Sie sind auf Seite 1von 83
Supplementary appendix This appendix formed part of the original submission and has been peer reviewed.

Supplementary appendix

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 Larkin 27

1 Moffitt Cancer Center, Tampa, FL, USA; 2 Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA; 3 California Pacific Center for Melanoma Research, San Francisco, CA, USA; 4 Dana-Farber Cancer Institute, Boston, MA, USA; 5 Medizinische Hochschule Hannover, Hannover, Germany; 6 Universitair Ziekenhuis Brussel, Brussels, Belgium; 7 Medical University of Vienna, Vienna, Austria; 8 Roswell Park Cancer Institute, Buffalo, NY, USA; 9 Segal Cancer Centre, Jewish General Hospital, McGill University, Montreal, QC Canada; 10 University of Michigan, Ann Arbor, MI, USA; 11 Washington University, St. Louis, MO, USA; 12 Centre Hospitalier Universitaire de Lyon, Lyon, France; 13 Christie Hospital, Manchester, UK; 14 Huntsman Cancer Institute, Salt Lake City, UT, USA; 15 German Cancer Research

Centre University Hospital Heidelberg, Germany; 16 Medical Oncology and Immunotherapy, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy; 17 Yale Cancer Center, New Haven, CT, USA; 18 Istituto Nazionale Tumori Fondazione

G. Pascale, Naples, Italy; 19 Elbe Kliniken Buxtehude, Buxtehude, Germany; 20 Department of Medicine, UCLA, Los Angeles,

CA, USA; 21 Department of Medicine, Mayo Clinic, Scottsdale, Arizona, USA, 22 Department of Oncology, Herlev Hospital, Copenhagen, Denmark; 23 Aix-Marseille University, Hopital de la Timone, Marseille, France; 24 TUM School of Medicine, III. Medical Department, Munich, Germany; 25 Bristol-Myers Squibb, Princeton, NJ, USA; 26 Bristol-Myers Squibb, Braine- I’Alleud, Belgium; 27 Royal 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 34, n (%)

Any grade, n (%)

Grade 34, 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

(n=120)

Dacarbazine

Paclitaxel/Carboplatin

 

(n=19)

 

(n=28)

 

ORR, * n (%), [95% CI]

38 (31·7) [23·540·8]

0 (0) [0·017·6]

5 (17·9) [6·136·9]

 

BOR, * n (%)

     
 

Complete response

 

4 (3·3)

 

0

(0)

 

0 (0)

 

Partial response

34

(28·3)

 

0

(0)

5

(17·9)

 

Stable disease

28

(23·3)

6

(31·6)

10 (35·7)

 

Progressive disease

42

(35·0)

8

(42·1)

7

(25·0)

 

Unable to determine

12

(10·0)

5

(26·3)

6

(21·4)

 

ORR difference to nivolumab group, % (95% CI)

 

31·7 (13·240·4)

13·8 (-5·527·1)

*

     

Confirmed response by independent radiology review committee per RECIST v1.1. Patients who did not have a protocol specified scan at 9 month, due to most commonly clinical progression,

consent withdrawal, or receiving subsequent therapy.

BOR=best overall response. CI=confidence interval. ORR=objective response rate. RECIST=Response Evaluation Criteria In Solid Tumours.

Table S3: Adverse events (reported in ≥10% of treated patients) by chemotherapy received

   

Dacarbazine (N=45) *

   

Paclitaxel/Carboplatin (N=57) *

 

AE term

Any grade

Grade 34

Grade 5

Any grade

Grade 34

Grade 5

Total patients with an event, n (%)

34

(75.6)

11 (24.4)

0

47

(82.5)

21

(36.8)

0

 

Alopecia

1

(2.2)

 

0

0

27

(47.4)

 

0

0

 

Nausea

15

(33.3)

1

(2.2)

0

23

(40.4)

1

(1.8)

0

 

Fatigue

14

(31.1)

 

0

0

21

(36.8)

4

(7.0)

0

 

Anemia

6

(13.3)

1

(2.2)

0

17

(29.8)

4

(7.0)

0

 

Neutropenia

6

(13.3)

3

(6.7)

0

13

(22.8)

11

(19.3)

0

 

Decreased appetite

10

(22.2)

 

0

0

6

(10.5)

 

0

0

 

Vomiting

9

(20.0)

1

(2.2)

0

11

(19.3)

1

(1.8)

0

 

Diarrhea

4

(8.9)

1

(2.2)

0

11

(19.3)

1

(1.8)

0

 

Arthralgia

1

(2.2)

 

0

0

11

(19.3)

1

(1.8)

0

 

Constipation

4

(8.9)

 

0

0

10

(17.5)

1

(1.8)

0

 

Thrombocytopenia

1

(2.2)

1

(2.2)

0

9

(15.8)

5

(8.8)

0

 

Peripheral neuropathy

 

0

 

0

0

9

(15.8)

1

(1.8)

0

 

Paraesthesia

 

0

 

0

0

9

(15.8)

 

0

0

 

Myalgia

 

0

 

0

0

7

(12.3)

 

0

0

 

WBC count decreased

2

(4.4)

 

0

0

6

(10.5)

1

(1.8)

0

*

       

Safety analysis included all treated patients. AEs=adverse events. ICC=investigator’s choice chemotherapy. WBC=white blood cell.

