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A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03520959
Recruitment Status : Terminated (Study was terminated due to sponsor's decision.)
First Posted : May 11, 2018
Results First Posted : April 1, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Immune Design

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Synovial Sarcoma
Cancer
Soft Tissue Sarcoma
Sarcoma
Metastatic Sarcoma
Interventions Biological: LV305
Biological: G305
Other: LV305-matching placebo
Other: G305-matching placebo
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo CMB305
Hide Arm/Group Description CMB305 placebo control CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
Period Title: Overall Study
Started 0 1
Completed 0 0
Not Completed 0 1
Reason Not Completed
Study terminated by Sponsor             0             1
Arm/Group Title Placebo CMB305 Total
Hide Arm/Group Description CMB305 placebo control CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}] Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
0 participants are reported due to the risk of identification of a person.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Ethnicity (NIH/OMB)  
Number Analyzed 0 participants 0 participants 0 participants
Hispanic or Latino
Not Hispanic or Latino
Unknown or Not Reported
Race (NIH/OMB)  
Number Analyzed 0 participants 0 participants 0 participants
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description 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).
Time Frame From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected or analyzed for this outcome measure due to early termination of the study.
Arm/Group Title Placebo CMB305
Hide Arm/Group Description:
CMB305 placebo control
CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time from randomization to the date of death.
Time Frame From randomization to date of death, assessed up to 66 months.
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected or analyzed for this outcome measure due to early termination of the study.
Arm/Group Title Placebo CMB305
Hide Arm/Group Description:
CMB305 placebo control
CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Time to Next Treatment (TTNT)
Hide Description 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.
Time Frame From last dose of CMB305 to initiation of new therapy, assessed up to 24 months.
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected or analyzed for this outcome measure due to early termination of the study.
Arm/Group Title Placebo CMB305
Hide Arm/Group Description:
CMB305 placebo control
CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Distant Metastasis Free Survival (DMFS)
Hide Description 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.
Time Frame From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected or analyzed for this outcome measure due to early termination of the study.
Arm/Group Title Placebo CMB305
Hide Arm/Group Description:
CMB305 placebo control
CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description 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.
Time Frame From randomization to investigator-determined date of disease progression, assessed up to 24 months.
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected or analyzed for this outcome measure due to early termination of the study.
Arm/Group Title Placebo CMB305
Hide Arm/Group Description:
CMB305 placebo control
CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)
Hide Description 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.
Time Frame From randomization to investigator-determined date of disease progression or death, assessed up to approximately 2 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants taking any amount of study drug.
Arm/Group Title Placebo CMB305
Hide Arm/Group Description:
CMB305 placebo control
CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: Participants
1
7.Secondary Outcome
Title Quality of Life (QoL): EuroQol 5-Dimension 5 Level (EQ-5D-5L) and EuroQol 5-Dimension Youth (EQ-5D-Y) Questionnaires
Hide Description 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).
Time Frame From Day 1 up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected or analyzed for this outcome measure due to early termination of the study.
Arm/Group Title Placebo CMB305
Hide Arm/Group Description:
CMB305 placebo control
CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants Who Discontinued Study Treatment Due to an AE
Hide Description The number of all participants who discontinued study treatment due to an AE is presented.
Time Frame Up to approximately 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants taking any amount of study drug.
Arm/Group Title Placebo CMB305
Hide Arm/Group Description:
CMB305 placebo control
CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: Participants
0
Time Frame Up to approximately 2 months
Adverse Event Reporting Description 0 participants are reported due to the risk of identification of a person.
 
Arm/Group Title Placebo CMB305
Hide Arm/Group Description CMB305 placebo control CMB305: Sequentially administered LV305 [lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene] and G305 [NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}]
All-Cause Mortality
Placebo CMB305
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Placebo CMB305
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo CMB305
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Study was stopped early due to Sponsor decision.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Immune Design
ClinicalTrials.gov Identifier: NCT03520959    
Other Study ID Numbers: IMDZ-04-1702
V943A-003 ( Other Identifier: Merck Unique ID )
First Submitted: March 30, 2018
First Posted: May 11, 2018
Results First Submitted: February 26, 2020
Results First Posted: April 1, 2020
Last Update Posted: April 16, 2020