Milind Javle, M.D.
Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine
Present Title & Affiliation
Primary Appointment
Professor, Department of Gastrointestinal (GI) Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
Education & Training
Degree-Granting Education
1991 | Grant Medical College, University of Bombay, India, Bombay, IND, MD, Medicine |
Postgraduate Training
1994-1995 | Clinical Residency, Internal Medicine, SUNY Buffalo, Buffalo, NY |
Experience & Service
Academic Appointments
Assistant Professor, Roswell Park Cancer Institute, Buffalo, NY, 2001 - 2006
Selected Publications
Peer-Reviewed Articles
- DiPeri TP, Evans KW, Wang B, Zhao M, Akcakanat A, Raso MG, Rizvi YQ, Zheng X, Korkut A, Varadarajan K, Uzunparmak B, Dumbrava EE, Pant S, Ajani JA, Pohlmann PR, Jensen VB, Javle M, Rodon J, Meric-Bernstam F. Co-clinical Trial of Novel Bispecific Anti-HER2 Antibody Zanidatamab in Patient-Derived Xenografts. Cancer Discov 14(5):828-845, 2024. PMID: 38358339.
- Jain AJ, Lendoire M, Boyev A, Newhook TE, Tzeng CD, Tran Cao HS, Coronel E, Lee SS, Hu ZI, Javle M, Lee JH, Vauthey JN, Chun YS. Revisiting the Malignant Masquerade at the Liver Hilum: Have We Made Progress?. Ann Surg Oncol 31(5):3062-3068, 2024. e-Pub 2024. PMID: 38282027.
- Moffat GT, Hu ZI, Meric-Bernstam F, Kong EK, Pavlick D, Ross JS, Murugesan K, Kwong L, De Armas AD, Korkut A, Javle M, Knox JJ. KRAS Allelic Variants in Biliary Tract Cancers. JAMA Netw Open 7(5):e249840, 2024. e-Pub 2024. PMID: 38709532.
- Piha-Paul SA, Xu B, Dumbrava EE, Fu S, Karp DD, Meric-Bernstam F, Hong DS, Rodon JA, Tsimberidou AM, Raghav K, Ajani JA, Conley AP, Mott F, Fan Y, Fan J, Peng P, Wang H, Ni S, Sun C, Qiang X, Levin WJ, Ngo B, Ru QC, Wu F, Javle MM. First-In-Human Phase I Study of Tinengotinib (TT-00420), a Multiple Kinase Inhibitor, as a Single Agent in Patients With Advanced Solid Tumors. Oncologist 29(4):e514-e525, 2024. PMID: 38297981.
- Zhu Y, Zhang D, Shukla P, Jung YH, Malgulwar PB, Chagani S, Colic M, Benjamin S, Copland Iii JA, Tan L, Lorenzi PL, Javle M, Huse JT, Roszik J, Hart T, Kwong LN. CRISPR screening identifies BET and mTOR inhibitor synergy in cholangiocarcinoma through serine glycine one carbon. JCI Insight. e-Pub 2023. PMID: 38060314.
- Tang TY, Nichetti F, Kaplan B, Lonardi S, Pietrantonio F, Salvatore L, Vivaldi C, Rimassa L, de Braud F, Rizzato MD, Pavlick D, Chu R, Danner De Armas A, Sharaf R, Sokol E, Rodon Ahnert J, Ross JS, Javle M, Niger M. Comparative Genomic Analysis and Clinical Outcomes of BRAF-mutated Advanced Biliary Tract Cancers. Clin Cancer Res 29(23):4853-4862, 2023. PMID: 37773629.
- DiPeri TP, Zhao M, Evans KW, Varadarajan K, Moss T, Scott S, Kahle MP, Byrnes CC, Chen H, Lee SS, Halim AB, Hirai H, Wacheck V, Kwong LN, Rodon J, Javle M, Meric-Bernstam F. Convergent MAPK pathway alterations mediate acquired resistance to FGFR inhibitors in FGFR2 fusion-positive cholangiocarcinoma. J Hepatol. e-Pub 2023. PMID: 37972659.
- Hatia RI, Eluri M, Hawk ET, Shalaby A, Karatas E, Shalaby A, Abdelhakeem A, Abdel-Wahab R, Chang P, Rashid A, Jalal PK, Amos CI, Han Y, Armaghany T, Shroff RT, Li D, Javle M, Hassan MM. Independent of Primary Sclerosing Cholangitis and Cirrhosis, Early Adulthood Obesity is Associated with Cholangiocarcinoma. Cancer Epidemiol Biomarkers Prev. e-Pub 2023. PMID: 37540502.
- De B, Upadhyay R, Liao K, Kumala T, Shi C, Dodoo G, Abi Jaoude J, Corrigan KL, Manzar GS, Marqueen KE, Bernard V, Lee SS, Raghav KPS, Vauthey JN, Tzeng CD, Tran Cao HS, Lee G, Wo JY, Hong TS, Crane CH, Minsky BD, Smith GL, Holliday EB, Taniguchi CM, Koong AC, Das P, Javle M, Ludmir EB, Koay EJ. Definitive Liver Radiotherapy for Intrahepatic Cholangiocarcinoma with Extrahepatic Metastases. Liver Cancer 12(3):198-208, 2023. e-Pub 2023. PMID: 37593365.
- Pappas L, Baiev I, Reyes S, Bocobo AG, Jain A, Spencer K, Le TM, Rahma OE, Maurer J, Stanton J, Zhang K, De Armas AD, Deleon TT, Roth M, Peters MLB, Zhu AX, Boyhen K, VanCott C, Patel T, Roberts LR, Lindsey S, Horick N, Lennerz JK, Iafrate AJ, Goff LW, Mody K, Borad MJ, Shroff RT, Javle MM, Kelley RK, Goyal L. The Cholangiocarcinoma in the Young (CITY) Study: Tumor Biology, Treatment Patterns, and Survival Outcomes in Adolescent Young Adults With Cholangiocarcinoma. JCO Precis Oncol 7:e2200594, 2023. PMID: 37561981.
- Ngo-Huang AT, Parker NH, Xiao L, Schadler KL, Petzel MQB, Prakash LR, Kim MP, Tzeng CD, Lee JE, Ikoma N, Wolff RA, Javle MM, Koay EJ, Pant SD, Folloder JP, Wang X, Cotto AM, Ju YR, Garg N, Wang H, Bruera ED, Basen-Engquist KM, Katz MHG. Effects of a Pragmatic Home-based Exercise Program Concurrent With Neoadjuvant Therapy on Physical Function of Patients With Pancreatic Cancer: The PancFit Randomized Clinical Trial. Ann Surg 278(1):22-30, 2023. e-Pub 2023. PMID: 37026453.
