A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer

NCT02387996 | Completed Phase 2 Results

• 1 other identifier: CA209-275
• Study Type: interventional
• Target: 270
• Locations: 11 countries
• Sites: 67

Brief Summary

The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.

Conditions

Various Advanced Cancer

Outcome Measures

Primary Outcomes (4)

• Objective Response Rate Per BIRC Assessment

  Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee

  From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)

• ORR Per BIRC Assessment by PD-L1 Expression Level

  Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee PD-L1 expression level= membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category

  From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)

• Time to Response (TTR)

  TTR is defined as the time from first dosing date to the date of the first confirmed complete response (CR) or partial response (PR), as assessed by the Blinded Independent Review Committee (BIRC). Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  From first dosing date to the date of the first confirmed response (up to approximately 14 months)

• Duration of Response (DOR)

  DOR is defined as the time from first confirmed response, complete response (CR) or partial response (PR) to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment.

  From the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 14 months)

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  From first dosing date to the date of the first documented tumor progression (up to approximately 6 months)

• Overall Survival (OS)

  From first dosing date to the date of death (up to approximately 23 months)

• Objective Response Rate (ORR) Per Investigator

  From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 45 months)

Study Arms (1)

Nivolumab

EXPERIMENTAL

Nivolumab intravenous infusion as specified

Drug: Nivolumab

Interventions

Nivolumab DRUG

Also known as: BMS(936558)

Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of metastatic or surgically unresectable transitional cell carcinoma of the urothelium involving the bladder,urethra,ureter or renal pelvis
• Measurable disease by CT or MRI
• Progression or recurrence after treatment
• i) With at least 1 platinum-containing chemotherapy regimen for metastatic or surgically unresectable locally advanced urothelial cancer, or
• ii) Within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment with a platinum agent in the setting of cystectomy for localized muscle-invasive urothelial cancer
• Subject that have received more than 2 prior lines of chemotherapy must not have liver metastases
• Tumor tissues (archived or new biopsy) must be provided for biomarker analysis
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

You may not qualify if:

• Subjects with active cancer that has spread to the central nervous system
• Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
• Subject with active, known or suspected autoimmune disease
• Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 day of study drug administration
• Prior treatment with an anti-PD-1,anti-PD-L1,anti-PD-L2,anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, anti-CD137 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
• Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
• Known history of testing positive for human Immunodeficiency virus (HIV) or known acquired Immunodeficiency syndrome (AIDS)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (67)

Local Institution - 0013

Phoenix, Arizona, 85054, United States

Location

Local Institution - 0012

Duarte, California, 91010-3000, United States

Location

Pacific Hematology Oncology Associates

San Francisco, California, 94115, United States

Location

Local Institution - 0016

Aurora, Colorado, 80045, United States

Location

University Cancer Blood Ctr

Athens, Georgia, 30607, United States

Location

Ft. Wayne Med Onco-Hema Inc

Fort Wayne, Indiana, 46804, United States

Location

Local Institution - 0030

Indianapolis, Indiana, 46202, United States

Location

Local Institution - 0052

Iowa City, Iowa, 55242, United States

Location

Crescent City Research Consortium, LLC

Marrero, Louisiana, 70072, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201-2014, United States

