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

RecruitingTaking participants now, according to the registry record.
Contact this study

In brief

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 sought399 sites38 countries

Categories

Oncology100%

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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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.

Summary

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

Conditions

  • Cancer

Eligibility

SexAll
Ages18 Years – No maximum
Healthy volunteersNo

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhasePhase 2
AllocationNon-randomised
Intervention modelPARALLEL
Primary purposeTREATMENT
MaskingNONE (0)
Enrolment1,500 participants sought

Sponsor and collaborators

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

Arms and 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

  • Drug Bevacizumab

    Specified dose on specified days

  • Drug Cabozantinib

    Specified dose on specified days

  • Drug Capecitabine

    Specified dose on specified days

  • Drug Daratumumab

    Specified dose on specified days

  • Drug Enzalutamide

    Specified dose on specified days

  • Drug Fluorouracil

    Specified dose on specified days

  • Drug Ipilimumab

    Specified dose on specified days

  • Drug Leucovorin

    Specified dose on specified days

  • Drug Nivolumab

    Specified dose on specified days

  • Drug Nivolumab + Relatlimab

    Specified dose on specified days

  • Drug Oxaliplatin

    Specified dose on specified days

  • Drug Pembrolizumab

    Specified dose on specified days

  • Drug Pemetrexed

    Specified dose on specified days

  • Drug Regorafinib

    Specified dose on specified days

  • Drug Relatlimab

    Specified dose on specified days

  • Drug Rucaparib

    Specified dose on specified days

  • Drug Sunitinib

    Specified dose on specified days

  • Drug Temozolomide

    Specified dose on specified days

  • Drug Trametinib

    Specified dose on specified days

Outcome measures

  1. Primary outcome

    Incidence of Adverse Events (AEs)

    Time frame From Day 1 up to 135 Days after discontinuation of treatment

  2. Primary outcome

    Incidence of drug related AEs

    Time frame From Day 1 up to 135 Days after discontinuation of treatment

  3. Primary outcome

    Incidence of AEs leading to Discontinuation

    Time frame From Day 1 up to 135 Days after discontinuation of treatment

  4. Primary outcome

    Incidence of Serious Adverse Events (SAEs)

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

  5. Primary outcome

    Incidence of Select AEs

    Time frame From Day 1 up to 135 Days after discontinuation of treatment

  6. Primary outcome

    Incidence of Immune-Mediated AEs

    Time frame From Day 1 up to 135 Days after discontinuation of treatment

  7. Primary outcome

    Incidence of Death

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

Dates

Start dateAugust 9, 2019 (actual)
Primary completionAugust 25, 2029 (estimated)
CompletionAugust 25, 2029 (estimated)
First postedApril 2, 2019 (actual)
Last updatedJuly 29, 2026
Results postedNot stated in the registry record
Status last verifiedJuly 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

109 sites are recruiting

Argentina

FacilityCityState or regionStatus
Local Institution - 0199BerazateguiBuenos AiresCompleted
Local Institution - 0201Buenos AiresWithdrawn
Instituto FlemingBuenos AiresRecruiting
Local InstitutionCABAWithdrawn
Local Institution - 0170CórdobaWithdrawn
Fundacion Richardet Longo - IONCCórdobaRecruiting
Sanatorio ParqueRosarioSanta Fe ProvinceRecruiting
Instituto Medico Rio CuartoRío CuartoCórdoba ProvinceRecruiting
Local Institution - 0191San Miguel de TucumánTucumán ProvinceCompleted
CAIPO Centro para la Atencion Integral del Paciente OncologicoSan Miguel de TucumánTucumán ProvinceRecruiting
Centro de Investigaciones Clinicas. Clinica Viedma S.A.ViedmaRío Negro ProvinceRecruiting

Australia

FacilityCityState or regionStatus
Local InstitutionAdelaideSouth AustraliaWithdrawn
BRICC - Ballarat Health ServicesBallaratVictoriaRecruiting
Local Institution - 0045Coffs HarbourNew South WalesCompleted
Local Institution - 0196Elizabeth ValeSouth AustraliaCompleted
Local Institution - 0365FitzroyVictoriaCompleted
Local Institution - 0372GreenslopesQueenslandWithdrawn
Gallipoli Medical FoundationGreenslopesQueenslandRecruiting
Cabrini Hospital MalvernMalvernVictoriaRecruiting
Local Institution - 0174MurdochWestern AustraliaWithdrawn
Melanoma Institute AustraliaNorth SydneyNew South WalesRecruiting
Local InstitutionSouth BrisbaneQueenslandWithdrawn
Tasman Oncology Research LtdSouthportQueenslandRecruiting
Local Institution - 0009SydneyNew South WalesCompleted
Local Institution - 0193WaratahNew South WalesCompleted
Local Institution - 0208WestmeadNew South WalesCompleted

Austria

FacilityCityState or regionStatus
Local Institution - 0254GrazStyriaCompleted
Ordensklinikum Linz GmbH ElisabethinenLinzUpper AustriaRecruiting
Local Institution - 0321ViennaCompleted
Local Institution - 0104ViennaCompleted
Local Institution - 0145WelsCompleted

Belgium

FacilityCityState or regionStatus
Local Institution - 0329BrusselsWithdrawn
Local Institution - 0232GhentCompleted
Local Institution - 0139JetteCompleted
Local Institution - 0261LiègeWithdrawn
Local Institution - 0293Sint-NiklaasWithdrawn
Local Institution - 0157YvoirCompleted

Brazil

FacilityCityState or regionStatus
Local Institution - 0264BarretosSão PauloCompleted
Local Institution - 0260Belo HorizonteMinas GeraisCompleted
ONCOSITE - Centro de Pesquisa Clinica em OncologiaIjuíRio Grande do SulRecruiting
Local Institution - 0379Passo FundoRio Grande do SulWithdrawn
Local Institution - 0093Porto AlegreRio Grande do SulNot yet recruiting
Irmandade da Santa Casa de Misericordia de Porto AlegrePorto AlegreRio Grande do SulRecruiting
Hospital Sao Lucas Da PucrsPorto AlegreRio Grande do SulRecruiting
Local Institution - 0399Porto AlegreRio Grande do SulWithdrawn
Local Institution - 0258Rio de JaneiroCompleted
Local Institution - 0266Rio de JaneiroCompleted
Local Institution - 0262São José do Rio PretoSão PauloCompleted
Local Institution - 0355São PauloSão PauloCompleted
Local Institution - 0263São PauloSão PauloWithdrawn

349 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

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