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Michael J Birrer, MD, PhD

Alexandrov LB et al. Signatures of mutational processes in human cancer. Nature 2013;500(7463):415-21. Abstract

Borcoman E et al. Pembrolizumab in cervical cancer: Latest evidence and clinical usefulness. Ther Adv Med Oncol 2017;9(6):431-9. Abstract

Chen DS et al. Elements of cancer immunity and the cancer-immune set point. Nature 2017;541(7637):321-30. Abstract

Fleming GF et al. Clinical activity, safety and biomarker results from a phase Ia study of atezolizumab (atezo) in advanced/recurrent endometrial cancer (rEC). ASCO 2017;Abstract 5585.

Haanen JBAG. Converting cold into hot tumors by combining immunotherapies. Cell 2017;170(6):1055-6. Abstract

Le DT. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science 2017;357(6349):409-13. Abstract

Lorenzi M et al. Epidemiology of microsatellite instability high (MSI-H) and deficient mismatch repair (dMMR) in solid tumors: A structured literature review. Journal of Oncology 2020;1-17. Abstract

Makker V et al. Lenvatinib (LEN) and pembrolizumab (PEMBRO) in advanced endometrial cancer (EC). ESMO 2019;Abstract 994O.

Makker V et al. Lenvatinib + pembrolizumab in patients with advanced endometrial cancer: Updated results. ASCO 2018;Abstract 5596.

Oaknin A et al. Preliminary safety, efficacy, and PK/PD characterization from GARNET, a phase I clinical trial of the anti–PD-1 monoclonal antibody, TSR-042, in patients with recurrent or advanced MSI-H endometrial cancer. ESMO 2018;Abstract 935PD.

Ott PA et al. Safety and Antitumor Activity of Pembrolizumab in Advanced Programmed Death Ligand 1-Positive Endometrial Cancer: Results from the KEYNOTE-028 study. J Clin Oncol 2017;35(22):2535-41. Abstract

Phase 2 study of MK-3475 in patients with microsatellite unstable (MSI) tumors. NCT01876511

Zamarin D et al. Leveraging immunotherapy for the treatment of gynecologic cancers in the era of precision medicine. Gynecol Oncol 2016;141(1):86-94. Abstract

Ursula Matulonis, MD

A phase 3, multicenter, randomized, open-label study of avelumab (MSB0010718C) alone or in combination with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum-resistant/refractory ovarian cancer. NCT02580058

A phase III, multicenter, randomized, study of atezolizumab versus placebo administered in combination with paclitaxel, carboplatin, and bevacizumab to patients with newly-diagnosed stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer. NCT03038100

A phase 2 open-label, single-arm study to evaluate the efficacy and safety of the combination of niraparib and dostarlimab (TSR-042) in patients with platinum-resistant ovarian cancer (MOONSTONE). NCT03955471

A randomized, open-label, multicenter, phase 3 study to evaluate the efficacy and safety of avelumab (MSB0010718C) in combination with and/or following chemotherapy in patients with previously untreated epithelial ovarian cancer JAVELIN OVARIAN 100. NCT02718417

ATHENA (A multicenter, randomized, double-blind, placebo-controlled phase 3 study in ovarian cancer patients evaluating rucaparib and nivolumab as maintenance treatment following response to front-line platinum-based chemotherapy). NCT03522246

Ding L et al. PARP inhibition elicits STING-dependent antitumor immunity in BRCA1-deficient ovarian cancer. Cell Rep 2018;25(11):2972-80.e5. Abstract

ENGOT-0V44 The FIRST (First-line Ovarian Cancer Treatment With Niraparib Plus TSR-042) study: A randomized, double-blind, phase 3 comparison of platinum-based therapy with TSR-042 and niraparib versus standard of care platinum-based therapy as first-line treatment of stage III or IV nonmucinous epithelial ovarian cancer. NCT03602859

Hodi FS et al. Immunologic and clinical effects of antibody blockade of cytotoxic T lymphocyte-associated antigen 4 in previously vaccinated cancer patients. Natl Acad Sci USA 2008;26;105(8):3005-10. Abstract

