Prostatic NeoplasmsPhase 2NCT01420965
Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer
A Phase 2 study testing CT-011 (Anti-PD1 Antibody), Sipuleucel-T (Provenge) and Cyclophosphamide in people with Prostatic Neoplasms, run by Augusta University at 1 site in United States.
Trial summary
Background: Sipuleucel-T is a new treatment for advanced stage prostate cancer. It takes cells from a person with prostate cancer and treats them in the laboratory. Then it returns the cells to the person to help the immune system fight the cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- CT-011 (Anti-PD1 Antibody), Sipuleucel-T (Provenge) and Cyclophosphamide
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2016
- Phase
- Phase 2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histopathological documentation of prostate cancer prior to starting this study.
- Patients must have metastatic progressive castrate-resistant prostate cancer defined as progressive disease (see below) despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone. Criteria of progression for trial eligibility are defined from the Prostate Cancer Clinical Trials Working Group-253. Clinically progressive prostate cancer must be evidenced and documented by any of the following parameters:
- Two consecutively rising PSA values at a minimum of 1-week intervals (2.0 ng/mL is the minimum starting value for PSA)
- Appearance of one or more new lesions on bone scans
- Progressive measurable disease by RECIST 1.1
- Patients on flutamide for at least 6 months must have disease progression at least 4 weeks after withdrawal. Patients on bicalutamide or nilutamide for at least 6 months must have progression at least 6 weeks after withdrawal.2.1.1.4 Performance Status: ECOG 0-1 or Karnofsky 80-100% (asymptomatic or minimally symptomatic from metastatic disease).
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- No previous chemotherapy use.
- No therapeutic immunosuppression or immunomodulation altering bone marrow function within 6 weeks prior to study entry e.g. G-CSF, GM-CSF, EPO, prednisone etc.
- Must have adequate:
- Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. Platelets greater than or equal to 100,000/mcl.
- Renal function: Creatinine less than or equal to 1.5 times institutional upper limit normal (ULN)
- Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTCAE v4.0 grade 1) except patients with Gilbert's disease (up to 5.0 mg/dL). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN.
- Normal Cardiac function: ECG with no evidence of arrhythmia, conduction abnormality or ischemia. No active coronary artery disease; no New York Heart Association class II, III or IV disease; no arrhythmia requiring treatment.
- Must willing and able to sign an informed consent document that explains the neoplastic nature of the disease, the procedures to be followed, the experimental nature of the treatment, alternative treatment and potential risks and toxicities.
Who cannot join
- Concurrent treatment with any other cancer therapies including radiation (except palliative radiation therapy for bone metastases), chemotherapy or other investigational agent(s). Androgen suppression therapy will be allowed.
- History of a second active malignancy in the last 2 years other than non-melanoma skin cancers.
- Patients who have active or history of autoimmune disease/symptom/conditions including: type I diabetes, rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis. Type II diabetes mellitus, vitiligo or stable hypothyroidism are not considered exclusion criteria.
- Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH).
- Concurrent use of systemic glucocorticoids within 4 weeks prior to trial entry
- Patients who have acquired, hereditary, or congenital immunodeficiencies including cellular immunodeficiencies, hypogammaglobulinemia and dysgammaglobulinemia.
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- CNS, lung, or liver metastasis, because of the poor prognosis, and potential inability to meet study endpoints.
- Serious active infection at the time of pre-study screening.
- Positive HIV or Hepatitis C antibodies or Hepatitis B anti-core antibodies, because immunotherapies rely on intact immune systems, and toxicities may be exacerbated by the presence of infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Test the Feasibility and Immunologic Impact of Sipuleucel-T (Provenge) Administered With or Without Anti-PD-1 mAb (CT-011) and Low Dose Cyclophosphamide in Men With Advanced Castrate-Resistant Prostate Cancer
Background:
- Sipuleucel-T is a new treatment for advanced stage prostate cancer. It takes cells from a person with prostate cancer and treats them in the laboratory. Then it returns the cells to the person to help the immune system fight the cancer. Sipuleucel-T may be combined with the drug CT-011 to boost its ability to kill cancer cells. The chemotherapy drug cyclophosphamide will also be given, either before or after the cells are collected at the start of the treatment.
