjei, Alex A., and Molina, Julian R.

Published
2020
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26. A Phase I Study of the Oral Dual-Acting Pan-PI3K/mTOR Inhibitor Bimiralisib in Patients with Advanced Solid Tumors

Author

Janku, Filip, primary, Choong, Grace M., additional, Opyrchal, Mateusz, additional, Dowlati, Afshin, additional, Hierro, Cinta, additional, Rodon, Jordi, additional, Wicki, Andreas, additional, Forster, Martin D., additional, Blagden, Sarah P., additional, Yin, Jun, additional, Reid, Joel M., additional, Muller, Helene, additional, Cmiljanovic, Natasa, additional, Cmiljanovic, Vladimir, additional, and Adjei, Alex A., additional

Published
2024
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30. A first-in-human phase I study to evaluate the MEK1/2 inhibitor, cobimetinib, administered daily in patients with advanced solid tumors

Author

Rosen, Lee S, LoRusso, Patricia, Ma, Wen Wee, Goldman, Jonathan W, Weise, Amy, Colevas, A Dimitrios, Adjei, Alex, Yazji, Salim, Shen, Angela, Johnston, Stuart, Hsieh, Hsin-Ju, Chan, Iris T, and Sikic, Branimir I

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Vaccine Related, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Azetidines, Class I Phosphatidylinositol 3-Kinases, Female, Genes, ras, Humans, MAP Kinase Kinase 1, MAP Kinase Kinase 2, Male, Maximum Tolerated Dose, Middle Aged, Mutation, Neoplasms, Piperidines, Protein Kinase Inhibitors, Proto-Oncogene Proteins B-raf, Proto-Oncogene Proteins p21(ras), Treatment Outcome, Cobimetinib, Phase I, MEK inhibitor, BRAF, Melanoma, Pharmacology and Pharmaceutical Sciences, Oncology & Carcinogenesis, Oncology and carcinogenesis, Pharmacology and pharmaceutical sciences
Abstract

Objective Cobimetinib, a MEK1/2 inhibitor, was administered to patients with advanced solid tumors to assess safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity. Methods For dose-escalation, a 3 + 3 design was used. Oral cobimetinib was administered once daily on a 21-day on/7-day off (21/7) or a 14-day on/14-day off (14/14) schedule. Serial plasma samples were collected for pharmacokinetic (PK) analysis on Day 1 and at steady state. In expansion stages, patients with RAS or RAF mutant tumors were treated at the maximum tolerated dose (MTD) of the 21/7 or 14/14 schedule. Results Ninety-seven patients received cobimetinib. In the 21/7 dose escalation, 36 patients enrolled in 8 cohorts (0.05 mg/kg-80 mg). Dose-limiting toxicities (DLTs) were Grade 4 hepatic encephalopathy, Grade 3 diarrhea, and Grade 3 rash. In the 14/14 dose escalation, 20 patients enrolled in 4 cohorts (60-125 mg). DLTs were Grade 3 rash and Grade 3 blurred vision associated with presence of reversible subretinal fluid. The MTD was 60 mg on 21/7 schedule and 100 mg on 14/14 schedule. Cobimetinib PK showed dose-proportional increases in exposure. The most frequent adverse events attributed to cobimetinib were diarrhea, rash, fatigue, edema, nausea, and vomiting. In patients treated at the 60-mg (21/7) or 100-mg (14/14) dose, one unconfirmed complete response and 6 confirmed partial responses were observed. All responses occurred in melanoma patients; 6 harbored the BRAF(V600E) mutation. Conclusions Cobimetinib is generally well tolerated and durable responses were observed in BRAF(V600E) mutant melanoma patients. Evaluation of cobimetinib in combination with other therapies is ongoing.

Published
2016

33. Radiologic Considerations and Standardization of Malignant Pleural Mesothelioma Imaging Within Clinical Trials: Consensus Statement from the NCI Thoracic Malignancy Steering Committee – International Association for the Study of Lung Cancer – Mesothelioma Applied Research Foundation Clinical Trials Planning Meeting

Author

Gill, Ritu R., Tsao, Anne S., Kindler, Hedy L., Richards, William G, Armato, Samuel G., III, Francis, Roslyn J., Gomez, Daniel R., Dahlberg, Suzanne, Rimner, Andreas, Simone, Charles B., II, de Perrot, Marc, Blumenthal, Gideon, Adjei, Alex A., Bueno, Raphael, Harpole, David H., Jr., Hesdorffer, Mary, Hirsch, Fred R., Pass, Harvey I., Yorke, Ellen, Rosenzweig, Kenneth, Burt, Bryan, Fennell, Dean A., Lindwasser, Wolf, Malik, Shakun, Peikert, Tobias, Mansfield, Aaron S., Salgia, Ravi, Yang, Haining, Rusch, Valerie W., and Nowak, Anna K.

