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1. Expanding access to early phase trials: the CATCH-UP.2020 experience

Author

Baranda, Joaquina C, Diaz, Francisco J, Rubinstein, Larry, Shields, Anthony F, Dayyani, Farshid, Mehta, Amitkumar, Mehnert, Janice M, Trent, Jonathan, Mabaera, Rodwell, Mooney, Margaret, Moscow, Jeffrey A, Doroshow, James, Waters, Brittany, Ivy, Percy, Gore, Steven D, and Thomas, Alexandra

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Patient Safety, Rural Health, Cancer, Clinical Trials and Supportive Activities, Humans, COVID-19, Ethnicity, Minority Groups, Neoplasms, Pandemics, Clinical Trials as Topic, Oncology and carcinogenesis
Abstract

BackgroundDisparities in cancer outcomes persist for underserved populations; one important aspect of this is limited access to promising early phase clinical trials. To address this, the National Cancer Institute-funded Create Access to Targeted Cancer Therapy for Underserved Populations (CATCH-UP.2020) was created. We report the tools developed and accrual metrics of the initial year of CATCH-UP.2020 with a focus on racial, ethnic, geographic, and socioeconomically underserved populations.MethodsCATCH-UP.2020 is a P30 supplement awarded to 8 National Cancer Institute-designated cancer centers with existing resources to rapidly open and accrue to Experimental Therapeutics Clinical Trials Network (ETCTN) trials with emphasis on engaging patients from underserved populations. Sites used patient-based, community-based, investigator-based, and program-based tools to meet specific program goals.ResultsFrom September 2020 to August 2021, CATCH-UP.2020 sites opened 45 ETCTN trials. Weighted average trial activation time for the 7 sites reporting this was 107 days. In the initial year, sites enrolled 145 patients in CATCH-UP.2020 with 68 (46.9%) representing racial, ethnic, rural, and socioeconomically underserved populations using the broader definition of underserved encompassed in the grant charge. During the initial year of CATCH-UP.2020, a time impacted by the COVID-19 pandemic, 15.8% (66 of 417) and 21.4% (31 of 145) of patients enrolled to ETCTN trials at network and at CATCH-UP sites, respectively, were from racial and ethnic minority groups, a more limited definition of underserved for which comparable data are available.ConclusionTargeted funding accelerated activation and accrual of early phase trials and expanded access to this therapeutic option for underserved populations.

Published
2023

2. Outcomes of patients with resected stage III/IV acral or mucosal melanoma, treated with adjuvant anti-PD-1 based therapy

Author

Jacques, Sarah K., McKeown, Janet, Grover, Piyush, Johnson, Douglas B., Zaremba, Anne, Dimitriou, Florentia, Weiser, Roi, Farid, Mohamad, Namikawa, Kenjiro, Sullivan, Ryan J., Rutkowski, Piotr, Lebbe, Celeste, Hamid, Omid, Zager, Jonathan S., Michielin, Olivier, Neyns, Bart, Nakamura, Yasuhiro, Robert, Caroline, Mehnert, Janice, Ascierto, Paolo A., Bhave, Prachi, Park, Benjamin, Zimmer, Lisa, Mangana, Joanna, Mooradian, Megan, Placzke, Joanna, Allayous, Clare, Glitza Oliva, Isabella C., Mehmi, Inderjit, Depalo, Danielle, Wicky, Alexandre, Schwarze, Julia K., Roy, Severine, Boatwright, Christina, Vanella, Vito, Long, Georgina V., Menzies, Alexander M., Lo, Serigne N., and Carlino, Matteo S.

