Nivolumab plus ipilimumab, with or without enzalutamide, in AR‐V7‐expressing metastatic castration‐resistant prostate cancer: A phase‐2 nonrandomized clinical trial

AR‐V7‐positive metastatic prostate cancer is a lethal phenotype with few treatment options and poor survival.

[1]  J. Reis-Filho,et al.  Mutations in BRCA1 and BRCA2 differentially affect the tumor microenvironment and response to checkpoint blockade immunotherapy , 2020, Nature Cancer.

[2]  Reid F. Thompson,et al.  A phase II single-arm study of pembrolizumab with enzalutamide in men with metastatic castration-resistant prostate cancer progressing on enzalutamide alone , 2020, Journal for ImmunoTherapy of Cancer.

[3]  A. Sudo,et al.  Soluble programmed death-ligand 1 rather than PD-L1 on tumor cells effectively predicts metastasis and prognosis in soft tissue sarcomas , 2020, Scientific Reports.

[4]  Jun Luo,et al.  Androgen receptor variant-driven prostate cancer II: advances in clinical investigation , 2020, Prostate Cancer and Prostatic Diseases.

[5]  F. Saad,et al.  Androgen Receptor Modulation Optimized for Response-Splice Variant: A Phase 3, Randomized Trial of Galeterone Versus Enzalutamide in Androgen Receptor Splice Variant-7-expressing Metastatic Castration-resistant Prostate Cancer. , 2019, European urology.

[6]  C. Drake,et al.  Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study. , 2019, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[7]  G. Miller,et al.  Targeting the interleukin-17 immune axis for cancer immunotherapy , 2019, The Journal of experimental medicine.

[8]  E. Antonarakis,et al.  Genomic and clinical characterization of pulmonary‐only metastatic prostate cancer: A unique molecular subtype , 2019, The Prostate.

[9]  Y. Naito,et al.  Clinical significance of soluble forms of immune checkpoint molecules in advanced esophageal cancer , 2019, Medical Oncology.

[10]  Ce Li,et al.  Exosomal PD-L1 Retains Immunosuppressive Activity and is Associated with Gastric Cancer Prognosis , 2019, Annals of Surgical Oncology.

[11]  I. Kang,et al.  Interleukin-7 Contributes to the Invasiveness of Prostate Cancer Cells by Promoting Epithelial–Mesenchymal Transition , 2019, Scientific Reports.

[12]  S. Gregory,et al.  Prospective Multicenter Validation of Androgen Receptor Splice Variant 7 and Hormone Therapy Resistance in High-Risk Castration-Resistant Prostate Cancer: The PROPHECY Study , 2019, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[13]  L. Appleman,et al.  Keynote-365 cohort C: Pembrolizumab (pembro) plus enzalutamide (enza) in abiraterone (abi)-pretreated patients (pts) with metastatic castrate resistant prostate cancer (mCRPC). , 2019, Journal of Clinical Oncology.

[14]  D. Schadendorf,et al.  Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial , 2019, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[15]  M. Galsky,et al.  Initial results from a phase II study of nivolumab (NIVO) plus ipilimumab (IPI) for the treatment of metastatic castration-resistant prostate cancer (mCRPC; CheckMate 650). , 2019, Journal of Clinical Oncology.

[16]  S. Mori,et al.  Clinical significance of soluble programmed cell death-1 and soluble programmed cell death-ligand 1 in patients with locally advanced rectal cancer treated with neoadjuvant chemoradiotherapy , 2019, PloS one.

[17]  Yan Zhang,et al.  Soluble programmed death-ligand 1 are highly expressed in peripheral T-cell lymphoma: a biomarker for prognosis , 2019, Hematology.

[18]  D. Schadendorf,et al.  Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. , 2019, The New England journal of medicine.

[19]  Y. Toiyama,et al.  Soluble PD-L1 Expression in Circulation as a Predictive Marker for Recurrence and Prognosis in Gastric Cancer: Direct Comparison of the Clinical Burden Between Tissue and Serum PD-L1 Expression , 2019, Annals of Surgical Oncology.

[20]  Jun Luo,et al.  Alternative splicing in prostate cancer , 2018, Nature Reviews Clinical Oncology.

[21]  P. Ott,et al.  Pembrolizumab for advanced prostate adenocarcinoma: findings of the KEYNOTE-028 study , 2018, Annals of oncology : official journal of the European Society for Medical Oncology.

[22]  A. Elia,et al.  Immune Checkpoint-Mediated Interactions Between Cancer and Immune Cells in Prostate Adenocarcinoma and Melanoma , 2018, Front. Immunol..

