Real-Life Effectiveness and Safety in Participants With Advanced/Metastatic Renal Cell Carcinoma Starting 1st Line Nivolumab and Ipilimumab Combination Therapy or Nivolumab Monotherapy After Prior Therapy

NCT02940639 | Completed

• 1 other identifier: CA209-653
• Study Type: observational
• Target: 499
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to estimate overall survival over a 5-year follow-up period among adult participants with advanced/metastatic kidney cancer, starting 1st line nivolumab and ipilimumab combination therapy or nivolumab monotherapy after prior therapy, in real-life conditions in Germany

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  In participants with nivolumab and ipilimumab or nivolumab therapy

  Approximately 5 years

Secondary Outcomes (17)

• Overall Survival (OS)

  Approximately 5 years

• Progression-Free Survival (PFS)

  Approximately 5 years

• Overall response rate (ORR)

  Approximately 5 years

• Best Overall Response (BOR)

  Approximately 5 years

• Best Overall Response Rate (BORR)

  Approximately 5 years

Study Arms (2)

Cohort 1

Participants with advanced/metastatic renal cell cancer (RCC) starting nivolumab monotherapy after prior therapy

Cohort 2

Participants with advanced/metastatic RCC starting 1st line therapy with nivolumab and ipilimumab combination therapy, in intermediate/poor risk participants

Eligibility Criteria

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

Study Population

Adult participants who are at least 18 years of age at the time of the treatment decision with the diagnosis of advanced/metastatic RCC (histologically or cytologically confirmed) and whose physician has already decided to initiate a treatment with 1st line nivolumab and ipilimumab nivolumab combination therapy in intermediate/poor risk participants according to International Metastatic RCC Database Consortium (IMDC) score or with nivolumab monotherapy after prior therapy for the first time for the treatment of advanced/metastatic RCC, according to the label approved in Germany.

You may qualify if:

• Adult participants, at least 18 years of age at time of treatment decision
• Diagnosis of advanced/metastatic renal cell carcinoma (RCC) (confirmed by histology or cytology)
• Treatment decision to initiate a treatment with nivolumab and ipilimumab or nivolumab for the first time for the treatment of advanced/metastatic RCC (according to the label approved in Germany) has already been taken
• Signed informed consent

You may not qualify if:

• Participants with a diagnosis of a cancer other than advanced/metastatic advanced RCC within the past five years, ie, a cancer other than advanced/metastatic RCC that requires systemic or other treatment. Participants that have been treated curatively more than five years ago with no evidence of recurrence and prostate cancer patients in active surveillance can be included.
• Participants previously treated with nivolumab and/or ipilimumab
• Participants currently included in an interventional clinical trial for their locally advanced or metastatic RCC. Participants who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for OS can be enrolled.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Jena, 07743, Germany

Location

Related Publications (1)

• Bedke J, Grimm MO, Grunwald V. Collection of real-world data on nivolumab's effectiveness in renal cell carcinoma: rationale for an observational study. Future Oncol. 2018 May;14(11):1023-1034. doi: 10.2217/fon-2017-0637. Epub 2018 Jan 12.

  PMID: 29325434 DERIVED

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 21, 2016
• Study Start: October 27, 2016
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

DE (1)