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603v16n04 90399541mmc1
603v16n04 90399541mmc1
This appendix formed part of the original submission and has been peer reviewed.
We post it as supplied by the authors.
Supplement to: Weber JS, D’Angelo SP, Minor D, et al. Nivolumab versus chemotherapy
in patients with advanced melanoma who progressed after anti-CTLA-4 treatment
(CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol 2015;
published online March 18. http://dx.doi.org/10.1016/S1470-2045(15)70076-8.
ONLINE SUPPLEMENTARY MATERIALS
A randomised, controlled, open-label, phase 3 trial of nivolumab versus chemotherapy in patients with advanced
melanoma who progressed after anti-CTLA-4 therapy (CheckMate 037)
Jeffrey S. Weber,1 Sandra P. D’Angelo,2 David Minor,3 F. Stephen Hodi,4 Ralf Gutzmer,5 Bart Neyns,6 Christoph Hoeller,7
Nikhil I. Khushalani,8 Wilson H. Miller, Jr.,9 Christopher D. Lao,10 Gerald Linette,11 Luc Thomas,12 Paul Lorigan,13 Kenneth
F. Grossmann,14 Jessica C. Hassel,15 Michele Maio,16 Mario Sznol,17 Paolo A. Ascierto,18 Peter Mohr,19 Bartosz
Chmielowski,20 Alan Bryce,21 Inge M. Svane,22 Jean-Jacques Grob,23 Angela M. Krackhardt,24 Christine Horak,25 Alexandre
Lambert,26 Arvin S. Yang,25 James Larkin27
1
Moffitt Cancer Center, Tampa, FL, USA; 2Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College,
New York, NY, USA; 3California Pacific Center for Melanoma Research, San Francisco, CA, USA; 4Dana-Farber Cancer
Institute, Boston, MA, USA; 5Medizinische Hochschule Hannover, Hannover, Germany; 6Universitair Ziekenhuis Brussel,
Brussels, Belgium; 7Medical University of Vienna, Vienna, Austria; 8Roswell Park Cancer Institute, Buffalo, NY, USA;
9
Segal Cancer Centre, Jewish General Hospital, McGill University, Montreal, QC Canada; 10University of Michigan, Ann
Arbor, MI, USA; 11Washington University, St. Louis, MO, USA; 12Centre Hospitalier Universitaire de Lyon, Lyon, France;
13
Christie Hospital, Manchester, UK; 14Huntsman Cancer Institute, Salt Lake City, UT, USA; 15German Cancer Research
Centre University Hospital Heidelberg, Germany; 16Medical Oncology and Immunotherapy, University Hospital of Siena,
Istituto Toscano Tumori, Siena, Italy; 17Yale Cancer Center, New Haven, CT, USA; 18Istituto Nazionale Tumori Fondazione
G. Pascale, Naples, Italy; 19Elbe Kliniken Buxtehude, Buxtehude, Germany; 20Department of Medicine, UCLA, Los Angeles,
CA, USA; 21Department of Medicine, Mayo Clinic, Scottsdale, Arizona, USA, 22Department of Oncology, Herlev Hospital,
Copenhagen, Denmark; 23Aix-Marseille University, Hopital de la Timone, Marseille, France; 24TUM School of Medicine, III.
Medical Department, Munich, Germany; 25Bristol-Myers Squibb, Princeton, NJ, USA; 26Bristol-Myers Squibb, Braine-
I’Alleud, Belgium; 27Royal Marsden Hospital, London, UK
Table S1: Treatment-related select AEs of potential immune-related aetiology reported in ≥ 1% of patients
Nivolumab ICC
Select AE (organ category) (N=268) (N=102)
Any grade, n (%) Grade 3–4, n (%) Any grade, n (%) Grade 3–4, n (%)
Skin 78 (29·1) 1 (0·4) 12 (11·8) 0 (0)
Pruritus 43 (16·0) 0 (0) 2 (2·0) 0 (0)
Rash 25 (9·3) 1 (0·4) 5 (4·9) 0 (0)
Rash maculo-papular 14 (5·2) 0 (0) 2 (2·0) 0 (0)
Vitiligo 14 (5·2) 0 (0) 0 (0) 0 (0)
Dermatitis 5 (1·9) 0 (0) 0 (0) 0 (0)
Rash erythematous 3 (1·1) 0 (0) 0 (0) 0 (0)
Gastrointestinal 31 (11·6) 3 (1·1) 15 (14·7) 2 (2·0)
Diarrhea 30 (11·2) 1 (0·4) 15 (14·7) 2 (2·0)
Colitis 3 (1·1) 2 (0·7) 0 (0) 0 (0)
Endocrine 21 (7·8) 0 (0) 1 (1·0) 0 (0)
Hypothyroidism 15 (5·6) 0 (0) 0 (0) 0 (0)
Hyperthyroidism 5 (1·9) 0 (0) 1 (1·0) 0 (0)
Blood TSH increased 3 (1·1) 0 (0) 0 (0) 0 (0)
Hepatic 12 (4·5) 2 (0·7) 6 (5·9) 0 (0)
AST increased 11 (4·1) 1 (0·4) 2 (2·0) 0 (0)
ALT increased 7 (2·6) 2 (0·7) 1 (1·0) 0 (0)
Pulmonary 6 (2·2) 0 (0) 0 (0) 0 (0)
Pneumonitis 5 (1·9) 0 (0) 0 (0) 0 (0)
Renal 4 (1·5) 1 (0·4) 1 (1·0) 0 (0)
Blood creatine increase 2 (0·7) 0 (0) 0 (0) 0 (0)
Hypersensitivity/infusion reaction 5 (1·9) 1 (0·4) 8 (7·8) 0 (0)
Infusion-related reaction 3 (1·1) 1 (0·4) 7 (6·9) 0 (0)
AE=adverse event. ALT=alanine aminotransferase. AST=aspertate aminotransferase. ICC= investigator’s choice chemotherapy. TSH=thyroid stimulating hormone.
