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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03899155
Registration number
NCT03899155
Ethics application status
Date submitted
1/04/2019
Date registered
2/04/2019
Date last updated
14/08/2024
Titles & IDs
Public title
Pan Tumor Rollover Study
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Scientific title
Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies
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Secondary ID [1]
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0
2018-004362-34
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Secondary ID [2]
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0
CA209-8TT
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab
Treatment: Drugs - Ipilimumab
Treatment: Drugs - Cabozantinib
Treatment: Drugs - Trametinib
Treatment: Drugs - Relatlimab
Treatment: Drugs - Nivolumab + Relatlimab
Treatment: Drugs - Capecitabine
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Temozolomide
Treatment: Drugs - Rucaparib
Treatment: Drugs - Daratumumab
Treatment: Drugs - Regorafinib
Treatment: Drugs - Leucovorin
Treatment: Drugs - Fluorouracil
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Sunitinib
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Pembrolizumab
Experimental: A1: Nivolumab Monotherapy Dose 1 -
Experimental: A2: Nivolumab Monotherapy Dose 2 -
Experimental: B1: Nivolumab + Ipilimumab -
Experimental: B2: Nivolumab + Ipilimumab + Cabozantinib -
Experimental: B3: Nivolumab + Ipilimumab + Trametinib -
Experimental: C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1 -
Experimental: C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2 -
Experimental: C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1 -
Experimental: C4: Relatlimab + Nivolumab SAV Dose 2 -
Experimental: C5: Relatlimab + Nivolumab + Ipilimumab -
Experimental: C6: Relatlimab + Nivolumab + Capecitabine -
Experimental: C7: Relatlimab + Nivolumab SAV Dose 3 -
Experimental: C10: Relatlimab + Nivolumab SAV Dose 4 -
Experimental: C12: Relatlimab + Nivolumab SAV Dose 5 -
Experimental: C8: Relatlimab + Nivolumab SAV + PDCT Dose 1 -
Experimental: C9: Relatlimab + Nivolumab SAV + Bevacizumab -
Experimental: C11: Relatlimab + Nivolumab SAV + PDCT Dose 2 -
Experimental: D1: Nivolumab + Temozolomide -
Experimental: D2: Nivolumab + Rucaparib -
Experimental: D3: Nivolumab + Daratumumab -
Experimental: D4: Nivolumab + Bevacizumab -
Experimental: E1: Bevacizumab Monotherapy -
Experimental: E2: Regorafinib Monotherapy -
Experimental: E4: Leucovorin + Oxaliplatin + Fluorouracil -
Experimental: E5: Enzalutamide Monotherapy -
Experimental: E6: Sunitinib Monotherapy -
Experimental: E7: Rucaparib Monotherapy -
Experimental: E8: Capecitabine Monotherapy -
Experimental: E9: Cabozantinib Monotherapy -
Experimental: E10: Pemetrexed Monotherapy -
Experimental: E11: Pembrolizumab Monotherapy -
Experimental: E3: Leucovorin + Fluorouracil -
Treatment: Drugs: Nivolumab
Specified dose on specified days
Treatment: Drugs: Ipilimumab
Specified dose on specified days
Treatment: Drugs: Cabozantinib
Specified dose on specified days
Treatment: Drugs: Trametinib
Specified dose on specified days
Treatment: Drugs: Relatlimab
Specified dose on specified days
Treatment: Drugs: Nivolumab + Relatlimab
Specified dose on specified days
Treatment: Drugs: Capecitabine
Specified dose on specified days
Treatment: Drugs: Bevacizumab
Specified dose on specified days
Treatment: Drugs: Temozolomide
Specified dose on specified days
Treatment: Drugs: Rucaparib
Specified dose on specified days
Treatment: Drugs: Daratumumab
Specified dose on specified days
Treatment: Drugs: Regorafinib
Specified dose on specified days
Treatment: Drugs: Leucovorin
Specified dose on specified days
Treatment: Drugs: Fluorouracil
Specified dose on specified days
Treatment: Drugs: Oxaliplatin
Specified dose on specified days
Treatment: Drugs: Enzalutamide
Specified dose on specified days
Treatment: Drugs: Sunitinib
Specified dose on specified days
Treatment: Drugs: Pemetrexed
Specified dose on specified days
Treatment: Drugs: Pembrolizumab
Specified dose on specified days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Adverse Events (AEs)
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Assessment method [1]
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0
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Timepoint [1]
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From Day 1 up to 135 Days after discontinuation of treatment
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Primary outcome [2]
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Incidence of drug related AEs
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Assessment method [2]
0
0
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Timepoint [2]
0
0
From Day 1 up to 135 Days after discontinuation of treatment
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Primary outcome [3]
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Incidence of AEs leading to Discontinuation
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Assessment method [3]
0
0
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Timepoint [3]
0
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From Day 1 up to 135 Days after discontinuation of treatment
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Primary outcome [4]
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Incidence of Serious Adverse Events (SAEs)
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Assessment method [4]
0
0
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Timepoint [4]
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From signature of Informed Consent up to 135 Days after discontinuation of treatment
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Primary outcome [5]
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Incidence of Select AEs
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Assessment method [5]
0
0
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Timepoint [5]
0
0
From Day 1 up to 135 Days after discontinuation of treatment
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Primary outcome [6]
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Incidence of Immune-Mediated AEs
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Assessment method [6]
0
0
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Timepoint [6]
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From Day 1 up to 135 Days after discontinuation of treatment
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Primary outcome [7]
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Incidence of Death
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Assessment method [7]
0
0
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Timepoint [7]
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From signature of Informed Consent up to 135 Days after discontinuation of treatment
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/08/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
25/08/2029
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Actual
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Sample size
Target
1500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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North Coast Area Health Service NCAHS - The North Coast Cancer Institute NCCI - Coffs Harbour Health Campus - Coffs Harbour
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Recruitment hospital [2]
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Local Institution - 0062 - North Sydney
