Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Sarcoma, Synovial

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Synovial Sarcoma

All Drugs and Chemicals

Vaccines

Immunomodulating Agents

A sequential regimen of LV305-matching placebo and G305-matching placebo.

Administered via subcutaneous (SC) injection.

LV305

Administered via intramuscular (IM) injection.

G305

LV305-matching placebo

G305-matching placebo

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.

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

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)

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).

OS is defined as the time from randomization to the date of death.

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.

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.

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.

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.

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).

The number of all participants who discontinued study treatment due to an AE is presented.

Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

0 participants are reported due to the risk of identification of a person.

Placebo

CMB305: Sequentially administered LV305 \[lentiviral vector encoding New York esophogeal squamous cell carcinoma-1 {NY-ESO-1} gene\] and G305 \[NY-ESO-1 recombinant protein plus glucopyranosyl lipid A stable emulsion {GLA-SE}\]

CMB305

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Study was stopped early due to Sponsor decision.

Senior Vice President, Global Clinical Development

No data were collected or analyzed for this outcome measure due to early termination of the study.

Progression-Free Survival (PFS)

Overall Survival (OS)

Time to Next Treatment (TTNT)

Distant Metastasis Free Survival (DMFS)

Overall Response Rate (ORR)

All participants taking any amount of study drug.

Spots Global Cancer Trial Database for g305

Every month we try and update this database with for g305 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for g305

Every month we try and update this database with for g305 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for g305 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.