Table S2: ORR by chemotherapy received
Nivolumab Dacarbazine Paclitaxel/Carboplatin
(n=120) (n=19) (n=28)
ORR,* n (%), [95% CI] 38 (31·7) [23·5–40·8] 0 (0) [0·0–17·6] 5 (17·9) [6·1–36·9]
BOR,* n (%)
Paraesthesia 0 0 0 9 (15.8) 0 0
Myalgia 0 0 0 7 (12.3) 0 0
Exclusion Criteria
1) Target Disease Exceptions
a) Active brain metastasis or leptomeningeal metastasis. Subjects with brain metastases are eligible if these have been treated,
and must be without MRI (except where contraindicated in which case CT scan is acceptable) evidence of progression for
at least 8 weeks and not require immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone or
equivalent) for at least 2 weeks prior to study drug administration.
b) Ocular melanoma.
c) Subjects whose melanoma is BRAF status unknown.
2) Medical History and Concurrent Diseases
a) Any treatment in a BMS-936558 (nivolumab) trial.
b) Prior systemic melanoma therapy with both dacarbazine and carboplatin and paclitaxel. Prior systemic therapy with one of
the treatments is permitted.
c) Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the
risk associated with study participation, study drug administration, or would impair the ability of the subject to receive
protocol therapy.
d) Subjects with previous malignancies (except non-melanoma skin cancers, in situ bladder cancer, gastric or colon cancers,
cervical cancers/dysplasia, or breast carcinoma in situ) are excluded unless a complete remission was achieved at least 2
years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
e) Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual
hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic
treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
f) Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone
equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical
steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active
autoimmune disease.
g) Subjects who received prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2, (or any other antibody or drug
specifically targeting T-cell co-stimulation or checkpoint pathways except for anti-CTLA-4 therapy as described above).
h) Known drug or alcohol abuse.
i) Yellow fever vaccine, live attenuated vaccines, or prophylactic phenytoin within 28 days prior to the first dose of study
drug.
3) Physical and Laboratory Test Findings
a) Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
b) Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency
syndrome (AIDS).
4) Allergies and Adverse Drug Reaction
a) Subjects with a known history of the following anti-CTLA-4 therapy related adverse reactions based on the CTCAE v4.0
criteria:
i) Grade 4 anti-CTLA-4 therapy related adverse reaction except resolved nausea, fatigue, infusion reactions or
endocrinopathies where clinical symptoms were able to be controlled with appropriate hormone replacement therapy.
Grade 3 anti-CTLA-4 therapy related adverse reactions must have resolved or been controlled within 12 weeks.
ii) Any ≥ Grade 2 eye pain or reduction of visual acuity that did not respond to topical therapy and did not improve to ≤
Grade 1 severity within 2 weeks of starting topical therapy or required systemic treatment.
iii) Any ≥ Grade 3 sensory neurologic toxicity.
iv) Any Grade 4 laboratory abnormalities, except AST, ALT or T. bilirubin;
(1) AST or ALT > 10 x ULN
(2) T. bilirubin > 5 x ULN
v) Subjects who required infliximab or other immune suppressants including mycophenolic acid for management of drug
related toxicities.
b) History of Grade ≥ 3 neurologic toxicity.
c) History of Grade ≥ 3 allergy to study drug components.
5) Sex and Reproductive Status
a) WOCBP who are pregnant or breastfeeding.
b) Women with a positive pregnancy test at enrollment or prior to administration of study medication.
6) Other Exclusion Criteria
a) Prisoners or subjects who are involuntarily incarcerated.
b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
c) Current participation in another clinical study involving treatment with medications, radiation or surgery.
Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and that the results of the
study can be used. It is imperative that subjects fully meet all eligibility criteria.
(P) +3227641111
(F) +3227641620
Email: jf.baurain@uclouvain.be
CA209-037-0002* Neyns, Bart, MD, PhD Universitair Ziekenhuis Brussel 18
Medische Oncologie
Boulet, Cedric, MD (Office)
De Greve, Jacques, MD, PhD Laarbeeklaan 101
Jansen, Yanina Brussels, 1090
Schreuer, Max, MD Belgium
Wilgenhof, Sofie, MD, PhD
Universitair Ziekenhuis Brussel
Medische Oncologie
(P) +3224776045 (Pt Tx Ctr - Hosp/Med Ctr)
(F) +3224775460 Laarbeeklaan 101
Brussels, 1090
Belgium
Email: bart.neyns@uzbrussel.be
9888
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0003* Schoffski, Patrick, MD, PhD Uz Leuven (Office) 5
Herestraat 49
Bechter, Olivier, MD Leuven, 3000
Beuselinck, Benoit, MD, PhD Belgium
Clement, Paul, MD, PhD
Dumez, Herlinde, MD Uz Leuven (Pt Tx Ctr - Hosp/Med Ctr)
Paridaens, Robert, MD, PhD Interne Geneeskunde - Algemene
Wildiers, Hans, MD, PhD Medische Oncologie
Wolter, Pascal, MD Herestraat 49
Leuven, 3000
Belgium
(P) +3216345506
(F) +3216343209
Email: patrick.schoffski@uzleuven.be
9889
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0006* Specenier, Pol, MD Universitair Ziekenhuis Antwerpen 2
(Office)
Altintas, Sevilay, MD, PhD Wilrijkstraat 10
Huizing, Manon Thirza, MD Edegem, 2650
Op De Beeck, Bart, MD Belgium
Papadimitriou, Konstantinos, MD
Peeters, Marc, MD, PhD Universitair Ziekenhuis Antwerpen
Rolfo, Christian, MD, PhD (Pt Tx Ctr - Hosp/Med Ctr)
Van Den Brande, Jan, MD Wilrijkstraat 10
Edegem, 2650
(P) +3238215466 Belgium
(F) +3238214488
Email: pol.specenier@uza.be
9890
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0008* Ottensmeier, Christian, MD, PhD Southampton University Hospital NHS 6
Trust (Office)
Bradbury, Jennifer, MBChB, MRCP Tremona Road
Chau, Caroline Shuet Yiu, MRCP Southampton, Hampshire, SO16 6YD
Wheater, Matthew, MD United Kingdom
9891
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0010* Larkin, James, MD The Royal Marsden Hospital 43
Medical Oncology (Office)
Georgios Antoniou, MD 203 Fulham Road
Biondo, Andrea, MD London, SW3 6JJ
Boafo-Yirenkyi, Melanie, MD United Kingdom
Davidson, Michael Edward, MBBS
Fisher, Rosalie, MDChB The Royal Marsden Hospital
Furness, Andrew, MD Medical Oncology
Georgiou, Alexandros (Pt Tx Ctr - Hosp/Med Ctr)
Gore, Martin, PhD 203 Fulham Road
Hewish, Madeleine, MD London, SW3 6JJ
Joshi, Kroopa, MD United Kingdom
Lee, Alexander
Letsa, Ioanna, GP
Lima, Joao
Lote, Hazel, MD
Macklin-Doherty, Aislinn
Martin, Juan
McCulloh, Gemma
Ng-Cheng-Hin, Brian
Okines, Alicia, MD
Seifert, Heike, MD
Stares, Mark, MBBS
Yousaf, Nadia
(P) +442078082123
(F) +442073512477
Email: james.larkin@rmh.nhs.uk
9892
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
Email: mark.middleton@oncology.ox.ac.uk
9893
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
9894
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0016 Weber, Jeffrey S, MD, PhD H. Lee Moffitt Cancer Center & 23
Research Institute (Office)
Deconti, Ronald, MD 12902 Magnolia Dr.