Published
2024
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3. A phase 2 open-label study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1): Final long-term analysis of groups 1, 2, and 3, and primary analysis of fixed-dose treatment group 6

Author

Hughes, Brett G.M., Guminski, Alexander, Bowyer, Samantha, Migden, Michael R., Schmults, Chrysalyne D., Khushalani, Nikhil I., Chang, Anne Lynn S., Grob, Jean-Jacques, Lewis, Karl D., Ansstas, George, Day, Fiona, Ladwa, Rahul, Stein, Brian N., Muñoz Couselo, Eva, Meier, Friedegund, Hauschild, Axel, Schadendorf, Dirk, Basset-Seguin, Nicole, Modi, Badri, Dalac-Rat, Sophie, Dunn, Lara A., Flatz, Lukas, Mortier, Laurent, Guégan, Sarah, Heinzerling, Lucie M., Mehnert, Janice M., Trabelsi, Sabiha, Soria-Rivas, Ainara, Stratigos, Alexander J., Ulrich, Claas, Wong, Deborah J., Beylot-Barry, Marie, Bossi, Paolo, Bugés Sánchez, Cristina, Chandra, Sunandana, Robert, Caroline, Russell, Jeffery S., Silk, Ann W., Booth, Jocelyn, Yoo, Suk-Young, Seebach, Frank, Lowy, Israel, Fury, Matthew G., and Rischin, Danny

Published
2024
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4. A phase 1b single-arm trial of intratumoral oncolytic virus V937 in combination with pembrolizumab in patients with advanced melanoma: results from the CAPRA study

Author

Silk, Ann W., O’Day, Steven J., Kaufman, Howard L., Bryan, Jennifer, Norrell, Jacqueline T., Imbergamo, Casey, Portal, Daniella, Zambrano-Acosta, Edwin, Palmeri, Marisa, Fein, Seymour, Wu, Cai, Guerreiro, Leslie, Medina, Daniel, Bommareddy, Praveen K., Zloza, Andrew, Fox, Bernard A., Ballesteros-Merino, Carmen, Ren, Yixin, Shafren, Darren, Grose, Mark, Vieth, Joshua A., and Mehnert, Janice M.

Published
2023
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7. Continuous versus intermittent BRAF and MEK inhibition in patients with BRAF-mutated melanoma: a randomized phase 2 trial

Author

Algazi, Alain P, Othus, Megan, Daud, Adil I, Lo, Roger S, Mehnert, Janice M, Truong, Thach-Giao, Conry, Robert, Kendra, Kari, Doolittle, Gary C, Clark, Joseph I, Messino, Michael J, Moore, Dennis F, Lao, Christopher, Faller, Bryan A, Govindarajan, Rangaswamy, Harker-Murray, Amy, Dreisbach, Luke, Moon, James, Grossmann, Kenneth F, and Ribas, Antoni

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Clinical Trials and Supportive Activities, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Administration, Oral, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Drug Administration Schedule, Female, Humans, Imidazoles, MAP Kinase Kinase Kinases, Male, Melanoma, Middle Aged, Mutation, Missense, Oximes, Protein Kinase Inhibitors, Proto-Oncogene Proteins B-raf, Pyridones, Pyrimidinones, Skin Neoplasms, Survival Analysis, Treatment Outcome, Young Adult, Medical and Health Sciences, Immunology, Biomedical and clinical sciences, Health sciences
Abstract

Preclinical modeling suggests that intermittent BRAF inhibitor therapy may delay acquired resistance when blocking oncogenic BRAFV600 in melanoma1,2. We conducted S1320, a randomized, open-label, phase 2 clinical trial (NCT02196181) evaluating whether intermittent dosing of the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib improves progression-free survival in patients with metastatic and unresectable BRAFV600 melanoma. Patients were enrolled at 68 academic and community sites nationally. All patients received continuous dabrafenib and trametinib during an 8-week lead-in period, after which patients with non-progressing tumors were randomized to either continuous or intermittent dosing of both drugs on a 3-week-off, 5-week-on schedule. The trial has completed accrual and 206 patients with similar baseline characteristics were randomized 1:1 to the two study arms (105 to continuous dosing, 101 to intermittent dosing). Continuous dosing yielded a statistically significant improvement in post-randomization progression-free survival compared with intermittent dosing (median 9.0 months versus 5.5 months, P = 0.064, pre-specified two-sided α = 0.2). Therefore, contrary to the initial hypothesis, intermittent dosing did not improve progression-free survival in patients. There were no differences in the secondary outcomes, including overall survival and the overall incidence of treatment-associated toxicity, between the two groups.