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Recruitment hospital [3]
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Local Institution - 0009 - Sydney
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Recruitment hospital [4]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [5]
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Westmead Hospital - Westmead
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Recruitment hospital [6]
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Gallipoli Medical Foundation - Greenslopes
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Recruitment hospital [7]
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Local Institution - 0372 - Greenslopes
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Recruitment hospital [8]
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Local Institution - South Brisbane
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Recruitment hospital [9]
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Tasman Oncology Research Ltd - Southport
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Recruitment hospital [10]
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Local Institution - Adelaide
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Recruitment hospital [11]
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Local Institution - 0196 - Elizabeth Vale
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Recruitment hospital [12]
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Local Institution - 0365 - Fitzroy
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Recruitment hospital [13]
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Cabrini Hospital Malvern - Malvern
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Recruitment hospital [14]
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Local Institution - 0174 - Murdoch
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Recruitment postcode(s) [1]
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2450 - Coffs Harbour
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Recruitment postcode(s) [2]
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2060 - North Sydney
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Recruitment postcode(s) [3]
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2050 - Sydney
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Recruitment postcode(s) [4]
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2298 - Waratah
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Recruitment postcode(s) [5]
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2145 - Westmead
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Recruitment postcode(s) [6]
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4120 - Greenslopes
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Recruitment postcode(s) [7]
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4101 - South Brisbane
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Recruitment postcode(s) [8]
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4215 - Southport
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Recruitment postcode(s) [9]
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5000 - Adelaide
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Recruitment postcode(s) [10]
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05112 - Elizabeth Vale
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Recruitment postcode(s) [11]
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3065 - Fitzroy
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Recruitment postcode(s) [12]
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3144 - Malvern
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Recruitment postcode(s) [13]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Kansas
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United States of America
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State/province [9]
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Kentucky
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United States of America
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Maryland
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United States of America
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State/province [11]
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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Missouri
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Nebraska
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New Hampshire
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New York
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North Carolina
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Ohio
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Oklahoma
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China
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China
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China
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China
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China
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Jilin
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China
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China
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Hangzhou
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NY
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Rennes
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Germany
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State/province [101]
0
0
Nordrhein-Westfalen
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Aachen
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Country [103]
0
0
Germany
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State/province [103]
0
0
Berlin
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Country [104]
0
0
Germany
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State/province [104]
0
0
Cologne
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Country [105]
0
0
Germany
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State/province [105]
0
0
Freiburg
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Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Gera
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Country [107]
0
0
Germany
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State/province [107]
0
0
Goettingen
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Country [108]
0
0
Germany
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State/province [108]
0
0
Gottingen
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Country [109]
0
0
Germany
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State/province [109]
0
0
Hamburg
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Country [110]
0
0
Germany
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State/province [110]
0
0
Heidelberg
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Country [111]
0
0
Germany
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State/province [111]
0
0
Heilbronn
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Country [112]
0
0
Germany
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State/province [112]
0
0
Jena
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Country [113]
0
0
Germany
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State/province [113]
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0
Kiel
Query!
Country [114]
0
0
Germany
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State/province [114]
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0
Koeln
Query!
