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| ID | Type | Description | Link |
|---|---|---|---|
| V943A-003 | Other Identifier | Merck Unique ID |
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Study was terminated due to sponsor's decision.
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To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the growth of synovial sarcoma tumor and improve survival.
The Synovate Study is a global, randomized, double-blind, placebo-controlled, phase 3 study in patients with unresectable, locally-advanced or metastatic New York esophageal squamous cell carcinoma 1 (NY-ESO-1) positive synovial sarcoma following first-line systemic anti-cancer therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | A sequential regimen of LV305-matching placebo and G305-matching placebo. |
|
| CMB305 | Experimental | A sequential regimen of LV305 and G305. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LV305 | Biological | Administered via subcutaneous (SC) injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | 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). | From randomization to investigator-determined date of disease progression or death, assessed up to 24 months. |
| Overall Survival (OS) | OS is defined as the time from randomization to the date of death. | From randomization to date of death, assessed up to 66 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Next Treatment (TTNT) | 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. |
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Selected Inclusion Criteria:
Selected Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic- Scottsdale | Scottsdale | Arizona | 85259 | United States | ||
| University of Arizona Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | CMB305 placebo control |
| FG001 | CMB305 | 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}] |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 19, 2018 | Mar 19, 2020 |
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| G305 |
| Biological |
Administered via intramuscular (IM) injection. |
|
| LV305-matching placebo | Other | Administered via SC injection. |
|
| G305-matching placebo | Other | Administered via IM injection. |
|
| From last dose of CMB305 to initiation of new therapy, assessed up to 24 months. |
| Distant Metastasis Free Survival (DMFS) | 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. | From randomization to investigator-determined date of disease progression or death, assessed up to 24 months. |
| Overall Response Rate (ORR) | 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. | From randomization to investigator-determined date of disease progression, assessed up to 24 months. |
| Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) | 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. | From randomization to investigator-determined date of disease progression or death, assessed up to approximately 2 months. |
| Quality of Life (QoL): EuroQol 5-Dimension 5 Level (EQ-5D-5L) and EuroQol 5-Dimension Youth (EQ-5D-Y) Questionnaires | 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). | From Day 1 up to 12 months |
| Number of Participants Who Discontinued Study Treatment Due to an AE | The number of all participants who discontinued study treatment due to an AE is presented. | Up to approximately 2 months |
| Tucson |
| Arizona |
| 85724 |
| United States |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Stanford University | Palo Alto | California | 94305 | United States |
| Sarcoma Oncology Center | Santa Monica | California | 90403 | United States |
| University of Colorado Cancer Center | Boulder | Colorado | 80309 | United States |
| Yale University School of Medicine- Cancer Center | New Haven | Connecticut | 06520 | United States |
| University of Miami | Coral Gables | Florida | 33146 | United States |
| Mayo Clinic- Jacksonville | Jacksonville | Florida | 32224 | United States |
| Moffitt Cancer Center at USF | Tampa | Florida | 33612 | United States |
| Northwestern | Chicago | Illinois | 60611 | United States |
| Dana Farber Cancer Institute/Mass General Hospital | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Hackensack University Medical Center | Edison | New Jersey | 08837 | United States |
| Cohen Children's Medical Center (Northwell) | Astoria | New York | 11105 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University | Durham | North Carolina | 27708 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| University of Alberta Hospital- Cross Cancer Institute | Edmonton | Canada |
| McGill University | Montreal East | Canada |
| COMPLETED |
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| NOT COMPLETED |
|
|
0 participants are reported due to the risk of identification of a person.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | CMB305 placebo control |
| BG001 | CMB305 | 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}] |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
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| Sex: Female, Male |
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| Ethnicity (NIH/OMB) |
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| Race (NIH/OMB) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | 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). | No data were collected or analyzed for this outcome measure due to early termination of the study. | Posted | From randomization to investigator-determined date of disease progression or death, assessed up to 24 months. |
|
| ||||||||||||||||||||||
| Primary | Overall Survival (OS) | OS is defined as the time from randomization to the date of death. | No data were collected or analyzed for this outcome measure due to early termination of the study. | Posted | From randomization to date of death, assessed up to 66 months. |
|
| ||||||||||||||||||||||
| Secondary | Time to Next Treatment (TTNT) | 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. | No data were collected or analyzed for this outcome measure due to early termination of the study. | Posted | From last dose of CMB305 to initiation of new therapy, assessed up to 24 months. |
|
| ||||||||||||||||||||||
| Secondary | Distant Metastasis Free Survival (DMFS) | 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. | No data were collected or analyzed for this outcome measure due to early termination of the study. | Posted | From randomization to investigator-determined date of disease progression or death, assessed up to 24 months. |
|
| ||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | 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. | No data were collected or analyzed for this outcome measure due to early termination of the study. | Posted | From randomization to investigator-determined date of disease progression, assessed up to 24 months. |
|
| ||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) | 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. | All participants taking any amount of study drug. | Posted | Number | Participants | From randomization to investigator-determined date of disease progression or death, assessed up to approximately 2 months. |
|
| ||||||||||||||||||||
| Secondary | Quality of Life (QoL): EuroQol 5-Dimension 5 Level (EQ-5D-5L) and EuroQol 5-Dimension Youth (EQ-5D-Y) Questionnaires | 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). | No data were collected or analyzed for this outcome measure due to early termination of the study. | Posted | From Day 1 up to 12 months |
| |||||||||||||||||||||||
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | The number of all participants who discontinued study treatment due to an AE is presented. | All participants taking any amount of study drug. | Posted | Number | Participants | Up to approximately 2 months |
|
|
Up to approximately 2 months
0 participants are reported due to the risk of identification of a person.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | CMB305 placebo control | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | CMB305 | 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}] | 0 | 0 | 0 | 0 | 0 | 0 |
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Study was stopped early due to Sponsor decision.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 25, 2018 | Mar 19, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013584 | Sarcoma, Synovial |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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