Published
2019
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34. Pathologic Considerations and Standardization in Mesothelioma Clinical Trials

Author

Tsao, Ming-Sound, Carbone, Michele, Galateau-Salle, Francoise, Moreira, Andre L., Nicholson, Andrew G., Roden, Anja C., Adjei, Alex A., Aubry, Marie-Christine, Fennell, Dean A., Gomez, Daniel, Harpole, David, Hesdorffer, Mary, Hirsch, Fred R., Liu, Geoffrey, Malik, Shakun, Nowak, Anna, Peikert, Tobias, Salgia, Ravi, Szlosarek, Peter, Taioli, Emanuela, Yang, Haining, Tsao, Anne, and Mansfield, Aaron S.

Published
2019
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35. A Proposed System Toward Standardizing Surgical-Based Treatments for Malignant Pleural Mesothelioma, From the Joint National Cancer Institute–International Association for the Study of Lung Cancer–Mesothelioma Applied Research Foundation Taskforce

Author

Friedberg, Joseph S., Culligan, Melissa J., Tsao, Anne S., Rusch, Valerie, Sepesi, Boris, Pass, Harvey I., Bueno, Raphael, Burt, Bryan, Sugarbaker, David J., de Perrot, Marc, Adjei, Alex A., Adusumilli, Prasad S., Hirsch, Fred R., Malik, Shakuntala M., and Harpole, David J., Jr.

Published
2019
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38. The Use of Radiation Therapy for the Treatment of Malignant Pleural Mesothelioma: Expert Opinion from the National Cancer Institute Thoracic Malignancy Steering Committee, International Association for the Study of Lung Cancer, and Mesothelioma Applied Research Foundation

Author

Gomez, Daniel R., Rimner, Andreas, Simone, Charles B., II, Cho, B.C. John, de Perrot, Marc, Adjei, Alex A., Bueno, Raphael, Gill, Ritu R., Harpole, David H., Jr., Hesdorffer, Mary, Hirsch, Fred R., Jackson, Andrew A., Pass, Harvey I., Rice, David C., Rusch, Valerie W., Tsao, Anne S., Yorke, Ellen, and Rosenzweig, Kenneth

Published
2019
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40. A phase 2 and pharmacological study of sapanisertib in patients with relapsed and/or refractory acute lymphoblastic leukemia

Author

Al‐Kali, Aref, primary, Aldoss, Ibrahim, additional, Atherton, Pamela J., additional, Strand, Carrie A., additional, Shah, Bijal, additional, Webster, Jonathan, additional, Bhatnagar, Bhavana, additional, Flatten, Karen S., additional, Peterson, Kevin L., additional, Schneider, Paula A., additional, Buhrow, Sarah A., additional, Kong, Jianping, additional, Reid, Joel M., additional, Adjei, Alex A., additional, and Kaufmann, Scott H., additional

Published
2023
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41. CTNI-03. EFFICACY OF WSD0922-FU IN OSIMERTINIB-RESISTANT NSCLC WITH CENTRAL NERVOUS SYSTEM (CNS) METASTASES – UPDATES FROM THE DOSE ESCALATION COHORT OF A FIRST-IN-HUMAN PHASE 1 CLINICAL TRIAL (MC1914)

Author

Kizilbash, Sani H, primary, Jaeckle, Kurt, additional, Mrugala, Maciej, additional, Allred, Jacob, additional, Safgren, Stephanie, additional, McGovern, Renee, additional, Remick, Adam, additional, Reid, Joel, additional, Lammers, Anita, additional, Zhong, Wei, additional, Leventakos, Konstantinos, additional, Mansfield, Aaron, additional, Shanshal, Mohamed, additional, Ma, Wen, additional, Uhm, Joon, additional, Campian, Jian, additional, Ruff, Michael, additional, Sener, Ugur, additional, Galanis, Evanthia, additional, Burns, Terry, additional, Parney, Ian, additional, Raghunathan, Aditya, additional, Vaubel, Rachael, additional, Jentoft, Mark, additional, Roden, Anja, additional, Giannini, Caterina, additional, Sarkaria, Jann, additional, and Adjei, Alex, additional