Figure S1: Study design

Figure S1: Study design

Figure S2: PFS per IRC in the intention-to-treat ORR analysis population

Figure S2: PFS per IRC in the intention-to-treat ORR analysis population

Full List of Inclusion and Exclusion Criteria

Inclusion Criteria

1)

Signed Written Informed Consent

a) Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.

2)

b) Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. Target Population

a) Eastern Cooperative Oncology Group (ECOG) performance status of

b) Histologically confirmed Stage III (unresectable) or Stage IV melanoma.

c) Measurable disease by CT or MRI per RECIST 1.1 criteria.

d) A pre-treatment recent core, excision or punch biopsy must be provided for PD-L1 status determination prior to randomization and for exploratory biomarker analyses. The biopsy must be from an unresectable or metastatic site, and the subject must have had no intervening systemic therapy between the time of biopsy and randomization. In order to be randomized, a subject must be classified as PD-L1 positive, PD-L1 negative or PD-L1 indeterminate. If an insufficient amount of recently acquired tumor tissue from an unresectable or metastatic site is available prior to the start of the screening phase, subjects must consent to allow the acquisition of tumor biopsy by study personnel for performance of biomarker analyses.

e) Subjects must consent to allow the acquisition of existing formalin-fixed paraffin-embedded (FFPE) material (“archival”) (block or a minimum of 10 unstained slides) if available, for performance of correlative studies.

f) Subjects must have objective evidence of disease progression (eg, clinical or radiological) during or after at least 1(V600 wildtype) or at least 2 (V600 mutation positive) prior treatment regimens for advanced melanoma.

positive) prior treatment regimens for advanced melanoma. 1 (Refer to Appendix 2). 1. Subjects BRAF wildtype:

1 (Refer to Appendix 2).

1. Subjects BRAF wildtype:

a)

Must have objective evidence of progression of disease (PD) post (during or following) treatment with anti- CTLA-4 containing therapy for advanced melanoma.

AND

b)

In addition to progression post anti-CTLA-4 therapy, subjects that have received another treatment regimen must have objective evidence of progression of disease (PD) during or following at least 1 cycle of treatment for advanced melanoma.

2. Subjects BRAF V600 mutation positive:

a) Must have objective evidence of progression of disease (PD) post treatment with anti-CTLA-4 containing

therapy for advanced melanoma.

AND

b) In addition to progressing post anti-CTLA-4 therapy, subjects must have objective evidence of progression of

disease (PD) post treatment with a BRAF inhibitor.

c) Subjects may have received prior anti-CTLA-4 therapy and a BRAF inhibitor in any sequence or in

combination.

g) Prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) must have been completed at least 4 weeks before study drug administration, and all adverse events have either returned to baseline or stabilized.

h) Prior anti-CTLA-4 therapy must have been completed at least 6 weeks before study drug administration.

i) Prior radiotherapy must have been completed at least 2 weeks prior to study drug administration.

j) Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization:

should be obtained within 14 days prior to randomization: 3) Age and Reproductive Status a) Men

3)

Age and Reproductive Status

a) Men and women aged

b) Women of childbearing potential (WOCBP) must use method(s) of contraception based on the tables in Appendix 1. Dacarbazine, carboplatin and paclitaxel are teratogenic. There is an insufficient amount of information to assess teratogenicity for BMS-936558 (nivolumab). For a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. The individual methods of contraception and duration should be determined in consultation with the investigator. WOCBP must follow instructions for birth control when the half life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 30 days plus the time required for the investigational drug to undergo five half lives. The half-life of BMS-936558 (nivolumab) is up to 25 days; therefore, WOCBP who received BMS-936558 (nivolumab) should use an adequate method to avoid pregnancy for 23 weeks after the last dose of BMS-936558 (nivolumab). WOCBP must follow instructions for birth control when the half life of the investigational drug is less than 24 hours, contraception should be continued for a period of 30 days after the last dose of investigational product. The half-life of dacarbazine and carboplatin is less than 24 hours, therefore WOCBP who

product. The half-life of dacarbazine and carboplatin is less than 24 hours, therefore WOCBP who 18

18 years of age.

received either dacarbazine or carboplatin should use an adequate method to avoid pregnancy for 30 days after the last dose of either dacarbazine or carboplatin. The paclitaxel product label requires WOCBP to use an effective method of contraception for at least 6 months after the last dose of paclitaxel.

c) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product.

d) Women must not be breastfeeding

e) Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year (See Appendix 1). The investigator shall review contraception methods and the time period that contraception must be followed. Men that are sexually active with WOCBP must follow instructions for birth control when the half life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 90 days plus the time required for the investigational drug to undergo five half lives. The half-life of BMS-936558 (nivolumab) is up to 25 days; therefore, men who received BMS-936558 (nivolumab) and are sexually active with WOCBP must continue contraception for 31 weeks after the last dose of BMS-936558 (nivolumab). The half-life of dacarbazine, carboplatin and paclitaxel is less than 24 hours. However, the dacarbazine and paclitaxel product labels require men who received dacarbazine or paclitaxel and are sexually active with WOCBP to use an effective method of contraception for at least 6 months after the last dose of dacarbazine or paclitaxel.

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.

2)

c) Subjects whose melanoma is BRAF status unknown. 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.