Country [115]
0
0
Germany
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State/province [115]
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0
Loewenstein
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Country [116]
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0
Germany
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Luebeck
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0
Germany
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Mainz
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Country [118]
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0
Germany
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0
Tubingen
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Country [119]
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0
Germany
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State/province [119]
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0
Tuebingen
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Country [120]
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0
Greece
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State/province [120]
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0
Crete
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Country [121]
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0
Greece
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State/province [121]
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0
Athens
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Country [122]
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0
Greece
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State/province [122]
0
0
Patras
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Country [123]
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0
Greece
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State/province [123]
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0
Piraeus
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Country [124]
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0
Greece
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State/province [124]
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0
Thessaloniki
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0
Hong Kong
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State/province [125]
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Hong Kong
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0
Hungary
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State/province [126]
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Heves
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Country [127]
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Hungary
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Budapest
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Country [128]
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0
Hungary
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State/province [128]
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Debrecen
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Ireland
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Dublin
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Ireland
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Limerick
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Country [131]
0
0
Israel
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State/province [131]
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Haifa
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Country [132]
0
0
Israel
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State/province [132]
0
0
Jerusalem
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Country [133]
0
0
Israel
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State/province [133]
0
0
Petach Tikva
Query!
Country [134]
0
0
Israel
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State/province [134]
0
0
Ramat Gan
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Country [135]
0
0
Israel
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State/province [135]
0
0
Tiqwa
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Country [136]
0
0
Italy
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State/province [136]
0
0
Fc
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Country [137]
0
0
Italy
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State/province [137]
0
0
MI
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Country [138]
0
0
Italy
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State/province [138]
0
0
RM
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Country [139]
0
0
Italy
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State/province [139]
0
0
Bari
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Country [140]
0
0
Italy
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State/province [140]
0
0
Bergamo
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Country [141]
0
0
Italy
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State/province [141]
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0
Candiolo
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Country [142]
0
0
Italy
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State/province [142]
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0
Catania
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Country [143]
0
0
Italy
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State/province [143]
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Genova
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Country [144]
0
0
Italy
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State/province [144]
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0
Meldola
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Country [145]
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0
Italy
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State/province [145]
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Milano
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Country [146]
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0
Italy
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State/province [146]
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Milan
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Country [147]
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0
Italy
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State/province [147]
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Modena
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Country [148]
0
0
Italy
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State/province [148]
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0
Napoli
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Country [149]
0
0
Italy
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State/province [149]
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Padova
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Country [150]
0
0
Italy
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State/province [150]
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0
Ravenna
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Country [151]
0
0
Italy
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State/province [151]
0
0
Siena
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Country [152]
0
0
Italy
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State/province [152]
0
0
Terni
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Country [153]
0
0
Italy
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State/province [153]
0
0
Torino
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Country [154]
0
0
Japan
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State/province [154]
0
0
Aichi
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Country [155]
0
0
Japan
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State/province [155]
0
0
Aomori
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Country [156]
0
0
Japan
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State/province [156]
0
0
Chiba
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Country [157]
0
0
Japan
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State/province [157]
0
0
Hyogo
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Country [158]
0
0
Japan
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State/province [158]
0
0
Ibaraki
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Country [159]
0
0
Japan
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State/province [159]
0
0
Ishikawa
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Country [160]
0
0
Japan
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State/province [160]
0
0
Kanagawa
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Country [161]
0
0
Japan
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State/province [161]
0
0
Miyagi
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Country [162]
0
0
Japan
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State/province [162]
0
0
Niigata
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Country [163]
0
0
Japan
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State/province [163]
0
0
Osaka
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Country [164]
0
0
Japan
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State/province [164]
0
0
Tokyo
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Country [165]
0
0
Japan
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State/province [165]
0
0
Fukuoka
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Country [166]
0
0
Japan
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State/province [166]
0
0
Hiroshima
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Country [167]
0
0
Korea, Republic of
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State/province [167]
0
0
Songpa-gu
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Country [168]
0
0
Korea, Republic of
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State/province [168]
0
0
Gyeonggi-do
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Country [169]
0
0
Korea, Republic of
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State/province [169]
0
0
Seongnam-si
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Country [170]
0
0
Korea, Republic of
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State/province [170]
0
0
Seoul
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Country [171]
0
0
Korea, Republic of
Query!
