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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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

שלב 2דרושים 1,500 משתתפים399 אתרים38 מדינות

קטגוריות

אונקולוגיה100%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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

מצבים רפואיים

  • Cancer

זכאות

מיןהכול
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 2
הקצאהלא אקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהNONE (0)
גיוסדרושים 1,500 משתתפים

נותן חסות ושותפים

  • Bristol-Myers Squibb נותן חסות
  • Exelixis שותפים
  • Novartis שותפים
  • Clovis Oncology, Inc. שותפים
  • Janssen Pharmaceuticals שותפים

זרועות והתערבויות

  • 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

התערבויות

  • תרופה Bevacizumab

    Specified dose on specified days

  • תרופה Cabozantinib

    Specified dose on specified days

  • תרופה Capecitabine

    Specified dose on specified days

  • תרופה Daratumumab

    Specified dose on specified days

  • תרופה Enzalutamide

    Specified dose on specified days

  • תרופה Fluorouracil

    Specified dose on specified days

  • תרופה Ipilimumab

    Specified dose on specified days

  • תרופה Leucovorin

    Specified dose on specified days

  • תרופה Nivolumab

    Specified dose on specified days

  • תרופה Nivolumab + Relatlimab

    Specified dose on specified days

  • תרופה Oxaliplatin

    Specified dose on specified days

  • תרופה Pembrolizumab

    Specified dose on specified days

  • תרופה Pemetrexed

    Specified dose on specified days

  • תרופה Regorafinib

    Specified dose on specified days

  • תרופה Relatlimab

    Specified dose on specified days

  • תרופה Rucaparib

    Specified dose on specified days

  • תרופה Sunitinib

    Specified dose on specified days

  • תרופה Temozolomide

    Specified dose on specified days

  • תרופה Trametinib

    Specified dose on specified days

מדדי תוצאה

  1. מדד תוצאה ראשוני

    Incidence of Adverse Events (AEs)

    מסגרת זמן From Day 1 up to 135 Days after discontinuation of treatment

  2. מדד תוצאה ראשוני

    Incidence of drug related AEs

    מסגרת זמן From Day 1 up to 135 Days after discontinuation of treatment

  3. מדד תוצאה ראשוני

    Incidence of AEs leading to Discontinuation

    מסגרת זמן From Day 1 up to 135 Days after discontinuation of treatment

  4. מדד תוצאה ראשוני

    Incidence of Serious Adverse Events (SAEs)

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

  5. מדד תוצאה ראשוני

    Incidence of Select AEs

    מסגרת זמן From Day 1 up to 135 Days after discontinuation of treatment

  6. מדד תוצאה ראשוני

    Incidence of Immune-Mediated AEs

    מסגרת זמן From Day 1 up to 135 Days after discontinuation of treatment

  7. מדד תוצאה ראשוני

    Incidence of Death

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

תאריכים

תאריך התחלה9 באוגוסט 2019 (בפועל)
סיום ראשוני25 באוגוסט 2029 (משוער)
סיום25 באוגוסט 2029 (משוער)
פורסם לראשונה2 באפריל 2019 (בפועל)
עודכן לאחרונה29 ביולי 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהיולי 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

109 אתרים מגייסים

Argentina

מתקןעירמדינה או אזורמצב
Local Institution - 0199BerazateguiBuenos Airesהושלם
Local Institution - 0201Buenos Airesבוטל
Instituto FlemingBuenos Airesמגייס
Local InstitutionCABAבוטל
Local Institution - 0170Córdobaבוטל
Fundacion Richardet Longo - IONCCórdobaמגייס
Sanatorio ParqueRosarioSanta Fe Provinceמגייס
Instituto Medico Rio CuartoRío CuartoCórdoba Provinceמגייס
Local Institution - 0191San Miguel de TucumánTucumán Provinceהושלם
CAIPO Centro para la Atencion Integral del Paciente OncologicoSan Miguel de TucumánTucumán Provinceמגייס
Centro de Investigaciones Clinicas. Clinica Viedma S.A.ViedmaRío Negro Provinceמגייס

Australia

מתקןעירמדינה או אזורמצב
Local InstitutionAdelaideSouth Australiaבוטל
BRICC - Ballarat Health ServicesBallaratVictoriaמגייס
Local Institution - 0045Coffs HarbourNew South Walesהושלם
Local Institution - 0196Elizabeth ValeSouth Australiaהושלם
Local Institution - 0365FitzroyVictoriaהושלם
Local Institution - 0372GreenslopesQueenslandבוטל
Gallipoli Medical FoundationGreenslopesQueenslandמגייס
Cabrini Hospital MalvernMalvernVictoriaמגייס
Local Institution - 0174MurdochWestern Australiaבוטל
Melanoma Institute AustraliaNorth SydneyNew South Walesמגייס
Local InstitutionSouth BrisbaneQueenslandבוטל
Tasman Oncology Research LtdSouthportQueenslandמגייס
Local Institution - 0009SydneyNew South Walesהושלם
Local Institution - 0193WaratahNew South Walesהושלם
Local Institution - 0208WestmeadNew South Walesהושלם

Austria

מתקןעירמדינה או אזורמצב
Local Institution - 0254GrazStyriaהושלם
Ordensklinikum Linz GmbH ElisabethinenLinzUpper Austriaמגייס
Local Institution - 0321Viennaהושלם
Local Institution - 0104Viennaהושלם
Local Institution - 0145Welsהושלם

Belgium

מתקןעירמדינה או אזורמצב
Local Institution - 0329Brusselsבוטל
Local Institution - 0232Ghentהושלם
Local Institution - 0139Jetteהושלם
Local Institution - 0261Liègeבוטל
Local Institution - 0293Sint-Niklaasבוטל
Local Institution - 0157Yvoirהושלם

Brazil

מתקןעירמדינה או אזורמצב
Local Institution - 0264BarretosSão Pauloהושלם
Local Institution - 0260Belo HorizonteMinas Geraisהושלם
ONCOSITE - Centro de Pesquisa Clinica em OncologiaIjuíRio Grande do Sulמגייס
Local Institution - 0379Passo FundoRio Grande do Sulבוטל
Local Institution - 0093Porto AlegreRio Grande do Sulטרם מגייס
Irmandade da Santa Casa de Misericordia de Porto AlegrePorto AlegreRio Grande do Sulמגייס
Hospital Sao Lucas Da PucrsPorto AlegreRio Grande do Sulמגייס
Local Institution - 0399Porto AlegreRio Grande do Sulבוטל
Local Institution - 0258Rio de Janeiroהושלם
Local Institution - 0266Rio de Janeiroהושלם
Local Institution - 0262São José do Rio PretoSão Pauloהושלם
Local Institution - 0355São PauloSão Pauloהושלם
Local Institution - 0263São PauloSão Pauloבוטל

349 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

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