- Maithel SK, Keilson JM, Cao HST, Rupji M, Mahipal A, Lin BS, Javle MM, Cleary SP, Akce M, Switchenko JM, Rocha FG. ASO Visual Abstact: NEO-GAP: A Single-Arm, Phase II Feasibility Trial of Neoadjuvant Gemcitabine, Cisplatin, and Nab-paclitaxel for Resectable, High-Risk Intrahepatic Cholangiocarcinoma. Ann Surg Oncol. e-Pub 2023. PMID: 37468674.
- Spencer K, Pappas L, Baiev I, Maurer J, Bocobo AG, Zhang K, Jain A, De Armas AD, Reyes S, Le TM, Rahma OE, Stanton J, DeLeon TT, Roth M, Peters MLB, Zhu AX, Lennerz JK, Iafrate AJ, Boyhen K, VanCott C, Roberts LR, Lindsey S, Horick N, Goff LW, Mody K, Borad MJ, Shroff RT, Kelley RK, Javle MM, Goyal L. Molecular profiling and treatment pattern differences between intrahepatic and extrahepatic cholangiocarcinoma. J Natl Cancer Inst 115(7):870-880, 2023. PMID: 37040087.
- Javle M, King G, Spencer K, Borad MJ. Futibatinib, an Irreversible FGFR1-4 Inhibitor for the Treatment of FGFR-Aberrant Tumors. Oncologist. e-Pub 2023. PMID: 37390492.
- Maithel SK, Keilson JM, Cao HST, Rupji M, Mahipal A, Lin BS, Javle MM, Cleary SP, Akce M, Switchenko JM, Rocha FG. NEO-GAP: A Single-Arm, Phase II Feasibility Trial of Neoadjuvant Gemcitabine, Cisplatin, and Nab-Paclitaxel for Resectable, High-Risk Intrahepatic Cholangiocarcinoma. Ann Surg Oncol. e-Pub 2023. PMID: 37368098.
- Harding JJ, Fan J, Oh DY, Choi HJ, Kim JW, Chang HM, Bao L, Sun HC, Macarulla T, Xie F, Metges JP, Ying J, Bridgewater J, Lee MA, Tejani MA, Chen EY, Kim DU, Wasan H, Ducreux M, Bao Y, Boyken L, Ma J, Garfin P, Pant S, HERIZON-BTC-01 study group. Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study. Lancet Oncol. e-Pub 2023. PMID: 37276871.
- Yoo C, Javle MM, Verdaguer Mata H, de Braud F, Trojan J, Raoul JL, Kim JW, Ueno M, Lee CK, Hijioka S, Cubillo A, Furuse J, Azad N, Sato M, Vugmeyster Y, Machl A, Bajars M, Bridgewater J, Oh DY, Borad MJ. Phase 2 trial of bintrafusp alfa as second-line therapy for patients with locally advanced/metastatic biliary tract cancers. Hepatology. e-Pub 2023. PMID: 36999533.
- Janku F, Javle MM, Sen S, Pant S, Bramwell LG, Subbiah V, Way T, Wages DS, Wheeler CA, Suzuki T, Saeki K, Subach RA, Madden T, Maier G, Johansen MJ, Cheung K, Falchook GS. A phase 1/2a safety, pharmacokinetics, and efficacy study of the novel nucleoside analog FF-10502-01 for the treatment of advanced solid tumors. Cancer. e-Pub 2023. PMID: 36882377.
- Nelson BE, Roszik J, Janku F, Hong DS, Kato S, Naing A, Piha-Paul S, Fu S, Tsimberidou A, Cabanillas M, Busaidy NL, Javle M, Byers LA, Heymach JV, Meric-Bernstam F, Subbiah V. BRAF v600E-mutant cancers treated with vemurafenib alone or in combination with everolimus, sorafenib, or crizotinib or with paclitaxel and carboplatin (VEM-PLUS) study. NPJ Precis Oncol 7(1):19, 2023. e-Pub 2023. PMID: 36801912.
- Abboud K, Umoru G, Esmail A, Abudayyeh A, Murakami N, Al-Shamsi HO, Javle M, Saharia A, Connor AA, Kodali S, Ghobrial RM, Abdelrahim M. Immune Checkpoint Inhibitors for Solid Tumors in the Adjuvant Setting: Current Progress, Future Directions, and Role in Transplant Oncology. Cancers (Basel) 15(5), 2023. e-Pub 2023. PMID: 36900226.
- Dodoo GN, De B, Lee SS, Abi Jaoude J, Vauthey JN, Tzeng CD, Tran Cao HS, Katlowitz KA, Mandel JJ, Beckham TH, Minsky BD, Smith GL, Holliday EB, Koong AC, Das P, Taniguchi CM, Javle M, Koay EJ, Ludmir EB. Brain Metastases from Biliary Tract Cancer: Case Series and Clinicogenomic Analysis. Oncologist. e-Pub 2023. PMID: 36715178.
- Ayabe RI, Paez-Arango N, Estrella JS, Newhook TE, Tzeng CD, Chun YS, Lee S, Javle M, Vauthey JN, Tran Cao HS. Neoadjuvant chemotherapy for high-risk intrahepatic cholangiocarcinoma - does pathologic response mean better outcomes?. HPB (Oxford). e-Pub 2023. PMID: 36781357.
- Koay EJ, Javle M, Belknap M, Derasari S, Roach M, Ludmir EB. What Role Does Radiotherapy Play in the Molecular Era for Intrahepatic Cholangiocarcinoma?. Cancer J 29(5):272-278, 2023. PMID: 37796645.
- Roa JC, García P, Kapoor VK, Maithel SK, Javle M, Koshiol J. Publisher Correction: Gallbladder cancer. Nat Rev Dis Primers 8(1):75, 2022. e-Pub 2022. PMID: 36400795.
- Tennison JM, Asher A, Hui D, Javle M, Bassett RL, Bruera E. Palliative Rehabilitation in Acute Inpatient Rehabilitation: Prognostic Factors and Functional Outcomes in Patients with Cancer. Oncologist. e-Pub 2022. PMID: 36367387.
- Roa JC, García P, Kapoor VK, Maithel SK, Javle M, Koshiol J. Gallbladder cancer. Nat Rev Dis Primers 8(1):69, 2022. e-Pub 2022. PMID: 36302789.
- Berchuck JE, Facchinetti F, DiToro DF, Baiev I, Majeed U, Reyes S, Chen C, Zhang K, Sharman R, Junior PLSU, Maurer J, Shroff RT, Pritchard CC, Wu MJ, Catenacci DVT, Javle M, Friboulet L, Hollebecque A, Bardeesy N, Zhu AX, Lennerz JK, Tan B, Borad M, Parikh AR, Kiedrowski LA, Kelley RK, Mody K, Juric D, Goyal L. The Clinical Landscape of Cell-Free DNA Alterations in 1,671 Patients with Advanced Biliary Tract Cancer. Ann Oncol. e-Pub 2022. PMID: 36089135.
- Javle M, Lee S, Azad NS, Borad MJ, Kate Kelley R, Sivaraman S, Teschemaker A, Chopra I, Janjan N, Parasuraman S, Bekaii-Saab TS. Temporal Changes in Cholangiocarcinoma Incidence and Mortality in the United States from 2001 to 2017. Oncologist. e-Pub 2022. PMID: 35972334.
