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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

18. maj 2022 opdateret af: Bristol-Myers Squibb

A National, Prospective, Non-Interventional Study (NIS) in Patients With Advanced/Metastatic Renal Cell Carcinoma Starting 1st Line Nivolumab and Ipilimumab Combination Therapy or Nivolumab Monotherapy After Prior Therapy

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

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

499

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Jena, Tyskland, 07743
        • Local Institution

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: Approximately 5 years
In participants with nivolumab and ipilimumab or nivolumab therapy
Approximately 5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: Approximately 5 years
Separate by nivolumab and ipilimumab or nivolumab therapy, estimated overall lines of therapy, per line of therapy, per cohort, per index date (initial diagnosis vs start of therapy in the trial) and per subgroups of interest.
Approximately 5 years
Progressionsfri overlevelse (PFS)
Tidsramme: Cirka 5 år
Cirka 5 år
Overall response rate (ORR)
Tidsramme: Approximately 5 years
Approximately 5 years
Bedste overordnede respons (BOR)
Tidsramme: Cirka 5 år
Cirka 5 år
Bedste samlede svarprocent (BORR)
Tidsramme: Cirka 5 år
Cirka 5 år
Duration of Response
Tidsramme: Approximately 5 years
Approximately 5 years
Distribution of socio-demographic characteristics
Tidsramme: Approximately 5 years
Socio-demographic characteristics (Gender, Height, Weight, Age) will be summarized using descriptive statistics.
Approximately 5 years
Distribution of clinical characteristics
Tidsramme: Approximately 5 years
Clinical characteristics (Initial Diagnosis of RCC, Histological subtypes, Performance status, Comorbidities, history of cancer) will be summarized using descriptive statistics
Approximately 5 years
Distribution of Renal Cell Carcinoma (RCC) Treatment History
Tidsramme: At Baseline
At Baseline
Distribution of Nivolumab Treatment Characteristics
Tidsramme: At initiation - index date, baseline
Nivolumab monotherapy (cohort 1) or nivolumab and ipilimumab combination therapy (cohort 2)
At initiation - index date, baseline
Distribution of Treatment Patterns
Tidsramme: Approximately 5 years
Details on prior and evolution of current treatment patterns
Approximately 5 years
Incidence rate of Adverse Events (AEs), treatment-related AEs, select AEs and other immune-related AEs
Tidsramme: Approximately 5 years
Approximately 5 years
Distribution of Adverse Events (AE) characteristics
Tidsramme: Approximately 5 years
Approximately 5 years
Distribution of severity of Adverse Events (AEs)
Tidsramme: Approximately 5 years
Approximately 5 years
Distribution of management of Adverse Events (AEs)
Tidsramme: Approximately 5 years
Approximately 5 years
Quality of Life as assessed by Functional Assessment of Cancer Therapy - Kidney Symptom Index (FKSI-19) Questionnaire
Tidsramme: Approximately 5 years
Approximately 5 years
Utility as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire
Tidsramme: Approximately 5 years
Approximately 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. oktober 2016

Primær færdiggørelse (Forventet)

15. december 2025

Studieafslutning (Forventet)

15. december 2025

Datoer for studieregistrering

Først indsendt

12. oktober 2016

Først indsendt, der opfyldte QC-kriterier

19. oktober 2016

Først opslået (Skøn)

21. oktober 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CA209-653

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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