Clinical Trial: NCT03036098 - My Cancer Genome

NCT03036098

Description:

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.

Related Conditions:

Urothelial Carcinoma

Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT03036098

Trial Eligibility

Document

Title

Brief Title: Study of 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
Official Title: 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

Clinical Trial IDs

ORG STUDY ID: CA209-901
SECONDARY ID: 2016-003881-14
NCT ID: NCT03036098

Conditions

Urothelial Cancer

Interventions

Drug	Synonyms	Arms
Nivolumab	BMS-936558, Opdivo	Arm A: Investigational immunotherapy
Ipilimumab	BMS-734016, Yervoy	Arm A: Investigational immunotherapy
Gemcitabine		Arm B: Standard of care chemotherapy
Cisplatin		Arm B: Standard of care chemotherapy
Carboplatin		Arm B: Standard of care chemotherapy

Purpose

Trial Arms

Name	Type	Interventions
Arm A: Investigational immunotherapy	Experimental	Nivolumab Ipilimumab
Arm B: Standard of care chemotherapy	Active Comparator	Gemcitabine Cisplatin Carboplatin
Arm C: Investigational immunotherapy	Experimental	Nivolumab Gemcitabine Cisplatin
Arm D: Standard of care chemotherapy	Active Comparator	Gemcitabine Cisplatin

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Overall survival (OS) in cisplatin-ineligible randomized participants
Time Frame:	Up to 55 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Overall survival (OS) in all randomized participants
Time Frame:	Up to 55 months
Safety Issue:
Description:

Measure:	Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-ineligible randomized participants
Time Frame:	Up to 55 months
Safety Issue:
Description:

Measure:	Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in PD-L1 positive (≥1%) randomized participants
Time Frame:	Up to 55 months
Safety Issue:
Description:

Measure:	Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in all randomized participants
Time Frame:	Up to 55 months
Safety Issue:
Description:

Measure:	European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants
Time Frame:	Up to 55 months
Safety Issue:
Description:

Measure:	European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in cisplatin eligible participants with previously untreated, unresectable or metastatic UC
Time Frame:	Up to 64 months
Safety Issue:
Description:

Measure:	Progression-free survival (PFS) by BICR (using RECIST 1.1) by immunohistochemistry (IHC)
Time Frame:	Up to 64 months
Safety Issue:
Description:

Measure:	Overall survival (OS) by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC)
Time Frame:	Up to 64 months
Safety Issue:
Description:

Details

Phase:	Phase 3
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Bristol-Myers Squibb

Last Updated

August 17, 2021

Clinical Trials /

Study of 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