State/province [171]
0
0
Suwon Si
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Country [172]
0
0
Mexico
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State/province [172]
0
0
Ciudad De Mexico
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Country [173]
0
0
Mexico
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State/province [173]
0
0
Guanajuato
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Country [174]
0
0
Mexico
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State/province [174]
0
0
Jalisco
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Country [175]
0
0
Mexico
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State/province [175]
0
0
Michoacan
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Country [176]
0
0
Mexico
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State/province [176]
0
0
Nuevo Leon
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Country [177]
0
0
Mexico
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State/province [177]
0
0
Queretaro
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Country [178]
0
0
Mexico
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State/province [178]
0
0
Ciudad de Mexico
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Country [179]
0
0
Mexico
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State/province [179]
0
0
Oaxaca
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Country [180]
0
0
Netherlands
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0
Noord-Holland
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0
Netherlands
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Rotterdam
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Country [182]
0
0
New Zealand
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State/province [182]
0
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Auckland
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Country [183]
0
0
New Zealand
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State/province [183]
0
0
Christchurch
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Country [184]
0
0
New Zealand
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State/province [184]
0
0
Dunedin
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Country [185]
0
0
New Zealand
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State/province [185]
0
0
Tauranga
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Country [186]
0
0
Norway
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State/province [186]
0
0
Bergen
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Country [187]
0
0
Norway
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State/province [187]
0
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Oslo
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Country [188]
0
0
Peru
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State/province [188]
0
0
Lima
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Country [189]
0
0
Poland
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State/province [189]
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Kujawsko-pomorskie
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Country [190]
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0
Poland
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State/province [190]
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0
Lubelskie
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0
0
Poland
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State/province [191]
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Gdansk
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Country [192]
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0
Poland
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State/province [192]
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Krakow
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Country [193]
0
0
Poland
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State/province [193]
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Lodz
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0
Poland
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State/province [194]
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Lublin
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Country [195]
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0
Poland
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State/province [195]
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Poznan
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Country [196]
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0
Poland
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State/province [196]
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Warsaw
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0
Poland
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State/province [197]
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Warszawa
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Country [198]
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0
Portugal
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State/province [198]
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Lisboa
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Country [199]
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0
Portugal
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State/province [199]
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Lisbon
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0
Portugal
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Porto
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Country [201]
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0
Puerto Rico
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0
0
San Juan
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Country [202]
0
0
Romania
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State/province [202]
0
0
Bucharest
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Country [203]
0
0
Romania
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State/province [203]
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0
Cluj Napoca
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Country [204]
0
0
Romania
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State/province [204]
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Cluj-Napoca
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Country [205]
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0
Romania
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State/province [205]
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0
Craiova
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Country [206]
0
0
Romania
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State/province [206]
0
0
Oradea
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Country [207]
0
0
Russian Federation
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0
Krasnodar Region
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Country [208]
0
0
Russian Federation
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0
Krasnoyarsk
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Country [209]
0
0
Russian Federation
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0
Moscow
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Country [210]
0
0
Spain
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State/province [210]
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0
Guipuzcoa
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0
0
Spain
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State/province [211]
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0
Madrid
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Country [212]
0
0
Spain
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State/province [212]
0
0
Navarra
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Country [213]
0
0
Spain
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State/province [213]
0
0
A Coruna
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Country [214]
0
0
Spain
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State/province [214]
0
0
Alicante
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0
0
Spain
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State/province [215]
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0
Badalona
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0
0
Spain
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State/province [216]
0
0
Barcelona
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Country [217]
0
0
Spain
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0
Burgos
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Country [218]
0
0
Spain
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State/province [218]
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0
Granada
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Country [219]
0
0
Spain
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State/province [219]
0
0
Malaga
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Country [220]
0
0
Spain
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State/province [220]
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0
Santa Cruz de Tenerife
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Country [221]
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0
Spain
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State/province [221]
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Santander
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Country [222]
0
0
Spain
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State/province [222]
0
0
Sevilla
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Country [223]
0
0
Spain
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State/province [223]
0
0
Valencia
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Country [224]
0
0
Sweden
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State/province [224]
0
0
Goteborg
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Country [225]
0
0
Sweden
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State/province [225]
0
0
Malmoe
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Country [226]
0
0
Sweden
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State/province [226]
0
0
Umea
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Country [227]
0
0
Switzerland
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State/province [227]
0
0
Basel
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0
Switzerland
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0
Zurich
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Country [229]
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0
Taiwan
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0
Tainan
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Country [230]
0
0
Taiwan
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State/province [230]
0
0
Taipei
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Country [231]
0
0
Turkey
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State/province [231]
0
0
Ankara
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Country [232]
0
0
United Kingdom
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State/province [232]
0
0
Greater London
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Country [233]
0
0
United Kingdom
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State/province [233]
0
0
Greater Manchester
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Country [234]
0
0
United Kingdom
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State/province [234]
0
0
Hampshire
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Country [235]
0
0
United Kingdom
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0
0
Kent
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Country [236]
0
0
United Kingdom
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State/province [236]
0
0
Middlesex
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Country [237]
0
0
United Kingdom
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State/province [237]
0
0
Scotland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
Exelixis
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Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/industry
Query!
Name [2]
0
0
Novartis
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Commercial sector/industry
Query!
Name [3]
0
0
Clovis Oncology, Inc.
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Other collaborator category [4]
0
0
Commercial sector/industry
Query!
Name [4]
0
0
Janssen Pharmaceuticals
Query!
Address [4]
0
0
Query!
Country [4]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03899155
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
BMS Study Connect Contact http://www.bmsstudyconnect.com/
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
855-907-3286
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03899155
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