Gibney, Geoffrey T, MD Tampa, FL 33612
Kudchadkar, Ragini, MD USA
Royster, Erica B, MPH
Thebeau, Melissa S, ARNP H. Lee Moffitt Cancer Center &
Research Institute
(P) 8137454960 (Pt Tx Ctr - Hosp/Med Ctr)
(F) 8137451835 12902 Magnolia Dr.
Tampa, FL 33612
Email: jeffrey.weber@moffitt.org USA
9895
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
9896
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
9897
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
9898
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
9899
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
9900
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
Orlando Heart Health Institute
CA209-037-0023 (Pt Tx Ctr - Hosp/Med Ctr) (Previous)
Thomas Sajeve, MD 1222 South Orange Ave.
(Cont’d) Orlando, FL 32806
USA
9901
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0024 Hamid, Omid, MD The Angeles Clinic & Research Institute 5
(Office)
Balmanoukian, Ani, MD 11818 Wilshire Blvd.
Boasberg, Peter D, MD Ste 200
Chung, Cathie, MD Los Angeles, CA 90025
Hoffner, Brianna, NP USA
9902
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0025 Infante, Jeffrey R, MD Tennessee Oncology, PLLC (Office) 4
250 25th Avenue North
Bauer, Todd, MD Suite 307
Bendell, Johanna Chock, SB, MD Nashville, TN 37203
Bi, Jia, MD USA
Burris, III, Howard A, MD
Cooper, Robert S, MD Tennessee Oncology, PLLC
Dickson, Natalie Renee, MD (Pt Tx Ctr - Med Office/Clinic)
Greco, F. Anthony, MD 4230 Harding Rd. Ste 707
Hollis, Laura T, APRN, BC Nashville, TN, 37205
Hronek, Jan W, ACNP USA
Ingle, Rebecca J, FNP
Lehner, Maureen E, ACNP Tennessee Oncology, PLLC
Morris, Patricia A, APN-C (Pt Tx Ctr - Med Office/Clinic)
Porter III, Lester L, MD 250 25th Avenue North
Shepard, Gregg Christian, MD Suite 100
Shih, Kent C, MD Nashville, TN 37203
Spigel, David Robert, MD USA
Thompson, Dana Shelton, MD
Utley, Susan M., BSN, MSN, FNP Sarah Cannon Research Institute
Vantrease, Amanda G, APN, RN (Pt Tx Ctr - Med Office/Clinic)
Yardley, Denise Aysel, MD 250 25th Ave. N
St 312
(P) 6153421741 Nashville, TN 37203
(F) 6153421738 USA
9903
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0027 Linette, Gerald P, MD, PhD Washington University School of 14
Medicine (Office)
Cornelius, Lynn Anne, MD 660 South Euclid Ave.
Curran, Christen M, MSN, RN, ANP-BC St. Louis, MO 63110
Tan, Benjamin, MD USA
Wildes, Tanya M, MD
Washington University School of
(P) 3147471217 Medicine
(F) 3147471404 (Pt Tx Ctr - Hosp/Med Ctr)
Site Man Cancer Ctr.
Email: glinette@dom.wustl.edu 4921 Parkview Pl. Fl 7th
Saint Louis, MO 63110
USA
Barnes-Jewish Hospital
(Pt Tx Ctr - Hosp/Med Ctr)
1 Barnes-Jewish Hosp Plz.
Saint Louis, MO 63110
USA
9904
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0028 D'angelo, Sandra Pierina, MD Memorial Sloan Kettering Cancer Center 24
(Office)
Callahan, Margaret Kathleen, MD, PhD 1275 York Ave.
Carvajal, Richard D, MD Inpatient Hospital & Main Campus
Chapman, Paul B, MD New York, NY 10065
Chi, Ping, MD, PhD USA
Dickson, Mark A, MD
Erinjeri, Joseph P, MD, PhD Memorial Sloan-Kettering Cancer Center
Gounder, Mrinal M, MD (Pt Tx Ctr - Hosp/Med Ctr)
Harding, James J, MD Laurence S. Rockefeller Outpatient
Keohan, Mary Louise, MD Pavillion
Lefkowitz, Robert Andrew, MD 160 East 53rd Street
Postow, Michael A, MD New York, NY 10022
Schwartz, Gary K, MD USA
Tap, William D, MD
Weinstein, Alyona, NP Memorial Sloan Kettering Cancer Center
Wolchok, Jedd, MD, PhD (Pt Tx Ctr - Hosp/Med Ctr)
1275 York Ave. RM C-1087
(P) 6462272189 Attn: Gerry O-Neill
(F) 6464222164 New York, NY 10065
USA
Email: dangelos@mskcc.org
Memorial Sloan Kettering Cancer Center
(Pt Tx Ctr - Hosp/Med Ctr)
1275 York Ave
Inpatient Hospital & Main Campus
New York, NY 10065
USA
9905
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0029 Chmielowski, Bartosz, MD, PhD University of California - Los Angeles 14
Hematology-Oncology Outpatient Clinic
Branch, Suzanne, CCRP (Office)
Glaspy, John A., MD, MPH 100 UCLA Medical Plaza
Oseguera, Denise K, FNP Suite 550
Ribas, Antoni, MD Los Angeles, CA 90095
Tumeh, Paul, MD USA
9906
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0029 Ronald Reagan Ucla Medical Center
Chmeilowski, Bartosz, MD, (Pt Tx Ctr - Hosp/Med Ctr)
PhD (Cont’d) Department of Radiological Sciences
757 Westwood Plaza
Los Angeles, CA 90095
USA
9907
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0030 Agarwala, Sanjiv S., MD St.Luke's Cancer Center (Office) 6
Anderson Campus
Ali, Asim, MD 1600 Riverside Circle
Belman, Neil, DO Easton, PA 18045
Faroun, Yacoub, MD USA
Holden, Rita, CRNP
Leonard, Jillian Foster, PA-C St.Luke's Quakertown Hospital
Nakajima, Hikaru, MD (Pt Tx Ctr - Hosp/Med Ctr) (Previous)
Peartree, Michelle, PA-C 1021 Park Ave
Proothi, Subhash, MD Quakertown, PA 18951
USA
(P) 4845034500
(F) 4845034510 St.Luke's Cancer Center
(Pt Tx Ctr - Hosp/Med Ctr)
Email: agarwas@slhn.org Anderson Campus
1600 Riverside Circle
Easton, PA 18045
USA
9908
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA203-037-0030 St. Luke's University Hospital
Agarwala, Sanjiv, S., MD Bethlehem Campus
(Cont’d) (Pt Tx Ctr - Hosp/Med Ctr)