Read more
Objectives:
- To test the effectiveness of Sipuleucel-T, CT-011, and cyclophosphamide for prostate cancer.
Eligibility:
- Men at least 18 years of age who have advanced prostate cancer.
Design:
- Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies.
- This study has two parts, with different participants in each part. All participants will be monitored with frequent blood tests and imaging studies.
- Part I:
- Participants will provide cells for the Sipuleucel-T treatment three times. The first time will be 3 days before the chemotherapy. The second time will be 10 days after chemotherapy. The third time will be 24 days after chemotherapy.
- Participants will have one dose of cyclophosphamide the day before the first dose of Sipuleucel-T.
- Participants will have Sipuleucel-T about 3 days after each cell donation.
- Part II:
- Participants will be in three groups: Sipuleucel-T given alone, given with CT-011, or given with both cyclophosphamide and CT-011.
- Participants will provide cells for the Sipuleucel-T treatment three times, as in Part I.
- Participants will have Sipuleucel-T about 3 days after each cell donation, and will receive treatment with the other drugs as directed by the study doctors.
Read the detailed description
Background:
- Prostate cancer is the most common cancer and the second leading cause of cancer deaths among males in most Western countries.
- Sipuleucel-T, a recently FDA approved treatment for prostate cancer, is designed to induce an immune response targeted against PAP, an antigen expressed in most prostate cancers. .
- Blockade of PD-1/PD-L1 has been shown to enhance the therapeutic efficacy of peptide cancer vaccines in pre-clinical animal models. CT-011 is a humanized IgG1 kappa recombinant monoclonal antibody against PD-1 receptor that blocks the interaction of PD-L1 with PD-1.
- Preclinical studies demonstrated that CT-011 when administered with low dose cyclophosphamide led to synergistic antitumor effects when combined with HPV16 E749-57 peptide vaccine.
- Given the role CT-011 plays in down-regulating peripheral tolerance and the synergistic relationship it has with cyclophosphamide in doing so, in this study we propose to treat patients with advanced, castrate-resistant disease with CT-011 and low-dose cyclophosphamide as adjuvants in combination with Provenge(Trademark) activated cell vaccine.
Objectives:
- To assess the feasibility of administration of Sipuleucel-T (Provenge(Trademark)) autologous active cellular immunotherapy in combination with low dose cyclophosphamide in men with advanced castrate-resistant (hormone refractory) prostate cancer.
- To determine the immune efficacy of Sipuleucel-T (Provenge(Trademark)) autologous active cellular immunotherapy alone vs. Sipuleucel-T (Provenge(Trademark)) in combination with CT- 011 vs. Sipuleucel-T (Provenge(Trademark)) in combination with low-dose cyclophosphamide and CT-011 on the change in PA2024-specific IFN-? ELISPOT responses in men with advanced, castrate-resistant prostate cancer.
- Secondary objectives will determine the tolerability and toxicities of the combination of low-dose cyclophosphamide/CT-011/ Sipuleucel-T (Provenge(Trademark)) and determine in a preliminary fashion whether this regimen correlates with increased progression-free survival (PFS) and overall survival (OS) in patients and with growth rate in an exploratory fashion.
Eligibility:
- Males greater than or equal to 18 years old with chemotherapy na ve metastatic progressive castrate-resistant prostate cancer defined as progressive disease (two consecutively rising PSA values at a minimum of 1-week intervals (2.0 ng/mL is the minimum starting value for PSA), appearance of one or more new lesions on bone scans, progressive disease by Recist 1.1).
- Must meet minimum organ safety requirements and length of time since prior therapy.
- May not have active infections, autoimmune disease or require immunosuppressive therapies.
