Lung Cancer, Non-Small CellNCT00685750

Expression Analysis of Specific Markers in Non-small Cell Lung Cancer or Melanoma

A study testing Collection of tumor and blood samples in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 34 sites in 5 countries.

Terminated

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

Official record

Search all trials

Trial summary

This study intends to analyze the expression of specific sets of markers in tumor samples and in serum from patients with Non-Small Cell lung Cancer (NSCLC) or Stage III or IV melanoma. The data obtained in this study will be used to guide future development of immunotherapies for melanoma or NSCLC patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Non-Small Cell
What is being tested?: Collection of tumor and blood samples
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 34 sitesin 5 countries
Study dates: 28 Apr 2008to 17 Dec 2013
Phase: Interventional
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient (male or female) is at least 18 years of age.
The investigator believes that the patient can and will comply with the requirements of the protocol.
The patient has given his/her written informed consent to take part in the study.
The investigator believes that it will be possible to obtain a tumor tissue sample of at least 3 mm3 before treatment and all required tumor tissues several weeks after the initiation of the treatment.
The patient has cancer in one of the following histological types, fulfilling all of the characteristics listed for the respective cancer type:
Cutaneous Melanoma, unresectable stage III or stage IV • The patient has histologically documented unresectable stage III or stage IV metastatic cutaneous melanoma.

Show all 19Show fewer

AND
The patient is a candidate for one of the following treatments:
First-line chemotherapy with DTIC or TMZ as monotherapy [group ME1],
First-line chemotherapy with an agent other than DTIC/TMZ as monotherapy or a combination (that may, but need not, include DTIC, TMZ, IL-2 or IFNγ) [group ME2],
Second- or higherline chemotherapy with any agent or combination of agents (that may, but need not, include DTIC, TMZ, IL-2 or IFNγ ; i.e., systemic chemotherapy after isolated limb perfusion should be considered as second-line) [group ME3],
Palliative irradiation of skin lesion(s)/region, irrespective of what line of treatment is planned [group ME4],
Topical palliative treatment by imiquimod of skin lesion(s), irrespective of what line of treatment is planned [group ME5].
First or higher line treatment with ipilimumab [group ME6].
NSCLC, any stage if the patient is eligible for neo-adjuvant chemotherapy with subsequent resection • The patient has NSCLC at any stage (as defined by the International Staging System) if the patient is eligible for neo-adjuvant chemotherapy with subsequent resection.
AND
The patient is a candidate for chemo(radio)-therapy induction doublet neoadjuvant chemotherapy with platinum plus a second chemotherapy drug.
[Note: Induction radiotherapy is permitted.]
The recruitment of patients to the NSCLC group has been ended prematurely.

Who cannot join

The patient has any family history of congenital or hereditary immunodeficiency.
The patient has in the two weeks before baseline received any of the following:
Chemotherapeutic agents,
Immune-modulating agents such as (but not confined to) IFN-α, IL-2, BCG and anti-cancer therapeutic vaccines,
Immunosuppressive agents such as corticosteroids [except for prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day, maximum duration of treatment three weeks), and inhaled and topical steroids, which are allowed].
The patient is currently receiving an anti cancer treatment in another clinical trial. However, if the patient has finished the drug administration phase of that trial and has entered the follow-up phase, this patient can be included.

Trial locations and contacts

34 sites in 5 countries.

Country

City, postcode or hospital

34 sites in 5 countries

Germany16 sites

GSK Investigational Site
Berlin, 12200
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51109
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, 17487
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927
GSK Investigational Site
Hamburg, 20246
GSK Investigational Site
Hanover, Lower Saxony, 30625
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69126
GSK Investigational Site
Hemer, North Rhine-Westphalia, 58675
GSK Investigational Site
Kiel, Schleswig-Holstein, 24105
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167
GSK Investigational Site
Ostercappeln, Lower Saxony, 49179
GSK Investigational Site
Regensburg, Bavaria, 93049
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72076
GSK Investigational Site
Würzburg, Bavaria, 97080

Other trials in Germany

France7 sites

GSK Investigational Site
Dijon, 21079
GSK Investigational Site
Lille, 59037
GSK Investigational Site
Marseille, 13274
GSK Investigational Site
Marseille, 13385
GSK Investigational Site
Montpellier, 34295
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Paris, 75012

