Description:
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.
Title
- Brief Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)
- 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)
Clinical Trial IDs
- ORG STUDY ID:
IMDZ-04-1702
- SECONDARY ID:
V943A-003
- NCT ID:
NCT03520959
Conditions
- Synovial Sarcoma
- Cancer
- Soft Tissue Sarcoma
- Sarcoma
- Metastatic Sarcoma
Interventions
Drug | Synonyms | Arms |
---|
LV305 | | CMB305 |
G305 | | CMB305 |
Purpose
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.
Detailed Description
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Placebo | Placebo Comparator | A sequential regimen of LV305-matching placebo and G305-matching placebo. | |
CMB305 | Experimental | A sequential regimen of LV305 and G305. | |
Eligibility Criteria
Selected Inclusion Criteria:
- Histological diagnosis of synovial sarcoma
- Immunohistochemistry (IHC) results from tumor biopsy for New York esophageal squamous
cell carcinoma 1 (NY-ESO-1) are positive
- Participants have received at least 4 but no more than 8 cycles of first-line
anthracycline or ifosfamide-containing systemic anti-cancer therapy regimen
- Must have documentation of no evidence of disease progression of the tumor during or
after completion of first line systemic anti-cancer therapy
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
- Age >/= 12 years
- Life expectancy of at least 6 months
Selected Exclusion Criteria:
- Have received last dose of first-line systemic anti-cancer therapy or date of most
recent local regional therapy >28 days prior to day 1
- Have received prior anti-NY-ESO-1 therapy
- Have received first-line systemic anti-cancer therapy with an agent other than
anthracycline or ifosfamide
- Have received treatment with systemic immunomodulatory agents within 28 days prior to
administration of the first dose of CMB305, or 5 half-lives of the drug, whichever
occurs sooner.
- Have significant immunosuppression from concurrent, recent, or anticipated need for
chronic treatment with systemic immunosuppressive dose of corticosteroids or
immunosuppressive medications.
- Have psychiatric or other medical illness, or any other condition that in the opinion
of the investigator prevents compliance with the study procedures or ability to
provide valid informed consent.
- Have history of uncontrolled autoimmune disease.
- Have a significant electrocardiogram finding or cardiovascular disease
- have inadequate organ function per protocol
- History of other cancer within 3 years
- Evidence of active tuberculosis or recent clinically-significant infection requiring
systemic therapy.
- Evidence of active Hepatitis B, Hepatitis C, or Human Immunodeficiency virus (HIV)
infection
- Have a history of brain metastasis
- Have received cancer therapies including chemotherapy, radiation, biologic, or kinase
inhibitors, granulocyte-colony stimulating factor (G-CSF), or granulocyte-macrophage
colony-stimulating factor (GM-CSF) within 3 weeks prior ot the first scheduled dose of
CMB305
- Female of child bearing potential who is pregnant, is planning to become pregnant, or
is breast feeding; or male who is sexually active with a female of child bearing
potential who is planning to become pregnant.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 12 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-Free Survival (PFS) |
Time Frame: | From randomization to investigator-determined date of disease progression or death, assessed up to 24 months. |
Safety Issue: | |
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). |
Secondary Outcome Measures
Measure: | Time to Next Treatment (TTNT) |
Time Frame: | From last dose of CMB305 to initiation of new therapy, assessed up to 24 months. |
Safety Issue: | |
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. |
Measure: | Distant Metastasis Free Survival (DMFS) |
Time Frame: | From randomization to investigator-determined date of disease progression or death, assessed up to 24 months. |
Safety Issue: | |
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. |
Measure: | Overall Response Rate (ORR) |
Time Frame: | From randomization to investigator-determined date of disease progression, assessed up to 24 months. |
Safety Issue: | |
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. |
Measure: | 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 Issue: | |
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. |
Measure: | 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 |
Safety Issue: | |
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). |
Measure: | Number of Participants Who Discontinued Study Treatment Due to an AE |
Time Frame: | Up to approximately 2 months |
Safety Issue: | |
Description: | The number of all participants who discontinued study treatment due to an AE is presented. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Immune Design |
Trial Keywords
- Synovate Study
- NY-ESO-1
- cancer vaccine
- Sarcoma
- soft tissue sarcoma
- immunotherapy
Last Updated
April 16, 2020