Location

GU Research Network, LLC

Omaha, Nebraska, 68130, United States

Location

Local Institution - 0028

New York, New York, 10029, United States

Location

Local Institution - 0004

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 0051

Portland, Oregon, 97213, United States

Location

Local Institution - 0029

Philadelphia, Pennsylvania, 19111-2412, United States

Location

Local Institution - 0059

Pittsburgh, Pennsylvania, 15212-0000, United States

Location

Erlanger Oncology & Hematology - Univ. of TN

Chattanooga, Tennessee, 37404, United States

Location

Local Institution - 0001

Houston, Texas, 77030, United States

Location

Local Institution - 0036

Seattle, Washington, 98101, United States

Location

Local Institution - 0060

Waratah, New South Wales, 2298, Australia

Location

Local Institution - 0070

Elizabeth Vale, South Australia, 5112, Australia

Location

Local Institution - 0022

Brussels, 1090, Belgium

Location

Local Institution - 0023

Edegem, 2650, Belgium

Location

Local Institution - 0024

Hasselt, 3500, Belgium

Location

Local Institution - 0027

Brno, 656 53, Czechia

Location

Local Institution - 0026

Olomouc, 779 00, Czechia

Location

Local Institution

Prague, 150 06, Czechia

Location

Local Institution - 0010

Helsinki, 00029, Finland

Location

Local Institution - 0009

Tampere, 33521, Finland

Location

Local Institution - 0049

Erfurt, 99028, Germany

Location

Local Institution - 0047

Erlangen, 91054, Germany

Location

Local Institution - 0042

Hamburg, 20246, Germany

Location

Local Institution - 0043

Heidelberg, 69120, Germany

Location

Local Institution - 0015

Jena, 07747, Germany

Location

Local Institution - 0041

München, 81675, Germany

Location

Local Institution

Rostock, 18107, Germany

Location

Local Institution - 0048

Tübingen, 72076, Germany

Location

Local Institution - 0017

Arezzo, 52100, Italy

Location

Local Institution - 0020

Milan, 20133, Italy

Location

Local Institution - 0018

Napoli, 80131, Italy

Location

Local Institution - 0050

Pavia, 27100, Italy

Location

Local Institution - 0021

Roma, 00149, Italy

Location

Local Institution - 0074

Akita, Akita, 0108543, Japan

Location

Local Institution - 0083

Hirosaki-shi, Aomori, 036-8563, Japan

Location

Local Institution - 0081

Tsukuba, Ibaraki, 3058576, Japan

Location

Local Institution - 0078

Morioka, Iwate, 0208505, Japan

Location

Local Institution

Yokohama, Kanagawa, 2360004, Japan

Location

Local Institution - 0080

Kumamoto, Kumamoto, 8608556, Japan

Location

Local Institution - 0082

Kyoto, Kyoto, 602-8566, Japan

Location

Local Institution - 0076

Niigata, Niigata, 9518520, Japan

Location

Local Institution - 0084

Osaka-Sayama-Shi, Osaka, 5898511, Japan

Location

Local Institution - 0085

Bunkyo-ku, Tokyo, 1138431, Japan

Location

Local Institution - 0073

Bunkyo-ku, Tokyo, 1138603, Japan

Location

Local Institution - 0077

Bunkyo-ku, Tokyo, 1138655, Japan

Location

Local Institution - 0086

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Local Institution - 0075

Shinjuku-ku, Tokyo, 1628666, Japan

Location

Local Institution

Gdansk, 80-219, Poland

Location

Local Institution - 0046

Krakow, 31-531, Poland

Location

Local Institution - 0040

Lodz, 93-513, Poland

Location

Local Institution - 0056

Szczecin, 71-730, Poland

Location

Local Institution - 0038

Wroclaw, 50-556, Poland

Location

Local Institution - 0035

Badalona-barcelona, 08916, Spain

Location

Local Institution - 0033

Barcelona, 08035, Spain

Location

Local Institution - 0034

Hospitalet de Llobregat - Barcelona, 08908, Spain

Location

Local Institution - 0031

Madrid, 28007, Spain

Location

Local Institution - 0032

Seville, 41013, Spain

Location

Local Institution - 0014

Lund, 221 85, Sweden

Location

Related Publications (1)

• Sharma P, Retz M, Siefker-Radtke A, Baron A, Necchi A, Bedke J, Plimack ER, Vaena D, Grimm MO, Bracarda S, Arranz JA, Pal S, Ohyama C, Saci A, Qu X, Lambert A, Krishnan S, Azrilevich A, Galsky MD. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2017 Mar;18(3):312-322. doi: 10.1016/S1470-2045(17)30065-7. Epub 2017 Jan 26.

  PMID: 28131785 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 13, 2015
• Study Start: March 9, 2015
• Primary Completion: April 15, 2016
• Study Completion: November 12, 2021
• Last Updated: November 1, 2022
• Results First Posted: May 24, 2017

Record last verified: 2022-10

Locations

US (19); CZ (3); FI (2); JP (14); DE (8); AU (2); PL (5); ES (5); SE (1); IT (5); BE (3)