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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01968109
Registration number
NCT01968109
Ethics application status
Date submitted
25/09/2013
Date registered
23/10/2013
Date last updated
17/07/2024
Titles & IDs
Public title
An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
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Scientific title
A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
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Secondary ID [1]
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2023-508067-70
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Secondary ID [2]
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CA224-020
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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:
Neoplasms by Site
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Condition category
Condition code
Cancer
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0
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Any cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - BMS-986213
Experimental: Relatlimab - Relatlimab (BMS-986016) specified dose on specified days
Experimental: Relatlimab + Nivolumab - Relatlimab (BMS-986016) + Nivolumab (BMS-936558) specified dose on specified days
Experimental: BMS-986213 - Relatlimab (BMS-986016) + Nivolumab (BMS-936558)
Treatment: Other: BMS-986213
Relatlimab + Nivolumab
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Intervention code [1]
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Treatment: Other
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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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Proportion of participants with Adverse Events (AEs)
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Assessment method [1]
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Grade 3 or higher per CTCAE v4 (Common Terminology Criteria for Adverse Events)
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Timepoint [1]
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Approximately Up to 3 years
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Primary outcome [2]
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Proportion of participants with Serious Adverse Events (SAEs)
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Assessment method [2]
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Grade 3 or higher per CTCAE v4 ( Common Terminology Criteria for Adverse Events)
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Timepoint [2]
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Approximately Up to 3 years
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Primary outcome [3]
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0
Proportion of Deaths
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Assessment method [3]
0
0
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Timepoint [3]
0
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Approximately Up to 3 years
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Primary outcome [4]
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Proportion of participants with laboratory abnormalities in blood
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Assessment method [4]
0
0
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Timepoint [4]
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Approximately Up to 3 years
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Primary outcome [5]
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0
Proportion of participants with laboratory abnormalities in blood serum
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Assessment method [5]
0
0
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Timepoint [5]
0
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Approximately Up to 3 years
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Primary outcome [6]
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0
Proportion of participants with laboratory abnormalities in urine
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Assessment method [6]
0
0
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Timepoint [6]
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Approximately Up to 3 years
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Primary outcome [7]
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Objective response rate (ORR)
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Assessment method [7]
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0
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Timepoint [7]
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Approximately 3 years
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Primary outcome [8]
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Disease control rate (DCR)
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Assessment method [8]
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0
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Timepoint [8]
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Approximately 3 years
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Primary outcome [9]
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Duration of response (DOR)
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Assessment method [9]
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0
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Timepoint [9]
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Approximately 3 years
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Primary outcome [10]
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Number of AEs in the Broad Scope MedDRA Anaphylactic Reaction SMQ
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Assessment method [10]
0
0
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Timepoint [10]
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Approximately 3 years
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Primary outcome [11]
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Proportion of participants with AEs leading to discontinuation of treatment
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Assessment method [11]
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0
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Timepoint [11]
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Approximately up to 3 years
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Secondary outcome [1]
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Maximum observed serum concentration (Cmax) of BMS-986016 administered both alone and in combination with nivolumab
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Assessment method [1]
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0
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Timepoint [1]
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Approximately 2.3 years
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Secondary outcome [2]
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Time of maximum observed serum concentration (Tmax) of BMS-986016 administered both alone and in combination with nivolumab
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Assessment method [2]
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Timepoint [2]
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Approximately 2.3 years
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Secondary outcome [3]
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Trough observed serum concentration (Ctrough) of BMS-986016 administered both alone and in combination with nivolumab
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Assessment method [3]
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0
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Timepoint [3]
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Approximately 2.3 years
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Secondary outcome [4]
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Concentration at the end of a dosing interval (Ctau) [Eg: concentration at 336 hours] of BMS-986016 administered both alone and in combination with nivolumab
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Assessment method [4]
0
0
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Timepoint [4]
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Approximately 2.3 years
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Secondary outcome [5]
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Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986016 administered both alone and in combination with nivolumab
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Assessment method [5]
0
0
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Timepoint [5]
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Approximately 2.3 years
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Secondary outcome [6]
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Total body clearance (CLT) of BMS-986016 administered both alone and in combination with nivolumab
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Assessment method [6]
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0
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Timepoint [6]
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Approximately 2.3 years
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Secondary outcome [7]
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Volume of distribution at steady state (Vss) of BMS-986016 administered both alone and in combination with nivolumab
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Assessment method [7]
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Timepoint [7]
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Approximately 2.3 years
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Secondary outcome [8]
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Effective elimination half-life that explains the degree of area under the concentration-time curve (AUC) accumulation observed (T-HALFeff AUC) of BMS-986016 administered both alone and in combination with nivolumab
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Assessment method [8]
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Timepoint [8]
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Approximately 2.3 years
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Secondary outcome [9]
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Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016 administered both alone and in combination with nivolumab
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Assessment method [9]
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Timepoint [9]
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Approximately 2.3 years
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Secondary outcome [10]
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Accumulation index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016 administered both alone and in combination with nivolumab
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Assessment method [10]
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0
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Timepoint [10]
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Approximately 2.3 years
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Secondary outcome [11]
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Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016 administered both alone and in combination with nivolumab
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Assessment method [11]
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Timepoint [11]
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Approximately 2.3 years
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Secondary outcome [12]
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Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016 administered both alone and in combination with nivolumab
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Assessment method [12]
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Timepoint [12]
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Approximately 2.3 years
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Secondary outcome [13]
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Degree of fluctuation (DF) or fluctuation index ([Cmax - Ctau]/Css,avg]) of BMS-986016 administered both alone and in combination with nivolumab
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Assessment method [13]
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Timepoint [13]
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Approximately 2.3 years
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Secondary outcome [14]
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Immunogenicity measured by anti-drug antibody (ADA) for BMS-986016 (all participants) and nivolumab
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Assessment method [14]
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Timepoint [14]
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Approximately 2.3 years
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Secondary outcome [15]
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QTc interval from centrally read electrocardiograms (ECGs)
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Assessment method [15]
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Timepoint [15]
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Approximately 2.3 years
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Secondary outcome [16]
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Best overall response (BOR)
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Assessment method [16]
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Timepoint [16]
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Approximately 3 years
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Secondary outcome [17]
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ORR
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Assessment method [17]
0
0
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Timepoint [17]
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Approximately 3 years
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Secondary outcome [18]
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DCR
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Assessment method [18]
0
0
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Timepoint [18]
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Approximately 3 years
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Secondary outcome [19]
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Duration of response (DOR)
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Assessment method [19]
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Timepoint [19]
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Approximately 3 years
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Secondary outcome [20]
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Progression-free survival (PFS) rates
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Assessment method [20]
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Timepoint [20]
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Up to approximately 3 years
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Secondary outcome [21]
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Overall survival (OS)
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Assessment method [21]
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Timepoint [21]
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Approximately 2 years
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Secondary outcome [22]
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Number of AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ
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Assessment method [22]
0
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Timepoint [22]
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Approximately 3 years
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Eligibility
Key inclusion criteria
* For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4.
