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NCT03899155ClinicalTrials.gov

Pan Tumor Rollover Study

Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies

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En resumen

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

Fase 21500 participantes buscados399 centros38 países

Categorías

Oncología100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2019-04-02; recorded start 2019-08-09
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are not randomly assignedAllocation is recorded as non-randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 321 other studies in this databaseCounted from the lead sponsor named in the record (Bristol-Myers Squibb)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation0/20

    Non-randomised allocation

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 399 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 1,500 participants (target), run at 399 sites, across 38 countries.

How this score is built
  • Enrolment32/40

    1,500 participants (target)

  • Site count25/25

    399 sites

  • Country count15/15

    38 countries

  • Planned duration10/10

    Planned over about 122 months

  • Sponsor scale9/10

    Bristol-Myers Squibb has led 310 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

Afecciones

  • Cancer

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria * Signed Written Informed Consent. * Eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study. * On treatment hold in the Parent Study following long-lasting response or are eligible for treatment rechallenge as defined in the Parent Study. * WOCBP and male participants who are sexually active must agree to follow instructions for method(s) of contraception as described below and included in the ICF. Exclusion Criteria * Participant is not eligible for study treatment per the Parent Study eligibility criteria. * Participants not receiving clinical benefit as assessed by the Investigator. * Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant. * Other protocol-defined Inclusion/Exclusion Criteria apply

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 2
AsignaciónNo aleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoNONE (0)
Inscripción1500 participantes buscados

Patrocinador y colaboradores

  • Bristol-Myers Squibb Patrocinador
  • Exelixis Colaboradores
  • Novartis Colaboradores
  • Clovis Oncology, Inc. Colaboradores
  • Janssen Pharmaceuticals Colaboradores

Grupos e intervenciones

  • E10: Pemetrexed MonotherapyEXPERIMENTAL
  • E11: Pembrolizumab MonotherapyEXPERIMENTAL
  • E3: Leucovorin + FluorouracilEXPERIMENTAL
  • E6: Sunitinib MonotherapyEXPERIMENTAL
  • E7: Rucaparib MonotherapyEXPERIMENTAL
  • E8: Capecitabine MonotherapyEXPERIMENTAL
  • E9: Cabozantinib MonotherapyEXPERIMENTAL
  • A1: Nivolumab Monotherapy Dose 1EXPERIMENTAL
  • A2: Nivolumab Monotherapy Dose 2EXPERIMENTAL
  • B1: Nivolumab + IpilimumabEXPERIMENTAL
  • B2: Nivolumab + Ipilimumab + CabozantinibEXPERIMENTAL
  • B3: Nivolumab + Ipilimumab + TrametinibEXPERIMENTAL
  • C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1EXPERIMENTAL
  • C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2EXPERIMENTAL
  • C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1EXPERIMENTAL
  • C4: Relatlimab + Nivolumab SAV Dose 2EXPERIMENTAL
  • C5: Relatlimab + Nivolumab + IpilimumabEXPERIMENTAL
  • C6: Relatlimab + Nivolumab + CapecitabineEXPERIMENTAL
  • C7: Relatlimab + Nivolumab SAV Dose 3EXPERIMENTAL
  • C10: Relatlimab + Nivolumab SAV Dose 4EXPERIMENTAL
  • C12: Relatlimab + Nivolumab SAV Dose 5EXPERIMENTAL
  • C8: Relatlimab + Nivolumab SAV + PDCT Dose 1EXPERIMENTAL
  • C9: Relatlimab + Nivolumab SAV + BevacizumabEXPERIMENTAL
  • C11: Relatlimab + Nivolumab SAV + PDCT Dose 2EXPERIMENTAL
  • D1: Nivolumab + TemozolomideEXPERIMENTAL
  • D2: Nivolumab + RucaparibEXPERIMENTAL
  • D3: Nivolumab + DaratumumabEXPERIMENTAL
  • D4: Nivolumab + BevacizumabEXPERIMENTAL
  • E1: Bevacizumab MonotherapyEXPERIMENTAL
  • E2: Regorafinib MonotherapyEXPERIMENTAL
  • E4: Leucovorin + Oxaliplatin + FluorouracilEXPERIMENTAL
  • E5: Enzalutamide MonotherapyEXPERIMENTAL

Intervenciones

  • Fármaco Bevacizumab

    Specified dose on specified days

  • Fármaco Cabozantinib

    Specified dose on specified days

  • Fármaco Capecitabine

    Specified dose on specified days

  • Fármaco Daratumumab

    Specified dose on specified days

  • Fármaco Enzalutamide

    Specified dose on specified days

  • Fármaco Fluorouracil

    Specified dose on specified days

  • Fármaco Ipilimumab

    Specified dose on specified days

  • Fármaco Leucovorin

    Specified dose on specified days

  • Fármaco Nivolumab

    Specified dose on specified days

  • Fármaco Nivolumab + Relatlimab

    Specified dose on specified days

  • Fármaco Oxaliplatin

    Specified dose on specified days

  • Fármaco Pembrolizumab

    Specified dose on specified days

  • Fármaco Pemetrexed

    Specified dose on specified days

  • Fármaco Regorafinib

    Specified dose on specified days

  • Fármaco Relatlimab

    Specified dose on specified days

  • Fármaco Rucaparib

    Specified dose on specified days

  • Fármaco Sunitinib

    Specified dose on specified days

  • Fármaco Temozolomide

    Specified dose on specified days

  • Fármaco Trametinib

    Specified dose on specified days

Variables de resultado

  1. Variable de resultado principal

    Incidence of Adverse Events (AEs)

