Prostatic NeoplasmsPhase 1NCT00113984

Vaccine and Antibody Treatment of Prostate Cancer

A Phase 1 study testing PROSTVAC-V/TRICOM, PROSTVAC-F/TRICOM and MDX-010 in people with Prostatic Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 85 years, men only
Conditions the study is for: Prostatic Neoplasms
What is being tested?: PROSTVAC-V/TRICOM, PROSTVAC-F/TRICOM and MDX-010
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 8 Jun 2005to 1 Dec 2011
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 85 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Histopathological documentation of prostate cancer confirmed in the Laboratory of Pathology at the: NIH Clinical Center, National Institutes of Health (NIH), the National Naval Medical Center, or Walter Reed Army Medical Center prior to starting this study. If no pathologic specimen is available, patients may enroll with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
Must have metastatic androgen insensitive prostate cancer with no bone pain requiring narcotics and have had no prior chemotherapy.
Life expectancy greater than or equal to 6 months.
ECOG performance status of 0-1.
No systemic steroid or steroid eye drop use within 2 weeks prior to initiation of experimental therapy.
Hematological eligibility parameters

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Granulocyte count greater than or equal to1,500/mm(3)
Platelet count greater than or equal to100,000/mm(3)
Hgb greater than or equal to 9 Gm/dL
Lymphocyte count greater than or equal to 500/mm(3).
Biochemical eligibility parameters (within 16 days of starting therapy)
-Hepatic function: Bilirubin less than or equal to 1.5 mg/dl (OR in patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0 mg/dL), AST and ALT less than or equal to 2.5 times upper limit of normal
No other active malignancies within the past 12 months (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder) or life threatening illnesses.
Willing to travel to the NIH for follow-up visits.
18 years of age or greater.
Vaccinia-naive or vaccinia immune.
Able to understand and sign informed consent.
Agree to use adequate contraception prior to study entry and for at least 4 months following the last vaccine injection.
Patients must remain on medical castration therapy, unless they have had surgical castration
Patients must have recovered from acute toxicities related to prior therapy or surgery. For chemotherapy typically this is 3-4 weeks.
Parameters for assessment of baseline renal function:
Serum creatinine not above the institution limits of normal, OR creatinine clearance on a 24 hour urine collection of greater than or equal to 60 mL/min.
Patients must have less than grade 2 proteinuria (unless the cause is determined not to be renal.)

Who cannot join

Patients should have no evidence of being immunocompromised as listed below.
Human immunodeficiency virus positivity due to the potential for decreased tolerance and may be at risk for severe side effects.
Hepatitis B or C positivity
Concurrent use of topical steroids (including steroid eye drops) or systemic steroids. Nasal or inhaled steroid use is permitted
B.Patients should have no autoimmune diseases that have required treatment such as, Addison's disease, Hashimoto's thyroiditis, or systemic lupus erythematous, Sjogren syndrome, scleroderma, Goodpasture syndrome, and active Grave's disease. Also excluded are patients with autoimmune hemolytic anemia, ulcerative and hemorrhagic colitis, endocrine disorders (e.g., thyroiditis, hyperthyroidism, hypothyroidism, autoimmune hypophysitis/hypopituitarism, and adrenal insufficiency), sarcoid granuloma, myasthenia gravis, polymyositis, and Guillain-Barre syndrome. Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including CNS, heart, lungs, kidneys, skin, and GI tract will be allowed.
History of allergy or untoward reaction to prior vaccination with vaccinia virus or to any component of the vaccinia vaccine regimen.