801 Ostrum St.
Bethlehem, PA 18015
USA
9909
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0031 Daniels, Gregory, MD, PhD UCSD Moores Cancer Center (Office) 4
3855 Health Sciences Dr.
Sutton, Brian C, PA-C La Jolla, CA 92093
USA
(P) 8588226083
(F) 8588225380 UCSD Medical Center- Hillcrest
(Pt Tx Ctr - Hosp/Med Ctr)
Email: gdaniels@ucsd.edu 200 W Arbor Dr.
San Diego, CA 92103
USA
9910
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
9911
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0033 Providence Health and Services
Urba, Walter, J, MD, PhD (Pt Tx Ctr - Hosp/Med Ctr)
(Cont’d) 4805 NE Glisan Street
IDS: Suite 6N-45
Portland, OR 97213
USA
9912
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0035 Salama, April, MD Duke University Medical Center (Office) 7
200 Trent Drive
Hanks, Brent A, MD Box 3476, Room 459 Sealey G Mudd
Herrmann, Tara Rae, PA Building, Box 3118
Linney, Kristen, RN Durham, NC 27710
Morse, Michael A, MD USA
Mosca, Paul Jo, MD
Ready, Neal, MD Duke University Medical Center (Office)
Riedel, Richard, MD (Previous)
Scheri, Randall P, MD Box 3476, Room 459 Seely G. Mudd
Tyler, Douglas, MD Building
Durham, NC 27710
(P) 9195757213 USA
(F) 9195757042
Duke University Medical Center
Email: april.salama@duke.edu (Pt Tx Ctr - Hosp/Med Ctr)
200 Trent Drive
Durham, NC 27710
USA
Email: jean-jacques.grob@ap-hm.fr
9913
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0037* Robert, Caroline, MD Institut Gustave Roussy (Office) 7
Service Dermatologie
Boussemart, Lise, MD 39 rue Camille Desmoulins
Cazenave, Hugo, MD Villejuif, 94805
Mateus, Christine, MD France
Routier, Emilie, MD
Sebille, Gwendoline, MD Institut Gustave Roussy
Thomas, Marina, MD (Pt Tx Ctr - Hosp/Med Ctr)
Viollet, Roxane, MD, PhD Service Dermatologie
39 rue Camille Desmoulins
(P) +33142114211 Villejuif, 94805
(F) +33142115300 France
Email: caroline.robert@gustaveroussy.fr
CA209-037-0038* Lebbe, Celeste, MD, PhD Hopital Saint Louis (Office) 5
1 Avenue Claude Vellefaux
Basset-Seguin, Nicole, MD Paris, 75010
Bouaziz, Jean-David, MD France
Bruzzoni, Heriberto, MD
Kiladjian, Jean-Jacques, MD Hopital Saint Louis
Pages, Cecile, MD (Pt Tx Ctr - Hosp/Med Ctr)
Roux, Jennifer, MD Hopital Saint Louis
Sabatier, Francois, MD Dept Dermatologie
Schneider, Pierre, MD 1 Avenue Claude Vellefaux
Servy, Amandine, MD Paris, 75010
Viguier, Manuelle, MD France
(P) +33142499575
(F) +33142494227
Email: celeste.lebbe@sls.aphp.fr
9914
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0039* Dreno, Brigitte, MD Hotel Dieu - Chu De Nantes (Office) 4
1 Place Alexis Ricordeau
Brocard, Anabelle, MD Nantes Cedex 1, Na, 44093
Dupas, Benoit, MD, PhD France
Peuvrel, Lucie, MD
Quereux, Gaelle, MD Hotel Dieu - Chu De Nantes
Saint-Jean, Melanie, MD (Pt Tx Ctr - Hosp/Med Ctr)
Unite Cancero-Dermatologie
(P) +33240083333 1 Place Alexis Ricordeau
(F) +33240083250 Nantes Cedex 1, Na, 44093
France
Email: brigitte.dreno@wanadoo.fr
CA209-037-0040* Thomas, Luc, MD, PhD Centre Hospitalier Lyon Sud (Office) 10
Pavillon Medical, Service Dermatologie
Amini-Adle, Mona, MD PC Medicaux 3Eme Estage
Dalle, Stephane, MD 165 chemin du Grand Revoyet
Pierre Benite, 69495
(P) +33825082569 France
(F) +33478864410
Centre Hospitalier Lyon Sud
Email: luc.thomas@chu-lyon.fr (Pt Tx Ctr - Hosp/Med Ctr)
Service Dermatologie
PC Medicaux 3Eme Estage
165 chemin du Grand Revoyet
Pierre Benite, 69310
France
9915
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0041 Flaherty, Lawrence, MD Karmanos Cancer Institute (Office) 2
4100 John R
Lefkotwitz, Nancy, RN, MPH Detroit, MI 48201
Lewis, Rena, RN USA
Marsack, Cynthia H., MSN, RN, OCN, CS, NP
Miller, Elizabeth K, MHS, PA-C Karmanos Cancer Institute
Murray, Jennifer E, RN (Pt Tx Ctr - Hosp/Med Ctr)
Trojniak, Lynette Marie, MSN, RN, CNP 4100 John R
Vaishampayan, Ulka N, MD Detroit, MI 48201
USA
(P) 3135768808
(F) 3135768825 Karmanos Cancer Institute Of
Farmington Hills
Email: flaherty@karmanos.org (Pt Tx Ctr - Hosp/Med Ctr)
31995 Northwest Hwy.
Farmington Hills, MI 48334
USA
9916
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0042 Lutzky, Jose, MD Mount Sinai Medical Center 5
(Office)
Blaustein, Arnold, MD Comprehensive Cancer Center
Cusnir, Mike, MD 4306 Alton Rd.