Hwang WT et al. Prognostic significance of tumor-infiltrating T cells in ovarian cancer: A meta-analysis. Gynecol Oncol 2012;124(2):192-8. Abstract

Jiao S et al. PARP inhibitor upregulates PD-L1 expression and enhances cancer-associated immunosuppression. Clin Cancer Res 2017;15;23(14):3711-20. Abstract

Konstantinopoulos PA et al. Germline and somatic tumor testing in epithelial ovarian cancer: ASCO Guideline. J Clin Oncol 2020;10;38(11):1222-45. Abstract

Konstantinopoulos PA et al. Single-arm phases 1 and 2 trial of niraparib in combination with pembrolizumab in patients with recurrent platinum-resistant ovarian carcinoma. JAMA Oncol 2019;13;5(8):1141-9. Abstract

Ledermann JA et al. Avelumab in combination with and/or following chemotherapy vs chemotherapy alone in patients with previously untreated epithelial ovarian cancer: Results from the phase 3 javelin ovarian 100 trial. SGO 2020;Abstract 23.

Matulonis UA et al. Antitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: Results from the phase II KEYNOTE-100 study. Ann Oncol 2019;1;30(7):1080-7. Abstract

Morice P et al. Mucinous ovarian carcinoma. N Engl J Med 2019;28;380(13):1256-66. Abstract

Mouw KW, Konstantinopoulos PA. From checkpoint to checkpoint: DNA damage ATR/Chk1 checkpoint signalling elicits PD-L1 immune checkpoint activation. Br J Cancer 2018;118(7):933-5. Abstract

Murphy MA, Wentzensen N. Frequency of mismatch repair deficiency in ovarian cancer: A systematic review This article is a US Government work and, as such, is in the public domain of the United States of America. Int J Cancer 2011;129(8):1914-22. Abstract

Phase II randomized trial of nivolumab with or without ipilimumab in patients with persistent or recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. NCT02498600

Sato H. DNA double-strand break repair pathway regulates PD-L1 expression in cancer cells. Nat Commun 2017;24;8(1):1751. Abstract

Xiao X et al. Mismatch repair deficiency in ovarian cancer — Molecular characteristics and clinical implications. Gynecol Oncol 2014;132(2):506-12. Abstract

Zamarin D et al. Randomized Phase II Trial of Nivolumab Versus Nivolumab and Ipilimumab for Recurrent or Persistent Ovarian Cancer: An NRG Oncology Study. J Clin Oncol 2020;[Online ahead of print]. Abstract

David M O’Malley, MD

A phase 1b/2 open-label trial of tisotumab vedotin (HuMax®-TF-ADC) monotherapy and in combination with other agents in subjects with recurrent or stage IVB cervical cancer. NCT03786081

Breij EC et al. An antibody-drug conjugate that targets tissue factor exhibits potent therapeutic activity against a broad range of solid tumors. Cancer Res 2014;15;74(4):1214-26. Abstract

Cocco E et al. Expression of tissue factor in adenocarcinoma and squamous cell carcinoma of the uterine cervix: Implications for immunotherapy with hI-con1, a factor VII-IgGFc chimeric protein targeting tissue factor. BMC Cancer 2011;11:263. Abstract

Coleman RL et al. A single arm, phase 2, multicenter, international trial of tisotumab vedotin (HuMax-TF-ADC) in previously treated, recurrent or metastatic cervical cancer. ASCO 2018;Abstract TPS5601.

Concin N et al. A phase IIa study of tisotumab vedotin in patients with previously treated recurrent or metastatic cervical cancer: Updated analysis of full cervical expansion cohort. ESMO 2019;Abstract 963P.

de Goeij BE et al. High turnover of tissue factor enables efficient intracellular delivery of antibody-drug conjugates. Mol Cancer Ther 2015;14(5):1130-40. Abstract

Fader AN et al. Randomized phase II trial of carboplatin-paclitaxel compared to carboplatin-paclitaxel-trastuzumab in advanced or recurrent uterine serous carcinomas that overexpress Her2/neu (NCT01367002): Updated survival analysis. SGO 2020;Abstract 12.

