xMedica

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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati399 centri38 paesi

Categorie

Oncologia100%

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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

Patologie

  • Cancer

Idoneità

SessoTutti
Età18 Years – Nessun massimo
Volontari saniNo

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 2
AssegnazioneNon randomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoNONE (0)
Arruolamento1500 partecipanti ricercati

Sponsor e collaboratori

  • Bristol-Myers Squibb Sponsor
  • Exelixis Collaboratori
  • Novartis Collaboratori
  • Clovis Oncology, Inc. Collaboratori
  • Janssen Pharmaceuticals Collaboratori

Bracci e interventi

  • 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

Interventi

  • Farmaco Bevacizumab

    Specified dose on specified days

  • Farmaco Cabozantinib

    Specified dose on specified days

  • Farmaco Capecitabine

    Specified dose on specified days

  • Farmaco Daratumumab

    Specified dose on specified days

  • Farmaco Enzalutamide

    Specified dose on specified days

  • Farmaco Fluorouracil

    Specified dose on specified days

  • Farmaco Ipilimumab

    Specified dose on specified days

  • Farmaco Leucovorin

    Specified dose on specified days

  • Farmaco Nivolumab

    Specified dose on specified days

  • Farmaco Nivolumab + Relatlimab

    Specified dose on specified days

  • Farmaco Oxaliplatin

    Specified dose on specified days

  • Farmaco Pembrolizumab

    Specified dose on specified days

  • Farmaco Pemetrexed

    Specified dose on specified days

  • Farmaco Regorafinib

    Specified dose on specified days

  • Farmaco Relatlimab

    Specified dose on specified days

  • Farmaco Rucaparib

    Specified dose on specified days

  • Farmaco Sunitinib

    Specified dose on specified days

  • Farmaco Temozolomide

    Specified dose on specified days

  • Farmaco Trametinib

    Specified dose on specified days

Esiti misurati

  1. Esito primario

    Incidence of Adverse Events (AEs)

    Orizzonte temporale From Day 1 up to 135 Days after discontinuation of treatment

  2. Esito primario

    Incidence of drug related AEs

    Orizzonte temporale From Day 1 up to 135 Days after discontinuation of treatment

  3. Esito primario

    Incidence of AEs leading to Discontinuation

    Orizzonte temporale From Day 1 up to 135 Days after discontinuation of treatment

  4. Esito primario

    Incidence of Serious Adverse Events (SAEs)

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

  5. Esito primario

    Incidence of Select AEs

    Orizzonte temporale From Day 1 up to 135 Days after discontinuation of treatment

  6. Esito primario

    Incidence of Immune-Mediated AEs

    Orizzonte temporale From Day 1 up to 135 Days after discontinuation of treatment

  7. Esito primario

    Incidence of Death

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

Date

Data di inizio9 agosto 2019 (effettiva)
Conclusione primaria25 agosto 2029 (stimata)
Conclusione25 agosto 2029 (stimata)
Prima pubblicazione2 aprile 2019 (effettiva)
Ultimo aggiornamento29 luglio 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltaluglio 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

109 centri stanno reclutando

Argentina

StrutturaCittàStato o regioneStato
Local Institution - 0199BerazateguiBuenos AiresCompletato
Local Institution - 0201Buenos AiresRitirato
Instituto FlemingBuenos AiresIn reclutamento
Local InstitutionCABARitirato
Local Institution - 0170CórdobaRitirato
Fundacion Richardet Longo - IONCCórdobaIn reclutamento
Sanatorio ParqueRosarioSanta Fe ProvinceIn reclutamento
Instituto Medico Rio CuartoRío CuartoCórdoba ProvinceIn reclutamento
Local Institution - 0191San Miguel de TucumánTucumán ProvinceCompletato
CAIPO Centro para la Atencion Integral del Paciente OncologicoSan Miguel de TucumánTucumán ProvinceIn reclutamento
Centro de Investigaciones Clinicas. Clinica Viedma S.A.ViedmaRío Negro ProvinceIn reclutamento

Australia

StrutturaCittàStato o regioneStato
Local InstitutionAdelaideSouth AustraliaRitirato
BRICC - Ballarat Health ServicesBallaratVictoriaIn reclutamento
Local Institution - 0045Coffs HarbourNew South WalesCompletato
Local Institution - 0196Elizabeth ValeSouth AustraliaCompletato
Local Institution - 0365FitzroyVictoriaCompletato
Local Institution - 0372GreenslopesQueenslandRitirato
Gallipoli Medical FoundationGreenslopesQueenslandIn reclutamento
Cabrini Hospital MalvernMalvernVictoriaIn reclutamento
Local Institution - 0174MurdochWestern AustraliaRitirato
Melanoma Institute AustraliaNorth SydneyNew South WalesIn reclutamento
Local InstitutionSouth BrisbaneQueenslandRitirato
Tasman Oncology Research LtdSouthportQueenslandIn reclutamento
Local Institution - 0009SydneyNew South WalesCompletato
Local Institution - 0193WaratahNew South WalesCompletato
Local Institution - 0208WestmeadNew South WalesCompletato

Austria

StrutturaCittàStato o regioneStato
Local Institution - 0254GrazStyriaCompletato
Ordensklinikum Linz GmbH ElisabethinenLinzUpper AustriaIn reclutamento
Local Institution - 0321ViennaCompletato
Local Institution - 0104ViennaCompletato
Local Institution - 0145WelsCompletato

Belgium

StrutturaCittàStato o regioneStato
Local Institution - 0329BrusselsRitirato
Local Institution - 0232GhentCompletato
Local Institution - 0139JetteCompletato
Local Institution - 0261LiègeRitirato
Local Institution - 0293Sint-NiklaasRitirato
Local Institution - 0157YvoirCompletato

Brazil

StrutturaCittàStato o regioneStato
Local Institution - 0264BarretosSão PauloCompletato
Local Institution - 0260Belo HorizonteMinas GeraisCompletato
ONCOSITE - Centro de Pesquisa Clinica em OncologiaIjuíRio Grande do SulIn reclutamento
Local Institution - 0379Passo FundoRio Grande do SulRitirato
Local Institution - 0093Porto AlegreRio Grande do SulNon ancora in reclutamento
Irmandade da Santa Casa de Misericordia de Porto AlegrePorto AlegreRio Grande do SulIn reclutamento
Hospital Sao Lucas Da PucrsPorto AlegreRio Grande do SulIn reclutamento
Local Institution - 0399Porto AlegreRio Grande do SulRitirato
Local Institution - 0258Rio de JaneiroCompletato
Local Institution - 0266Rio de JaneiroCompletato
Local Institution - 0262São José do Rio PretoSão PauloCompletato
Local Institution - 0355São PauloSão PauloCompletato
Local Institution - 0263São PauloSão PauloRitirato

Nella scheda del registro sono indicati altri 349 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

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

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