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
Kurz gefasst
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 Teilnehmende gesucht399 Studienzentren38 Länder
Kategorien
In 1 Register registriert
- ClinicalTrials.govNCT03899155Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten
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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.
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.
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
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
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.
Zusammenfassung
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.
Erkrankungen
- Cancer
Eignung
| Geschlecht | Alle |
|---|---|
| Alter | 18 Years – Kein Höchstalter |
| Gesunde Freiwillige | Nein |
Eignung im Wortlaut des Registers
Eignung in einfachen Aussagen
Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.
Studiendesign
| Studientyp | Interventionell |
|---|---|
| Phase | Phase 2 |
| Zuteilung | Nicht randomisiert |
| Interventionsmodell | PARALLEL |
| Primäres Ziel | TREATMENT |
| Verblindung | NONE (0) |
| Teilnahme | 1.500 Teilnehmende gesucht |
Sponsor und Mitwirkende
- Bristol-Myers Squibb Sponsor
- Exelixis Mitwirkende
- Novartis Mitwirkende
- Clovis Oncology, Inc. Mitwirkende
- Janssen Pharmaceuticals Mitwirkende
Studienarme und Interventionen
- 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
Interventionen
- Arzneimittel Bevacizumab
Specified dose on specified days
- Arzneimittel Cabozantinib
Specified dose on specified days
- Arzneimittel Capecitabine
Specified dose on specified days
- Arzneimittel Daratumumab
Specified dose on specified days
- Arzneimittel Enzalutamide
Specified dose on specified days
- Arzneimittel Fluorouracil
Specified dose on specified days
- Arzneimittel Ipilimumab
Specified dose on specified days
- Arzneimittel Leucovorin
Specified dose on specified days
- Arzneimittel Nivolumab
Specified dose on specified days
- Arzneimittel Nivolumab + Relatlimab
Specified dose on specified days
- Arzneimittel Oxaliplatin
Specified dose on specified days
- Arzneimittel Pembrolizumab
Specified dose on specified days
- Arzneimittel Pemetrexed
Specified dose on specified days
- Arzneimittel Regorafinib
Specified dose on specified days
- Arzneimittel Relatlimab
Specified dose on specified days
- Arzneimittel Rucaparib
Specified dose on specified days
- Arzneimittel Sunitinib
Specified dose on specified days
- Arzneimittel Temozolomide
Specified dose on specified days
- Arzneimittel Trametinib
Specified dose on specified days
Endpunkte
Primärer Endpunkt
Incidence of Adverse Events (AEs)
Zeitrahmen From Day 1 up to 135 Days after discontinuation of treatment
Primärer Endpunkt
Incidence of drug related AEs
Zeitrahmen From Day 1 up to 135 Days after discontinuation of treatment
Primärer Endpunkt
Incidence of AEs leading to Discontinuation
Zeitrahmen From Day 1 up to 135 Days after discontinuation of treatment
Primärer Endpunkt
Incidence of Serious Adverse Events (SAEs)
Zeitrahmen From signature of Informed Consent up to 135 Days after discontinuation of treatment
Primärer Endpunkt
Incidence of Select AEs
Zeitrahmen From Day 1 up to 135 Days after discontinuation of treatment
Primärer Endpunkt
Incidence of Immune-Mediated AEs
Zeitrahmen From Day 1 up to 135 Days after discontinuation of treatment
Primärer Endpunkt
Incidence of Death
Zeitrahmen From signature of Informed Consent up to 135 Days after discontinuation of treatment
Daten
| Startdatum | 9. August 2019 (tatsächlich) |
|---|---|
| Primärer Abschluss | 25. August 2029 (geschätzt) |
| Abschluss | 25. August 2029 (geschätzt) |
| Erstveröffentlichung | 2. April 2019 (tatsächlich) |
| Zuletzt aktualisiert | 29. Juli 2026 |
| Ergebnisse veröffentlicht | Im Registereintrag nicht angegeben |
| Status zuletzt bestätigt | Juli 2026 |
Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.