Published
2020

8. Prognostic Gene Expression Profiling in Cutaneous Melanoma

Author

Grossman, Douglas, Okwundu, Nwanneka, Bartlett, Edmund K, Marchetti, Michael A, Othus, Megan, Coit, Daniel G, Hartman, Rebecca I, Leachman, Sancy A, Berry, Elizabeth G, Korde, Larissa, Lee, Sandra J, Bar-Eli, Menashe, Berwick, Marianne, Bowles, Tawnya, Buchbinder, Elizabeth I, Burton, Elizabeth M, Chu, Emily Y, Curiel-Lewandrowski, Clara, Curtis, Julia A, Daud, Adil, Deacon, Dekker C, Ferris, Laura K, Gershenwald, Jeffrey E, Grossmann, Kenneth F, Hu-Lieskovan, Siwen, Hyngstrom, John, Jeter, Joanne M, Judson-Torres, Robert L, Kendra, Kari L, Kim, Caroline C, Kirkwood, John M, Lawson, David H, Leming, Philip D, Long, Georgina V, Marghoob, Ashfaq A, Mehnert, Janice M, Ming, Michael E, Nelson, Kelly C, Polsky, David, Scolyer, Richard A, Smith, Eric A, Sondak, Vernon K, Stark, Mitchell S, Stein, Jennifer A, Thompson, John A, Thompson, John F, Venna, Suraj S, Wei, Maria L, and Swetter, Susan M

Subjects
Cancer, Clinical Research, Patient Safety, Prevention, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Good Health and Well Being, Clinical Decision-Making, Consensus, Consensus Development Conferences as Topic, Gene Expression Profiling, Humans, Melanoma, Neoplasm Staging, Practice Guidelines as Topic, Prognosis, Sentinel Lymph Node Biopsy, Skin Neoplasms, Clinical Sciences, Oncology and Carcinogenesis
Abstract

ImportanceUse of prognostic gene expression profile (GEP) testing in cutaneous melanoma (CM) is rising despite a lack of endorsement as standard of care.ObjectiveTo develop guidelines within the national Melanoma Prevention Working Group (MPWG) on integration of GEP testing into the management of patients with CM, including (1) review of published data using GEP tests, (2) definition of acceptable performance criteria, (3) current recommendations for use of GEP testing in clinical practice, and (4) considerations for future studies.Evidence reviewThe MPWG members and other international melanoma specialists participated in 2 online surveys and then convened a summit meeting. Published data and meeting abstracts from 2015 to 2019 were reviewed.FindingsThe MPWG members are optimistic about the future use of prognostic GEP testing to improve risk stratification and enhance clinical decision-making but acknowledge that current utility is limited by test performance in patients with stage I disease. Published studies of GEP testing have not evaluated results in the context of all relevant clinicopathologic factors or as predictors of regional nodal metastasis to replace sentinel lymph node biopsy (SLNB). The performance of GEP tests has generally been reported for small groups of patients representing particular tumor stages or in aggregate form, such that stage-specific performance cannot be ascertained, and without survival outcomes compared with data from the American Joint Committee on Cancer 8th edition melanoma staging system international database. There are significant challenges to performing clinical trials incorporating GEP testing with SLNB and adjuvant therapy. The MPWG members favor conducting retrospective studies that evaluate multiple GEP testing platforms on fully annotated archived samples before embarking on costly prospective studies and recommend avoiding routine use of GEP testing to direct patient management until prospective studies support their clinical utility.Conclusions and relevanceMore evidence is needed to support using GEP testing to inform recommendations regarding SLNB, intensity of follow-up or imaging surveillance, and postoperative adjuvant therapy. The MPWG recommends further research to assess the validity and clinical applicability of existing and emerging GEP tests. Decisions on performing GEP testing and patient management based on these results should only be made in the context of discussion of testing limitations with the patient or within a multidisciplinary group.

