NCT04895709 Change History

Timestamp Before After
2026-02-26 00:55:48 statusModule.statusVerifiedDate: 2025-12 statusModule.statusVerifiedDate: 2026-02
2026-02-26 00:55:48 statusModule.lastUpdateSubmitDate: 2025-12-16 statusModule.lastUpdateSubmitDate: 2026-02-23
2026-02-26 00:55:48 statusModule.lastUpdatePostDateStruct.date: 2025-12-17 statusModule.lastUpdatePostDateStruct.date: 2026-02-25
2026-02-26 00:55:48 contactsLocationsModule.centralContacts.[0]name: BMS Study Connect Contact Center www.BMSStudyConnect.com contactsLocationsModule.centralContacts.[0]name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
2026-02-26 00:55:48 contactsLocationsModule.locations.[3]status: COMPLETED contactsLocationsModule.locations.[3]status: ACTIVE_NOT_RECRUITING
2026-02-26 00:55:48 contactsLocationsModule.locations.[7]status: COMPLETED contactsLocationsModule.locations.[7]status: ACTIVE_NOT_RECRUITING
2026-02-26 00:55:48 - root['ipdSharingStatementModule'] (Added)
2026-03-21 02:05:09 contactsLocationsModule.locations.[39]city: Napoli contactsLocationsModule.locations.[39]city: Naples
2026-03-21 02:05:09 contactsLocationsModule.locations.[39]geoPoint.lat: 40.87618 contactsLocationsModule.locations.[39]geoPoint.lat: 40.85216
2026-03-21 02:05:09 contactsLocationsModule.locations.[39]geoPoint.lon: 14.5195 contactsLocationsModule.locations.[39]geoPoint.lon: 14.26811
2026-04-07 02:32:47 statusModule.statusVerifiedDate: 2026-02 statusModule.statusVerifiedDate: 2026-04
2026-04-07 02:32:47 statusModule.lastUpdateSubmitDate: 2026-02-23 statusModule.lastUpdateSubmitDate: 2026-04-03
2026-04-07 02:32:47 statusModule.lastUpdatePostDateStruct.date: 2026-02-25 statusModule.lastUpdatePostDateStruct.date: 2026-04-06
2026-04-07 02:32:47 contactsLocationsModule.locations.[3]facility: Local Institution - 0062 contactsLocationsModule.locations.[3]facility: University of Iowa
2026-04-07 02:32:47 contactsLocationsModule.locations.[3]status: ACTIVE_NOT_RECRUITING contactsLocationsModule.locations.[3]status: RECRUITING
2026-04-07 02:32:47 contactsLocationsModule.locations.[7]facility: Local Institution - 0001 contactsLocationsModule.locations.[7]facility: Providence Cancer Center Oncology and Hematology Care- Eastside
2026-04-07 02:32:47 contactsLocationsModule.locations.[7]status: ACTIVE_NOT_RECRUITING contactsLocationsModule.locations.[7]status: RECRUITING
2026-04-07 02:32:47 - root['contactsLocationsModule']['locations'][3]['contacts'] (Added)
2026-04-07 02:32:47 - root['contactsLocationsModule']['locations'][7]['contacts'] (Added)
2026-05-26 02:38:39 statusModule.lastUpdateSubmitDate: 2026-04-03 statusModule.lastUpdateSubmitDate: 2026-04-08
2026-05-26 02:38:39 statusModule.lastUpdatePostDateStruct.date: 2026-04-06 statusModule.lastUpdatePostDateStruct.date: 2026-04-13
2026-05-26 02:38:39 contactsLocationsModule.locations.[19]contacts.[0]phone: 9053170886 contactsLocationsModule.locations.[19]contacts.[0]phone: 905-387-9495
2026-06-05 03:53:46 identificationModule.briefTitle: A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors identificationModule.briefTitle: A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
2026-06-05 03:53:46 identificationModule.officialTitle: A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors identificationModule.officialTitle: A Phase 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
2026-06-05 03:53:46 statusModule.statusVerifiedDate: 2026-04 statusModule.statusVerifiedDate: 2026-06
2026-06-05 03:53:46 statusModule.primaryCompletionDateStruct.date: 2028-07-07 statusModule.primaryCompletionDateStruct.date: 2031-08-31
2026-06-05 03:53:46 statusModule.completionDateStruct.date: 2028-07-07 statusModule.completionDateStruct.date: 2031-08-31
2026-06-05 03:53:46 statusModule.lastUpdateSubmitDate: 2026-04-08 statusModule.lastUpdateSubmitDate: 2026-06-02
2026-06-05 03:53:46 statusModule.lastUpdatePostDateStruct.date: 2026-04-13 statusModule.lastUpdatePostDateStruct.date: 2026-06-04
2026-06-05 03:53:46 descriptionModule.briefSummary: The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors. descriptionModule.briefSummary: The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.