Krill-Jackson, Elisa, MD Miami Beach, FL 33140
Pizzolato, Joseph, MD USA
Rodriguez, Estelamari, MD
Schwartz, Michael, MD Mount Sinai Medical Center
(Pt Tx Ctr - Hosp/Med Ctr)
(P) 3055353350 4300 Alton Rd
(F) 3056743984 Miami Beach, FL 33140
USA
Email: jose.lutzky@msmc.com
Mount Sinai Medical Center
(Pt Tx Ctr - Hosp/Med Ctr)
Comprehensive Cancer Center
4306 Alton Rd.
Miami Beach, FL 33140
USA
9917
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0043 Khushalani, Nikhil, MD Roswell Park Cancer Institute (Office) 11
Elm And Carlton Streets
Cheney, Richard T, MD Buffalo, NY 14263
George, Saby MD USA
Loud, Peter A, MD
Skitzki, Joseph, MD Roswell Park Cancer Institute
(Pt Tx Ctr - Hosp/Med Ctr)
(P) 7168452300 Elm And Carlton Streets
(F) 7168458661 Buffalo, NY 14263
USA
Email: nikhil.khushalani@roswellpark.org
Email: bryce.alan@mayo.edu
9918
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0046 Nair, Suresh G, MD Network Office of Research and 1
Innovation (Office)
Agostino, Nicole M, DO 1210 Bldg, Suite 1000
Barnaby, Janine G, RPh Cedar Crest Blvd & I-78
Bolsover, Kathleen Marie, RN LVH/LVHN
Candelo, Yasmin, RN Allentown, PA 18103
Chase, Ramona E, CRNP USA
Ferguson, Tracey A, RN
Friedman, Eliot L, MD Lehigh Valley Health Network
Gallagher, Debra (Pt Tx Ctr - Hosp/Med Ctr)
Gardner, Nancy Sue, CRNP Cedar Crest Boulevard & I-78
Grace, Trina Lehigh Valley Hospital (LVH/LVHN)
Harris, Katherine A, MD Allentown, PA 18103
Kotkiewicz, Adam, DO USA
Lamparella, Nicholas, MD
Lichtenwalner, Sarah Elizabeth, RN
Patson, Brian J, MD
Scialla, William S, DO
Shah, Ashish Prabodh, MD
Shah, Usman, MD
Skandan, Savitri, MD
Smith, Georgeanne, CLA
Whitney, Samiyyah, RN
(P) 6104022273
(F) 6104020634
Email: suresh.nair@lvh.com
9919
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0047 Lao, Christopher, MD University of Michigan Health System 14
(Office)
Patton, Susan, RN, BSN 1500 East Medical Ctr Dr.
Redman, Bruce, DO Ann Arbor, MI 48109
USA
(P) 7349365215
(F) 7347635793 University of Michigan Health System
(Pt Tx Ctr - Med Office/Clinic)
Email: clao@umich.edu 1500 East Medical Ctr Dr.
Ann Arbor, MI 48109
USA
9920
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0049 Koon, Henry B, MD University Hospitals of Cleveland 6
(Office)
Bray, Julie, CNP 11100 Euclid Ave.
Nock, Charles J, MD Cleveland, OH 44106
USA
(P) 2168443681
(F) 2168443448 University Hospitals of Cleveland
(Pt Tx Ctr - Hosp/Med Ctr)
Email: henry.koon@uhhospitals.org 11100 Euclid Ave.
Cleveland, OH 44106
USA
Chagrin Highlands
(Pt Tx Ctr - Med Office/Clinic)
3909 Orange Place
Cleveland, OH 44122
USA
9921
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0050 Minor, David R, MD San Francisco Oncology Associates 28
(Office)
Wang, Wei, MD, PhD 2100 Webster St.
Ste 326
(P) 4156003027 San Francisco, CA 94115
(F) 4156001737 USA
9922
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0051* Maio, Michele, MD Azienda Ospedaliera Universitaria 10
Senese (Office)
Calabro, Luana, MD U.O.C. Immunoterapia Oncologica
Danielli, Riccardo, MD Strade Delle Scotte, 14
Di Giacomo, Anna Maria, MD Siena, 53100
Italy
(P) +390577586199
(F) +390577586599 Azienda Ospedaliera Universitaria
Senese
Email: mmaiocro@gmail.com (Pt Tx Ctr - Hosp/Med Ctr)
U.O.C. Immunoterapia Oncologica
Strade Delle Scotte, 14
Siena, 53100
Italy
9923
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0053* Chiarion-Sileni, Vanna, MD Irccs Istituto Oncologico Veneto IOV 3
(Office)
Pigozzo, Jacopo, MD IOV - SSD Oncologia Melanomi
Valpione, Sara, MD Via Gattamelata 64
Padova, 35128
(P) +390498215838 Italy
(F) +390498215837
Irccs Istituto Oncologico Veneto IOV
Email: vanna.chiarion@ioveneto.it (Pt Tx Ctr - Hosp/Med Ctr)
IOV - SSD Oncologia Melanomi
Via Gattamelata 64
Padova, 35128
Italy
9924
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0056* Queirolo, Paola, MD Istituto Nazionale Per La Ricerca Sul 6
Cancro (Office)
Biello, Federica, MD Oncologia Medica A
Monteghirfo, Stefano, MD Largo Rosanna Benzi, 10
Ottaviano, Vincenzo, MD Genova, 16132
Pesce, Marianna, MD Italy
Picasso, Virginia, MD
Spagnolo, Francesco, MD Istituto Nazionale Per La Ricerca Sul
Tornari, Elena, MD Cancro
(Pt Tx Ctr - Hosp/Med Ctr)
(P) +390105600665 Oncologia Medica A,
(F) +390105600850 Largo Rosanna Benzi, 10
Genova, 16132
Email: paola.queirolo@istge.it Italy
9925
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0058* Guida, Michele, MD Giovanni Paolo II Istituto 2
(Office)
Latorre, Agnese, MD Viale Orazio Flacco 65
Strippoli, Sabino, MD Bari, 70124
Italy
(P) +390805555256
(F) +390805555471 Giovanni Paolo II Istituto
(Pt Tx Ctr - Hosp/Med Ctr)
Email: micguida@libero.it Viale Orazio Flacco 65
Bari, 70124
Italy
9926
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0060* Jamal, Rahima, MD Chum, Hopital Notre-Dame (Office) 5
Pavillon Deschamps 5th Floor
Aubin, Francine, MD 1560 Sherbrooke E.