- Hester CA, Perri G, Prakash LR, Maxwell JE, Ikoma N, Kim MP, Tzeng CD, Smaglo B, Wolff R, Javle M, Overman MJ, Lee JE, Katz MHG. Radiographic and Serologic Response to First-Line Chemotherapy in Unresected Localized Pancreatic Cancer. J Natl Compr Canc Netw 20(8):887-897.e3, 2022. PMID: 35948035.
- De B, Tran Cao HS, Vauthey JN, Manzar GS, Corrigan KL, Raghav KPS, Lee SS, Tzeng CD, Minsky BD, Smith GL, Holliday EB, Taniguchi CM, Koong AC, Das P, Javle M, Ludmir EB, Koay EJ. Ablative liver radiotherapy for unresected intrahepatic cholangiocarcinoma: Patterns of care and survival in the United States. Cancer 128(13):2529-2539, 2022. e-Pub 2022. PMID: 35417569.
- Schalck A, Sakellariou-Thompson D, Forget MA, Sei E, Hughes TG, Reuben A, Bai S, Hu M, Kumar T, Hurd MW, Katz MHG, Tzeng CD, Pant S, Javle M, Fogelman DR, Maitra A, Haymaker CL, Kim MP, Navin NE, Bernatchez C. Single cell sequencing reveals trajectory of tumor-infiltrating lymphocyte states in pancreatic cancer. Cancer Discov. e-Pub 2022. PMID: 35849783.
- Koay EJ, Zaid M, Aliru M, Bagereka P, Van Wieren A, Rodriguez MJ, Jacobson G, Wolff RA, Overman M, Varadhachary G, Pant S, Wang H, Tzeng CW, Ikoma N, Kim M, Lee JE, Katz MH, Tamm E, Bhosale P, Taniguchi CM, Holliday EB, Smith GL, Ludmir EB, Minsky BD, Crane CH, Koong AC, Das P, Wang X, Javle M, Krishnan S. Nab-Paclitaxel, Capecitabine, and Radiation Therapy Following Induction Chemotherapy in Treating Patients with Locally Advanced and Borderline Resectable Pancreatic Cancer: Phase I Trial and Imaging-based Biomarker Validation. Int J Radiat Oncol Biol Phys. e-Pub 2022. PMID: 35863672.
- Lee S, Shroff RT, Makawita S, Xiao L, Danner De Armas A, Bhosale P, Reddy K, Shalaby A, Raghav K, Pant S, Wolff RA, Javle M. Phase II Study of Ramucirumab in Advanced Biliary Tract Cancer Previously Treated by Gemcitabine-based Chemotherapy. Clin Cancer Res 28(11):2229-2236, 2022. e-Pub 2022. PMID: 35312753.
- Silverman IM, Li M, Murugesan K, Krook MA, Javle MM, Kelley RK, Borad MJ, Roychowdhury S, Meng W, Yilmazel B, Milbury C, Shewale S, Feliz L, Burn TC, Albacker LA. Validation and Characterization of FGFR2 Rearrangements in Cholangiocarcinoma with Comprehensive Genomic Profiling. J Mol Diagn 24(22):351-364, 2022. e-Pub 2022. PMID: 35176488.
- Manzar GS, De BS, Abana CO, Lee SS, Javle M, Kaseb AO, Vauthey JN, Tran Cao HS, Koong AC, Smith GL, Taniguchi CM, Holliday EB, Das P, Koay EJ, Ludmir EB. Outcomes and Toxicities of Modern Combined Modality Therapy with Atezolizumab Plus Bevacizumab and Radiation Therapy for Hepatocellular Carcinoma. Cancers (Basel) 14(8), 2022. e-Pub 2022. PMID: 35454808.
- Lapin M, Huang HJ, Chagani S, Javle M, Shroff RT, Pant S, Gouda MA, Raina A, Madwani K, Holley VR, Call SG, Dustin DJ, Lanman RB, Meric-Bernstam F, Raymond VM, Kwong LN, Janku F. Monitoring of Dynamic Changes and Clonal Evolution in Circulating Tumor DNA From Patients With IDH-Mutated Cholangiocarcinoma Treated With Isocitrate Dehydrogenase Inhibitors. JCO Precis Oncol 6:e2100197, 2022. PMID: 35171660.
- DiPeri TP, Demirhan M, Karp DD, Fu S, Hong DS, Subbiah V, Lim J, Ballester LY, Tayar JH, Suarez-Almazor ME, Javle M, Meric-Bernstam F. Corticosteroid-Refractory Myositis After Dual BRAF and MEK Inhibition in a Patient with BRAF V600E-Mutant Metastatic Intrahepatic Cholangiocarcinoma. J Immunother Precis Oncol 5(1):26-30, 2022. e-Pub 2022. PMID: 35663835.
- Salcedo M, Vinaixa C, Javle M, Trapero-Marugán M, Bustamante J, Line PD. Evaluation and Management of Liver Transplant Candidates With Prior Nonhepatic Cancer: Guidelines From the ILTS/SETH Consensus Conference. Transplantation 106(1):e3-e11, 2022. PMID: 34905758.
- Connor AA, Kodali S, Abdelrahim M, Javle MM, Brombosz EW, Ghobrial RM. Intrahepatic cholangiocarcinoma: The role of liver transplantation, adjunctive treatments, and prognostic biomarkers. Front Oncol 12:996710, 2022. e-Pub 2022. PMID: 36479082.
- Gupta P, Dutta U, Rana P, Singhal M, Gulati A, Kalra N, Soundararajan R, Kalage D, Chhabra M, Sharma V, Gupta V, Yadav TD, Kaman L, Irrinki S, Singh H, Sakaray Y, Das CK, Saikia U, Nada R, Srinivasan R, Sandhu MS, Sharma R, Shetty N, Eapen A, Kaur H, Kambadakone A, de Haas R, Kapoor VK, Barreto SG, Sharma AK, Patel A, Garg P, Pal SK, Goel M, Patkar S, Behari A, Agarwal AK, Sirohi B, Javle M, Garcea G, Nervi F, Adsay V, Roa JC, Han HS. Gallbladder reporting and data system (GB-RADS) for risk stratification of gallbladder wall thickening on ultrasonography: an international expert consensus. Abdom Radiol (NY) 47(2):554-565. e-Pub 2021. PMID: 34851429.
- De B, Abu-Gheida I, Patel A, Ng SSW, Zaid M, Thunshelle CP, Elganainy D, Corrigan KL, Rooney MK, Javle M, Raghav K, Lee SS, Vauthey JN, Tzeng CD, Tran Cao HS, Ludmir EB, Minsky BD, Smith GL, Holliday EB, Taniguchi CM, Koong AC, Das P, Koay EJ. Benchmarking Outcomes after Ablative Radiotherapy for Molecularly Characterized Intrahepatic Cholangiocarcinoma. J Pers Med 11(12), 2021. e-Pub 2021. PMID: 34945742.
