Merkel Cell CarcinomaPhase 1NCT02035657
A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma
A Phase 1 study testing GLA-SE in people with Merkel Cell Carcinoma, run by Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
This is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma. Ten patients will be treated. The goal is for GLA-SE to assist the patient's own immune system in attacking the cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Merkel Cell Carcinoma
- What is being tested?
- GLA-SE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-confirmed Merkel cell carcinoma with metastatic or loco-regional disease.
- Patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable IT injection.
- ECOG performance status score 0, 1 or 2
- ≥ 18 years of age
- Life expectancy of ≥ three months.
- Adequate neutrophil and platelet counts
Show all 11Show fewer
- Adequate renal and hepatic function
- Willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy
- Use of effective contraception
- Signed informed consent document
- Members of all genders, races and ethnic groups are eligible for this trial
Who cannot join
- Prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment
- No concurrent anti-cancer treatment (including topical agents such as imiquimod) or investigational agents
- Active, untreated brain metastases
- Pregnant or nursing
- Use of any systemic immunosuppressive agents
- Immunosuppressed patients
- Uncontrolled depression or other major psychiatric disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center, Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: A Proof-of-Concept Clinical Trial of Intratumoral Injection of GLA-SE, a Toll-like Receptor-4 Agonist, in Patients With Merkel Cell Carcinoma
This is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma. Ten patients will be treated. The goal is for GLA-SE to assist the patient's own immune system in attacking the cancer cells.
Read the detailed description
This is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma. Ten patients with metastatic or locoregional disease will be treated. The goal is for GLA-SE to assist the patient's own immune system in attacking the cancer cells.
- Conditions
- Merkel Cell Carcinoma
- Being tested
- GLA-SE
- Keywords
- Merkel cell carcinoma, MCC
- Medical subject headings
- Carcinoma, Merkel Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLA-SEBiological
Also called Glucopyranosyl Lipid A in Stable Emulsion
Glucopyranosyl Lipid A in Stable Emulsion
| Study group | Role | What they receive |
|---|---|---|
| GLA-SE | Experimental | Glucopyranosyl Lipid A in Stable Emulsion Receives: Biological: GLA-SE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and feasibility
The number of treatment-related adverse events
Measured: 1 year
Secondary outcomes (2)
Clinical efficacy and Immunogenicity
The secondary objectives are to assess the clinical efficacy of as well as the immunological effects of GLA-SE in patients with MCC
Measured: 1 Year
Clinical efficacy and Immunogenicity
Objective tumor response rate, time to progression or relapse, survival, and cellular immune activation
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Merkel Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Hsu, MD, Study director, Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035657
- Sponsor's protocol ID
- IDC-G100-2013-001
- Status last verified
- Jun 2018
- First submitted
- 10 Jan 2014
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept Clinical Trial of Intratumoral Injection of GLA-SE, a Toll-like Receptor-4 Agonist, in Patients With Merkel Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02035657
- Acronym / sponsor ID
- IDC-G100-2013-001
- Conditions
- Merkel Cell Carcinoma
- Keywords
- Merkel cell carcinoma, MCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma. Ten patients will be treated. The goal is for GLA-SE to assist the patient's own immune system in attacking the cancer cells.
Detailed description
This is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma. Ten patients with metastatic or locoregional disease will be treated. The goal is for GLA-SE to assist the patient's own immune system in attacking the cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLA-SE | Experimental | Biological: GLA-SEGlucopyranosyl Lipid A in Stable Emulsion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Biopsy-confirmed Merkel cell carcinoma with metastatic or loco-regional disease.
- Patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable IT injection.
- ECOG performance status score 0, 1 or 2
- ≥ 18 years of age
- Life expectancy of ≥ three months.
Key exclusion criteria (7 listed)
- Prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment
- No concurrent anti-cancer treatment (including topical agents such as imiquimod) or investigational agents
- Active, untreated brain metastases
- Pregnant or nursing
- Use of any systemic immunosuppressive agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLA-SEAlso: Glucopyranosyl Lipid A in Stable EmulsionGlucopyranosyl Lipid A in Stable Emulsion | Biological | GLA-SE |
Primary outcome
Safety and feasibility
Time frame: 1 year
The number of treatment-related adverse events
2 secondary outcomes
Clinical efficacy and Immunogenicity
Time frame: 1 Year
Clinical efficacy and Immunogenicity
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Hsu, MD study director
Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLA-SE in people with Merkel Cell Carcinoma, run by Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. 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: finished, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and feasibility (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2018.