3)

i) Yellow fever vaccine, live attenuated vaccines, or prophylactic phenytoin within 28 days prior to the first dose of study drug. Physical and Laboratory Test Findings

a) Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.

4)

b) Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 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.

5)

c) History of Grade 3 allergy to study drug components. Sex and Reproductive Status

a) WOCBP who are pregnant or breastfeeding.

6)

b) Women with a positive pregnancy test at enrollment or prior to administration of study medication. 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.

Women of Childbearing Potential A Woman of Childbearing Potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over age 45 in the absence of other biological or physiological causes. In addition, women under the age of 62 must have a documented serum follicle stimulating hormone, (FSH) level > 40mIU/mL.

Treatment Guidelines for Immune-Related Select Adverse Events

Treatment Guidelines for Immune-Related Select Adverse Events

List of Trial Sites and Investigators

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Appendix 1.5 List and Description of Investigators for Study CA209-037

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

Study Center and Address

# of Patients Enrolled

CA209-037-0001*

Baurain, Jean-Francois, MD, PhD

Cliniques Universitaires Saint-Luc (Office) Avenue Hippocrate 10 Bruxelles, 1200 Belgium

Cliniques Universitaires Saint-Luc Service D'oncologie (Pt Tx Ctr - Med Office/Clinic) Avenue Hippocrate, 10 Bruxelles, 1200 Belgium

8

Cornelis, Frank, MD, PhD Danse, Etienne, MD, PhD Duhoux, Francois, MD, PhD Gizzi, Marco, MD Humblet, Yves, MD, PhD Machiels, Jean-Pascal, MD, PhD Mailleux, Marie, MD Mardjuadi, Feby, MD Mazzeo, Filomena, MD, PhD Taylor, Donatienne, MD Van Den Eynde, Marc, MD

(P)

+3227641111

 

(F)

+3227641620

Email: jf.baurain@uclouvain.be

CA209-037-0002*

Neyns, Bart, MD, PhD

Universitair Ziekenhuis Brussel Medische Oncologie (Office) Laarbeeklaan 101 Brussels, 1090 Belgium

Universitair Ziekenhuis Brussel Medische Oncologie (Pt Tx Ctr - Hosp/Med Ctr) Laarbeeklaan 101 Brussels, 1090 Belgium

18

Boulet, Cedric, MD De Greve, Jacques, MD, PhD Jansen, Yanina Schreuer, Max, MD Wilgenhof, Sofie, MD, PhD

(P)

+3224776045

(F)

+3224775460

Email: bart.neyns@uzbrussel.be

Approved v1.0

930081508 1.0

9888

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

Study Center and Address

# of Patients Enrolled

CA209-037-0003*

Schoffski, Patrick, MD, PhD

Uz Leuven (Office) Herestraat 49 Leuven, 3000 Belgium

Uz Leuven (Pt Tx Ctr - Hosp/Med Ctr) Interne Geneeskunde - Algemene Medische Oncologie Herestraat 49 Leuven, 3000 Belgium

5

Bechter, Olivier, MD Beuselinck, Benoit, MD, PhD Clement, Paul, MD, PhD Dumez, Herlinde, MD Paridaens, Robert, MD, PhD Wildiers, Hans, MD, PhD Wolter, Pascal, MD

(P)

+3216345506

 

(F)

+3216343209

Email: patrick.schoffski@uzleuven.be

CA209-037-0005*

Hospers, G. A. P, MD

Universitair Medisch Centrum Groningen (Office) Hanzeplein 1 Groningen, 9713 GZ Netherlands

5

Schroder, Carolina, MD, PhD Van Den Brom, Rob Rh, MD, PhD

(P)

+31503616161

Universitair Medisch Centrum Groningen (Pt Tx Ctr - Hosp/Med Ctr) Hanzeplein 1 Groningen, 9713 GZ Netherlands

(F)

+31503619320

Email: g.a.p.hospers@umcg.nl

Approved v1.0

930081508 1.0

9889

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

Study Center and Address

# of Patients Enrolled

CA209-037-0006*

Specenier, Pol, MD

Altintas, Sevilay, MD, PhD Huizing, Manon Thirza, MD Op De Beeck, Bart, MD Papadimitriou, Konstantinos, MD Peeters, Marc, MD, PhD Rolfo, Christian, MD, PhD Van Den Brande, Jan, MD

Universitair Ziekenhuis Antwerpen (Office) Wilrijkstraat 10 Edegem, 2650 Belgium

Universitair Ziekenhuis Antwerpen (Pt Tx Ctr - Hosp/Med Ctr) Wilrijkstraat 10 Edegem, 2650 Belgium

2

(P)

+3238215466

(F)

+3238214488

 

Email: pol.specenier@uza.be

CA209-037-0007*

Haanen, John, PhD

Antoni Van Leeuwenhoek Ziekenhuis (Office) Plesmanlaan 121 Amsterdam, 1066 CX Netherlands

5

Blank, Christian, MD Van Thienen, Hans, MD, PhD

(P)

+31205122569

Antoni Van Leeuwenhoek Ziekenhuis (Pt Tx Ctr - Hosp/Med Ctr) Plesmanlaan 121 Afdeling Medische Oncologie Amsterdam, 1066 CX Netherlands

(F)

