Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Discussion session - Genitourinary tumours, non prostate

5681 - A Phase Ib/2 study of neoadjuvant pembrolizumab (pembro) and chemotherapy for locally advanced Urothelial Cancer (UC)


20 Oct 2018


Poster Discussion session - Genitourinary tumours, non prostate


Cytotoxic Therapy;  Clinical Research;  Immunotherapy

Tumour Site

Urothelial Cancer


Christopher Hoimes


C.J. Hoimes1, C. Albany2, J. Hoffman-Censits3, M.T. Fleming4, E. Trabulsi5, J. Picus6, C. Cary7, M.O. Koch7, R. Walling8, W. Kelly3, J.L. Godwin3, M. Cooney1, P. Fu9, A. Nelson10, K. Patel11, C. Eitman11, T. Breen12, A. Neal12, H. Kaimakliotis7

Author affiliations

  • 1 Medical Oncology, Case Western Reserve University School of Medicine / University Hospitals Seidman Cancer Center, 44106 - Cleveland/US
  • 2 Hematology/oncology, Indiana University School of Medicine, Indianapolis/US
  • 3 Medicine, Thomas Jefferson University Kimmel Cancer Center, Philadelphia/US
  • 4 Hematology/oncology, US Oncology Research / Virginia Oncology Associates, Norfolk/US
  • 5 Urology, Thomas Jefferson University Kimmel Cancer Center, Philadelphia/US
  • 6 Medical Oncology, Washington University School of Medicine, 63110 - St. Louis/US
  • 7 Urology, Indiana University School of Medicine, Indianapolis/US
  • 8 Hematology/oncology, Community Regional Cancer Cancer, Indianapolis/US
  • 9 Biostatistics, Case Western Reserve University School of Medicine, 44106 - Cleveland/US
  • 10 Medicine, Case Western Reserve University School of Medicine / University Hospitals Seidman Cancer Center, 44106 - Cleveland/US
  • 11 Clinical research Unit, University Hospitals Cleveland Seidman Cancer Center, Cleveland/US
  • 12 Clinical research Unit, Hoosier Cancer Research Network, Indianapolis/US


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 5681


Pembro is FDA and EMA approved for metastatic UC and may improve response rates in the locally advanced setting when combined with gemcitabine (G) and cisplatin (C) neoadjuvant chemotherapy (NAC). Cohort I of the multicenter phase 1b/2 chemo-immunomodulation trial evaluated NAC GC and pembro in C-eligible patients (pts).


Pts with cT2-4aN0M0 UC or mixed histology are eligible on cohort I (C-eligible) or II (C-ineligible). Phase 1b and 2 treatments were the same: pembro 200mg q3wks on day 8 for 5 doses; with C (70mg/m2) day 1, and G (1000mg/m2) days 1 and 8 of a 21 day cycle, for 4 cycles; followed by radical cystectomy with node dissection (RC). Minimum criteria for evaluation of safety is one dose pembro and for efficacy is two doses and RC. The primary endpoint is pathologic non-muscle invasive rate (PaIR, ≤pT1N0M0) of ≥48%.


Cohort I completed accrual on phase 1b/2 and safety & efficacy analysis for 40 evaluable pts are presented. Median age 65 yrs, 75% male, 10% had mixed UC histology, and PD-L1 combined positive score ≥10 was 52%. No DLTs in 6 pts on phase 1b. There was 1 death on post-RC day 9 due to mesenteric ischemia (ileal conduit). One pt did not have RC due to AE (gr4 thrombocytopenic purpura); UC in remission at 14mo. One pt with presumed gr3 MI during cycle 4 had a negative inpatient cardiac workup and completed therapy and RC without further gr3/4 AE. One gr4 hyponatremia and ten gr3 events did not preclude RC (2-each thromboembolism, elevated creatinine, hyponatremia;1-each: dehydration, emesis, neutropenic fever, infection). Gr 3/4 cytopenias occurred in 57% of pts. Median number of doses given for pembro=5, C=4, G=8. Of 35 pts who had RC (4 refused, 1AE) the median time to surgery was 18.5wks from registration, and 5.3wks from last dose. Baseline stage was cT2 51%, cT3 44%, cT4a 5%. The PaIR was 60% (95% CI: 42, 74) and did not correlate with baseline PD-L1 score. At 14 months (1.6 – 33.3) median follow up, the estimated 12mo relapse free-, overall-, and disease specific survival, is 80%, 94%, and 97%, respectively.


Neoadjuvant GC with pembro in locally advanced UC has manageable toxicity, a comparable time to surgery as NAC, and is associated with robust disease downstage and control rate that warrants further study.

Clinical trial identification

Clinicaltrials.gov: NCT02365766

Editorial Acknowledgement

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.