Ayoub, Jean-Pierre, MD Montreal, QC, H2L 4M1
Belanger, Karl, MD Canada
Bestawros, Alain
Blais, Normand, MD Chum-Hopital Notre-Dame
Charpentier, Danielle, MD (Pt Tx Ctr - Hosp/Med Ctr)
Lemieux, Bernard, MD Oncology Center
Soulieres, Denis, MD CHUM - Hopital Notre-Dame
Tehfe, Mustapha, MD 1560 Sherbrooke E.
Montreal, QC, H2L 4M1
(P) 5148908000 Canada
(F) 5144127572
Email: rahima.jamal.chum@ssss.gouv.qc.ca
9927
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0062* Smylie, Michael G, MD Cross Cancer Institute (Office) 17
11560 University Ave NW
Chu, Siu-Chung Quincy, MD Edmonton, AB, T6G 1Z2
Joy, Anil Abraham, MD Canada
Walker, John, MD
Cross Cancer Institute
(Pt Tx Ctr - Hosp/Med Ctr)
(P) 7809898157 11560 University Ave NW
(F) 7805778138 Edmonton, AB, T6G 1Z2
Canada
Email: michaels@cancerboard.ab.ca
9928
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0065* Svane, Inge Marie, MD, PhD Herlev Hospital (Office) 5
Herlev Ringvej
Donia, Marco, MD, PhD Herlev, 2730
Engel Norregaard, Lotte, MD, PhD Denmark
Geertsen, Poul, MD, PhD
Mathiessen, Louise Wichman, MD, PhD Herlev Hospital
Sengelov, Lisa, MD (Pt Tx Ctr - Hosp/Med Ctr)
Skovgaard, Kristin, MD, PhD Dept. Of Oncology
Herlev Ringvej 75
(P) +4544884488 Herlev, DK-2730
(F) +4544883033 Denmark
Email: imsv@heh.regionh.dk
9929
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0067 Hodi, F. Stephen, MD Dana Farber Cancer Institute 7
(Office)
Beeler, Maureen, RN 450 Brookline Ave
Bhatt, Rupal S, MD Boston, MA 02215
Bowers, Mary Ellen, RN USA
Buchbinder, Elizabeth I., MD
Cho, Daniel C., MD Massachusetts General Hospital
Davis, Meredith, PA-C (Pt Tx Ctr - Hosp/Med Ctr)
Donahue, Hilary, MD 32 Fruit Street
Fadden, Riley M., NP Yawkey 8, Pharmacy
Flaherty, Keith T, MD Boston, MA 02214
Haq, Rizwan, MD USA
Ibrahim, Nageatte, MD
Kata, Caryn, RN Massachusetts General Hospital
Kelley, Kristina, RN (Pt Tx Ctr - Hosp/Med Ctr)
Lawrence, Donald, MD 55 Fruit Street
Lee, Mee-Young, NP Boston, MA 02215
Livengood, Amanda J., RN USA
Luke, Jason, MD
Marujo, Rose, RN Dana-Farber Cancer Institute
McDermott, David, MD (Pt Tx Ctr - Hosp/Med Ctr)
Mier, James, MD 450 Brookline Avenue
Ott, Patrick, MD Boston, MA 02215
Renzi, Sharon, RN USA
Rubin, Krista, RN
Seery, Virginia, RN
Sullivan, Ryan, MD Dana-Farber Cancer Institute
Wood, Valerie J, RN (Pt Tx Ctr - Hosp/Med Ctr)
450 Brookline Ave
Pharmacy - Yawkey Fl 5th
(P) 6176323786 Boston, MA 02215
(F) 6176324301 USA
9930
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0067 Beth Israel Deaconess Medical Center(Pt
Hodi, F. Stephen, MD Tx Ctr - Hosp/Med Ctr)
(Cont’d) 330 Brookline Ave
Boston, MA 02215
USA
Email: claus.garbe@med.uni-tuebingen.de
CA209-037-0069* Hassel, Jessica, MD Nationales Centrum Fuer 13
Tumorerkrakungen (NCT) Heidelberg
Berthold, Elisa, MD (Office)
Delavari, Delnaz Uniklinik Heidelberg
Hofmann, Frank, MD Im Neuenheimer Feld 460
Lang, Nina, MD Dermatoonkologie
Lee, Sophia B, MD Heidelberg, 6912
Lonsdorf, Anke Susanne, MD Germany
Salz, Mareen, MD
Schiller, Matthias Bastian, MD Nationales Centrum Fuer
Tumorerkrakungen (NCT) Heidelberg
(P) +4962215638522 (Pt Tx Ctr - Unspecified)
(F) +4962215688902 Uniklinik Heidelberg
Im Neuenheimer Feld 460
Email: jessica.hassel@med.uni-heidelberg.de Dermatoonkologie
Heidelberg, 69120
Germany
9931
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0070* Kahler, Katharina, MD Universitaetsklinikum 1
Schleswig-Holstein
Grewe, Lena, MD (Office)
Hauptmann, Nora, MD Klinik Fur Dermatologie Venerologie
Hauschild, Axel, MD Und Allergologie
Kornek, Thomas, MD Schittenhelmstrasse 7
Schafer, Shirley, MD Kiel, D-24105
Germany
(P) +4904315972483
(F) +4904315972482 Universitaetsklinikum
Schleswig-Holstein
Email: kckaehler@yahoo.de (Pt Tx Ctr - Hosp/Med Ctr)
Klinik Fur Dermatologie Venerologie
Und Allergologie
Schittenhelmstrasse 7
Kiel, D-24105
Germany
9932
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0072* Schadendorf, Dirk, MD, PhD Universitaetsklinikum Essen 11
(Office)
Cosgarea, Ioana, MD Klinik Fur Dermatologie
Freise-Vaubel, Julia M, MD Hufelandstrasse 55
Hermes, Isabel, MD Essen, 45122
Hohaus, Katja, MD Germany
Rompoti, Natalia, MD
Schilling, Bastian, MD Universitaetsklinikum Essen
Zimmer, Lisa, MD (Pt Tx Ctr - Hosp/Med Ctr)