- Panettieri E, Maki H, Kim BJ, Kang HC, Cox V, Vega EA, Mizuno T, Pant S, Javle M, Vauthey JN, Kawaguchi Y. Arterial enhancement pattern predicts survival in patients with resectable and unresectable intrahepatic cholangiocarcinoma. Surg Oncol 40:101696. e-Pub 2021. PMID: 34995974.
- Zhu AX, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DVT, Borad MJ, Bridgewater JA, Harris WP, Murphy AG, Oh DY, Whisenant JR, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Chamberlain CX, Aguado-Fraile E, Choe S, Wu B, Liu H, Gliser C, Pandya SS, Valle JW, Abou-Alfa GK. Final Overall Survival Efficacy Results of Ivosidenib for Patients With Advanced Cholangiocarcinoma With IDH1 Mutation: The Phase 3 Randomized Clinical ClarIDHy Trial. JAMA Oncol 7(11):1669-1677, 2021. PMID: 34554208.
- Mason MC, Massarweh NN, Tzeng CD, Chiang YJ, Chun YS, Aloia TA, Javle M, Vauthey JN, Tran Cao HS. Time to Rethink Upfront Surgery for Resectable Intrahepatic Cholangiocarcinoma? Implications from the Neoadjuvant Experience. Ann Surg Oncol 28(11):6725-6735, 2021. e-Pub 2021. PMID: 33586068.
- Javle M, Roychowdhury S, Kelley RK, Sadeghi S, Macarulla T, Weiss KH, Waldschmidt DT, Goyal L, Borbath I, El-Khoueiry A, Borad MJ, Yong WP, Philip PA, Bitzer M, Tanasanvimon S, Li A, Pande A, Soifer HS, Shepherd SP, Moran S, Zhu AX, Bekaii-Saab TS, Abou-Alfa GK. Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study. Lancet Gastroenterol Hepatol 6(10):803-815, 2021. e-Pub 2021. PMID: 34358484.
- Rogers JE, Mizrahi JD, Nogueras Gonzalez GM, Surana R, Shroff RT, Wolff R, Varadhachary GR, Javle MM, Overman M, Raghav K, Pant S. Outcomes of patients with metastatic pancreatic cancer who progress on first restaging imaging. J Gastrointest Oncol 12(5):2268-2274, 2021. PMID: 34790391.
- Javle M, Borad MJ, Azad NS, Kurzrock R, Abou-Alfa GK, George B, Hainsworth J, Meric-Bernstam F, Swanton C, Sweeney CJ, Friedman CF, Bose R, Spigel DR, Wang Y, Levy J, Schulze K, Cuchelkar V, Patel A, Burris H. Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol 22(9):1290-1300, 2021. e-Pub 2021. PMID: 34339623.
- Carapeto F, Bozorgui B, Shroff RT, Chagani S, Solis Soto L, Foo WC, Wistuba I, Meric-Bernstam F, Shalaby A, Javle M, Korkut A, Kwong LN. The immunogenomic landscape of resected intrahepatic cholangiocarcinoma. Hepatology 75(2):297-308. e-Pub 2021. PMID: 34510503.
- Meric-Bernstam F, Bahleda R, Hierro C, Sanson M, Bridgewater J, Arkenau HT, Tran B, Kelley RK, Park JO, Javle M, He Y, Benhadji KA, Goyal L. Futibatinib, an irreversible FGFR1-4 inhibitor, in patients with advanced solid tumors harboring FGF/FGFR aberrations: a phase I dose-expansion study. Cancer Discov. e-Pub 2021. PMID: 34551969.
- Javle M, Shacham-Shmueli E, Xiao L, Varadhachary G, Halpern N, Fogelman D, Boursi B, Uruba S, Margalit O, Wolff RA, Golan T. Olaparib Monotherapy for Previously Treated Pancreatic Cancer With DNA Damage Repair Genetic Alterations Other Than Germline BRCA Variants: Findings From 2 Phase 2 Nonrandomized Clinical Trials. JAMA Oncol 7(5):693-699, 2021. e-Pub 2021. PMID: 33662100.
- Xu M, Tapia C, Hajjar J, Sabir S, Colen R, Nagarajan P, Aung PP, Gong J, Rodon J, Fu S, Stephen B, Roy-Chowdhuri S, Le H, Yang V, Zarifa A, Abdelsalam ME, Jhingran A, Javle M, Pant S, Carter B, Milton DR, Sun R, Karp DD, Koay EJ, Yang Y, Wistuba II, Hwu P, Meric-Bernstam F, Naing A. Implementation of a Novel Web-Based Lesion Selection Tool to Improve Acquisition of Tumor Biopsy Specimens. J Immunother Precis Oncol 4(2):45-52, 2021. e-Pub 2021. PMID: 35663531.
- Martin NA, Tepper JE, Giri VN, Stinchcombe TE, Cheng HH, Javle MM, Konnick EQ. Adopting Consensus Terms for Testing in Precision Medicine. JCO Precis Oncol 5, 2021. e-Pub 2021. PMID: 34651094.
- Gulhati P, Prakash L, Katz MHG, Wang X, Javle M, Shroff R, Fogelman D, Lee JE, Tzeng CD, Lee JH, Weston B, Tamm E, Bhosale P, Koay EJ, Maitra A, Wang H, Wolff RA, Varadhachary GR. First-Line Gemcitabine and Nab-Paclitaxel Chemotherapy for Localized Pancreatic Ductal Adenocarcinoma. Ann Surg Oncol 26(2):619-627, 2019. e-Pub 2018. PMID: 30324485.
- Bhatty M, Kato S, Piha-Paul SA, Naing A, Subbiah V, Huang HJ, Karp DD, Tsimberidou AM, Zinner RG, Hwu WJ, Javle M, Patel SP, Hu MI, Varadhachary GR, Conley AP, Ramzanali NM, Holley VR, Kurzrock R, Meric-Bernstam F, Kwang Chae Y, Kim KB, Falchook GS, Janku F. Phase 1 study of the combination of vemurafenib, carboplatin, and paclitaxel in patients With BRAF-mutated melanoma and other advanced malignancies. Cancer 125(3):463-472, 2019. e-Pub 2018. PMID: 30383888.
- Bernard V, Kim DU, San Lucas FA, Castillo J, Allenson K, Mulu FC, Stephens BM, Huang J, Semaan A, Guerrero PA, Kamyabi N, Zhao J, Hurd MW, Koay EJ, Taniguchi CM, Herman JM, Javle M, Wolff R, Katz M, Varadhachary G, Maitra A, Alvarez HA. Circulating Nucleic Acids Associate with Outcomes of Patients with Pancreatic Cancer. Gastroenterology 156(1):108-118.e4, 2019. e-Pub 2018. PMID: 30240661.