+31205122572

Email: j.haanen@nki.nl

Approved v1.0

930081508 1.0

9890

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

Study Center and Address

# of Patients Enrolled

CA209-037-0008*

Ottensmeier, Christian, MD, PhD

Southampton University Hospital NHS Trust (Office) Tremona Road Southampton, Hampshire, SO16 6YD United Kingdom

6

Bradbury, Jennifer, MBChB, MRCP Chau, Caroline Shuet Yiu, MRCP Wheater, Matthew, MD

(P)

+442380796164

Southampton University Hospital NHS Trust (Pt Tx Ctr - Hosp/Med Ctr) Southampton University Hospital Tremona Road Southampton, Hampshire, SO16 6YD United Kingdom

(F)

+442380794313

Email: cho@soton.ac.uk

CA209-037-0009*

Lorigan, Paul, MD

The Christie NHS Foundation Trust (Office) Wilmslow Road Manchester, M20 4BX United Kingdom

13

Fusi, Alberto, MD Hodgetts, Jackie Howell, Matthew

(P)

+01614463000

The Christie NHS Foundation Trust

(F)

+01614463317

Email: paul.lorigan@christie.nhs.uk

(Pt Tx Ctr - Med Office/Clinic) Wilmslow Road Manchester, M20 4BX United Kingdom

Approved v1.0

930081508 1.0

9891

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

Study Center and Address

# of Patients Enrolled

CA209-037-0010*

Larkin, James, MD

Georgios Antoniou, MD Biondo, Andrea, MD Boafo-Yirenkyi, Melanie, MD Davidson, Michael Edward, MBBS Fisher, Rosalie, MDChB Furness, Andrew, MD Georgiou, Alexandros Gore, Martin, PhD Hewish, Madeleine, MD Joshi, Kroopa, MD 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)

(F)

+442078082123

+442073512477

Email: james.larkin@rmh.nhs.uk

The Royal Marsden Hospital Medical Oncology (Office)

203 Fulham Road

London, SW3 6JJ

United Kingdom

The Royal Marsden Hospital Medical Oncology (Pt Tx Ctr - Hosp/Med Ctr)

203 Fulham Road

London, SW3 6JJ United Kingdom

43

Approved v1.0

930081508 1.0

9892

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

Study Center and Address

# of Patients Enrolled

CA209-037-0011*

Plummer, Elizabeth, MD

Freeman Hospital (Office) Sir Bobby Robson Cancer Research & Trials Centre The Northern Centre For Cancer Care (NCCC) Freeman Road Newcastle Upon Tyne, Tyne And Wear NE7 7DN United Kingdom

5

Coyle, Vicky, MD Cresti, Nicola, MD Haney, Sophie, MD Haris, Noor, MBBS Kelly, Charles, MD Kovarikova, Jarmila, MD

(P)

+441912231144

(F)

+441912820288

 

Email: ruth.plummer@ncl.ac.uk

Freeman Hospital (Pt Tx Ctr - Hosp/Med Ctr) Sir Bobby Robson Cancer Research & Trials Centre The Northern Centre For Cancer Care (NCCC) Freeman Road Newcastle Upon Tyne, Tyne And Wear NE7 7DN United Kingdom

CA209-037-0013*

Middleton, Mark, MD

Church, David, MD Coupe, Nicholas, MBBS Gupta, Avinash, MBBS Karydis, Ionna, MRCP Malczewski, Agnieszka, MBBS Saka, Wasir O, MB, BCH

Churchill Hospital (Office) Old Road Oxford, Oxfordshire, OX3 7LJ United Kingdom

Churchill Hospital (Pt Tx Ctr - Hosp/Med Ctr) Old Road Oxford, Oxfordshire, OX3 7LJ United Kingdom

9

(P)

+4401865741841

(F)

+4401865768876

 

Email: mark.middleton@oncology.ox.ac.uk

Approved v1.0

930081508 1.0

9893

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0014

Amin, Asim, MD, PhD

Levine Cancer Institute (Office)

5

1021

Morehead Medical Drive

Adams, Tesa, RN Barrineau, Tara B, MS Brown, Miranda J. Eddins, Debby Hogan, Denise K, NP Johnson-Elmore, Sharon D, RN Parikh, Madhavi, PA-C Parker, Kimberly, RN

Charlotte, NC 28204 USA

Levine Cancer Institute

(Pt Tx Ctr - Hosp/Med Ctr)

1021

Morehead Medical Drive

Charlotte, NC 28204 USA

(P)

9804425300

Carolinas Medical Center

(F)

9804425261

(Pt Tx Ctr - Hosp/Med Ctr)

 

1000

Blythe Blvd.

Email: asim.amin@carolinashealthcare.org

Charlotte, NC 28203 USA

CA209-037-0015

Grossmann, Kenneth, MD, PhD

Huntsman Cancer Institute (Office)

13

2000

Circle Of Hope

Khong, Hung T, MD Luckett, Carolyn, NP

Salt Lake City, UT 84112 USA

(P)

8015874573

Huntsman Cancer Institute

(F)

8015817567

(Pt Tx Ctr - Hosp/Med Ctr) University Of Utah

Email: kenneth.grossmann@hci.utah.edu

2000

Circle Of Hope

Salt Lake City, UT 84112 USA

 

Huntsman Cancer Hospital

(Pt Tx Ctr - Hosp/Med Ctr) University of Utah

1950

Circle Of Hope

Salt Lake City, UT 84112 USA

Approved v1.0

930081508 1.0

9894

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0016

Weber, Jeffrey S, MD, PhD

H.