Standorte
109 Studienzentren rekrutieren
Argentina
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| Local Institution - 0199 | Berazategui | Buenos Aires | Abgeschlossen |
| Local Institution - 0201 | Buenos Aires | Zurückgezogen | |
| Instituto Fleming | Buenos Aires | Rekrutiert | |
| Local Institution | CABA | Zurückgezogen | |
| Local Institution - 0170 | Córdoba | Zurückgezogen | |
| Fundacion Richardet Longo - IONC | Córdoba | Rekrutiert | |
| Sanatorio Parque | Rosario | Santa Fe Province | Rekrutiert |
| Instituto Medico Rio Cuarto | Río Cuarto | Córdoba Province | Rekrutiert |
| Local Institution - 0191 | San Miguel de Tucumán | Tucumán Province | Abgeschlossen |
| CAIPO Centro para la Atencion Integral del Paciente Oncologico | San Miguel de Tucumán | Tucumán Province | Rekrutiert |
| Centro de Investigaciones Clinicas. Clinica Viedma S.A. | Viedma | Río Negro Province | Rekrutiert |
Australia
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| Local Institution | Adelaide | South Australia | Zurückgezogen |
| BRICC - Ballarat Health Services | Ballarat | Victoria | Rekrutiert |
| Local Institution - 0045 | Coffs Harbour | New South Wales | Abgeschlossen |
| Local Institution - 0196 | Elizabeth Vale | South Australia | Abgeschlossen |
| Local Institution - 0365 | Fitzroy | Victoria | Abgeschlossen |
| Local Institution - 0372 | Greenslopes | Queensland | Zurückgezogen |
| Gallipoli Medical Foundation | Greenslopes | Queensland | Rekrutiert |
| Cabrini Hospital Malvern | Malvern | Victoria | Rekrutiert |
| Local Institution - 0174 | Murdoch | Western Australia | Zurückgezogen |
| Melanoma Institute Australia | North Sydney | New South Wales | Rekrutiert |
| Local Institution | South Brisbane | Queensland | Zurückgezogen |
| Tasman Oncology Research Ltd | Southport | Queensland | Rekrutiert |
| Local Institution - 0009 | Sydney | New South Wales | Abgeschlossen |
| Local Institution - 0193 | Waratah | New South Wales | Abgeschlossen |
| Local Institution - 0208 | Westmead | New South Wales | Abgeschlossen |
Austria
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| Local Institution - 0254 | Graz | Styria | Abgeschlossen |
| Ordensklinikum Linz GmbH Elisabethinen | Linz | Upper Austria | Rekrutiert |
| Local Institution - 0321 | Vienna | Abgeschlossen | |
| Local Institution - 0104 | Vienna | Abgeschlossen | |
| Local Institution - 0145 | Wels | Abgeschlossen |
Belgium
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| Local Institution - 0329 | Brussels | Zurückgezogen | |
| Local Institution - 0232 | Ghent | Abgeschlossen | |
| Local Institution - 0139 | Jette | Abgeschlossen | |
| Local Institution - 0261 | Liège | Zurückgezogen | |
| Local Institution - 0293 | Sint-Niklaas | Zurückgezogen | |
| Local Institution - 0157 | Yvoir | Abgeschlossen |
Brazil
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| Local Institution - 0264 | Barretos | São Paulo | Abgeschlossen |
| Local Institution - 0260 | Belo Horizonte | Minas Gerais | Abgeschlossen |
| ONCOSITE - Centro de Pesquisa Clinica em Oncologia | Ijuí | Rio Grande do Sul | Rekrutiert |
| Local Institution - 0379 | Passo Fundo | Rio Grande do Sul | Zurückgezogen |
| Local Institution - 0093 | Porto Alegre | Rio Grande do Sul | Rekrutierung noch nicht begonnen |
| Irmandade da Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | Rekrutiert |
| Hospital Sao Lucas Da Pucrs | Porto Alegre | Rio Grande do Sul | Rekrutiert |
| Local Institution - 0399 | Porto Alegre | Rio Grande do Sul | Zurückgezogen |
| Local Institution - 0258 | Rio de Janeiro | Abgeschlossen | |
| Local Institution - 0266 | Rio de Janeiro | Abgeschlossen | |
| Local Institution - 0262 | São José do Rio Preto | São Paulo | Abgeschlossen |
| Local Institution - 0355 | São Paulo | São Paulo | Abgeschlossen |
| Local Institution - 0263 | São Paulo | São Paulo | Zurückgezogen |
349 weitere Studienzentren sind im Registereintrag aufgeführt.
Studiendokumente
In diesem Registereintrag sind keine Dokumente verlinkt.
Änderungen im Zeitverlauf
Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.
Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.