[23]  V. Velculescu,et al.  Ipilimumab plus nivolumab and DNA-repair defects in AR-V7-expressing metastatic prostate cancer , 2018, Oncotarget.

[24]  J. Szustakowski,et al.  Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden , 2018, The New England journal of medicine.

[25]  J. Eshleman,et al.  Clinical Utility of CLIA-Grade AR-V7 Testing in Patients With Metastatic Castration-Resistant Prostate Cancer. , 2017, JCO precision oncology.

[26]  M. Atkins,et al.  Standard-dose pembrolizumab in combination with reduced-dose ipilimumab for patients with advanced melanoma (KEYNOTE-029): an open-label, phase 1b trial. , 2017, The Lancet. Oncology.

[27]  Ludmila V. Danilova,et al.  Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade , 2017, Science.

[28]  E. Plimack,et al.  Safety and Efficacy of Nivolumab in Combination With Ipilimumab in Metastatic Renal Cell Carcinoma: The CheckMate 016 Study. , 2017, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[29]  Y. Hosomi,et al.  High plasma levels of soluble programmed cell death ligand 1 are prognostic for reduced survival in advanced lung cancer. , 2017, Lung cancer.

[30]  F. Saad,et al.  Randomized, Double-Blind, Phase III Trial of Ipilimumab Versus Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naive Castration-Resistant Prostate Cancer. , 2017, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[31]  Parvez M Lokhandwala,et al.  Analytical Validation of Androgen Receptor Splice Variant 7 Detection in a Clinical Laboratory Improvement Amendments (CLIA) Laboratory Setting. , 2017, The Journal of molecular diagnostics : JMD.

[32]  David S. K. Lu,et al.  Association of AR-V7 on Circulating Tumor Cells as a Treatment-Specific Biomarker With Outcomes and Survival in Castration-Resistant Prostate Cancer. , 2016, JAMA oncology.

[33]  Ahmet Zehir,et al.  Inherited DNA-Repair Gene Mutations in Men with Metastatic Prostate Cancer. , 2016, The New England journal of medicine.

[34]  Ken Kato,et al.  Serum levels of soluble programmed cell death ligand 1 as a prognostic factor on the first-line treatment of metastatic or recurrent gastric cancer , 2016, Journal of Cancer Research and Clinical Oncology.

[35]  F. Greten,et al.  High levels of the soluble programmed death-ligand (sPD-L1) identify hepatocellular carcinoma patients with a poor prognosis. , 2016, European journal of cancer.

[36]  Nicolai J. Birkbak,et al.  Clonal neoantigens elicit T cell immunoreactivity and sensitivity to immune checkpoint blockade , 2016, Science.

[37]  Ricardo Villamarín-Salomón,et al.  ClinVar: public archive of interpretations of clinically relevant variants , 2015, Nucleic Acids Res..

[38]  L. Sas.  Androgen Receptor Splice Variant 7 and Efficacy of Taxane Chemotherapy in Patients with Metastatic Castration‑Resistant Prostate Cancer , 2016 .

[39]  M. Valsecchi.  Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. , 2015, The New England journal of medicine.

[40]  Lawrence D. True,et al.  Integrative Clinical Genomics of Advanced Prostate Cancer , 2015, Cell.

[41]  A. Zoubeidi,et al.  PD-L1 is highly expressed in Enzalutamide resistant prostate cancer , 2014, Oncotarget.

[42]  W. Isaacs,et al.  AR-V7 and resistance to enzalutamide and abiraterone in prostate cancer. , 2014, The New England journal of medicine.

[43]  N. Agarwal,et al.  Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial. , 2014, The Lancet. Oncology.

[44]  J. Cheville,et al.  Identification of a Soluble Form of B7-H1 That Retains Immunosuppressive Activity and Is Associated with Aggressive Renal Cell Carcinoma , 2011, Clinical Cancer Research.

[45]  R. Vessella,et al.  Ligand-independent androgen receptor variants derived from splicing of cryptic exons signify hormone-refractory prostate cancer. , 2009, Cancer research.

[46]  L. Schwartz,et al.  New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). , 2009, European journal of cancer.

[47]  Susan Halabi,et al.  Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[48]  M. Kattan,et al.  Plasma levels of interleukin-6 and its soluble receptor are associated with prostate cancer progression and metastasis. , 2001, Urology.

[49]  J. Simons,et al.  Interleukin-6: a candidate mediator of human prostate cancer morbidity. , 1995, Urology.