Lee Moffitt Cancer Center &

23

Research Institute (Office)

Deconti, Ronald, MD Gibney, Geoffrey T, MD Kudchadkar, Ragini, MD Royster, Erica B, MPH Thebeau, Melissa S, ARNP

12902

Magnolia Dr.

Tampa, FL 33612

USA

H.

Lee Moffitt Cancer Center &

 

Research Institute

(P)

8137454960

(Pt Tx Ctr - Hosp/Med Ctr)

(F)

8137451835

12902

Magnolia Dr.

Email: jeffrey.weber@moffitt.org

Tampa, FL 33612 USA

 

9895

Approved v1.0

930081508 1.0

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0017

Lawson, David H., MD

Winship Cancer Institute (Office) 1365-C Clifton Rd. NE Atlanta, GA 30322 USA

Winship Cancer Institute (Pt Tx Ctr - Hosp/Med Ctr) 1365-C Clifton Rd. NE Atlanta, GA 30322 USA

7

Kopcewicz, Katarzyna Kurilo, Tatiana Majdak, Susan Maynard, Necia, NP McKellar, Marjorie, PA Mcmillan, Stephanie, RN Olaifa, Olalekan I

(P)

4047127485

 

(F)

4047784389

Emory University Hospital

 

(Pt Tx Ctr - Hosp/Med Ctr)

Email: dlawson@emory.edu

1364

Clifton Rd. NE

Atlanta, GA

30322

USA

Emory University Hospital Midtown (Pt Tx Ctr - Hosp/Med Ctr) 550 Peachtree St. NE Atlanta, GA 30308 USA

The Emory Clinic (Pt Tx Ctr - Med Office/Clinic)

1365

Clifton Road NE

Drug Shipment Address Bldg. A Investigational Drug Service, Ste 1200 Atlanta, GA 30322 USA

The Emory Clinic

(Pt Tx Ctr - Med Office/Clinic)

1365

Clifton Rd. NE

Atlanta, GA 30322

USA

Approved v1.0

930081508 1.0

9896

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0018

Gonzalez, Rene, MD

University Of Colorado Cancer Center (Office)

0

Amaria, Rodabe Navroze, MD Benchich, Katherine Shryock, NP Lewis, Karl, MD Robinson, William A, MD

1665

Aurora Court

Cutaneous Oncology, Mail Stop F703

Anschutz Cancer Pavilion Room 3240 Aurora, CO 80045 USA

(P)

7208480584

(F)

7208484021

Email: rene.gonzalez@ucdenver.edu

University Of Colorado Cancer Center (Pt Tx Ctr - Hosp/Med Ctr) Anschutz Cancer Pavilion

1665

Aurora Ct

Aurora, CO 80045 USA

Anschutz Cancer Pavilion

(Pt Tx Ctr - Hosp/Med Ctr)

1665

Aurora Court

Pharmacy, Room 2221

Aurora, CO 80045 USA

CA209-037-0019

Daud, Adil, MD

UCSF Comprehensive Cancer Center (Office)

11

Algazi, Alain, MD Ashworth, Michelle T, MD Buljan, Michael, NP

1600

Divisadero Street

San Francisco, CA 94115 USA

(P)

4153537052

UCSF Medical Center at Mount Zion (Pt Tx Ctr - Hosp/Med Ctr)

(F)

4153537376

 

1600

Divisadero Street

Email: adaud@medicine.ucsf.edu

San Francisco, CA 94115 USA

Approved v1.0

930081508 1.0

9897

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0020

Hodi, F. Stephen, MD

Dana-Farber Cancer Institute (Office)

6

450

Brookline Ave

Beeler, Maureen, RN Bhatt, Rupal S, MD Bowers, Mary Ellen, RN Buchbinder, Elizabeth I., MD Cho, Daniel C, MD Davis, Meredith, PA-C Donahue, Hilary, MD Fadden, Riley M., NP Flaherty, Keith T, MD Haq, Rizwan, MD Ibrahim, Nageatte, MD Kata, Caryn, RN Kelley, Kristina, RN Lawrence, Donald, MD Lee, Mee-Young, NP Livengood, Amanda J, RN Luke, Jason, MD Marujo, Rose, RN McDermott, David, MD Mier, James, MD Ott, Patrick, MD Renzi, Sharon, RN Rubin, Krista, NP Seery, Virginia, RN Sullivan, Ryan, MD Wood, Valerie J, RN

Boston, MA, 02215 USA

Massachusetts General Hospital (Pt Tx Ctr - Hosp/Med Ctr)

32

Fruit Street

Yawkey 8, Pharmacy Boston, MA 02214

USA

Massachusetts General Hospital (Pt Tx Ctr - Hosp/Med Ctr) 55 Fruit Street Boston, MA 02215 USA

Dana-Farber Cancer Institute (Pt Tx Ctr - Hosp/Med Ctr)

450

Brookline Avenue

Boston, MA 02215 USA

Dana-Farber Cancer Institute (Pt Tx Ctr - Hosp/Med Ctr)

450

Brookline Ave.