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Do not administer the recombinant vaccinia vaccine if the recipient, or for at least three weeks after vaccination, their close household contacts (close household contacts are those who share housing or have close physical contact) are: persons with active or a history of eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) until condition resolves; pregnant or nursing women; children 3 years of age and under; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV infection.
Serious intercurrent medical illness (e.g., one that requires treatment) which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis.
Patients with cardiac disease that have fatigue, palpitation, dyspnea or angina with ordinary physical activity (New York Heart Association class 2 or greater) are not eligible.
Patients with a history of congestive heart failure or who have objective evidence of congestive heart failure by physical exam or imaging are not eligible.
Patients with pulmonary disease that have fatigue or dyspnea with ordinary physical activity are not eligible.
Concurrent chemotherapy.
No brain metastasis, or with a history of seizures, encephalitis, or multiple sclerosis.
Serious hypersensitivity reaction to egg products.
Prior splenectomy.
Patients who have received prior MDX-01.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Phase I Trial of a PSA Based Vaccine and an Anti-CTLA-4 Antibody in Adults With Metastatic Androgen Independent Prostrate Cancer

This study will evaluate the side effects of a fixed dose of vaccine and GM-CSF with increasing doses of anti-CTLA-4 antibody in patients with advanced prostate cancer. The vaccine consists of a "priming vaccine" called PROSTVAC/TRICOM, made from vaccinia virus, and a "boosting vaccine" called PROSTVAC-F/TRICOM, made from fowlpox virus. GM-CSF is a chemical that boosts the immune system, and anti-CTLA-4 antibody is a protein that may improve anti-tumor activity and the response to the vaccines. DNA is inserted into the priming and boosting vaccine viruses to cause production of proteins that enhance immune activity and also to produce prostate specific antigen (PSA)-a protein that is normally produced by the patient's tumor cells.

Patients 18 years of age and older with androgen-insensitive prostate cancer that has spread beyond the original site may be eligible for this 7-month study. Candidates must have disease that has worsened despite treatments with hormones and up to one chemotherapy regimen. Their tumor must produce PSA, and they must have no history of allergy to eggs or egg products Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram, pathological confirmation of the diagnosis and presence of the PSA marker, chest x-rays, imaging studies to assess the extent of tumor, and, if clinically indicated, a cardiologic evaluation.

Participants receive the priming vaccination on study day 1. After 2 weeks and then again every 4 weeks while on the study, they receive a boosting vaccine. All vaccines are injected under the skin. On the day of each vaccination and daily for the next 3 days, patients receive an injection of GM-CSF to increase the number of immune cells at the vaccination site. On the day of the first six boosting vaccinations, they receive anti-CTLA-4 antibody as an infusion through a vein over 90 minutes.

Patients are monitored for safety and treatment response with the following tests and procedures:

Blood and urine tests monthly, or more often if needed, to monitor liver, kidney, and other organ function.
Imaging studies to assess the tumor before starting treatment, again around study days 99 and 183, and then every 3 months after that while on study.
Apheresis (a procedure for collecting immune cells called lymphocytes) to measure the immune response to treatment. Apheresis is done three times: before starting the study and again around study days 99 and 183. For this procedure, blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components by spinning, and the lymphocytes are extracted. The rest of the blood is returned to the patient through the same needle. This will only be done in participants who have the tissue marker HLA-A2 (about 50% of patients).

Patients whose disease responds to treatment and who do not develop severe side effects may continue treatment beyond the initial 7-month study period on vaccine alone (without the antibody). After treatment is completed, patients are monitored for up to 15 years. This includes a medical history and physical examination for 5 years following the last vaccination. Information beyond 5 years is collected once a year by telephone.

Read the detailed description

Background:

Adenocarcinoma of the prostate is the most common cancer diagnosis in American males, and the second leading cause of cancer death.
The proposed vaccine strategy represents a third-generation design that elicits a T-cell immune response to cells expressing PSA and has been shown to break tolerance to this self-antigen, and cause objective response and PSA declines in patients with metastatic AIPC.
This strategy also utilizes an antibody to CTLA-4 that may block the normal signals to down regulate the immune response following active vaccination.
Anti CTLA-4 antibodies have been associated with autoimmune events that are generally manageable and have been associated with clinical response.

Objectives:

To determine the safety and tolerability of a combination of a fixed dose of vaccine and anti-CTLA4, which will be dose escalated.
To evaluate immunologic response (as measured by an increase in PSA specific T-cells measured by ELISPOT in HLA-A2+ patients), and clinical response (as measured by RECIST and PSA consensus criteria).

