A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)
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|ClinicalTrials.gov Identifier: NCT03520959|
Recruitment Status : Terminated (Study was terminated due to sponsor's decision.)
First Posted : May 11, 2018
Results First Posted : April 16, 2020
Last Update Posted : April 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Synovial Sarcoma Cancer Soft Tissue Sarcoma Sarcoma Metastatic Sarcoma||Biological: LV305 Biological: G305 Other: LV305-matching placebo Other: G305-matching placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1+ Synovial Sarcoma Participants Following First Line Systemic Anti-cancer Therapy (V943-003, IMDZ-04-1702)|
|Actual Study Start Date :||September 18, 2018|
|Actual Primary Completion Date :||November 20, 2018|
|Actual Study Completion Date :||November 20, 2018|
Placebo Comparator: Placebo
A sequential regimen of LV305-matching placebo and G305-matching placebo.
Other: LV305-matching placebo
Administered via SC injection.
Other: G305-matching placebo
Administered via IM injection.
A sequential regimen of LV305 and G305.
Administered via subcutaneous (SC) injection.
Administered via intramuscular (IM) injection.
- Progression-Free Survival (PFS) [ Time Frame: From randomization to investigator-determined date of disease progression or death, assessed up to 24 months. ]PFS is defined as the time from randomization to the investigator-determined date of disease progression or death, whichever comes first, using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- Overall Survival (OS) [ Time Frame: From randomization to date of death, assessed up to 66 months. ]OS is defined as the time from randomization to the date of death.
- Time to Next Treatment (TTNT) [ Time Frame: From last dose of CMB305 to initiation of new therapy, assessed up to 24 months. ]TTNT is defined as the time from randomization to the start of post-study treatment subsequent intervention: [TTNT = start date of subsequent intervention - randomization date + 1]. Subsequent intervention includes anticancer therapy, cancer-related surgery and local regional therapy. Participants who do not start any post-study treatment intervention will be censored at their last known date of being alive.
- Distant Metastasis Free Survival (DMFS) [ Time Frame: From randomization to investigator-determined date of disease progression or death, assessed up to 24 months. ]DMFS is defined as the time from randomization to evidence of a new distant metastasis not documented at time of randomization: [DMFS = a new distant metastasis documented date - randomization date + 1]. Participants who do not have any new distant metastasis will be censored at their last tumor assessment.
- Overall Response Rate (ORR) [ Time Frame: From randomization to investigator-determined date of disease progression, assessed up to 24 months. ]ORR defined by RECIST v1.1 will be summarized by the number and percent of subjects who achieve a complete response (CR) or partial response (PR) based on the investigator's assessment. ORR will be compared between treatment arms using a logistic regression.
- Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) [ Time Frame: From randomization to investigator-determined date of disease progression or death, assessed up to approximately 2 months. ]Safety will be assessed primarily based on reported adverse events (AEs), Medical Events of Interest (MEOIs), laboratory values, and concomitant medications reported from initiation of treatment with CMB305 or placebo.
- Quality of Life (QoL): EuroQol 5-Dimension 5 Level (EQ-5D-5L) and EuroQol 5-Dimension Youth (EQ-5D-Y) Questionnaires [ Time Frame: From Day 1 up to 12 months ]QoL evaluated using the EQ-5D-5L for participants ≥18 years of age or using the EQ-5D-Y for participants 12 to <18 years of age. EQ-5D-5L descriptive system is comprised of 5 dimensions-mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 5 levels: not at all (level 1), mild (level 2), moderate (level 3), severe (level 4), extreme/leading to incapacity (level 5), with highest level corresponding to worst outcome. Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group. In the EQ-VAS, participants recorded their health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
- Number of Participants Who Discontinued Study Treatment Due to an AE [ Time Frame: Up to approximately 2 months ]The number of all participants who discontinued study treatment due to an AE is presented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520959