Pharmacy - Yawkey Fl 5th

Boston, MA 02215 USA

(P)

6176323786

(F)

6176324301

 
 

Brigham & Women's Hospital

Email: stephen_hodi@dfci.harvard.edu

(Pt Tx Ctr - Hosp/Med Ctr)

75

Francis St.

Boston, MA 02215

USA

Approved v1.0

930081508 1.0

9898

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0020

Hodi, F. Stephen, MD (cont’d)

 

Beth Israel Deaconess Medical Center (Pt Tx Ctr - Hosp/Med Ctr)

 

330

Brookline Ave.

 

Boston, MA 02215

USA

CA209-037-0021

Pavlick, Anna Catherine, DO

NYU Clinical Cancer Center (Office)

3

160

E 34th St.

Kannan, Rajni, ANP Madden, Kathleen, FNP-C

9th Fl New York, NY 10016

USA

(P)

2127315757

(F)

2127315646

New York University Langone Medical Center (Pt Tx Ctr - Hosp/Med Ctr) Investigational Pharmacy

Email: anna.pavlick@nyumc.org

560

First Ave. HN300

New York, NY 10016 USA

New York University Langone Medical Center (Pt Tx Ctr - Hosp/Med Ctr)

550

First Avenue

New York, NY 10016 USA

New York University Clinical Cancer Center Pt Tx Ctr - Hosp/Med Ctr)

160

E 34th St.

New York, NY 10016 USA

Approved v1.0

930081508 1.0

9899

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0022

Sosman, Jeffrey A, MD

Vanderbilt-Ingram Cancer Center (Office)

11

Ancell, Kristin K, MD Kelley, Mark, MD Puzanov, Igor, MD Wallace, Deborah E, APN Wyman, Kenneth W, MD

2220

Pierce Ave.

777 Preston Research Bldg

Nashville, TN 37232 USA

Vanderbilt Oncology Pharmacy

(P)

6159368422

(Pt Tx Ctr - Med Office/Clinic)

(F)

6159365850

The

Vanderbilt Clinic Rm 2906

 

1301

Medical Ctr Dr.

Email: jeff.sosman@vanderbilt.edu

Nashville, TN 37232 USA

Henry-Joyce Cancer Clinic

(Pt Tx Ctr - Med Office/Clinic)

1301

Medical Ctr Dr.

1900

Vanderbilt Clinic

Nashville, TN 37232-5536 USA

CA209-037-0023

Thomas, Sajeve, MD Pennock, Gregory K, MD (Previous)

Orlando Health, Inc (Office)

9

1400

South Orange Avenue

 

Orlando, FL

32806

Johnson, Tirrell, MD Landau, Daniel A, MD Maddipatla, Sreeram, MD Thomas, Sajeve, MD

USA

MD

Anderson Cancer Center Orlando

(Office) (Previous)

 

1400

S Orange Ave.

(P)

4076483800

Orlando, FL 32806 USA

(F)

4074230840

Email: sajeve.thomas@orlandohealth.com

Orlando Regional Medical Center

(Pt Tx Ctr - Hosp/Med Ctr) (Previous)

1414

S Orange (kuhl) Ave.

Orlando, FL 32806 USA

Approved v1.0

930081508 1.0

9900

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

   

Orlando Heart Health Institute

 

CA209-037-0023

(Pt Tx Ctr - Hosp/Med Ctr) (Previous)

Thomas Sajeve, MD (Cont’d)

1222

South Orange Ave.

Orlando, FL 32806

USA

 

Orlando Health, Inc (Pt Tx Ctr - Hosp/Med Ctr)

1400

South Orange Avenue

Orlando, FL 32806

USA

Orlando Health, Inc

(Pt Tx Ctr - Hosp/Med Ctr)

1400

S Orange Ave.

5th Floor Investigational Pharmacy

MP720 Drug Shipment Orlando, FL 32806

USA

MD

Anderson Cancer Center Orlando (Pt

Tx Ctr - Hosp/Med Ctr) (Previous) 5th Fl Investigational Pharm

1400

S. Orange Ave. MP 720

Drug Shipment Orlando, FL 32806

USA

Md

Anderson Cancer Center Orlando

(Pt Tx Ctr - Hosp/Med Ctr) (Previous)

1400

S Orange Ave.

Orlando, FL 32806

USA

Approved v1.0

930081508 1.0

9901

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0024

Hamid, Omid, MD

The Angeles Clinic & Research Institute (Office)

5

Balmanoukian, Ani, MD Boasberg, Peter D, MD Chung, Cathie, MD Hoffner, Brianna, NP

11818

Wilshire Blvd.

Ste 200 Los Angeles, CA 90025 USA

(P)

3102940438

The Angeles Clinic & Research Institute (Pt Tx Ctr - Med Office/Clinic) 2001 Santa Monica Blvd. Ste 560W Santa Monica, CA 90404 USA

The Angeles Clinic & Research Institute (Pt Tx Ctr - Med Office/Clinic)

(F)

3102312199

Email: ohamid@theangelesclinic.org

11818

Wilshire Blvd.