Förster Y et al. Tissue factor and tumor: Clinical and laboratory aspects. Clin Chim Acta 2006;364(1-2):12-21. Abstract

Hamanishi J et al. Safety and antitumor activity of anti-PD-1 antibody, nivolumab, in patients with platinum-resistant ovarian cancer. J Clin Oncol 2015;33(34):4015-22. Abstract

Koh WJ et al. Cervical cancer, version 2.2015. J Natl Compr Canc Netw 2015;13(4):395-404. Abstract

Mahdi H et al. Phase 2 trial of tisotumab vedotin in platinum-resistant ovarian cancer (innovaTV 208). ASCO 2019;Abstract TPS5602.

Marth C et al. Cervical cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2017;28(Supp 4):iv72-iv83. Abstract

Nauman RW. Efficacy and safety of nivolumab (Nivo) 1 ipilimumab (Ipi) in patients (pts) with recurrent/metastatic (R/M) cervical cancer: Results from CheckMate 358. ESMO 2019;Abstract LBA62.

Non-comparative, open-label, multiple cohort, phase 1/2 study of nivolumab monotherapy and nivolumab combination therapy in subjects with virus-positive and virus-negative solid tumors. NCT02488759

Open label phase 2 study of tisotumab vedotin for patients with platinum-resistant ovarian cancer with a safety run-in of a dose-dense regimen. NCT03657043

Rocconi RP et al. Randomized double-blind placebo controlled trial of primary maintenance vigil immunotherapy (VITAL study) in stage III/IV ovarian cancer: Efficacy assessment in BRCA1/2-wt patients. SGO 2020;Abstract LBA7.

Senzer N et al. Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer. Mol Ther 2012;20(3):679-86. Abstract

Shimokawa M et al. Overall survival and post-progression survival are potent endpoint in phase III trials of second/third-line chemotherapy for advanced or recurrent epithelial ovarian cancer. J Cancer 2018;9(5):872-9. Abstract

Tewari KS et al. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med 2014;370(8):734-43. Abstract

Krishnansu S Tewari, MD

An open-label, randomized, phase 3 clinical trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma. NCT03257267

A phase 3 randomized, double-blind, placebo-controlled trial of pembrolizumab (MK-3475) plus chemotherapy versus chemotherapy plus placebo for the first-line treatment of persistent, recurrent, or metastatic cervical cancer (KEYNOTE-826). NCT03635567

A phase III, randomized, multi-center, double-blind, global study to determine the efficacy and safety of durvalumab in combination with and following chemoradiotherapy compared to chemoradiotherapy alone for treatment in women with locally advanced cervical cancer. NCT03830866

A randomized, open label, phase II trial of anti-PD-1, TSR-042, as maintenance therapy for patients with high-risk locally advanced cervical cancer after chemo-radiation. NCT03833479

A randomized phase III Trial of platinum chemotherapy plus paclitaxel with bevacizumab and atezolizumab versus platinum chemotherapy plus paclitaxel and bevacizumab in metastatic (Stage IVB), persistent, or recurrent carcinoma of the cervix. NCT03556839

Bray F et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;68(6):394-424. Abstract

Cancer Genome Atlas Research Network et al. Integrated genomic and molecular characterization of cervical cancer. Nature 2017;543(7645):378-84. Abstract

Chalmers ZR et al. Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden. Genome Med 2017;9(1):34. Abstract

Chung HC et al. Efficacy and safety of pembrolizumab in previously treated advanced cervical cancer: Results from the phase II KEYNOTE-158 study. J Clin Oncol 2019;37(17):1470-8. Abstract

A clinical trial of pembrolizumab (MK-3475) evaluating predictive biomarkers in subjects with advanced solid tumors (KEYNOTE 158). NCT02628067