Published
2020

12. Safety profile of avelumab in patients with advanced solid tumors: A pooled analysis of data from the phase 1 JAVELIN solid tumor and phase 2 JAVELIN Merkel 200 clinical trials

Author

Kelly, Karen, Infante, Jeffrey R, Taylor, Matthew H, Patel, Manish R, Wong, Deborah J, Iannotti, Nicholas, Mehnert, Janice M, Loos, Anja H, Koch, Helga, Speit, Isabell, and Gulley, James L

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Immunology, Cancer, Clinical Research, Clinical Trials and Supportive Activities, Patient Safety, Good Health and Well Being, Aged, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Immunological, B7-H1 Antigen, Clinical Trials, Phase I as Topic, Clinical Trials, Phase II as Topic, Disease Progression, Dose-Response Relationship, Drug, Fatigue, Female, Follow-Up Studies, Humans, Incidence, Infusions, Intravenous, Injection Site Reaction, Male, Middle Aged, Multicenter Studies as Topic, Neoplasms, Treatment Outcome, avelumab, immunotherapy, JAVELIN, programmed death-ligand 1, safety, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis, Public health
Abstract

BackgroundAntibodies targeting the programmed death-ligand 1 (PD-L1)/programmed cell death protein 1 (PD-1) checkpoint may cause adverse events (AEs) that are linked to the mechanism of action of this therapeutic class and unique from those observed with conventional chemotherapy.MethodsPatients with advanced solid tumors who were enrolled in the phase 1 JAVELIN Solid Tumor (1650 patients) and phase 2 JAVELIN Merkel 200 (88 patients) trials received avelumab, a human anti-PD-L1 IgG1 antibody at a dose of 10 mg/kg every 2 weeks. Treatment-related AEs (TRAEs) were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). In post hoc analyses, immune-related AEs (irAEs) were identified via an expanded AE list and medical review, and infusion-related reactions (IRRs) occurring ≤2 days after infusion and symptoms occurring ≤1 day after infusion and resolving ≤2 days after onset were identified based on prespecified Medical Dictionary for Regulatory Activities (MedDRA) terms.ResultsOf the 1738 patients analyzed, grade ≥3 TRAEs occurred in 177 (10.2%); the most common were fatigue (17 patients; 1.0%) and IRR (10 patients; 0.6%). TRAEs led to discontinuation in 107 patients (6.2%) and death in 4 patients (0.2%). Grade ≥3 irAEs occurred in 39 patients (2.2%) and led to discontinuation in 34 patients (2.0%). IRRs or related symptoms occurred in 439 patients (25.3%; grade 3 in 0.5% [9 patients] and grade 4 in 0.2% [3 patients]). An IRR occurred at the time of first infusion in 79.5% of 439 patients who had an IRR, within the first 4 doses in 98.6% of 439 patients who had an IRR, and led to discontinuation in 35 patients (2.0%).ConclusionsAvelumab generally was found to be well tolerated and to have a manageable safety profile. A minority of patients experienced grade ≥3 TRAEs or irAEs, and discontinuation was uncommon. IRRs occurred mainly at the time of first infusion, and repeated events were infrequent. Cancer 2018;124:2010-7. © 2018 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

Published
2018

15. The Challenge for Development of Valuable Immuno-oncology Biomarkers

Author

Mehnert, Janice M, Monjazeb, Arta M, Beerthuijzen, Johanna MT, Collyar, Deborah, Rubinstein, Larry, and Harris, Lyndsay N

Subjects
Cancer, Human Genome, Genetics, Detection, screening and diagnosis, 4.1 Discovery and preclinical testing of markers and technologies, Good Health and Well Being, Biomarkers, Tumor, Humans, Immunotherapy, Lymphocytes, Tumor-Infiltrating, Neoplasms, Quality of Life, Tumor Microenvironment, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

The development of immunotherapy is an important breakthrough for the treatment of cancer, with antitumor efficacy observed in a wide variety of tumors. To optimize immunotherapy use, approaches must be developed to identify which patients are likely to achieve benefit. To minimize therapeutic toxicities and costs, understanding the ideal choice and sequencing of the numerous immuno-oncology agents available for individual patients is thus critical, but fraught with challenges. The immune tumor microenvironment (TME) is a unique aspect of the response to immuno-oncology agents and measurement of single biomarkers does not adequately capture these complex interactions. Therefore, multiple potential biomarkers are likely needed. Current candidates in this area include PD-L1 expression, CD8+ tumor-infiltrating lymphocytes, tumor mutation load and neoantigen burden, immune-related gene signatures, and multiplex IHC assays that examine the pharmacodynamic and spatial interactions of the TME. The most fruitful investigations are likely to use several techniques to predict response and interrogate mechanisms of resistance. Immuno-oncology biomarker research must employ validated assays to ask focused research questions utilizing clinically annotated tissue collections and biomarker-focused clinical trial designs to investigate specific endpoints. Real-time input from patients and their advocates into biomarker discovery is necessary to ensure that the investigations pursued will improve both clinical outcomes and quality of life. We herein provide a framework of recommendations to guide the search for immuno-oncology biomarkers of value.

