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Synovial SarcomaPhase 3NCT03520959

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 study testing LV305 and G305 in people with Synovial Sarcoma and Cancer, run by Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 29 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Synovial Sarcoma, Cancer, Soft Tissue Sarcoma
What is being tested?
LV305 and G305
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1 participants
Where
29 sitesin 2 countries
Study dates
18 Sep 2018to 20 Nov 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Trial locations and contacts

29 sites in 2 countries.

29 sites in 2 countries

United States27 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Cohen Children's Medical Center (Northwell)

    Astoria, New York, 11105

  • Dana Farber Cancer Institute/Mass General Hospital

    Boston, Massachusetts, 02215

  • University of Colorado Cancer Center

    Boulder, Colorado, 80309

  • Northwestern

    Chicago, Illinois, 60611

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Miami

    Coral Gables, Florida, 33146

  • Duke University

    Durham, North Carolina, 27708

  • Hackensack University Medical Center

    Edison, New Jersey, 08837

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic- Jacksonville

    Jacksonville, Florida, 32224

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale University School of Medicine- Cancer Center

    New Haven, Connecticut, 06520

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Stanford University

    Palo Alto, California, 94305

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15224

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

  • Mayo Clinic- Scottsdale

    Scottsdale, Arizona, 85259

  • Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Moffitt Cancer Center at USF

    Tampa, Florida, 33612

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

Other trials in United States

Canada2 sites

  • University of Alberta Hospital- Cross Cancer Institute

    Edmonton

  • McGill University

    Montreal East

Other trials in Canada

About this study

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)

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.

Read the 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.

Being tested
LV305, G305, LV305-matching placebo, G305-matching placebo
Keywords
Synovate Study, NY-ESO-1, cancer vaccine, Sarcoma, soft tissue sarcoma, immunotherapy
Medical subject headings
Sarcoma, Synovial, Neoplasms, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LV305Biological

    Administered via subcutaneous (SC) injection.

  • G305Biological

    Administered via intramuscular (IM) injection.

  • LV305-matching placeboOther

    Administered via SC injection.

  • G305-matching placeboOther

    Administered via IM injection.

Study groups in NCT03520959
Study groupRoleWhat they receive
PlaceboPlacebo comparatorA sequential regimen of LV305-matching placebo and G305-matching placebo.
Receives: Other: LV305-matching placebo; Other: G305-matching placebo
CMB305ExperimentalA sequential regimen of LV305 and G305.
Receives: Biological: LV305; Biological: G305

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.

  2. Overall Survival (OS)

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

    Measured: From randomization to date of death, assessed up to 66 months.

Secondary outcomes (6)

  1. 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.

    Measured: From last dose of CMB305 to initiation of new therapy, assessed up to 24 months.

  2. 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.

    Measured: From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.

  3. 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.

    Measured: From randomization to investigator-determined date of disease progression, assessed up to 24 months.

  4. 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.

    Measured: From randomization to investigator-determined date of disease progression or death, assessed up to approximately 2 months.

  5. 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).

    Measured: From Day 1 up to 12 months

  6. 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.

    Measured: Up to approximately 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2018
  2. Study start18 Sep 2018
  3. Primary completion20 Nov 2018
  4. Study completion20 Nov 2018

Why it stopped: Study was terminated due to sponsor's decision.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03520959
Sponsor's protocol ID
IMDZ-04-1702
Other IDs
V943A-003
Status last verified
Apr 2020
First submitted
30 Mar 2018
Last updated
16 Apr 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LV305 and G305 in people with Synovial Sarcoma and Cancer, run by Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 29 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03520959.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.

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