Klinik Fur Dermatologie
(P) +492017230 Hufelandstrasse 55
(F) +492017230 Essen, 45122
Germany
Email: dirk.schadendorf@uk-essen.de
9933
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0074* Schmuth, Matthias, MD Med. Universitaet Innsbruck 0
(Office)
Bodenberger, Maresa, MD Dermatologie U. Venerologie
Moser-Oberthaler, Sabine, MD Anichstrasse 35
Mueller, Hansgeorg, MD Innsbruck, 6020
Nguyen, Van Anh, MD Austria
Stueckler, Christa, DR
Weinlich, Georg, MD Med. Universitaet Innsbruck
(Pt Tx Ctr - Hosp/Med Ctr)
(P) +4351250424801 Dermatologie U. Venerologie
(F) +4351250425267 Anichstrasse 35
Innsbruck, 6020
Email: matthias.schmuth@i-med.ac.at Austria
9934
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0076* Romano, Emanuela, MD Centre Hospitalier Universitaire Vaudois 4
(Office)
Michielin, Olivier, MD, PhD 46 Rue Du Bugnon
Centre D'oncologie
(P) +41213140185 Multidisciplinaire
(F) +41213144020 Lausanne, 1011
Switzerland
Email: emanuela.romano@chuv.ch
Centre Hospitalier Universitaire Vaudois
(Pt Tx Ctr - Hosp/Med Ctr)
46 Rue Du Bugnon
Centre D'oncologie
Multidisciplinaire
Lausanne, 1011
Switzerland
9935
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0079* Soetekouw, Patricia, MD University Hospital Maastricht 0
(Office)
Essers-Aarts, Maureen, MD Depart of Internal Medicine
Hoeben, Ann, MD, PhD Division of Med Oncolgy
Jansen, Robertus, MD P. Debyelaan 25,
Lalisang, Roy I, MD Maastricht, 6229 HX
Tjan-Heijnen, Vivianne Christine Gerarda, MD Netherlands
Vincent, Jeroen, MD
Vriens, Ingeborg, MD University Hospital Maastricht
de Vos-Geelen, Judith, MD (Pt Tx Ctr - Hosp/Med Ctr)
Department of Internal Medicine
Division of Med Oncology
(P) +31433874696 P. Debyelaan 25
(F) +31433874692 Maastricht, 6229 HX,
Netherlands
Email: p.soetekouw@mumc.nl
9936
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0081* Berrocal, Alfonso, MD Hospital General Univ De Valencia 1
(Office)
Palomar, Virginia, MD Avda. Tres Cruces,2
Umanzor, Gerardo, MD Pabellon A Planta 1-Seminario
Serv. Oncologia Medica
(P) +34961972141 Valencia, 46014
(F) +34961972085 Spain
9937
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0082* Lopez-Martin, Jose A, MD, PhD Hospital Universitario 12 de Octubre 3
(Office)
Adeva, Jorge, MD Oncología Medica (UFTO)
Calvo, Aitana, MD Edificio Maternidad, Pl. 2
Parrilla, Lucia, MD Madrid, 28041
Spain
(P) +34913908000
Hospital Universitario 12 de Octubre
(F) +34914695775
(Pt Tx Ctr - Hosp/Med Ctr)
Email: jalopezmartin@gmail.com Oncología Medica (UFTO)
Edificio Maternidad, Pl. 2
Madrid, 28041
Spain
9938
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0084* Ochoa De Olza, Maria, MD Instituto Catalan De Oncologia 1
(Office)
Jove Casulleras, Maria Avda. Gran Via De L'hospitalet 199-203
Jimenez-Colomo, Laura Hospitalet
Barcelona, 08908
Spain
9939
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0086 Hodi, F. Stephen, MD Dana Farber Cancer Institute 3
(Office)
Beeler, Maureen, RN 450 Brookline Ave.
Bhatt, Rupal S., MD Boston, MA 02215
Bowers, Mary Ellen, RN USA
Buchbinder, Elizabeth I, MD
Cho, Daniel C., MD Massachusetts General Hospital
Davis, Meredith, PA-C (Pt Tx Ctr - Hosp/Med Ctr)
Donahue, Hilary, MD 55 Fruit Street
Fadden, Riley M., NP Boston, MA 02215
Flaherty, Keith T, MD USA
Haq, Rizwan, MD
Ibrahim, Nageatte, MD Dana-Farber Cancer Institute
Kata, Caryn, RN (Pt Tx Ctr - Hosp/Med Ctr)
Kelley, Kristina, RN 450 Brookline Avenue
Lawrence, Donald, MD Boston, MA 0221
Lee, Mee-Young, NP USA
Livengood, Amanda J, RN
Luke, Jason, MD Dana-Farber Cancer Institute
Marujo, Rose, RN (Pt Tx Ctr - Hosp/Med Ctr)
McDermott, David, MD 450 Brookline Ave.
Mier, James, MD Pharmacy - Yawkey Fl 5th
Ott, Patrick, MD Boston, MA 02215
Renzi, Sharon, RN USA
Rubin, Krista, RN
Seery, Virginia J, NP
Sullivan, Ryan, MD Brigham & Women'S Hospital
Wood, Valerie J, RN (Pt Tx Ctr - Hosp/Med Ctr)
75 Francis St.
Boston, MA 02215
(P) 6176323786 USA
(F) 6176324301
Beth Israel Deaconess Medical Center
Email: (Pt Tx Ctr - Hosp/Med Ctr)
Email: stephen_hodi@dfci.harvard.edu 330 Brookline Ave
Boston, MA 02215
USA
9940
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0086 Massachusetts General Hospital
Hodi, F. Stephen, MD (Pt Tx Ctr - Hosp/Med Ctr)
(Cont’d) 32 Fruit St.