Published
2023
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42. 729 A first-in-human, open-label, multicenter, phase 1/2a, dose escalation and expansion study of GI-102, a novel immunocytokine combining CD80-IL2v3, in patients with advanced or metastatic solid tumors

Author

Lee, Jeeyun, primary, Cho, Byoung Chul, additional, Lee, Jae Lyun, additional, Lee, Jung-Yun, additional, Campian, Jian L, additional, Zhao, Yujie, additional, Seetharam, Mahesh, additional, Adjei, Alex A, additional, Ma, Wen Wee, additional, Chae, Dongwoo, additional, Yun, Nari, additional, Lee, Woosun, additional, Lee, Wooyul, additional, Park, Sosun, additional, Seo, Bochan, additional, Lee, Kyungwha, additional, Park, Chong Woo, additional, and Jang, Myoung Ho, additional

Published
2023
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43. Bintrafusp Alfa With CCRT Followed by Bintrafusp Alfa Versus Placebo With CCRT Followed by Durvalumab in Patients With Unresectable Stage III NSCLC: A Phase 2 Randomized Study

Author

Vokes, Everett E., primary, Mornex, Francoise, additional, Sezer, Ahmet, additional, Cheng, Ying, additional, Fang, Jian, additional, Baz, David Vicente, additional, Cil, Timucin, additional, Adjei, Alex A., additional, Ahn, Myung-Ju, additional, Barlesi, Fabrice, additional, Felip, Enriqueta, additional, Garon, Edward B., additional, Audhuy, Francois, additional, Ito, Rena, additional, Sato, Masashi, additional, Eggleton, S. Peter, additional, Martin, Claudio Marcelo, additional, Reck, Martin, additional, Robinson, Clifford G., additional, and Paz-Ares, Luis, additional

Published
2023
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44. Current and Future Management of Malignant Mesothelioma: A Consensus Report from the National Cancer Institute Thoracic Malignancy Steering Committee, International Association for the Study of Lung Cancer, and Mesothelioma Applied Research Foundation

Author

Tsao, Anne S., Lindwasser, O. Wolf, Adjei, Alex A., Adusumilli, Prasad S., Beyers, Matthew L., Blumenthal, Gideon M., Bueno, Raphael, Burt, Bryan M., Carbone, Michele, Dahlberg, Suzanne E., de Perrot, Marc, Fennell, Dean A., Friedberg, Joseph, Gill, Ritu R., Gomez, Daniel R., Harpole, David H., Jr., Hassan, Raffit, Hesdorffer, Mary, Hirsch, Fred R., Hmeljak, Julija, Kindler, Hedy L., Korn, Edward L., Liu, Geoffrey, Mansfield, Aaron S., Nowak, Anna K., Pass, Harvey I., Peikert, Tobias, Rimner, Andreas, Robinson, Bruce W.S., Rosenzweig, Kenneth E., Rusch, Valerie W., Salgia, Ravi, Sepesi, Boris, Simone, Charles B., II, Sridhara, Rajeshwari, Szlosarek, Peter, Taioli, Emanuela, Tsao, Ming-Sound, Yang, Haining, Zauderer, Marjorie G., and Malik, Shakun M.

Published
2018
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47. Development and Reporting of Prediction Models: Guidance for Authors From Editors of Respiratory, Sleep, and Critical Care Journals

Author

Leisman, Daniel E., Harhay, Michael O., Lederer, David J., Abramson, Michael, Adjei, Alex A., Bakker, Jan, Ballas, Zuhair K., Barreiro, Esther, Bell, Scott C., Bellomo, Rinaldo, Bernstein, Jonathan A., Branson, Richard D., Brusasco, Vito, Chalmers, James D., Chokroverty, Sudhansu, Citerio, Giuseppe, Collop, Nancy A., Cooke, Colin R., Crapo, James D., Donaldson, Gavin, Fitzgerald, Dominic A., Grainger, Emma, Hale, Lauren, Herth, Felix J., Kochanek, Patrick M., Marks, Guy, Moorman, J. Randall, Ost, David E., Schatz, Michael, Sheikh, Aziz, Smyth, Alan R., Stewart, Iain, Stewart, Paul W., Swenson, Erik R., Szymusiak, Ronald, Teboul, Jean-Louis, Vincent, Jean-Louis, Wedzicha, Jadwiga A., and Maslove, David M.

Published
2020
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