Eligibility:

Must have metastatic androgen insensitive prostate cancer with no bone pain requiring narcotics and have had no more prior chemotherapy.
Life expectancy greater than or equal to 6 months. ECOG 0-1
Should have no autoimmune diseases; no evidence of being immunocompromised; no serious intercurrent medical illness; no cardiac disease; no prior splenectomy.
No prior treatment with MDX-010 (Ipilimumab).
No brain metastasis, history of seizures, encephalitis, or multiple sclerosis.
No serious hypersensitivity reaction to egg products.

Design:

This is an open label, phase I safety trial with sequential cohorts of patients all receiving a fixed dose of PSA-TRICOM vaccines and sargramostim, with dose escalation of MDX-010 (Ipilimumab).
PROSTVAC -V/TRICOM (vaccinia) 2 x 10(8) pfu subcutaneously will be administered as the initial priming vaccine on day 1 of cycle 1 only.
PROSTVAC -F/TRICOM (fowlpox) 1 x 10(9) pfu subcutaneously starting on day 15 followed by monthly boosting vaccination. Sargramostim 100 mcg per day will be administered subcutaneously at the vaccination site on days 1-4 of each vaccine cycle (prime and boost).
MDX-010 (Ipilimumab) will be administered, as per the assigned dose level, as a 90-minute intravenous infusion on the same day as the monthly boosting vaccinations with PROSTVAC-F/TRICOM (fowlpox). After 6 courses of MDX-010, patients may receive Maintenance dose of MDX-010 every 3 months until there is evidence of disease progression or toxicity, for up to an additional 12 months (equivalent to 4 additional MDX-010 courses).
Monthly boosting vaccinations with PROSTVAC-F/TRICOM (fowlpox) and sargramostim may then continue until patients meet off study criteria.

Conditions: Prostatic Neoplasms
Being tested: PROSTVAC-V/TRICOM, PROSTVAC-F/TRICOM, MDX-010, Sargramostim
Keywords: Monoclonal Antibody, Vaccine, Cytokines, Immunotherapy, Elispot Assay, Prostate Cancer, Metastatic Prostate Cancer
Medical subject headings: Prostatic Neoplasms

What participants receive

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

PROSTVAC-V/TRICOMBiological
PROSTVAC-F/TRICOMBiological
MDX-010Drug
SargramostimDrug

What is being measured

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

To determine the safety and tolerability of a combination of a fixed dose of vaccine and anti-CTLA4, which will be dose escalated.

Secondary outcomes (1)

To evaluate immunologic response (as measured by an increase in PSA specific T-cells measured by ELISPOT in HLA-A2+ patients), and clinical response (as measured by RECIST and PSA consensus criteria).

Timeline

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

8 Jun 20051 Dec 2011

First posted13 Jun 2005 (estimated)
Study start8 Jun 2005
Primary completion1 Feb 2008
Study completion1 Dec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The 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 1
Primary purpose: Treatment
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00113984
Sponsor's protocol ID: 050167
Other IDs: 05-C-0167
Status last verified: 7 Nov 2012
First submitted: 11 Jun 2005
Last updated: 16 Dec 2019
Results posted: No

Publications

Madan RA, Mohebtash M, Arlen PM, Vergati M, Rauckhorst M, Steinberg SM, Tsang KY, Poole DJ, Parnes HL, Wright JJ, Dahut WL, Schlom J, Gulley JL. Ipilimumab and a poxviral vaccine targeting prostate-specific antigen in metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial. Lancet Oncol. 2012 May;13(5):501-8. doi: 10.1016/S1470-2045(12)70006-2. Epub 2012 Feb 10.
PubMed 22326924
Gulley JL, Dahut WL. Future directions in tumor immunotherapy: CTLA4 blockade. Nat Clin Pract Oncol. 2007 Mar;4(3):136-7. doi: 10.1038/ncponc0749. No abstract available.
PubMed 17327854
Theoret MR, Arlen PM, Pazdur M, Dahut WL, Schlom J, Gulley JL. Phase I trial of an enhanced prostate-specific antigen-based vaccine and anti-CTLA-4 antibody in patients with metastatic androgen-independent prostate cancer. Clin Genitourin Cancer. 2007 Jun;5(5):347-50. doi: 10.3816/CGC.2007.n.017. No abstract available.
PubMed 17645835

