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 Display session 3

4505 - Initial Results of a Phase II study of Nivolumab and Ipilimumab in Metastatic Adrenal Tumors.


30 Sep 2019


Poster Display session 3


Matthew Campbell


Annals of Oncology (2019) 30 (suppl_5): v356-v402. 10.1093/annonc/mdz249


M.T. Campbell1, W. Xie2, A.Y. Shah3, M.A. Habra4, C. Jimenez4, A.M. Venkatesan5, G. Bubley6, R.R. McKay7, T.K. Choueiri8, B.A. McGregor9, K.L. Killbridge8, A. Mortazavi10, M.A. Bilen11

Author affiliations

  • 1 Genitourinary Medical Oncology, The M. D. Anderson Cancer Center, 77030 - Houston/US
  • 2 Dept. Of Data Sciences, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 3 Genitourinary Medical Oncology, MD Anderson Cancer Center, 77030 - Houston/US
  • 4 Endocrine Neoplasia And Hormonal Disorders, The University of Texas MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 5 Diag Rad - Body Imaging, The University of Texas MD Anderson Cancer Center, 77030 - HOUSTON/US
  • 6 Genitourinary Oncology Program, Beth Israel Deaconess Medical Center, 02215-5400 - Boston/US
  • 7 Department Of Medicine, Division Of Hematology/oncology, University of California San Diego, 92037 - La Jolla/US
  • 8 Medical Oncology, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 9 Medical Oncology, Dana Farber Cancer Institute, 02115 - Boston/US
  • 10 Internal Medicine, The Ohio State University, 43210 - Columbus/US
  • 11 Oncology, Emory University Winship Cancer Institute, 30322 - Atlanta/US


Abstract 4505


Metastatic primary adrenal tumors include those of cortical origin (ACC) and medullary origin (malignant pheochromocytoma/paraganglioma (MP)). Given the rarity of these cancers, standard treatment options are limited, and outcomes are often dismal. In a previous study of single agent pembrolizumab, the proportion of patients with ACC and MP found to have disease control at 6 months defined as stable disease or better using RECIST v1.1 was greater than 25% of patients. Given the FDA approval of nivolumab and ipilimumab (N+I) with both melanoma and metastatic renal cell carcinoma with enhanced overall response rates (ORR) compared to single agent nivolumab in these diseases we sought to study this combination in rare genitourinary tumors (GU). NCT03333616 is a multicenter, single arm, phase II study of N+I in rare GU tumors including cohorts for ACC and MP, urothelial cancer pure variants, and other rare GU tumors. Herein, we report the preliminary results of the fully accrued adrenal cohort.


Eligible patients with ACC or MP required measurable disease as defined by RECIST v1.1, an ECOG performance status of 0-2, and may have received any line of prior therapy excluding prior immunotherapy. Hormonal therapy for hormonally active tumors was allowed. Patients underwent a baseline biopsy and received treatment with N 3 mg/kg and I 1 mg/kg intravenously every 3 weeks for 4 cycles with continued maintenance of N 480 mg IV every 4 weeks. The primary endpoint is overall response rate (ORR) by RECIST 1.1. Accrual is complete with 19 patients enrolled into ACC cohort.


The ORR will be reported with 80% CI with all patients completing at least one scan. Secondary endpoints of immune-related toxicity rates will also be presented.


These results will inform the role of immunotherapy combinations in the management of advanced ACC.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

The authors.




M.T. Campbell: Honoraria (self): Pfizer; Honoraria (self): Genentech; Honoraria (self): Apricity Health LLC; Advisory / Consultancy: EMD Serono, Inc; Advisory / Consultancy: Genentech, Inc. A.Y. Shah: Honoraria (self): Eisai; Honoraria (self): Oncology Information Group; Honoraria (self): Roche Pharmaceuticals; Research grant / Funding (institution): Eisai; Research grant / Funding (institution): BMS; Research grant / Funding (institution): EMD Serono. M.A. Habra: Research grant / Funding (self): Exelixis; Research grant / Funding (self): HRA Pharma. B.A. McGregor: Honoraria (self), Advisory / Consultancy: Astellas; Honoraria (self), Advisory / Consultancy: Seattle Genetics; Honoraria (self), Advisory / Consultancy: Nektar; Honoraria (self), Advisory / Consultancy: Exiles; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: Genentech; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy: EMD Serono; Honoraria (self), Advisory / Consultancy: Decibel; Research grant / Funding (institution): BMS. M.A. Bilen: Advisory / Consultancy: Exelixis; Advisory / Consultancy: Nektar; Advisory / Consultancy: GenomicHealth; Advisory / Consultancy: EMD Serono; Advisory / Consultancy: Sanofi; Research grant / Funding (institution): Bayer; Research grant / Funding (self): Bristol-Myers Squibb; Research grant / Funding (self): Genentech/Roche; Research grant / Funding (self): Incyte; Research grant / Funding (self): Nektar; Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): Tricon Pharmaceuticals; Research grant / Funding (self): Peleton; Research grant / Funding (self): Pfizer. All other authors have declared no conflicts of interest.

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.