- Odisio BC, Krampitz GW, Murthy R, Mahvash A, Javle M, Vauthey JN. Preoperative drainage for perihilar cholangiocarcinoma. Lancet Gastroenterol Hepatol 4(1):10-11, 2019. e-Pub 2018. PMID: 30527574.
- Finn RS, Ahn DH, Javle MM, Tan BR, Weekes CD, Bendell JC, Patnaik A, Khan GN, Laheru D, Chavira R, Christy-Bittel J, Barrett E, Sawyer MB, Bekaii-Saab TS. Phase 1b investigation of the MEK inhibitor binimetinib in patients with advanced or metastatic biliary tract cancer. Invest New Drugs 36(6):1037-1043, 2018. e-Pub 2018. PMID: 29785570.
- Koay EJ, Lee Y, Cristini V, Lowengrub JS, Kang Y, Lucas FAS, Hobbs BP, Ye R, Elganainy D, Almahariq M, Amer AM, Chatterjee D, Yan H, Park PC, Rios Perez MV, Li D, Garg N, Reiss KA, Yu S, Chauhan A, Zaid M, Nikzad N, Wolff RA, Javle M, Varadhachary GR, Shroff RT, Das P, Lee JE, Ferrari M, Maitra A, Taniguchi CM, Kim MP, Crane CH, Katz MH, Wang H, Bhosale P, Tamm EP, Fleming JB. A Visually Apparent and Quantifiable CT Imaging Feature Identifies Biophysical Subtypes of Pancreatic Ductal Adenocarcinoma. Clin Cancer Res 24(23):5883-5894, 2018. e-Pub 2018. PMID: 30082477.
- Lapin M, Oltedal S, Tjensvoll K, Buhl T, Smaaland R, Garresori H, Javle M, Glenjen NI, Abelseth BK, Gilje B, Nordgård O. Fragment size and level of cell-free DNA provide prognostic information in patients with advanced pancreatic cancer. J Transl Med 16(1):300, 2018. e-Pub 2018. PMID: 30400802.
- Elganainy D, Holliday EB, Taniguchi CM, Smith GL, Shroff R, Javle M, Raghav K, Kaseb A, Aloia TA, Vauthey JN, Tzeng CD, Herman JM, Koong AC, Krishnan SX, Minsky BD, Crane CH, Das P, Koay EJ. Dose escalation of radiotherapy in unresectable extrahepatic cholangiocarcinoma. Cancer Med 7(10):4880-4892, 2018. e-Pub 2018. PMID: 30152073.
- Fountzilas C, Javle M, Tan W, Ma Y, Fetterly G, Iyer R, Johnson C. A phase 1, open-label, dose escalation study of intravenous paricalcitol in combination with gemcitabine in patients with advanced malignancies. Cancer 124(19):3890-3899, 2018. e-Pub 2018. PMID: 30299542.
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- Liu C, Karam R, Zhou Y, Su F, Ji Y, Li G, Xu G, Lu L, Wang C, Song M, Zhu J, Wang Y, Zhao Y, Foo WC, Zuo M, Valasek MA, Javle M, Wilkinson MF, Lu Y. The UPF1 RNA Surveillance Gene is Commonly Mutated in Pancreatic Adenosquamous Carcinoma. Nat Med 20(6):596-8, 2014. e-Pub 2014. PMID: 24859531.
- Javle M, Rashid A, Churi C, Kar S, Zuo M, Eterovic AK, Nogueras-Gonzalez GM, Janku F, Shroff RT, Aloia TA, Vauthey JN, Curley S, Mills G, Roa I. Molecular Characterization of Gallbladder Cancer using Somatic Mutation Profiling. Hum Pathol 45(4):701-8, 2014. e-Pub 2013. PMID: 24508317.
- Van Loon K, Espinoza AM, Fogelman DR, Wolff RA, Javle MM, Iyer RV, Picozzi VJ, Martin LK, Bekaii-Saab T, Tempero MA, Foster NR, Kim GP, Ko AH. Should combination chemotherapy serve as the backbone in clinical trials of advanced pancreatic cancer? A pooled analysis of phase II trials of gemcitabine-containing doublets plus bevacizumab. Pancreas 43(3):343-9, 2014. PMID: 24622062.
- Koay EJ, Truty MJ, Cristini V, Thomas RM, Chen R, Chatterjee D, Kang Y, Bhosale PR, Tamm EP, Crane CH, Javle M, Katz MH, Gottumukkala VN, Rozner MA, Shen H, Lee JE, Wang H, Chen Y, Plunkett W, Abbruzzese JL, Wolff RA, Varadhachary GR, Ferrari M, Fleming JB. Transport properties of pancreatic cancer describe gemcitabine delivery and response. J Clin Invest 124(4):1525-36, 2014. e-Pub 2014. PMID: 24614108.
- Koay EJ, Baio FE, Ondari A, Truty MJ, Cristini V, Thomas RM, Chen R, Chatterjee D, Kang Y, Zhang J, Court L, Bhosale PR, Tamm EP, Qayyum A, Crane CH, Javle M, Katz MH, Gottumukkala VN, Rozner MA, Shen H, Lee JE, Wang H, Chen Y, Plunkett W, Abbruzzese JL, Wolff RA, Maitra A, Ferrari M, Varadhachary GR, Fleming JB. Intra-tumoral heterogeneity of gemcitabine delivery and mass transport in human pancreatic cancer. Phys Biol 11(6):065002, 2014. e-Pub 2014. PMID: 25427073.
- Javle M, Li Y, Tan D, Dong X, Chang P, Kar S, Li D. Biomarkers of TGF-β signaling pathway and prognosis of pancreatic cancer. PLoS One 9(1):e85942, 2014. e-Pub 2014. PMID: 24465802.
- Churi CR, Shroff R, Wang Y, Rashid A, Kang HC, Weatherly J, Zuo M, Zinner R, Hong D, Meric-Bernstam F, Janku F, Crane CH, Mishra L, Vauthey JN, Wolff RA, Mills G, Javle M. Mutation profiling in cholangiocarcinoma: prognostic and therapeutic implications. PLoS One 9(12):e115383, 2014. e-Pub 2014. PMID: 25536104.
- Javle M, Hsueh CT. Recent advances in gastrointestinal oncology--updates and insights from the 2009 annual meeting of the American Society of Clinical Oncology. J Hematol Oncol 3:11, 2010. e-Pub 2010. PMID: 20331897.
- Javle MM, Shroff RT, Xiong H, Varadhachary GA, Fogelman D, Reddy SA, Davis D, Zhang Y, Wolff RA, Abbruzzese JL. Inhibition of the mammalian target of rapamycin (mTOR) in advanced pancreatic cancer: results of two phase II studies. BMC Cancer 10:368, 2010. e-Pub 2010. PMID: 20630061.
- Donthireddy KR, Ailawadhi S, Nasser E, Schiff MD, Nwogu CE, Nava HR, Javle MM. Malignant gastroparesis: pathogenesis and management of an underrecognized disorder. J Support Oncol 5(8):355-63, 2007. PMID: 17944143.