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?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Trial of a PSA Based Vaccine and an Anti-CTLA-4 Antibody in Adults With Metastatic Androgen Independent Prostrate Cancer
ClinicalTrials.gov ID: NCT00113984
Acronym / sponsor ID: 050167
Conditions: Prostatic Neoplasms
Keywords: Monoclonal Antibody, Vaccine, Cytokines, Immunotherapy, Elispot Assay, Prostate Cancer, Metastatic Prostate Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: 8 Jun 2005
Primary completion: 1 Feb 2008 (actual)
Study completion: 1 Dec 2011 (actual)
First posted: 13 Jun 2005 (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.

Patients are monitored for safety and treatment response with the following tests and procedures:

Blood and urine tests monthly, or more often if needed, to monitor liver, kidney, and other organ function.
Imaging studies to assess the tumor before starting treatment, again around study days 99 and 183, and then every 3 months after that while on study.
Apheresis (a procedure for collecting immune cells called lymphocytes) to measure the immune response to treatment. Apheresis is done three times: before starting the study and again around study days 99 and 183. For this procedure, blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components by spinning, and the lymphocytes are extracted. The rest of the blood is returned to the patient through the same needle. This will only be done in participants who have the tissue marker HLA-A2 (about 50% of patients).

Detailed description

Background:

Adenocarcinoma of the prostate is the most common cancer diagnosis in American males, and the second leading cause of cancer death.
The proposed vaccine strategy represents a third-generation design that elicits a T-cell immune response to cells expressing PSA and has been shown to break tolerance to this self-antigen, and cause objective response and PSA declines in patients with metastatic AIPC.
This strategy also utilizes an antibody to CTLA-4 that may block the normal signals to down regulate the immune response following active vaccination.
Anti CTLA-4 antibodies have been associated with autoimmune events that are generally manageable and have been associated with clinical response.

Objectives:

To determine the safety and tolerability of a combination of a fixed dose of vaccine and anti-CTLA4, which will be dose escalated.
To evaluate immunologic response (as measured by an increase in PSA specific T-cells measured by ELISPOT in HLA-A2+ patients), and clinical response (as measured by RECIST and PSA consensus criteria).

Eligibility:

Must have metastatic androgen insensitive prostate cancer with no bone pain requiring narcotics and have had no more prior chemotherapy.
Life expectancy greater than or equal to 6 months. ECOG 0-1
Should have no autoimmune diseases; no evidence of being immunocompromised; no serious intercurrent medical illness; no cardiac disease; no prior splenectomy.
No prior treatment with MDX-010 (Ipilimumab).
No brain metastasis, history of seizures, encephalitis, or multiple sclerosis.
No serious hypersensitivity reaction to egg products.

Design:

This is an open label, phase I safety trial with sequential cohorts of patients all receiving a fixed dose of PSA-TRICOM vaccines and sargramostim, with dose escalation of MDX-010 (Ipilimumab).
PROSTVAC -V/TRICOM (vaccinia) 2 x 10(8) pfu subcutaneously will be administered as the initial priming vaccine on day 1 of cycle 1 only.
PROSTVAC -F/TRICOM (fowlpox) 1 x 10(9) pfu subcutaneously starting on day 15 followed by monthly boosting vaccination. Sargramostim 100 mcg per day will be administered subcutaneously at the vaccination site on days 1-4 of each vaccine cycle (prime and boost).
MDX-010 (Ipilimumab) will be administered, as per the assigned dose level, as a 90-minute intravenous infusion on the same day as the monthly boosting vaccinations with PROSTVAC-F/TRICOM (fowlpox). After 6 courses of MDX-010, patients may receive Maintenance dose of MDX-010 every 3 months until there is evidence of disease progression or toxicity, for up to an additional 12 months (equivalent to 4 additional MDX-010 courses).
Monthly boosting vaccinations with PROSTVAC-F/TRICOM (fowlpox) and sargramostim may then continue until patients meet off study criteria.