Published
2017

17. Phase I Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced Melanoma.

Author

Hamid, Omid, Lewis, Karl D., Weise, Amy, McKean, Meredith, Papadopoulos, Kyriakos P., Crown, John, Kim, Tae Min, Lee, Dae Ho, Thomas, Sajeve S., Mehnert, Janice, Kaczmar, John, Lakhani, Nehal J., Kim, Kevin B., Middleton, Mark R., Rabinowits, Guilherme, Spira, Alexander I., Yushak, Melinda, Mehmi, Inderjit, Fang, Fang, and Chen, Shuquan

Published
2024
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18. Pembrolizumab After Two or More Lines of Previous Therapy in Patients With Recurrent or Metastatic SCLC: Results From the KEYNOTE-028 and KEYNOTE-158 Studies

Author

Chung, Hyun Cheol, Piha-Paul, Sarina A., Lopez-Martin, Jose, Schellens, Jan H.M., Kao, Steven, Miller, Wilson H., Jr., Delord, Jean-Pierre, Gao, Bo, Planchard, David, Gottfried, Maya, Zer, Alona, Jalal, Shadia I., Penel, Nicolas, Mehnert, Janice M., Matos, Ignacio, Bennouna, Jaafar, Kim, Dong-Wan, Xu, Lei, Krishnan, Suba, Norwood, Kevin, and Ott, Patrick A.

Published
2020
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21. Phase I neoadjuvant study of intravesical recombinant fowlpox-GM-CSF (rF-GM-CSF) or fowlpox-TRICOM (rF-TRICOM) in patients with bladder carcinoma

Author

Portal, Daniella E., Weiss, Robert E., Wojtowicz, Malgorzata, Mansour, Amal, Monken, Claude, Mehnert, Janice M., Aisner, Joseph A., Kane, Michael, Nishioka, Jennifer, Aisner, Seena, Peters, Stephen, Stein, Mark N., Kim, Isaac Y., Mayer, Tina M., Shih, Weichung, Gulley, James, Streicher, Howard, Singer, Eric A., and Lattime, Edmund C.

Published
2020
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27. Early objective response to avelumab treatment is associated with improved overall survival in patients with metastatic Merkel cell carcinoma

Author

D’Angelo, Sandra P., Hunger, Matthias, Brohl, Andrew S., Nghiem, Paul, Bhatia, Shailender, Hamid, Omid, Mehnert, Janice M., Terheyden, Patrick, Shih, Kent C., Brownell, Isaac, Lebbé, Céleste, Lewis, Karl D., Linette, Gerald P., Milella, Michele, Schlichting, Michael, Hennessy, Meliessa H., and Bharmal, Murtuza

Published
2019
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28. Extended Follow-Up of Chronic Immune-Related Adverse Events Following Adjuvant Anti–PD-1 Therapy for High-Risk Resected Melanoma

Author

Goodman, Rachel S., primary, Lawless, Aleigha, additional, Woodford, Rachel, additional, Fa’ak, Faisal, additional, Tipirneni, Asha, additional, Patrinely, J. Randall, additional, Yeoh, Hui Ling, additional, Rapisuwon, Suthee, additional, Haydon, Andrew, additional, Osman, Iman, additional, Mehnert, Janice M., additional, Long, Georgina V., additional, Sullivan, Ryan J., additional, Carlino, Matteo S., additional, Menzies, Alexander M., additional, and Johnson, Douglas B., additional

Published
2023
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29. Autophagy maintains tumour growth through circulating arginine