Abstracts
- Sarina A. Piha-Paul, Sanjay Goel, Chih-Yi Liao, Nashat Y. Gabrail, Farshid Dayyani, Syed Mohammad Ali Kazmi, Yuan Yuan, Sayeh Moazami Lavasani, Jean Fan, Peng Peng, Caixia Sun, Hui Wang, Katie Hennessy, Ximei Fu, Shumao Ni, Hui Xian Tan, Brenda Ngo, Qinhua Cindy Ru, Frank Wu, Milind M. Javle. Preliminary safety and efficacy of tinengotinib tablets as monotherapy and combination therapy in advanced solid tumors: A phase Ib/II clinical trial. J Clin Oncol, 2023.
- Milind M. Javle, Christos Fountzilas, Daneng Li, Lionel Aurelien Kankeu Fonkoua, Jean Fan, Peng Peng, Hui Wang, Brenda Ngo, Caixia Sun, Qinhua Cindy Ru, Frank Wu, Amit Mahipal. Phase II study of FGFR1-3 inhibitor tinengotinib as monotherapy in patients with advanced or metastatic cholangiocarcinoma: Interim analysis. J Clin Oncol, 2023.
- Gordon Taylor Moffat, Zishuo Ian Hu, Anaemy Danner De Armas, Jeffrey S. Ross, Milind M. Javle, Jennifer J. Knox. Characterizing KRAS allele variants within biliary tract cancers. J Clin Onco, 2023.
- Amanda Nottke, Milind M. Javle, Mitesh J. Borad, Nilofer Saba Azad, Elise Brimble, Richard L Martin, Conner OBrien, Stacie Lindsey, Melinda Bachini, Shishir K. Maithel. A novel patient-centric longitudinal data registry platform to generate insights into real-world cholangiocarcinoma (CCA) clinical practice. J Clin Onco, 2023.
- Lipika Goyal, James J. Harding, Makoto Ueno, Angela Lamarca, Teresa Macarulla, Noboru Yamamoto, Joy Hu, Michael Teufel, Angela Maerten, Arndt Vogel, Milind M. Javle. A phase IIa/IIb, open-label trial of BI 907828, an MDM2–p53 antagonist, in patients with locally advanced/metastatic biliary tract carcinoma or pancreatic ductal adenocarcinoma: Brightline-2. J Clin Oncol, 2023.
- Madhulika Eluri, Anaemy Danner De Armas, Jeffrey S. Ross, Radwa Sharaf, Dean C. Pavlick, Deyali Chatterjee, Milind M. Javle. Clinical and mutational profiles of microsatellite instability (MSI-H) in intrahepatic cholangiocarcinoma (iCCA). J Clin Oncol, 2023.
- Tin-Yun Tang, Anaemy Danner De Armas, Jeffrey S. Ross, Dean C. Pavlick, Radwa Sharaf, Benjamin G Kaplan, Ethan Sokol, Jordi Rodon Ahnert, Milind M. Javle. Landscape of BRAF mutation classes in intrahepatic cholangiocarcinoma. J Clin Onco, 2023.
- Blessie Elizabeth Nelson, Jason Roszik, CARMELIA MARIA NOIA BARRETO, Mirella Nardo, Jibran Ahmed, Erick Campbell, Amber Johnson, Sarina A. Piha-Paul, Isabella Claudia Glitza, Shiao-Pei S. Weathers, Maria E. Cabanillas, Milind M. Javle, Funda Meric-Bernstam, Vivek Subbiah. RAF-inhibitor rechallenge therapy in BRAF aberrated pan-cancers: RE-RAFFLE study. J Clin Oncol, 2023.
- Rachna T. Shroff, Katherine A Guthrie, Aaron James Scott, Mitesh J. Borad, Laura Williams Goff, Khalid Matin, Amit Mahipal, Aparna Kalyan, Milind M. Javle, Carol Aghajanian, Benjamin R. Tan, Puneet S. Cheema, Anuj K. Patel, Renuka V. Iyer, Robin Kate Kelley, Jaykumar Ranchodbhai Thumar, Anthony B. El-Khoueiry, E. Gabriela Chiorean, Howard S. Hochster, Philip Agop Philip. SWOG 1815: A phase III randomized trial of gemcitabine, cisplatin, and nab-paclitaxel versus gemcitabine and cisplatin in newly diagnosed, advanced biliary tract cancers. J Clin Oncol, 2023.
- Milind M. Javle. Overcoming Emerging Drug Resistance in Intrahepatic Cholangiocarcinoma. J Clin Oncol, 2022.
- Tin-Yun Tang, Jeffrey S. Ross, Jordi Rodon Ahnert, Milind M. Javle. Genomic profile of intrahepatic cholangiocarcinoma with MTAP loss. J Clin Oncol, 2022.
- Liya Wang, Mukul Singhal, Madhulika Eluri, Adriana Valderrama, Bal Nepal, Shital Kamble, Michael Grabner, Usha Malhotra, Abby B. Siegel, Shilpi Swami, Milind M. Javle. Health care resource utilization (HCRU) and costs in patients with biliary tract cancer (BTC) treated with systemic therapy in the United States (US). J Clin Onco, 2022.
- Hitendra Patel, Alex Barrett, Elizabeth Mauer, Shumei Kato, Benjamin D. Leibowitz, Aatur D. Singhi, Milind M. Javle, Andrew M. Lowy. Homologous recombination repair pathway alterations and their relationship to homologous recombination deficiency in advanced pancreatic cancer patients, 2022.
- Timothy P. DiPeri, Timothy E. Newhook, Ching-Wei D. Tzeng, Yun Shin Chun, Sunyoung S. Lee, Milind M. Javle, Jean-Nicolas Vauthey, Hop Sanderson Tran Cao. Prognostic significance of serum CA 19-9 response and dynamics in patients with intrahepatic cholangiocarcinoma undergoing surgical resection, 2022.
- Natalie Ngoi, Emma L. Scholefield, Vamsi Parini, Richard S.P. Huang, Tyler Janovitz, Natalie Danziger, Mia Alyce Levy, Shubham Pant, Milind M. Javle, Jeffrey S. Ross, Jordi Rodon Ahnert. Genomic classification of clinically advanced pancreatic ductal adenocarcinoma (PDAC) based on methylthioadenosine phosphorylase (MTAP) genomic loss (MTAP loss), 2022.
- Rituraj Upadhyay, Ethan B. Ludmir, Brian De, Emma Holliday, Grace L. Smith, Cullen M. Taniguchi, Prajnan Das, Bruce D. Minsky, Albert C. Koong, Milind M. Javle, Sunyoung S. Lee, Jean-Nicolas Vauthey, Ching-Wei D. Tzeng, Hop Tran Cao, Eugene Jon Koay. Preservation of liver function with local radiation therapy in patients with metastatic intrahepatic cholangiocarcinoma with extrahepatic disease. J Clin Oncol, 2022.