2026-06-05 03:53:46 designModule.designInfo.allocation: NON_RANDOMIZED designModule.designInfo.allocation: RANDOMIZED
2026-06-05 03:53:46 designModule.enrollmentInfo.count: 949 designModule.enrollmentInfo.count: 1109
2026-06-05 03:53:46 outcomesModule.primaryOutcomes.[2]measure: Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria outcomesModule.primaryOutcomes.[2]measure: Number of deaths
2026-06-05 03:53:46 - Field `eligibilityModule.eligibilityCriteria` changed from `Inclusion Criteria
2026-06-05 03:53:46 - * Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
2026-06-05 03:53:46 - * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
2026-06-05 03:53:46 - * Eastern Cooperative Oncology Group Performance Status of 0 or 1.
2026-06-05 03:53:46 - * Radiographically documented progressive disease on or after the most recent therapy.
2026-06-05 03:53:46 - * Received standard-of-care therapies, (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
2026-06-05 03:53:46 - * Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
2026-06-05 03:53:46 - Exclusion Criteria
2026-06-05 03:53:46 - * Women` to `Inclusion Criteria
2026-06-05 03:53:46 - * Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
2026-06-05 03:53:46 - * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
2026-06-05 03:53:46 - * Eastern Cooperative Oncology Group Performance Status of 0 or 1.
2026-06-05 03:53:46 - * Radiographically documented progressive disease on or after the most recent therapy.
2026-06-05 03:53:46 - * Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
2026-06-05 03:53:46 - * Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
2026-06-05 03:53:46 - Exclusion Criter`
2026-06-05 03:53:46 contactsLocationsModule.locations.[24]facility: Universitaetsklinikum Ulm contactsLocationsModule.locations.[24]facility: Local Institution - 0044
2026-06-05 03:53:46 contactsLocationsModule.locations.[24]status: RECRUITING contactsLocationsModule.locations.[24]status: COMPLETED
2026-06-05 03:53:46 root['contactsLocationsModule']['locations'][24]['contacts'] (Removed) -
2026-07-28 00:26:03 statusModule.lastUpdateSubmitDate: 2026-06-02 statusModule.lastUpdateSubmitDate: 2026-06-29
2026-07-28 00:26:03 statusModule.lastUpdatePostDateStruct.date: 2026-06-04 statusModule.lastUpdatePostDateStruct.date: 2026-06-30
2026-07-28 00:26:03 contactsLocationsModule.locations.[18]facility: BC Cancer Vancouver contactsLocationsModule.locations.[18]facility: Local Institution - 0030
2026-07-28 00:26:03 contactsLocationsModule.locations.[18]status: RECRUITING contactsLocationsModule.locations.[18]status: COMPLETED
2026-07-28 00:26:03 contactsLocationsModule.locations.[22]facility: The Ottawa Hospital Cancer Centre contactsLocationsModule.locations.[22]facility: Local Institution - 0016
2026-07-28 00:26:03 contactsLocationsModule.locations.[22]status: RECRUITING contactsLocationsModule.locations.[22]status: COMPLETED
2026-07-28 00:26:03 root['contactsLocationsModule']['locations'][18]['contacts'] (Removed) -
2026-07-28 00:26:03 root['contactsLocationsModule']['locations'][22]['contacts'] (Removed) -