Ste 200 Los Angeles, CA 90025 USA

Approved v1.0

930081508 1.0

9902

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0025

Infante, Jeffrey R, MD

Tennessee Oncology, PLLC (Office)

4

250

25th Avenue North

Bauer, Todd, MD Bendell, Johanna Chock, SB, MD Bi, Jia, MD Burris, III, Howard A, MD Cooper, Robert S, MD Dickson, Natalie Renee, MD Greco, F. Anthony, MD Hollis, Laura T, APRN, BC Hronek, Jan W, ACNP Ingle, Rebecca J, FNP Lehner, Maureen E, ACNP Morris, Patricia A, APN-C Porter III, Lester L, MD Shepard, Gregg Christian, MD Shih, Kent C, MD Spigel, David Robert, MD Thompson, Dana Shelton, MD Utley, Susan M., BSN, MSN, FNP Vantrease, Amanda G, APN, RN Yardley, Denise Aysel, MD

Suite 307 Nashville, TN 37203

USA

Tennessee Oncology, PLLC (Pt Tx Ctr - Med Office/Clinic) 4230 Harding Rd. Ste 707 Nashville, TN, 37205 USA

Tennessee Oncology, PLLC

(Pt Tx Ctr - Med Office/Clinic)

250

25th Avenue North

Suite 100 Nashville, TN 37203 USA

Sarah Cannon Research Institute (Pt Tx Ctr - Med Office/Clinic)

250

25th Ave. N

(P)

6153421741

St 312 Nashville, TN 37203 USA

(F)

6153421738

Email: jinfante@tnonc.com

Sarah Cannon Research Institute (Pt Tx Ctr - Med Office/Clinic)

250

25th Ave. N

St 307 Nashville, TN 37203 USA

Approved v1.0

930081508 1.0

9903

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0027

Linette, Gerald P, MD, PhD

Washington University School of Medicine (Office) 660 South Euclid Ave. St. Louis, MO 63110 USA

14

Cornelius, Lynn Anne, MD Curran, Christen M, MSN, RN, ANP-BC Tan, Benjamin, MD Wildes, Tanya M, MD

(P)

3147471217

Washington University School of Medicine (Pt Tx Ctr - Hosp/Med Ctr) Site Man Cancer Ctr.

(F)

3147471404

Email: glinette@dom.wustl.edu

4921

Parkview Pl. Fl 7th

Saint Louis, MO 63110

 

USA

Washington University Infusion Center Pharmacy (Pt Tx Ctr - Hosp/Med Ctr)

4921

Parkview Pl. Ste 7F

Saint Louis, MO 63110

USA

Barnes-Jewish Hospital (Pt Tx Ctr - Hosp/Med Ctr) 1 Barnes-Jewish Hosp Plz. Saint Louis, MO 63110 USA

Approved v1.0

930081508 1.0

9904

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0028

D'angelo, Sandra Pierina, MD

Memorial Sloan Kettering Cancer Center (Office)

24

Callahan, Margaret Kathleen, MD, PhD Carvajal, Richard D, MD Chapman, Paul B, MD Chi, Ping, MD, PhD Dickson, Mark A, MD Erinjeri, Joseph P, MD, PhD Gounder, Mrinal M, MD Harding, James J, MD Keohan, Mary Louise, MD Lefkowitz, Robert Andrew, MD Postow, Michael A, MD Schwartz, Gary K, MD Tap, William D, MD Weinstein, Alyona, NP Wolchok, Jedd, MD, PhD

1275

York Ave.

Inpatient Hospital & Main Campus

New York, NY 10065 USA

Memorial Sloan-Kettering Cancer Center (Pt Tx Ctr - Hosp/Med Ctr) Laurence S. Rockefeller Outpatient Pavillion 160 East 53rd Street New York, NY 10022 USA

Memorial Sloan Kettering Cancer Center (Pt Tx Ctr - Hosp/Med Ctr)

 

1275

York Ave. RM C-1087

(P)

6462272189

Attn: Gerry O-Neill New York, NY 10065 USA

(F)

6464222164

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 v1.0

930081508 1.0

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0029

Chmielowski, Bartosz, MD, PhD

Branch, Suzanne, CCRP Glaspy, John A., MD, MPH Oseguera, Denise K, FNP Ribas, Antoni, MD Tumeh, Paul, MD

University of California - Los Angeles Hematology-Oncology Outpatient Clinic (Office)

14

100

UCLA Medical Plaza

Suite 550 Los Angeles, CA 90095 USA

(P)

3107944955

Westwood Bowyer Clinic (Pt Tx Ctr - Hosp/Med Ctr)

(F)

3107943190

 

200

UCLA Medical Plaza

Email: bchmielowski@mednet.ucla.edu

Suite 120 Los Angeles, CA 90095 USA

University of California - Los Angeles (Pt Tx Ctr - Hosp/Med Ctr) Hematology-Oncology Outpatient Clinic

100

UCLA Medical Plaza

Suite 550 Los Angeles, CA 90095 USA

UCLA Dermatology Clinic

(Pt Tx Ctr - Hosp/Med Ctr)

200

UCLA Medical Plaza

Suite 450 Los Angeles, CA 90095 USA

Ronald Reagan UCLA Medical Center (Pt Tx Ctr - Hosp/Med Ctr) Surgery Center

200

Medical Plaza

6th Floor Los Angeles, CA 90095 USA

Approved v1.0

930081508 1.0

9906

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0029

 

Ronald Reagan Ucla Medical Center

 

Chmeilowski, Bartosz, MD, PhD (Cont’d)

(Pt Tx Ctr - Hosp/Med Ctr) Department of Radiological Sciences

757

Westwood Plaza

Los Angeles, CA 90095 USA

Ronald Reagan UCLA Medical Center (Pt Tx Ctr - Hosp/Med Ctr)