Pharmacy Yawkey 8
Boston, MA 02114
USA
9941
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0089* Schmerling, Rafael Aron, MD Real E Benemerita Associacao 4
Portuguesa De Beneficencia
Almeida Thiago, MD (Office)
Brandao, Erika Rua Martiniano De Carvalho, 951
Buzaid, Antonio Carlos, MD Bela Vista
Carvalho, Ricardo S, MD Sao Paulo, Sao Paulo, 01323-900
Costa, Marcos Andre Brazil
De Padua, Fernando
Kawamura, Carolina, MD Real E Benemerita Associacao
Maluf, Fernando Portuguesa De Beneficencia
Meirelles, Melissa, DR (Pt Tx Ctr - Hosp/Med Ctr)
Pimenta, Juliana, DR Rua Maritiniano De Carvalho,965
Schutz, Fabio Augusto Barros, PhD Bela Vista
Yamada, Camilla A. F. Sao Paulo, Sao Paulo, 01321-001
Brazil
(P) +551135051140
(F) +551135056614 Real E Benemerita Associacao
Portuguesa De Beneficencia
Email: rafael.schmerling@hospitalsjose.org.br (Pt Tx Ctr - Hosp/Med Ctr)
Rua Maestro Cardim, 769
Paraiso
Sao Paulo, Sao Paulo, 01323-900
Brazil
9942
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0090* Azevedo, Sergio Jobim, MD, PhD Hospital De Clinicas De Porto Alegre 4
(Office)
Casarotto Fernanda Cano, MD Ramiro Barcelos, 2350
Gastal, Gustavo Predio 21 /cpc, Sala 21502
Liedke, Pedro Rubini Bom Fim
Pereira, Rodrigo Perez, MD Porto Alegre, Rio Grande Do Sul
Schmidt, Luis Felipe Carissimi, MD 90035-903
Seewald, Rafael, MD Brazil
9943
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0092* Lotem, Michal, MD Hadassah Hebrew University Hospital 1
(Office)
Frank, Stephen Jay, MD Sharett Institue Of Oncology
Merims, Sharon, MD Jerusalem, 71908
Sonnenblick, Amir, MD Israel
Tahover, Ester, MD
Hadassah Hebrew University Hospital
(P) +972508573528 (Pt Tx Ctr - Hosp/Med Ctr)
(F) +97226778841 Sharett Institue Of Oncology
Jerusalem, 71908
Email: mlotem@hadassah.org.il Israel
9944
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0095* Mortier, Laurent, MD Chru De Lille - Hopital Claude Huriez 3
(Office)
Bertrand, Marie, MD Service des Dermatologie
Desmedt, Eve, MD rue Michel Polonovski
Maire, Cyril, MD Lille Cedex, 59037
Vercambre-Darras, Sophie, MD France
9945
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0097* Lacour, Jean-Philippe, MD, PhD C H U Hopital De L'Archet 2 0
(Office)
Giacchero, Damien, MD Service de Dermatologie
Montaudie, Henri 151 route Saint Antoine de Ginestiere
BP 3079
(P) +33492037777 Nice, 06200
(F) +33492039368 France
9946
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0099* Goeppner, Daniela, MD Universitaetsklinikum Magdeburg 2
(Office)
Bellutti, Michael, MD Leipziger Str. 44
Gollnick, Harald, MD Magdeburg, 39120
Papathemeli, Despoina, MD Germany
Schott, Regina, MD
Universitaetsklinikum Magdeburg
(P) +4939167113100 (Pt Tx Ctr - Hosp/Med Ctr)
(F) +4939167113105 Leipziger Str. 44
Magdeburg, 39120
Email: daniela.goeppner@med.ovgu.de Germany
9947
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0101* Stein, Annette, MD Universitaetsklinikum Carl Gustav Carus 2
(Office)
Beissert, Stefan Carl Gustav Carus
Garzarolli, Marlene, MD Fetscherstrasse 74
Rauschenberg, Ricarda, DR Dresden, 01307
Viehweg, Antje Germany
9948
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0105 Amatruda, Thomas, MD Allina Health (Office) 2
Virginia Piper Cancer Institute
Anderson, Chara J, ANP 800 East 28th Street, Suite 602
Bloom, Stuart, MD Minneapolis, MN, 55407
Bosshardt, Laura, RN USA
Finnes, Laura, RN
Gesme, Dean H, MD Minnesota Oncology Hematology, P.A.
Houselog, Kathryn Lynn, CNP (Pt Tx Ctr - Med Office/Clinic)
Larson, Tim G, MD 910 E 26th St. Ste 200
Leach, Joseph Ward, MD Minneapolis, MN, 55404
Seng, John E, MD USA
Tsai, Michaela, MD
Underhill, Jacquelyn, RN Allina Health
Wojchik, Alicia J, CNP (Pt Tx Ctr - Med Office/Clinic)
Yilek, Amy K, CNP Virginia Piper Cancer Institute
800 East 28th Street, Suite 602
(P) 6128634633 Minneapolis, MN, 55407
(F) 6128633883 USA
9949
Approved v 1.0 930081508 1.0
Interim Clinical Study Report CA209037
BMS-936558 Nivolumab
Site # Principal Investigator/ Sub Investigators and Responsible Study Center and Address # of Patients
Medical Personnel Enrolled
CA209-037-0110* Terheyden, Patrick, MD Medizinische Universitaet Zu Luebeck 4
(Office)
Anguen, Ozan, MD Ratzeburger Allee 160
Fischer, Tobias, MD Luebeck, 23538
Frambach, Yvonne, MD Germany
Moeckel, Nicole
Mohr, Martin, MD Medizinische Universitaet Zu Luebeck
(Pt Tx Ctr - Hosp/Med Ctr)
(P) +494515002056 Ratzeburger Allee 160
(F) +494515005024 Luebeck, 23538
Germany
Email: patrick.terheyden@uk-sh.de
*denotes non-IND site
9950
Approved v 1.0 930081508 1.0