Author

Poillet-Perez, Laura, Xie, Xiaoqi, Zhan, Le, Yang, Yang, Sharp, Daniel W., Hu, Zhixian Sherrie, Su, Xiaoyang, Maganti, Anurag, Jiang, Cherry, Lu, Wenyun, Zheng, Haiyan, Bosenberg, Marcus W., Mehnert, Janice M., Guo, Jessie Yanxiang, Lattime, Edmund, Rabinowitz, Joshua D., and White, Eileen

Published
2018
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30. Talimogene laherparepvec in combination with ipilimumab versus ipilimumab alone for advanced melanoma: 5-year final analysis of a multicenter, randomized, open-label, phase II trial

Author

Chesney, Jason A, primary, Puzanov, Igor, additional, Collichio, Frances A, additional, Singh, Parminder, additional, Milhem, Mohammed M, additional, Glaspy, John, additional, Hamid, Omid, additional, Ross, Merrick, additional, Friedlander, Philip, additional, Garbe, Claus, additional, Logan, Theodore, additional, Hauschild, Axel, additional, Lebbé, Celeste, additional, Joshi, Harshada, additional, Snyder, Wendy, additional, and Mehnert, Janice M, additional

Published
2023
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31. Abstract CT032: Trials in progress: a global phase 1/1b clinical trial evaluating exarafenib (KIN-2787), a highly selective pan-RAF inhibitor, in adult patients with BRAF-altered solid tumors and NRAS mutant melanoma

Author

Spira, Alexander, primary, Gambardella, Valentina, additional, Kato, Shumei, additional, Perez, Cesar Batista, additional, Mckean, Meredith, additional, Cao, Maria Gonzalez, additional, Kim, Richard, additional, Chen, Chris T, additional, Italiano, Antoine, additional, Cassier, Philippe, additional, Mehnert, Janice, additional, Chmielowski, Bartosz, additional, Lee, Gerri, additional, Severson, Paul, additional, Unger, Caro, additional, Guan, Xiaowei, additional, Williams, Richard, additional, and Long, Georgina, additional

Published
2023
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32. A phase I trial of riluzole and sorafenib in patients with advanced solid tumors: CTEP #8850

Author

Spencer, Kristen R., primary, Portal, Daniella E., additional, Aisner, Joseph, additional, Stein, Mark N., additional, Malhotra, Jyoti, additional, Shih, Weichung, additional, Chan, Nancy, additional, Silk, Ann W., additional, Ganesan, Shridar, additional, Goodin, Susan, additional, Gounder, Murugesan, additional, Lin, Hongxia, additional, Li, Jiadong, additional, Cerchio, Robert, additional, Marinaro, Christina, additional, Chen, Suzie, additional, and Mehnert, Janice M., additional

Published
2023
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33. 876 Significant Survival Improvements for Patients with Melanoma Brain Metastases: Can We Reach Cure in the Current Era?

Author

Berger, Assaf, primary, Bernstein, Kenneth, additional, AlzateRamirez, Juan, additional, Mullen, Reed, additional, Silverman, Joshua S., additional, Sulman, Erik P., additional, Donahue, Bernadine, additional, Anna, Pavlick, additional, Gurewitz, Jason, additional, Mureb, Monica, additional, Mehnert, Janice, additional, Madden, Kathleen, additional, Palermo, Amy, additional, Weber, Jeffrey, additional, Golfinos, John G., additional, and Kondziolka, Douglas, additional

Published
2023
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34. Publisher Correction: Autophagy promotes growth of tumors with high mutational burden by inhibiting a T-cell immune response

Author

Poillet-Perez, Laura, Sharp, Daniel W., Yang, Yang, Laddha, Saurabh V., Ibrahim, Maria, Bommareddy, Praveen K., Hu, Zhixian Sherrie, Vieth, Joshua, Haas, Michael, Bosenberg, Marcus W., Rabinowitz, Joshua D., Cao, Jian, Guan, Jun-Lin, Ganesan, Shridar, Chan, Chang S., Mehnert, Janice M., Lattime, Edmund C., and White, Eileen

Published
2021
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35. Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma

Author

Schadendorf, Dirk, Dummer, Reinhard, Hauschild, Axel, Robert, Caroline, Hamid, Omid, Daud, Adil, van den Eertwegh, Alfons, Cranmer, Lee, O'Day, Steven, Puzanov, Igor, Schachter, Jacob, Blank, Christian, Salama, April, Loquai, Carmen, Mehnert, Janice M., Hille, Darcy, Ebbinghaus, Scot, Kang, S. Peter, Zhou, Wei, and Ribas, Antoni

