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Brief Title: Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer

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A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer

INTRODUCTION

  • Org Study ID: CA209-901
  • Secondary ID: N/A
  • NCT ID: NCT03036098
  • Sponsor: Bristol-Myers Squibb

DESCRIPTION

To learn more about this study, visit: https://www.bmsstudyconnect.com/us/en/clinical-trials/NCT03036098.html

Who is this trial for?

Patients who have urothelial cancer (UC -cancer of the bladder, ureter, urethra or renal pelvis) that has spread or cannot  be removed by surgery

What is the goal of this study?

To purpose of this study is to assess the effects of addition of immunotherapy to chemotherapy in patients with  untreated inoperable UC or UC that has spread to different parts of the body (metastatic).

Background

Patients with advanced UC have poor outcomes, with 5-year survival rates of <5% for those with metastatic, stage IV disease. Median overall survival with standard of care chemotherapy is ~13 months.  Therefore, there is a need for studying novel treatment approaches that might improve patient outcomes.   This clinical trial is exploring the addition of immunotherapy to standard of care chemotherapy. Clinical trials are conducted to learn whether a new drug, treatment, or combination works and is safe to use for people. You can volunteer to take part in a clinical trial if you are eligible.

You may be eligible for this clinical study if you:

– Have bladder cancer that has spread or cannot be removed with surgery

– Have not been treated since your cancer has spread

– Are eligible for cisplatin treatment

Participation in this clinical trial is determined using the full eligibility criteria. Some key eligibility criteria are above. To pre-screen for this study or other bladder cancer studies, please take the Bladder Cancer Screener on BMS Study Connect.

Gender: All              Minimum Age: 18 Years          Maximum Age: N/A

Study Design

If enrolled in the study you will be assigned to one of the following study treatment arms and receive the outlined study treatment

Arm  C: Nivolumab + chemotherapy

Arm  D: chemotherapy

Considering a clinical trial?

There is a lot to think about when considering a clinical trial.

Download this pdf to discuss 2 clinical trial options with your doctor.

Visit BMSSTUDYCONNECT.com/ to learn move and to take a screener to see if you qualify

BRIEF SUMMARY

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.

  • Overall Status
    Active, not recruiting
  • Start Date
    March 24, 2017
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall survival (OS) in cisplatin-ineligible randomized participants

Primary Outcome 1 - Timeframe: Up to 55 months

Primary Outcome 2 - Measure: Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC)

Primary Outcome 2 - Timeframe: Up to 52 months

Primary Outcome 3 - Measure: Progression-free survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-eligible participants with previously untreated

Primary Outcome 3 - Timeframe: Up to 64 months

Primary Outcome 4 - Measure: unresectable or metastatic UC

Primary Outcome 4 - Timeframe: Up to 64 months

Primary Outcome 5 - Measure: Overall survival (OS) in cisplatin-eligible participants with previously untreated

Primary Outcome 5 - Timeframe: N/A

Primary Outcome 6 - Measure: unresectable or metastatic UC

Primary Outcome 6 - Timeframe: N/A

CONDITION

  • Urothelial Cancer

ELIGIBILITY

Inclusion Criteria:
* Histological or cytological evidence of metastatic or surgically inoperable transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra

- * No prior systemic chemotherapy for metastatic or surgically inoperable urothelial cancer (UC)

- * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

- * Women and men must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
* Disease that is suitable for local therapy administered with curative intent

- * Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with study participation or study drug administration or interfere with the interpretation of study results

- * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Other protocol-defined inclusion/exclusion criteria apply

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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