Other trials in France

United States4 sites

GSK Investigational Site
Los Angeles, California, 90025
GSK Investigational Site
Murray, Utah, 84107
GSK Investigational Site
Park Ridge, Illinois, 60068
GSK Investigational Site
St Louis, Missouri, 63110

Other trials in United States

Italy4 sites

GSK Investigational Site
Milan, Lombardy, 20141
GSK Investigational Site
Naples, Campania, 80131
GSK Investigational Site
Padova, Veneto, 35128
GSK Investigational Site
Siena, Tuscany, 53100

Other trials in Italy

Sweden3 sites

GSK Investigational Site
Gothenburg, SE-413 45
GSK Investigational Site
Lund, SE-221 85
GSK Investigational Site
Stockholm, SE-171 76

Other trials in Sweden

About this study

Official title: Analysis of the Expression of a Specific Set of Genes and Tumor Antigens in Patients With Non-small Cell Lung Cancer or Melanoma

Read the detailed description

This protocol posting has been updated due to a protocol amendment.

Conditions: Lung Cancer, Non-Small Cell
Being tested: Collection of tumor and blood samples
Keywords: tumor antigen, biomarkers
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

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

Collection of tumor and blood samplesProcedure or surgery
Samples will be collected before and after standard treatment

Study groups in NCT00685750
Study group	Role	What they receive
ME1	Other	Patients with cutaneous metastatic melanoma receiving dacarbazine or temozolomide as first line treatment Receives: Procedure: Collection of tumor and blood samples
ME2	Other	Patients with cutaneous metastatic melanoma receiving first line treatment other than dacarbazine or temozolomide only Receives: Procedure: Collection of tumor and blood samples
ME3	Other	Patients with cutaneous metastatic melanoma receiving any second-or higherline chemotherapy treatment Receives: Procedure: Collection of tumor and blood samples
ME4	Other	Patients with cutaneous metastatic melanoma receiving local irradiation of cutaneous/subcutaneous tumor lesions Receives: Procedure: Collection of tumor and blood samples
ME5	Other	Patients with cutaneous metastatic melanoma receiving local imiquimod Receives: Procedure: Collection of tumor and blood samples
NSC	Other	Non-small cell lung cancer patients Receives: Procedure: Collection of tumor and blood samples
ME6	Other	Patients with cutaneous metastatic melanoma receiving ipilimumab Receives: Procedure: Collection of tumor and blood samples

What is being measured

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

Number of Subjects With Expression of Tumor Antigens
The outcome presents the number of participants with expression of MAGE-A3 and NY-ESO-1 tumor antigens, after administration of standard of care treatment course compared to before administration
Measured: Before and after administration of standard of care treatment course, up to 3 months
Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic
The outcome presents the number of participants with a pre-identified gene signature (GS) to the recMAGE-A3 cancer immunotherapeutic from before and after standard cancer treatment, for comparison.
Measured: Before and after administration of standard of care treatment course, up to 3 months
The Serum Proteome
Measured: After administration of standard of care treatment course
Correlation of Relevant Markers of the Pre-identified Gene-expression Signature as Measured by Immunohistochemical Methods and by Quantitative PCR.
Measured: After administration of standard of care treatment course
Number of NSCLC Patients With Gene-expression Signature and Tumor Antigens in Distinct Concomitant Tumor Lesions Obtained at the Same Time From the Same Patient.
Measured: After administration of standard of care treatment course
Number of Patients Responding to Treatment, by Best Clinical Response Type
This outcome was assessed for metastatic melanoma patients treated with ipilimumab, in order to explore the predictive value to clinical activity of pre-identified immune-related gene-expression signature, by evaluating the patient's best clinical response to this treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.
Measured: At 6 months after the initiation of the ipilimumab therapy

Timeline

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

28 Apr 200817 Dec 2013

First posted28 May 2008 (estimated)
Study start28 Apr 2008
Primary completion17 Dec 2013
Study completion17 Dec 2013

Why it stopped: Slow enrolment over the last 2 years with none in the past 1 year. No increase in the number of completed subjects for 1 year and no more ongoing study subjects