- Rodabe Navroze Amaria, David J. Vining, Scott Kopetz, Michael J. Overman, Milind M. Javle, Mara Antonoff, Ching-Wei D. Tzeng, Robert A. Wolff, Shubham Pant, Kathryn Lito, Kelly M. Rangel, Louis Wilson, Bryan M. Fellman, Cara L. Haymaker, Ying Yuan, Marie-Andree Forget, Patrick Hwu, Chantale Bernatchez, Amir A. Jazaeri. Efficacy and safety of autologous expanded tumor infiltrating lymphocytes (TILs) in multiple solid tumors. J Clin Onco, 2022.
- Sarina Anne Piha-Paul, Binghe Xu, Kanwal Pratap Singh Raghav, Funda Meric-Bernstam, Filip Janku, Ecaterina Elena Dumbrava, Siqing Fu, Daniel D. Karp, Jordi Rodon Ahnert, Anthony Paul Conley, Frank Mott, Jaffer A. Ajani, David S. Hong, Ying Fan, Peng Peng, Wendy J. Levin, Brenda Ngo, Qinhua Cindy Ru, Frank Wu, Milind M. Javle. First-in-human, phase I study of TT-00420, a multiple kinase inhibitor, as a single agent in advanced solid tumors. J Clin Oncol, 2022.
- Milind M. Javle. Moderated Panel Discussion with Drs. Kulik, Spencer, Lamarca, Rocha, Javle, 2022.
- Milind M. Javle, Ghassan K. Abou-Alfa, Teresa Macarulla, Nicola Personeni, Jorge Adeva, Francesca Bergamo, David Malka, Arndt Vogel, Jennifer J. Knox, T.R. Jeffry Evans, Miryana Dimova-Dobreva, William Proctor Harris, Mikael Saulay, Marc Engelhardt, Stephan Braun, Michele Droz Dit Busset, Mitesh J. Borad. Efficacy of derazantinib in intrahepatic cholangiocarcinoma patients with FGFR2 mutations or amplifications: Interim results from the phase 2 study FIDES-01. 2022 ASCO Gastrointestinal Cancers Symposium, 2022.
- Madhulika Eluri, Rikita Hatia, Milind M. Javle, Manal Hassan. The association of family history of primary liver cancer with cholangiocarcinoma: USA case-control study. 2022 ASCO Gastrointestinal Cancers Symposium, 2022.
- Adriana Valderrama, Mukul Singhal, Liya Wang, Bal Nepal, Shital Kamble, Michael Grabner, Usha Malhotra, Milind M. Javle. Treatment patterns and clinical outcomes among patients with biliary tract cancers in a large commercially insured US population. 2022 ASCO Gastrointestinal Cancers Symposium, 2022.
- Shishir K. Maithel, Milind M. Javle, Amit Mahipal, Bruce Shih-Li Lin, Mehmet Akce, Jeffrey M. Switchenko, Manali Rupji, Hop Tran Cao, Sean P. Cleary, Flavio G. Rocha. NEO-GAP: A phase II single-arm prospective feasibility study of neoadjuvant gemcitabine/cisplatin/nab-paclitaxel for resectable high-risk intrahepatic cholangiocarcinoma. J Clin Oncol, 2022.
- Ghassan K. Abou-Alfa, Ivan Borbath, Lipika Goyal, Angela Lamarca, Teresa Macarulla, Do-Youn Oh, Sameek Roychowdhury, Saeed Sadeghi, Rachna T. Shroff, Ai Li, Jose Soto, Francesca Avogadri, Carl L. Dambkowski, Milind M. Javle. PROOF 301: A multicenter, open-label, randomized, phase 3 trial of infigratinib versus gemcitabine plus cisplatin in patients with advanced cholangiocarcinoma with an FGFR2 gene fusion/rearrangement. J Clin Oncol, 2022.
- Milind M. Javle, John A. Bridgewater, Olumide B. Gbolahan, Christiane Jungels, May Thet Cho, Kyriakos P. Papadopoulos, Fiona C. Thistlethwaite, Jean-Luc Re Canon, Lulu Cheng, Sonia Ioannidis, Sven Gogov, Aung Naing. A phase I/II study of safety and efficacy of the arginase inhibitor INCB001158 plus chemotherapy in patients (Pts) with advanced biliary tract cancers. J Clin Oncol, 2021.
- Milind M. Javle, Robin Kate Kelley, Christoph Springfeld, Ghassan K. Abou-Alfa, Teresa Macarulla, Suebpong Tanasanvimon, Lipika Goyal, Ivan Borbath, Michael Bitzer, Wei-Peng Yong, Philip Agop Philip, Rafael Alvarez-Gallego, Amit Pande, Stacie Peacock Shepherd, Jacki Fontaine, Sameek Roychowdhury. A phase II study of infigratinib in previously treated advanced/metastatic cholangiocarcinoma with FGFR gene fusions/alterations. J Clin Oncol, 2021.
- Milind M. Javle, Sameek Roychowdhury, Robin Kate Kelley, Saeed Sadeghi, Teresa Macarulla, Dirk Thomas Waldschmidt, Lipika Goyal, Ivan Borbath, Anthony B. El-Khoueiry, Wei-Peng Yong, Philip Agop Philip, Michael Bitzer, Suebpong Tanasanvimon, Ai Li, Amit Pande, Stacie Peacock Shepherd, Susan Moran, Ghassan K. Abou-Alfa. Final results from a phase II study of infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor, in patients with previously treated advanced cholangiocarcinoma harboring an FGFR2 gene fusion or rearrangement. J Clin Onco, 2021.
- Shalini Makawita, Mitesh J. Borad, Fernando Carapeto, Lawrence Kwong, Tanios S. Bekaii-Saab, Karthikeyan Murugesan, Jeffrey S. Ross, Natalie Danziger, Mason A. Israel, Kimberly McGregor, Filip Janku, Milind M. Javle. IDH1 and IDH2 Driven Intrahepatic Cholangiocarcinoma (IHCC): A comprehensive genomic and immune profiling study. J Clin Oncol, 2021.
- David Lawrence Bajor, Martin Gutierrez, Gina M. Vaccaro, Ashiq Masood, Ursa Abigail Brown-Glaberman, Juneko E. Grilley-Olson, Milind M. Javle, Hedy L. Kindler, Olumide B. Gbolahan, Anthony Frank Shields, Mark Zalupski, Michael W. Schmitt, Andrew L. Coveler. Phase I study of SEA-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab in patients (pts) with metastatic pancreatic ductal adenocarcinoma (PDAC) (trial in progress). J Clin Oncol, 2021.