Study design

Primary purpose: Treatment

Who may qualify

Ages: 18 to 85 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Histopathological documentation of prostate cancer confirmed in the Laboratory of Pathology at the: NIH Clinical Center, National Institutes of Health (NIH), the National Naval Medical Center, or Walter Reed Army Medical Center prior to starting this study. If no pathologic specimen is available, patients may enroll with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
Must have metastatic androgen insensitive prostate cancer with no bone pain requiring narcotics and have had no prior chemotherapy.
Life expectancy greater than or equal to 6 months.
ECOG performance status of 0-1.
No systemic steroid or steroid eye drop use within 2 weeks prior to initiation of experimental therapy.

Key exclusion criteria (16 listed)

Patients should have no evidence of being immunocompromised as listed below.
Human immunodeficiency virus positivity due to the potential for decreased tolerance and may be at risk for severe side effects.
Hepatitis B or C positivity
Concurrent use of topical steroids (including steroid eye drops) or systemic steroids. Nasal or inhaled steroid use is permitted
B.Patients should have no autoimmune diseases that have required treatment such as, Addison's disease, Hashimoto's thyroiditis, or systemic lupus erythematous, Sjogren syndrome, scleroderma, Goodpasture syndrome, and active Grave's disease. Also excluded are patients with autoimmune hemolytic anemia, ulcerative and hemorrhagic colitis, endocrine disorders (e.g., thyroiditis, hyperthyroidism, hypothyroidism, autoimmune hypophysitis/hypopituitarism, and adrenal insufficiency), sarcoid granuloma, myasthenia gravis, polymyositis, and Guillain-Barre syndrome. Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including CNS, heart, lungs, kidneys, skin, and GI tract will be 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
PROSTVAC-V/TRICOM	Biological	–
PROSTVAC-F/TRICOM	Biological	–
MDX-010	Drug	–
Sargramostim	Drug	–

Primary outcome

To determine the safety and tolerability of a combination of a fixed dose of vaccine and anti-CTLA4, which will be dose escalated.

1 secondary outcome

To evaluate immunologic response (as measured by an increase in PSA specific T-cells measured by ELISPOT in HLA-A2+ patients), and clinical response (as measured by RECIST and PSA consensus criteria).

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 16 Dec 2019.
Background: PubMed 22326924Madan RA, Mohebtash M, Arlen PM, Vergati M, Rauckhorst M, Steinberg SM, Tsang KY, Poole DJ, Parnes HL, Wright JJ, Dahut WL, Schlom J, Gulley JL. Ipilimumab and a poxviral vaccine targeting prostate-specific antigen in metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial. Lancet Oncol. 2012 May;13(5):501-8. doi: 10.1016/S1470-2045(12)70006-2. Epub 2012 Feb 10.
Background: PubMed 17327854Gulley JL, Dahut WL. Future directions in tumor immunotherapy: CTLA4 blockade. Nat Clin Pract Oncol. 2007 Mar;4(3):136-7. doi: 10.1038/ncponc0749. No abstract available.
Background: PubMed 17645835Theoret MR, Arlen PM, Pazdur M, Dahut WL, Schlom J, Gulley JL. Phase I trial of an enhanced prostate-specific antigen-based vaccine and anti-CTLA-4 antibody in patients with metastatic androgen-independent prostate cancer. Clin Genitourin Cancer. 2007 Jun;5(5):347-50. doi: 10.3816/CGC.2007.n.017. No abstract available.

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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.

James L Gulley, M.D. principal investigator

National Cancer Institute (NCI)

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 PROSTVAC-V/TRICOM, PROSTVAC-F/TRICOM and MDX-010 in people with Prostatic Neoplasms, run by National Cancer Institute (NCI) 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 23 inclusion and 16 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 16 Dec 2019. 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?

To determine the safety and tolerability of a combination of a fixed dose of vaccine and anti-CTLA4, which will be dose escalated.. 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 NCT00113984, which also lists 3 linked publications.

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 Dec 2019.