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung Cancer, Non-Small CellStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
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 N/A
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00685750
Sponsor's protocol ID: 109752
Status last verified: Mar 2019
First submitted: 23 May 2008
Last updated: 20 Jun 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic
RecruitingObservational study
Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
HER2-mutant Advanced Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 2
Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin

All Lung Cancer, Non-Small Cell trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analysis of the Expression of a Specific Set of Genes and Tumor Antigens in Patients With Non-small Cell Lung Cancer or Melanoma
ClinicalTrials.gov ID: NCT00685750
Acronym / sponsor ID: 109752
Conditions: Lung Cancer, Non-Small Cell
Keywords: tumor antigen, biomarkers
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow enrolment over the last 2 years with none in the past 1 year. No increase in the number of completed subjects for 1 year and no more ongoing study subjects
Enrolment: 88 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 28 Apr 2008 (actual)
Primary completion: 17 Dec 2013 (actual)
Study completion: 17 Dec 2013 (actual)
First posted: 28 May 2008 (estimated)
Results: Posted 20 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This protocol posting has been updated due to a protocol amendment.

Study design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
ME1	Other	Procedure: Collection of tumor and blood samplesPatients with cutaneous metastatic melanoma receiving dacarbazine or temozolomide as first line treatment
ME2	Other	Procedure: Collection of tumor and blood samplesPatients with cutaneous metastatic melanoma receiving first line treatment other than dacarbazine or temozolomide only
ME3	Other	Procedure: Collection of tumor and blood samplesPatients with cutaneous metastatic melanoma receiving any second-or higherline chemotherapy treatment
ME4	Other	Procedure: Collection of tumor and blood samplesPatients with cutaneous metastatic melanoma receiving local irradiation of cutaneous/subcutaneous tumor lesions
ME5	Other	Procedure: Collection of tumor and blood samplesPatients with cutaneous metastatic melanoma receiving local imiquimod
NSC	Other	Procedure: Collection of tumor and blood samplesNon-small cell lung cancer patients
ME6	Other	Procedure: Collection of tumor and blood samplesPatients with cutaneous metastatic melanoma receiving ipilimumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

The patient (male or female) is at least 18 years of age.
The investigator believes that the patient can and will comply with the requirements of the protocol.
The patient has given his/her written informed consent to take part in the study.
The investigator believes that it will be possible to obtain a tumor tissue sample of at least 3 mm3 before treatment and all required tumor tissues several weeks after the initiation of the treatment.
The patient has cancer in one of the following histological types, fulfilling all of the characteristics listed for the respective cancer type:

Key exclusion criteria (6 listed)

The patient has any family history of congenital or hereditary immunodeficiency.
The patient has in the two weeks before baseline received any of the following:
Chemotherapeutic agents,
Immune-modulating agents such as (but not confined to) IFN-α, IL-2, BCG and anti-cancer therapeutic vaccines,
Immunosuppressive agents such as corticosteroids [except for prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day, maximum duration of treatment three weeks), and inhaled and topical steroids, which are allowed].

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
Collection of tumor and blood samplesSamples will be collected before and after standard treatment	Procedure or surgery	ME1, ME2, ME3, ME4, ME5, ME6, NSC

Primary outcome

Number of Subjects With Expression of Tumor Antigens
Time frame: Before and after administration of standard of care treatment course, up to 3 months
The outcome presents the number of participants with expression of MAGE-A3 and NY-ESO-1 tumor antigens, after administration of standard of care treatment course compared to before administration
Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic
Time frame: Before and after administration of standard of care treatment course, up to 3 months
The outcome presents the number of participants with a pre-identified gene signature (GS) to the recMAGE-A3 cancer immunotherapeutic from before and after standard cancer treatment, for comparison.
The Serum Proteome
Time frame: After administration of standard of care treatment course
Correlation of Relevant Markers of the Pre-identified Gene-expression Signature as Measured by Immunohistochemical Methods and by Quantitative PCR.
Time frame: After administration of standard of care treatment course
Number of NSCLC Patients With Gene-expression Signature and Tumor Antigens in Distinct Concomitant Tumor Lesions Obtained at the Same Time From the Same Patient.
Time frame: After administration of standard of care treatment course
Number of Patients Responding to Treatment, by Best Clinical Response Type
Time frame: At 6 months after the initiation of the ipilimumab therapy
This outcome was assessed for metastatic melanoma patients treated with ipilimumab, in order to explore the predictive value to clinical activity of pre-identified immune-related gene-expression signature, by evaluating the patient's best clinical response to this treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.