Cohen EEW et al. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): A randomised, open-label, phase 3 study. Lancet 2019;393(10167):156-67. Abstract

Ferris RL et al. Nivolumab for recurrent squamous-cell carcinoma of the head and neck. N Engl J Med 2016;375(19):1856-67. Abstract

Hodi FS et al. Immune-modified response evaluation criteria in solid tumors (imRECIST): Refining guidelines to assess the clinical benefit of cancer immunotherapy. J Clin Oncol 2018;20;36(9):850-8. Abstract

Kang Z et al. Circulating cell-free DNA for metastatic cervical cancer detection, genotyping, and monitoring. Clin Cancer Res 2017;23(22):6856-62. Abstract

Kitagawa R et al. Paclitaxel plus carboplatin versus paclitaxel plus cisplatin in metastatic or recurrent cervical cancer: The open-label randomized phase III trial JCOG0505. J Clin Oncol 2015;1;33(19):2129-35. Abstract

Kudelka AP et al. Complete remission of metastatic cervical cancer with the angiogenesis inhibitor TNP-470. N Engl J Med 1998;338(14):991-2. Abstract

Marth C et al. Cervical cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2017;28(Supp 4):iv72-iv83. Abstract

Massad LS et al. 2012 ASCCP Consensus Guidelines Conference. 2012 updated consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. J Low Genit Tract Dis 2013;17(5Suppl 1):S1-S27. Abstract

Migden MR et al. PD-1 blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma. N Engl J Med 2018;379(4):341-51. Abstract

Minion LE, Tewari KS. Cervical cancer - State of the science: From angiogenesis blockade to checkpoint inhibition. Gynecol Oncol 2018;148(3):609-21. Abstract

Monk BJ et al. Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: A Gynecologic Oncology Group study. J Clin Oncol 2009;27(28):4649-55. Abstract

Monk BJ et al. Phase II, open-label study of pazopanib or lapatinib monotherapy compared with pazopanib plus lapatinib combination therapy in patients with advanced and recurrent cervical cancer. J Clin Oncol 2010;28(22):3562-9. Abstract

Monk BJ et al. Phase II trial of bevacizumab in the treatment of persistent or recurrent squamous cell carcinoma of the cervix: A gynecologic oncology group study. J Clin Oncol 2009;27(7):1069-74. Abstract

Ojesina AI et al. Landscape of genomic alterations in cervical carcinomas. Nature 2014;506(7488):371-5. Abstract

Penson RT et al. Bevacizumab for advanced cervical cancer: Patient-reported outcomes of a randomised, phase 3 trial (NRG Oncology-Gynecologic Oncology Group protocol 240). Lancet Oncol 2015;16(3):301-11. Abstract

Seamon LG et al. Impact of tumour histology on survival in advanced cervical carcinoma: An NRG Oncology/Gynaecologic Oncology Group Study. Br J Cancer 2018;118(2):162-70. Abstract

Siegel RL et al. Cancer statistics, 2020. CA Cancer J Clin 2020;70(1):7-30. Abstract

Tewari KS, Monk BJ. Evidence-based treatment paradigms for management of invasive cervical carcinoma. J Clin Oncol 2019;37(27):2472-89. Abstract

Tewari KS et al. Validation of pooled prognostic factors in women with advanced cervical cancer treated with chemotherapy with/without bevacizumab: NRG Oncology/GOG study. Clin Cancer Res 2015;21(24):5480-7. Abstract

Tewari KS et al. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med 2014;370(8):734-43. Abstract

Tewari KS et al. Development and assessment of a general theory of cervical carcinogenesis utilizing a severe combined immunodeficiency murine-human xenograft model. Gynecol Oncol 2000;77:137-48. Abstract

Wolford JE, Tewari KS. Rational design for cervical cancer therapeutics: Cellular and non-cellular based strategies on the horizon for recurrent, metastatic or refractory cervical cancer. Expert Opin Drug Discov 2018;13(5):445-57. Abstract