* For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC
* Progressed, or been intolerant to, at least one standard treatment regimen, except for participants in 1st line cohorts.
* ECOG performance status between 0 and 2
* At least 1 lesion with measurable disease at baseline
* Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)
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Minimum age
12
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
* Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease
* Autoimmune disease
* Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
* Uncontrolled CNS metastases
Other protocol defined inclusion/exclusion criteria could apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not 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
5/11/2013
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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
31/01/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
1499
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0029 - North Sydney
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Recruitment hospital [2]
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Local Institution - 0031 - Brisbane
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Recruitment hospital [3]
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Local Institution - 0039 - Southport
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Recruitment hospital [4]
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Local Institution - 0033 - Melbourne
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Recruitment hospital [5]
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Local Institution - 0032 - Nedlands
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Recruitment postcode(s) [1]
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2060 - North Sydney
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Recruitment postcode(s) [2]
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4120 - Brisbane
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Recruitment postcode(s) [3]
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4215 - Southport
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
0
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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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State/province [3]
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Florida
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Country [4]
0
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United States of America
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Illinois
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Country [5]
0
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United States of America
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State/province [5]
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Maryland
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Country [6]
0
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United States of America
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State/province [6]
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Massachusetts
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Country [7]
0
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United States of America
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State/province [7]
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Michigan
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Country [8]
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United States of America
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State/province [8]
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Minnesota
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United States of America
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State/province [9]
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Missouri
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Country [10]
0
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United States of America
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State/province [10]
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New York
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0
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United States of America
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State/province [11]
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Oregon
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Country [12]
0
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United States of America
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State/province [12]
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Pennsylvania
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Country [13]
0
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United States of America
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State/province [13]
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Texas
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Country [14]
0
0
United States of America
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State/province [14]
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Washington
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Country [15]
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Austria
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State/province [15]
0
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Wien
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Country [16]
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Canada
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State/province [16]
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Ontario
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Country [17]
0
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Canada
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State/province [17]
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Quebec
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Country [18]
0
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Denmark
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State/province [18]
0
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Copenhagen
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Country [19]
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Denmark
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State/province [19]
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Herlev
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Country [20]
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Finland
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Uusimaa
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Country [21]
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France
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State/province [21]
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Marseille Cedex 5
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Country [22]
0
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France
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State/province [22]
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Nantes Cedex 01
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Country [23]
0
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France
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State/province [23]
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Pierre Benite Cedex
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Country [24]
0
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France
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State/province [24]
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Toulouse Cedex 9
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Country [25]
0
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France
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State/province [25]
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Villejuif
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Country [26]
0
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Germany
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State/province [26]
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Essen
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Country [27]
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Germany
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State/province [27]
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Heilbronn
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Country [28]
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Germany
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State/province [28]
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Wuerzburg
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Country [29]
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Italy
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State/province [29]
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Milano
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Italy
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Napoli
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Country [31]
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Italy
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State/province [31]
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Padova
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Japan
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State/province [32]
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Aichi
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Country [33]
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Japan
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State/province [33]
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Hokkaido
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Country [34]
0
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Japan
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State/province [34]
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Shizuoka
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Country [35]
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Japan
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Tokyo
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Netherlands
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Amsterdam
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Norway
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Oslo
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Spain
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Barcelona
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Country [39]
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Spain
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Malaga
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Spain
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Pamplona
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Country [41]
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Switzerland
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Lausanne
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Switzerland
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Zuerich
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Country [43]
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United Kingdom
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Greater London
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Country [44]
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United Kingdom
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State/province [44]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.
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Trial website
https://clinicaltrials.gov/study/NCT01968109
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Trial related presentations / publications
Nielsen M, Presti M, Sztupinszki Z, Jensen AWP, Draghi A, Chamberlain CA, Schina A, Yde CW, Wojcik J, Szallasi Z, Crowther MD, Svane IM, Donia M. Coexisting Alterations of MHC Class I Antigen Presentation and IFNgamma Signaling Mediate Acquired Resistance of Melanoma to Post-PD-1 Immunotherapy. Cancer Immunol Res. 2022 Oct 4;10(10):1254-1262. doi: 10.1158/2326-6066.CIR-22-0326.
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Phone
0
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Fax
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Email
0
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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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/NCT01968109
Download to PDF