Home/Get Matched/NCT03899155
Phase 2Recruiting
View on ClinicalTrials.gov

Comparing 32 approaches for cancer

Official title: 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

Condition: CancerSponsor: Bristol-Myers SquibbTarget enrollment: 1500
  • Phase 2
  • 32 groups
  • Sites in Edmonton, Vancouver and 4 more cities
  • Recruiting
Local Institution, Vancouver, British ColumbiaLocal Institution, Halifax, Nova ScotiaLocal Institution - 0168, Oshawa, OntarioLocal Institution - 0040, Montreal, QuebecLocal Institution - 0308, Montreal, QuebecCross Cancer Institute, Edmonton, AlbertaPrincess Margaret Cancer Centre, Toronto, Ontario

Interventions (19)

  • Medication

    Nivolumab

    Specified dose on specified days

  • Medication

    Ipilimumab

    Specified dose on specified days

  • Medication

    Cabozantinib

    Specified dose on specified days

Canadian Sites (7)

2 of 7 recruiting

  • Cross Cancer Institute

    Edmonton, Alberta

    Recruiting
  • Princess Margaret Cancer Centre

    Toronto, Ontario

    Recruiting
  • Local Institution

    Vancouver, British Columbia

    Withdrawn

Eligibility Criteria

See who this study is looking for13 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Signed Written Informed ConsentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
  • +Eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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.
  • +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
  • +Participant is not eligible for study treatment per the Parent Study eligibility criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more →.
  • +Participants not receiving clinical benefit as assessed by the Investigator.
  • +Any clinical adverse eventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (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 protocolProtocolThe detailed plan a study must follow.Read more →-defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion Criteria apply
  • +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

  • Participant is not eligible for study treatment per the Parent Study eligibility criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more →.
  • Participants not receiving clinical benefit as assessed by the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
  • Any clinical adverse eventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (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 protocolProtocolThe detailed plan a study must follow.Read more →-defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 32 groups in this study.

Groups A, B and U receive Nivolumab.

Registry label: A: A1: Nivolumab Monotherapy Dose 1 · B: A2: Nivolumab Monotherapy Dose 2 · U: D4: Nivolumab + Bevacizumab

Groups C and J receive Nivolumab and Ipilimumab.

Registry label: C: B1: Nivolumab + Ipilimumab · J: C5: Relatlimab + Nivolumab + Ipilimumab

Group D receives Nivolumab, Ipilimumab and Cabozantinib.

Registry label: D: B2: Nivolumab + Ipilimumab + Cabozantinib

Group E receives Nivolumab, Ipilimumab and Trametinib.

Registry label: E: B3: Nivolumab + Ipilimumab + Trametinib

Groups F and G receive Nivolumab + Relatlimab.

Registry label: F: C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1 · G: C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2

Groups H, I, L, M, N, O and Q receive Relatlimab and Nivolumab.

Registry label: H: C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1 · I: C4: Relatlimab + Nivolumab SAV Dose 2 · L: C7: Relatlimab + Nivolumab SAV Dose 3 · M: C10: Relatlimab + Nivolumab SAV Dose 4 · N: C12: Relatlimab + Nivolumab SAV Dose 5 · O: C8: Relatlimab + Nivolumab SAV + PDCT Dose 1 · Q: C11: Relatlimab + Nivolumab SAV + PDCT Dose 2

Group K receives Capecitabine, together with one or more of: Nivolumab + Relatlimab.

Registry label: K: C6: Relatlimab + Nivolumab + Capecitabine

Group P receives Relatlimab, Nivolumab and Bevacizumab.

Registry label: P: C9: Relatlimab + Nivolumab SAV + Bevacizumab

Group R receives Nivolumab and Temozolomide.

Registry label: R: D1: Nivolumab + Temozolomide

Group S receives Nivolumab and Rucaparib.

Registry label: S: D2: Nivolumab + Rucaparib

Group T receives Nivolumab and Daratumumab.

Registry label: T: D3: Nivolumab + Daratumumab

Group V receives Bevacizumab.

Registry label: V: E1: Bevacizumab Monotherapy

Group W receives Regorafinib.

Registry label: W: E2: Regorafinib Monotherapy

Group X receives Leucovorin, Oxaliplatin and Fluorouracil.

Registry label: X: E4: Leucovorin + Oxaliplatin + Fluorouracil

Group Y receives Enzalutamide.

Registry label: Y: E5: Enzalutamide Monotherapy

Group Z receives Sunitinib.

Registry label: Z: E6: Sunitinib Monotherapy

Group AA receives Rucaparib.

Registry label: AA: E7: Rucaparib Monotherapy

Group AB receives Capecitabine.

Registry label: AB: E8: Capecitabine Monotherapy

Group AC receives Cabozantinib.

Registry label: AC: E9: Cabozantinib Monotherapy

Group AD receives Pemetrexed.

Registry label: AD: E10: Pemetrexed Monotherapy

Group AEAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → receives Pembrolizumab.

Registry label: AE: E11: Pembrolizumab Monotherapy

Group AF receives Leucovorin.

Registry label: AF: E3: Leucovorin + Fluorouracil

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Groups are assigned by the study team using set rules, rather than by chance.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 1,500 people.

The study is currently expected to finish around August 2029.

The main measurement is taken over: From Day 1 up to 135 Days after discontinuation of treatment.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Incidence of Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over From Day 1 up to 135 Days after discontinuation of treatment.

Incidence of drug related AEs — measured over From Day 1 up to 135 Days after discontinuation of treatment.

Incidence of AEs leading to Discontinuation — measured over From Day 1 up to 135 Days after discontinuation of treatment.

Incidence of Serious Adverse EventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → (SAEs) — measured over From signature of Informed ConsentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → up to 135 Days after discontinuation of treatment.

The study lists 3 further main measurements.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT03899155 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About NivolumabDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About IpilimumabDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About CabozantinibDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About TrametinibDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About RelatlimabDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Nivolumab + RelatlimabDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About CapecitabineDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About BevacizumabDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About TemozolomideDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About RucaparibDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About DaratumumabDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About RegorafinibDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About LeucovorinDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About FluorouracilDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About OxaliplatinDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About EnzalutamideDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About SunitinibDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About PemetrexedDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About PembrolizumabDrug

Specified dose on specified days

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Groups are assigned by the study team using set rules, rather than by chance.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: From Day 1 up to 135 Days after discontinuation of treatment.

The study as a whole is currently expected to finish around 2029-08-25.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 1,500 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 12 locations, including: Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Oshawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada, and 6 more.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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

Other Sites (9)

Local Institution - 0143

Ann Arbor, Michigan, United States

Local Institution - 0100

Minneapolis, Minnesota, United States

Local Institution - 0128

Buffalo, New York, United States

NYU Langone Hematology Oncology Associates-Mineola

Mineola, New York, United States

Local Institution

New York, New York, United States

Local Institution - 0185

New York, New York, United States

Local Institution - 0202

New York, New York, United States

Local Institution

New York, New York, United States

Public Hospital of King County District 1 Valley Medical Center

Renton, Washington, United States

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.