    Plazo From Day 1 up to 135 Days after discontinuation of treatment

  2. Variable de resultado principal

    Incidence of drug related AEs

    Plazo From Day 1 up to 135 Days after discontinuation of treatment

  3. Variable de resultado principal

    Incidence of AEs leading to Discontinuation

    Plazo From Day 1 up to 135 Days after discontinuation of treatment

  4. Variable de resultado principal

    Incidence of Serious Adverse Events (SAEs)

    Plazo From signature of Informed Consent up to 135 Days after discontinuation of treatment

  5. Variable de resultado principal

    Incidence of Select AEs

    Plazo From Day 1 up to 135 Days after discontinuation of treatment

  6. Variable de resultado principal

    Incidence of Immune-Mediated AEs

    Plazo From Day 1 up to 135 Days after discontinuation of treatment

  7. Variable de resultado principal

    Incidence of Death

    Plazo From signature of Informed Consent up to 135 Days after discontinuation of treatment

Fechas

Fecha de inicio9 de agosto de 2019 (real)
Finalización principal25 de agosto de 2029 (estimada)
Finalización25 de agosto de 2029 (estimada)
Primera publicación2 de abril de 2019 (real)
Última actualización29 de julio de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezjulio de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

109 centros están en reclutamiento

Argentina

CentroCiudadEstado o regiónEstado
Local Institution - 0199BerazateguiBuenos AiresCompletado
Local Institution - 0201Buenos AiresRetirado
Instituto FlemingBuenos AiresEn reclutamiento
Local InstitutionCABARetirado
Local Institution - 0170CórdobaRetirado
Fundacion Richardet Longo - IONCCórdobaEn reclutamiento
Sanatorio ParqueRosarioSanta Fe ProvinceEn reclutamiento
Instituto Medico Rio CuartoRío CuartoCórdoba ProvinceEn reclutamiento
Local Institution - 0191San Miguel de TucumánTucumán ProvinceCompletado
CAIPO Centro para la Atencion Integral del Paciente OncologicoSan Miguel de TucumánTucumán ProvinceEn reclutamiento
Centro de Investigaciones Clinicas. Clinica Viedma S.A.ViedmaRío Negro ProvinceEn reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Local InstitutionAdelaideSouth AustraliaRetirado
BRICC - Ballarat Health ServicesBallaratVictoriaEn reclutamiento
Local Institution - 0045Coffs HarbourNew South WalesCompletado
Local Institution - 0196Elizabeth ValeSouth AustraliaCompletado
Local Institution - 0365FitzroyVictoriaCompletado
Local Institution - 0372GreenslopesQueenslandRetirado
Gallipoli Medical FoundationGreenslopesQueenslandEn reclutamiento
Cabrini Hospital MalvernMalvernVictoriaEn reclutamiento
Local Institution - 0174MurdochWestern AustraliaRetirado
Melanoma Institute AustraliaNorth SydneyNew South WalesEn reclutamiento
Local InstitutionSouth BrisbaneQueenslandRetirado
Tasman Oncology Research LtdSouthportQueenslandEn reclutamiento
Local Institution - 0009SydneyNew South WalesCompletado
Local Institution - 0193WaratahNew South WalesCompletado
Local Institution - 0208WestmeadNew South WalesCompletado

Austria

CentroCiudadEstado o regiónEstado
Local Institution - 0254GrazStyriaCompletado
Ordensklinikum Linz GmbH ElisabethinenLinzUpper AustriaEn reclutamiento
Local Institution - 0321ViennaCompletado
Local Institution - 0104ViennaCompletado
Local Institution - 0145WelsCompletado

Belgium

CentroCiudadEstado o regiónEstado
Local Institution - 0329BrusselsRetirado
Local Institution - 0232GhentCompletado
Local Institution - 0139JetteCompletado
Local Institution - 0261LiègeRetirado
Local Institution - 0293Sint-NiklaasRetirado
Local Institution - 0157YvoirCompletado

Brazil

CentroCiudadEstado o regiónEstado
Local Institution - 0264BarretosSão PauloCompletado
Local Institution - 0260Belo HorizonteMinas GeraisCompletado
ONCOSITE - Centro de Pesquisa Clinica em OncologiaIjuíRio Grande do SulEn reclutamiento
Local Institution - 0379Passo FundoRio Grande do SulRetirado
Local Institution - 0093Porto AlegreRio Grande do SulAún no recluta
Irmandade da Santa Casa de Misericordia de Porto AlegrePorto AlegreRio Grande do SulEn reclutamiento
Hospital Sao Lucas Da PucrsPorto AlegreRio Grande do SulEn reclutamiento
Local Institution - 0399Porto AlegreRio Grande do SulRetirado
Local Institution - 0258Rio de JaneiroCompletado
Local Institution - 0266Rio de JaneiroCompletado
Local Institution - 0262São José do Rio PretoSão PauloCompletado
Local Institution - 0355São PauloSão PauloCompletado
Local Institution - 0263São PauloSão PauloRetirado

En el registro figuran 349 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT03899155