NCT03455452

Brief Summary

This is a French, nationwide, prospective, observational, multi-center study in participants diagnosed with advanced renal cell carcinoma, who start a new systemic therapy with nivolumab with or without ipilimumab for the first time and within the market authorization approval.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 21, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

7.9 years

First QC Date

February 21, 2018

Last Update Submit

June 19, 2025

Conditions

Renal Cell CarcinomaRenal Cell CancerAdenocarcinoma Of KidneyAdenocarcinoma, Renal CellKidney CancerCancer of the Kidney

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    By Cohort

    Up to 3 years

Secondary Outcomes (16)

  • Overall Survival (OS)

    Up to 3 years

  • Progression Free Survival (PFS)

    Up to 3 years

  • Overall Response Rate (ORR)

    Up to 3 years

  • Best Overall Response Rate (BORR)

    Up to 3 years

  • Best Overall Response (BOR)

    Up to 3 years

  • +11 more secondary outcomes

Study Arms (2)

Cohort 1: Nivolumab

Participants diagnosed with advanced renal cell carcinoma (RCC) and whose physician has decided to initiate a treatment with Nivolumab for the first time for the treatment of RCC

Cohort 2: Nivolumab + Ipilimumab

Participants diagnosed with advanced RCC and whose physician has decided to start a new systemic therapy with nivolumab + ipilimumab for the first time for the treatment of RCC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants who are at least 18 of age at the time of the treatment decision with the diagnosis of advanced renal cell cancer (RCC) (histologically or cytologically confirmed) and whose physician has already decided to initiate a treatment with nivolumab or with nivolumab plus ipilimumab for the first time for the treatment of RCC, according to the label approved in France.

You may qualify if:

  • Adult participants with the diagnosis of advanced renal cell cancer (RCC) (histologically or cytologically) whose physician has already decided to initiate a treatment with nivolumab with or without ipilimumab for the first time for the treatment of RCC, according to the label approved in France
  • NOTE: Nivolumab with ipilimumab is indicated for the first-line treatment of adult participants with intermediate/poor-risk advanced RCC

You may not qualify if:

  • Primary diagnosis of a cancer other than advanced RCC within the past five years, ie, a cancer other than RCC that requires systemic or other treatment
  • Previously treated with anti-PD1, anti-programmed death-ligand 1 (anti-PDL1) or anti-CTLA4 therapy
  • Currently included in an interventional clinical trial for advanced or RCC. Participants who have completed participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival (OS) can be enrolled
  • Pregnant women and participants under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution - 0001

Paris, 75002, France

Location

Related Publications (1)

  • Barthelemy P, Albiges L, Escudier B, Narciso B, Bigot P, Chehimi M, Emambux S, Calcagno F, Mouillet G, Eymard JC, Schlurmann F, Bailly S, Garbay D, Berdah JF, Palmaro MB, Goupil MG, Spaeth D, Nere S, Quentric C, Vano YA, Thiery-Vuillemin A. Nivolumab in patients with advanced renal cell carcinoma in France: interim results of the observational, real-world WITNESS study. ESMO Open. 2024 Jul;9(7):103602. doi: 10.1016/j.esmoop.2024.103602. Epub 2024 Jun 18.

    PMID: 38897136DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Renal CellKidney Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale 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

February 21, 2018

First Posted

March 6, 2018

Study Start

January 21, 2018

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Locations

FR(1)