- Sarina Anne Anne Piha-Paul, Binghe Xu, Filip Janku, Ecaterina Elena Dumbrava, Siqing Fu, Daniel D. Karp, Funda Meric-Bernstam, David S. Hong, Jordi Rodon Ahnert, Apostolia Maria Tsimberidou, Milind M. Javle, Ying Fan, Peng Peng, Wendy J. Levin, Brenda Ngo, Hui Wang, Caixia Sun, Qinhua Cindy Ru, Frank Wu. Phase I study of TT-00420, a multiple kinase inhibitor, as a single agent in advanced solid tumors. J Clin Oncol, 2021.
- Funda Meric-Bernstam, Diana L. Hanna, Anthony B. El-Khoueiry, Yoon-Koo Kang, Do-Youn Oh, Jorge M Chaves, Sun Young Rha, Erika P. Hamilton, Shubham Pant, Milind M. Javle, Kanwal Pratap Singh Raghav, Allison Fortenberry, Todd Gray, Joseph Woolery, Keun Wook Lee. Zanidatamab (ZW25) in HER2-positive biliary tract cancers (BTCs): Results from a phase I study. J Clin Oncol, 2021.
- Ghassan K. Abou-Alfa, Teresa Macarulla, Milind M. Javle, Robin Kate Kelley, Sam Joseph Lubner, Jorge Adeva, James M. Cleary, Daniel V.T. Catenacci, Mitesh J. Borad, John A. Bridgewater, William Proctor Harris, Adrian Gerard Murphy, Do-Youn Oh, Jonathan R. Whisenant, Christina X. Chamberlain, Liewen Jiang, Camelia Gliser, Shuchi Sumant Pandya, Juan W. Valle, Andrew X. Zhu. Final results from ClarIDHy, a global, phase 3, randomized, double-blind study of ivosidenib (IVO) versus placebo (PBO) in patients (pts) with previously treated cholangiocarcinoma (CCA) and an isocitrate dehydrogenase 1 (IDH1) mutation. J Clin Oncol, 2021.
- Milind M. Javle, Saeed Sadeghi, Anthony B. El-Khoueiry, Lipika Goyal, Philip Agop Philip, Robin Kate Kelley, Ivan Borbath, Teresa Macarulla, Wei-Peng Yong, Suebpong Tanasanvimon, Amit Pande, Gary Li, Michael Howland, Craig Berman, Ghassan K. Abou-Alfa. A retrospective analysis of post second-line chemotherapy treatment outcomes for patients with advanced or metastatic cholangiocarcinoma and FGFR2 fusions. J Clin Onco, 2020.
- Milind M. Javle, Saeed Sadeghi, Anthony B. El-Khoueiry, Lipika Goyal, Philip Agop Philip, Robin Kate Kelley, Ivan Borbath, Teresa Macarulla, Wei-Peng Yong, Suebpong Tanasanvimon, Amit Pande, Gary Li, Michael Howland, Craig Berman, Ghassan K. Abou-Alfa. A retrospective analysis of post second-line chemotherapy treatment outcomes for patients with advanced or metastatic cholangiocarcinoma and FGFR2 fusions. J Clin Onco, 2020.
- Milind M. Javle, Walid Labib Shaib, Stephan Braun, Marc Engelhardt, Mitesh J. Borad, Ghassan K. Abou-Alfa, Andrea Boncompagni, Silke Friedmann, Christoph Georg Gahlemann. FIDES-01, a phase II study of derazantinib in patients with unresectable intrahepatic cholangiocarcinoma (iCCA) and FGFR2 fusions and mutations or amplifications (M/A). J Clin Oncol, 2020.
- Shifeng Xu, Wei Rao, Yuanwen Zheng, Jianping Wang, Weiyu Hu, Guilan Dong, Jiangong Wang, Guibing Ren, Junping Shi, Yafei Wang, Milind M. Javle, Ming Yao. The landscape of MET mutations in Chinese biliary tract cancers. J Clin Oncol, 2020.
- Anna M. Varghese, Celina Ang, Christopher J. Dimaio, Milind M. Javle, Martin Gutierrez, Nirit Yarom, Salomon M. Stemmer, Talia Golan, Ravit Geva, Valeriya Semenisty, Iyad Khamaysi, Rosario Ligresti, Shay Rotkopf, Racheli Gabai-Malka, Eithan Galun, Amotz Shemi, Mark Schattner, Eileen Mary O'Reilly. A phase II study of siG12D-LODER in combination with chemotherapy in patients with locally advanced pancreatic cancer (PROTACT). J Clin Oncol, 2020.
- Lipika Goyal, Angela Lamarca, John H. Strickler, Michael Cecchini, Daniel H. Ahn, Islam Baiev, Alice Boileve, Melodie Tazdait, Lindsay Marie Hannan, Jingquan Jia, Hetal Desai Marble, Afsaneh Barzi, Vaibhav Sahai, Jochen K Lennerz, Robin Kate Kelley, Tanios S. Bekaii-Saab, Milind M. Javle, Nataliya Volodymyrivna Uboha, William P. Harris, Antoine Hollebecque. The natural history of fibroblast growth factor receptor (FGFR)-altered cholangiocarcinoma (CCA). J Clin Onco, 2020.
Grant & Contract Support
Title: | A Phase I/Randomized Phase II Study of Gemcitabine + Erlotinib + MK-0646; Gemcitabine + MK-0646 and Gemcitabine + Erlotinib for Patients with Advanced Pancreatic Cancer |
Funding Source: | Merk and Company |
Role: | Principal Investigator |
Title: | Devising effective treatment for PDAC by co-targeting tumor cells and the tumor microenvironment |
Funding Source: | Cancer Prevention & Research Institute of Texas (CPRIT) |
Role: | Co-Investigator |
Title: | Therapeutic inhibition of cholangiocarcinoma progression by targeting tumor-lymphatic crosstalk |
Funding Source: | CPRIT – Subcontract with Texas A&M University System Health Science Center |
Role: | Principal Investigator |
Title: | Development and Validation of an Imaging-based Deep Learning Neural Network Model to Predict Tumor-related Liver Failure in Unresectable Intrahepatic Cholangiocarcinoma |
Funding Source: | Radiological Society of North America (RSNA) |
Role: | Collaborator |
Title: | A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers |
Funding Source: | NCI/CTEP |
Role: | Protocol PI |
Title: | University of Texas PDX Development and Trial Center - Project 3: Developing therapeutic approaches to Biliary Track Tumors based on vulnerabilities identified by molecular subtype using patient derived models |
Funding Source: | NIH/NCI |
Role: | Co-Investigator |
Title: | A phase III, randomized, controlled, global multicenter study to evaluate the efficacy and safety of oral Tinengotinib versus physician's choice in subjects with fibroblast growth factor receptor (FGFR)-altered, chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma (FIRST-308) |
Funding Source: | TransThera Biosciences Co. Ltd |
Role: | Principal Investigator |
Title: | Phase 1b/2a Study of GNS561 in Combination with Trametinib in Advanced KRAS Mutated Cholangiocarcinoma |
Funding Source: | Genfit S.A |
Role: | Principal Investigator |
Patient Reviews
CV information above last modified June 28, 2024