Published
2016
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38. Safety and enhanced immunostimulatory activity of the DRD2 antagonist ONC201 in advanced solid tumor patients with weekly oral administration

Author

Stein, Mark N., Malhotra, Jyoti, Tarapore, Rohinton S., Malhotra, Usha, Silk, Ann W., Chan, Nancy, Rodriguez, Lorna, Aisner, Joseph, Aiken, Robert D., Mayer, Tina, Haffty, Bruce G., Newman, Jenna H., Aspromonte, Salvatore M., Bommareddy, Praveen K., Estupinian, Ricardo, Chesson, Charles B., Sadimin, Evita T., Li, Shengguo, Medina, Daniel J., Saunders, Tracie, Frankel, Melissa, Kareddula, Aparna, Damare, Sherrie, Wesolowsky, Elayne, Gabel, Christian, El-Deiry, Wafik S., Prabhu, Varun V., Allen, Joshua E., Stogniew, Martin, Oster, Wolfgang, Bertino, Joseph R., Libutti, Steven K., Mehnert, Janice M., and Zloza, Andrew

Published
2019
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41. Supplementary Figures 1-6, Supplementary Tables 1-5 from First-in-Human Clinical Trial of Oral ONC201 in Patients with Refractory Solid Tumors

Author

Stein, Mark N., primary, Bertino, Joseph R., primary, Kaufman, Howard L., primary, Mayer, Tina, primary, Moss, Rebecca, primary, Silk, Ann, primary, Chan, Nancy, primary, Malhotra, Jyoti, primary, Rodriguez, Lorna, primary, Aisner, Joseph, primary, Aiken, Robert D., primary, Haffty, Bruce G., primary, DiPaola, Robert S., primary, Saunders, Tracie, primary, Zloza, Andrew, primary, Damare, Sherri, primary, Beckett, Yasmeen, primary, Yu, Bangning, primary, Najmi, Saltanat, primary, Gabel, Christian, primary, Dickerson, Siobhan, primary, Zheng, Ling, primary, El-Deiry, Wafik S., primary, Allen, Joshua E., primary, Stogniew, Martin, primary, Oster, Wolfgang, primary, and Mehnert, Janice M., primary

Published
2023
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44. Supplementary Methods, Tables 1 - 2 from Phase I Dose-Escalation Study of Onartuzumab as a Single Agent and in Combination with Bevacizumab in Patients with Advanced Solid Malignancies

Author

Salgia, Ravi, primary, Patel, Premal, primary, Bothos, John, primary, Yu, Wei, primary, Eppler, Steve, primary, Hegde, Priti, primary, Bai, Shuang, primary, Kaur, Surinder, primary, Nijem, Ihsan, primary, Catenacci, Daniel V.T., primary, Peterson, Amy, primary, Ratain, Mark J., primary, Polite, Blase, primary, Mehnert, Janice M., primary, and Moss, Rebecca A., primary

Published
2023
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46. Supplementary Data from BAMM (BRAF Autophagy and MEK Inhibition in Melanoma): A Phase I/II Trial of Dabrafenib, Trametinib, and Hydroxychloroquine in Advanced BRAFV600-mutant Melanoma

Author

Mehnert, Janice M., primary, Mitchell, Tara C., primary, Huang, Alexander C., primary, Aleman, Tomas S., primary, Kim, Benjamin J., primary, Schuchter, Lynn M., primary, Linette, Gerald P., primary, Karakousis, Giorgos C., primary, Mitnick, Sheryl, primary, Giles, Lydia, primary, Carberry, Mary, primary, Frey, Noelle, primary, Kossenkov, Andrew, primary, Groisberg, Roman, primary, Hernandez-Aya, Leonel F., primary, Ansstas, George, primary, Silk, Ann W., primary, Chandra, Sunandana, primary, Sosman, Jeffrey A., primary, Gimotty, Phyllis A., primary, Mick, Rosemarie, primary, and Amaravadi, Ravi K., primary

Published
2023
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