662

Gayley Avenue Room B504A

Drug Information Center Dept. of Pharmaceutical Services Los Angeles, CA 90095 USA

Clinical Research Unit

(Pt Tx Ctr - Hosp/Med Ctr)

924

Westwood Plaza

Suite 200 Los Angeles, CA 90095 USA

Approved v1.0

930081508 1.0

9907

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0030

Agarwala, Sanjiv S., MD

St.Luke's Cancer Center (Office) Anderson Campus

6

Ali, Asim, MD Belman, Neil, DO Faroun, Yacoub, MD Holden, Rita, CRNP Leonard, Jillian Foster, PA-C Nakajima, Hikaru, MD Peartree, Michelle, PA-C Proothi, Subhash, MD

1600

Riverside Circle

Easton, PA 18045

USA

St.Luke's Quakertown Hospital (Pt Tx Ctr - Hosp/Med Ctr) (Previous)

1021

Park Ave

Quakertown, PA 18951

 

USA

(P)

4845034500

(F)

4845034510

St.Luke's Cancer Center

Email: agarwas@slhn.org

(Pt Tx Ctr - Hosp/Med Ctr) Anderson Campus

1600

Riverside Circle

Easton, PA 18045 USA

St.Luke's Cancer Center

(Pt Tx Ctr - Hosp/Med Ctr) Allentown Campus

1736

Hamilton Street

Allentown, PA 18104 USA

St.Luke's Cancer Center (Pt Tx Ctr - Hosp/Med Ctr) (Previous) Anderson Campus

1872

Riverside Circle

Easton, PA 18045 USA

Approved v1.0

930081508 1.0

9908

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA203-037-0030

 

St. Luke's University Hospital Bethlehem Campus (Pt Tx Ctr - Hosp/Med Ctr)

 

Agarwala, Sanjiv, S., MD (Cont’d)

801

Ostrum St.

Bethlehem, PA 18015 USA

St. Luke'S Cancer Center - Allentown Campus (Pt Tx Ctr - Hosp/Med Ctr)

240

Cetronia Rd.

Allentown, PA 18104 USA

Cancer Care Associates Medical

Oncology (Pt Tx Ctr - Hosp/Med Ctr)

701

Ostrum St.

Ste 403 Bethlehem, PA 18015

USA

Cancer Care Associates Medical Oncology (Pt Tx Ctr - Hosp/Med Ctr)

240

Cetronia Road

Suite 225 South Allentown, PA 18104 USA

St. Luke's Hospital - Quakertown Campus (Pt Tx Ctr - Med Office/Clinic) 1021 Park Ave. Quakertown, PA 18951 USA

Approved v1.0

930081508 1.0

9909

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients 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) 200 W Arbor Dr. San Diego, CA 92103 USA

UCSD Medical Center - La Jolla (Pt Tx Ctr - Hosp/Med Ctr)

Email: gdaniels@ucsd.edu

9300

Campus Point Dr.

La Jolla, CA 92037 USA

UCSD Moores Cancer Center

(Pt Tx Ctr - Hosp/Med Ctr) Investigational Drug Services

3855

Health Science Drive

Room 1036 La Jolla, CA 92037 USA

UCSD Moores Cancer Center (Pt Tx Ctr - Hosp/Med Ctr)

3855

Health Sciences Dr.

La Jolla, CA 92093

USA

Approved v1.0

930081508 1.0

9910

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab

Site #

Principal Investigator/ Sub Investigators and Responsible Medical Personnel

 

Study Center and Address

# of Patients Enrolled

CA209-037-0033

Urba, Walter J, MD, PhD

Providence Oncology and Hematology Care (Office)

4

Abar, Farnoush, MD Barber, Nicholas Andrew, MD Conlin, Alison K., MD Crocenzi, Todd S, MD Curti, Brendan, MD Eddington, Joanne T, NP Godwin, John Edward, MD Griswold, Roxanne R, NP Kefer, Catherine A, NP Kurup, Anupama, MD Lanier, Keith S, MD Leidner, Rom S, MD Lewis, Stacy K., MD Li, Rui, MD, PhD Lin, Christine L, MD Myklebust, Erin K, NP Sanborn, Rachel E, MD Zilverberg, Jamie Rae, NP

4805

NE Glisan Street

#6N40/2N35

Portland, OR 97213

USA

Providence St. Vincent Medical Center (Pt Tx Ctr - Hosp/Med Ctr)

9205

SW Barnes Rd.

Portland, OR 97225 USA

Providence Portland Medical Center (Pt Tx Ctr - Hosp/Med Ctr)

4805

NE Glisan St.

Portland, OR 97213

USA

Providence Oncology and Hematology Care Westside (Pt Tx Ctr - Hosp/Med Ctr)

(P)

5032166300

(F)

5032156725

9135

SW Barnes Road

Email: walter.urba@providence.org

Suite 261 Portland, OR 97225 USA

Providence Oncology & Hematology Care Eastside (Pt Tx Ctr - Hosp/Med Ctr)

4805

NE Gilsan St. #6N40

Portland, OR 97213 USA

Approved v1.0

930081508 1.0

9911

Interim Clinical Study Report

CA209037

BMS-936558

Nivolumab