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

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

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

Phase 21 500 participants recherchés399 sites38 pays

Catégories

Oncologie100%

Enregistré dans 1 registre

ClinicalTrials.govNCT03899155Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 mois

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Present: Registered before enrolment beganFirst posted 2019-04-02; recorded start 2019-08-09
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: 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.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 321 other studies in this databaseCounted from the lead sponsor named in the record (Bristol-Myers Squibb)
Present: 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.

Résumé

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

Affections

Cancer

Éligibilité

Éligibilité
Sexe	Tous
Âges	18 Years – Aucun maximum
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Phase 2
Répartition	Non randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	NONE (0)
Recrutement	1 500 participants recherchés

Promoteur et collaborateurs

Bristol-Myers Squibb Promoteur
Exelixis Collaborateurs
Novartis Collaborateurs
Clovis Oncology, Inc. Collaborateurs
Janssen Pharmaceuticals Collaborateurs

Groupes et interventions

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

Interventions

Médicament Bevacizumab
Specified dose on specified days
Médicament Cabozantinib
Specified dose on specified days
Médicament Capecitabine
Specified dose on specified days
Médicament Daratumumab
Specified dose on specified days
Médicament Enzalutamide
Specified dose on specified days
Médicament Fluorouracil
Specified dose on specified days
Médicament Ipilimumab
Specified dose on specified days
Médicament Leucovorin
Specified dose on specified days
Médicament Nivolumab
Specified dose on specified days
Médicament Nivolumab + Relatlimab
Specified dose on specified days
Médicament Oxaliplatin
Specified dose on specified days
Médicament Pembrolizumab
Specified dose on specified days
Médicament Pemetrexed
Specified dose on specified days
Médicament Regorafinib
Specified dose on specified days
Médicament Relatlimab
Specified dose on specified days
Médicament Rucaparib
Specified dose on specified days
Médicament Sunitinib
Specified dose on specified days
Médicament Temozolomide
Specified dose on specified days
Médicament Trametinib
Specified dose on specified days

Critères de jugement

Critère de jugement principal
Incidence of Adverse Events (AEs)
Délai From Day 1 up to 135 Days after discontinuation of treatment
Critère de jugement principal
Incidence of drug related AEs
Délai From Day 1 up to 135 Days after discontinuation of treatment
Critère de jugement principal
Incidence of AEs leading to Discontinuation
Délai From Day 1 up to 135 Days after discontinuation of treatment
Critère de jugement principal
Incidence of Serious Adverse Events (SAEs)
Délai From signature of Informed Consent up to 135 Days after discontinuation of treatment
Critère de jugement principal
Incidence of Select AEs
Délai From Day 1 up to 135 Days after discontinuation of treatment
Critère de jugement principal
Incidence of Immune-Mediated AEs
Délai From Day 1 up to 135 Days after discontinuation of treatment
Critère de jugement principal
Incidence of Death
Délai From signature of Informed Consent up to 135 Days after discontinuation of treatment

Dates

Dates
Date de début	9 août 2019 (réelle)
Achèvement principal	25 août 2029 (estimée)
Achèvement	25 août 2029 (estimée)
Première publication	2 avril 2019 (réelle)
Dernière mise à jour	29 juillet 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	juillet 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

109 sites sont en recrutement

Argentina

Argentina
Établissement	Ville	État ou région	Statut
Local Institution - 0199	Berazategui	Buenos Aires	Terminé
Local Institution - 0201	Buenos Aires		Retiré
Instituto Fleming	Buenos Aires		En recrutement
Local Institution	CABA		Retiré
Local Institution - 0170	Córdoba		Retiré
Fundacion Richardet Longo - IONC	Córdoba		En recrutement
Sanatorio Parque	Rosario	Santa Fe Province	En recrutement
Instituto Medico Rio Cuarto	Río Cuarto	Córdoba Province	En recrutement
Local Institution - 0191	San Miguel de Tucumán	Tucumán Province	Terminé
CAIPO Centro para la Atencion Integral del Paciente Oncologico	San Miguel de Tucumán	Tucumán Province	En recrutement
Centro de Investigaciones Clinicas. Clinica Viedma S.A.	Viedma	Río Negro Province	En recrutement

Australia

Australia
Établissement	Ville	État ou région	Statut
Local Institution	Adelaide	South Australia	Retiré
BRICC - Ballarat Health Services	Ballarat	Victoria	En recrutement
Local Institution - 0045	Coffs Harbour	New South Wales	Terminé
Local Institution - 0196	Elizabeth Vale	South Australia	Terminé
Local Institution - 0365	Fitzroy	Victoria	Terminé
Local Institution - 0372	Greenslopes	Queensland	Retiré
Gallipoli Medical Foundation	Greenslopes	Queensland	En recrutement
Cabrini Hospital Malvern	Malvern	Victoria	En recrutement
Local Institution - 0174	Murdoch	Western Australia	Retiré
Melanoma Institute Australia	North Sydney	New South Wales	En recrutement
Local Institution	South Brisbane	Queensland	Retiré
Tasman Oncology Research Ltd	Southport	Queensland	En recrutement
Local Institution - 0009	Sydney	New South Wales	Terminé
Local Institution - 0193	Waratah	New South Wales	Terminé
Local Institution - 0208	Westmead	New South Wales	Terminé

Austria

Austria
Établissement	Ville	État ou région	Statut
Local Institution - 0254	Graz	Styria	Terminé
Ordensklinikum Linz GmbH Elisabethinen	Linz	Upper Austria	En recrutement
Local Institution - 0321	Vienna		Terminé
Local Institution - 0104	Vienna		Terminé
Local Institution - 0145	Wels		Terminé

Belgium

Belgium
Établissement	Ville	Statut
Local Institution - 0329	Brussels	Retiré
Local Institution - 0232	Ghent	Terminé
Local Institution - 0139	Jette	Terminé
Local Institution - 0261	Liège	Retiré
Local Institution - 0293	Sint-Niklaas	Retiré
Local Institution - 0157	Yvoir	Terminé

Brazil

Brazil
Établissement	Ville	État ou région	Statut
Local Institution - 0264	Barretos	São Paulo	Terminé
Local Institution - 0260	Belo Horizonte	Minas Gerais	Terminé
ONCOSITE - Centro de Pesquisa Clinica em Oncologia	Ijuí	Rio Grande do Sul	En recrutement
Local Institution - 0379	Passo Fundo	Rio Grande do Sul	Retiré
Local Institution - 0093	Porto Alegre	Rio Grande do Sul	Pas encore en recrutement
Irmandade da Santa Casa de Misericordia de Porto Alegre	Porto Alegre	Rio Grande do Sul	En recrutement
Hospital Sao Lucas Da Pucrs	Porto Alegre	Rio Grande do Sul	En recrutement
Local Institution - 0399	Porto Alegre	Rio Grande do Sul	Retiré
Local Institution - 0258	Rio de Janeiro		Terminé
Local Institution - 0266	Rio de Janeiro		Terminé
Local Institution - 0262	São José do Rio Preto	São Paulo	Terminé
Local Institution - 0355	São Paulo	São Paulo	Terminé
Local Institution - 0263	São Paulo	São Paulo	Retiré

349 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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