Results and safety

Results posted to the registry on 20 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Melanoma 1 Group	17	17
Melanoma 2 Group	3	3
Melanoma 3 Group	21	19
Melanoma 4 Group	2	2
Melanoma 5 Group	15	15
Melanoma 6 Group	20	20
Non-Small Cell Group	10	9

Primary outcome: Number of Subjects With Expression of Tumor Antigens

Time frame: Before and after administration of standard of care treatment course, up to 3 months. Count of participants. Unit: Participants

Measure	Melanoma 1 Group n = 17	Melanoma 2 Group n = 3	Melanoma 3 Group n = 21	Melanoma 4 Group n = 2	Melanoma 5 Group n = 15	Melanoma 6 Group n = 20	Non-Small Cell Group n = 10
MAGE-A3: Remained Positive	8	0	11	1	5	6	1
MAGE-A3: Remained negative	7	0	0	0	5	6	5
MAGE-A3: Turned Positive	0	0	0	0	1	1	0
MAGE-A3: Turned Negative	0	2	9	0	2	3	2
MAGE-A3: Not tested	1	0	0	1	2	1	0
MAGE-A3: Invalid testing	1	1	1	0	0	3	2
NY-ESO-01: Remained Positive	4	1	2	1	4	4	NA
NY-ESO-01: Remained negative	9	1	14	0	6	11	NA

Population analysed: The analysis was performed on the Total Treated cohort.

Primary outcome: Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic

Time frame: Before and after administration of standard of care treatment course, up to 3 months. Count of participants. Unit: Participants

Measure	Melanoma 1 Group n = 17	Melanoma 2 Group n = 3	Melanoma 3 Group n = 21	Melanoma 4 Group n = 2	Melanoma 5 Group n = 15	Melanoma 6 Group n = 20
Remained positive	4	0	4	0	4	6
Remained Negative	9	0	7	0	3	5
Turned Positive	0	1	2	0	4	2
Turned Negative	1	1	1	1	1	4
Not tested	2	0	6	1	3	0
Invalid testing	1	1	1	0	0	3

Population analysed: The analysis was performed on the Total Treated cohort. Data was not collected for the subjects in Non-Small Cell Group.

Primary outcome: The Serum Proteome

Time frame: After administration of standard of care treatment course

Population analysed: Proteome analysis on serum samples was not performed, because they, as a consequence of the early study termination, would not have added any scientific value and would not have benefited any individual patient.

Primary outcome: Correlation of Relevant Markers of the Pre-identified Gene-expression Signature as Measured by Immunohistochemical Methods and by Quantitative PCR.

Time frame: After administration of standard of care treatment course

Population analysed: The testing was not be performed, because, as a consequence of the early study termination, no scientific value would have been brought and no patient would have benefited from it.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events
Melanoma 1 Group	0 of 0	0 of 0
Melanoma 2 Group	0 of 0	0 of 0
Melanoma 3 Group	0 of 0	0 of 0
Melanoma 4 Group	0 of 0	0 of 0
Melanoma 5 Group	0 of 0	0 of 0
Melanoma 6 Group	0 of 0	0 of 0
Non-Small Cell Group	0 of 0	0 of 0

Limitations and caveats (from the sponsor): The study was terminated prematurely and, as a consequence, all the study objectives were not fully assessed as specified in the protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lung Cancer, Non-Small Cell

RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic
RecruitingObservational study
Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
HER2-mutant Advanced Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 2
Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin

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.

GSK Clinical Trials study director

GlaxoSmithKline

34 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Collection of tumor and blood samples in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 34 sites in 5 countries.

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 19 inclusion and 6 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: stopped early, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Germany, France, United States, Italy, Sweden. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2019). 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?

Number of Subjects With Expression of Tumor Antigens (time frame: Before and after administration of standard of care treatment course, up to 3 months). The study lists 6 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 NCT00685750.

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 20 Jun 2019.