Design:
Part 1: Initially the feasibility generating Sipuleucel-T after administration of low dose cyclophosphamide , and will be evaluated using a standard 3 + 3 design for doses of cyclophosphamide 250 mg/m2 or 125 mg/m2. Initially 3 patients will receive cyclophosphamide on day -1 of the first cycle (one day prior to the first infusion of Sipuleucel-T). All patients will receive Sipuleucel-T cell infusion on Day 0. The Sipuleucel-T cell infusion will be repeated every two weeks for a total of three cycles. If Sipuleucel-T active cellular immunotherapy from an apheresis obtained after infusion of cyclophosphamide, which meets the FDA approved Certificate of Analysis (COA) release criteria from Dendreon, cannot be generated, a second apheresis will be performed. Failure of two attempts to generate Sipuleucel-T product after two aphereses at either the 2nd or 3rd scheduled Sipuleucel-T infusion will be considered failure of one patient to meet release criteria .
- Conditions
- Prostatic Neoplasms
- Being tested
- CT-011 (Anti-PD1 Antibody), Sipuleucel-T (Provenge), Cyclophosphamide
- Keywords
- Anti PD-1 Monoclonal Antibody, Vaccine, Autologous Cellular Immunotherapy, 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.
CT-011 (Anti-PD1 Antibody)Drug
Also called Anti-PD1 Antibody
Immune Enhancer
Sipuleucel-T (Provenge)Other
Also called Provenge
Vaccine
CyclophosphamideDrug
Also called Cytoxan
Low dose- Immune Enhancer
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Sipuleucel-T autologous active cellular immunotherapy only for 3 cycles (cycle = 14 days) Receives: Other: Sipuleucel-T (Provenge) |
| Arm B | Experimental | Sipuleucel-T for 3 cycles (cycle = 14 days) + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion Receives: Drug: CT-011 (Anti-PD1 Antibody); Other: Sipuleucel-T (Provenge) |
| Arm C | Experimental | Sipuleucel-T for 3 cycles (cycle = 14 days)+ cyclophosphamide (125 or 250mg/m2) IV [first cycle only] + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion Receives: Drug: CT-011 (Anti-PD1 Antibody); Other: Sipuleucel-T (Provenge); Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Feasibility of Provenge Plus Low-dose Cyclophosphamide as Well as the Immune Efficacy of Provenge Alone Versus Provenge Plus Low-dose Cyclophosphamide and Anti PD1 Monoclonal Antibodies (CT011) on the Change in Specific Immune Response.
Measured: 2 years
Secondary outcomes (1)
Determine Whether the Combination of Low Dose-Cyclophosphamide and Anti PD1 Monoclonal Antibodies (CT-011) With Provenge(tm) Lead to Improvement in Increase Progression Free Survival (PFS) and Overall Survival (OS) in Patients With Advanced, Min...
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startSep 2012
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Drug supply issues
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samir N. Khleif, Augusta University
- Investigators
- Samir N. Khleif, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420965
- Sponsor's protocol ID
- 11C0231
- Status last verified
- Jun 2019
- First submitted
- 19 Aug 2011
- Last updated
- 10 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jemal A, Center MM, DeSantis C, Ward EM. Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomarkers Prev. 2010 Aug;19(8):1893-907. doi: 10.1158/1055-9965.EPI-10-0437. Epub 2010 Jul 20.
PubMed 20647400Gittes RF. Carcinoma of the prostate. N Engl J Med. 1991 Jan 24;324(4):236-45. doi: 10.1056/NEJM199101243240406. No abstract available.
PubMed 1985245Crawford ED, Eisenberger MA, McLeod DG, Spaulding JT, Benson R, Dorr FA, Blumenstein BA, Davis MA, Goodman PJ. A controlled trial of leuprolide with and without flutamide in prostatic carcinoma. N Engl J Med. 1989 Aug 17;321(7):419-24. doi: 10.1056/NEJM198908173210702.
PubMed 2503724
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Test the Feasibility and Immunologic Impact of Sipuleucel-T (Provenge) Administered With or Without Anti-PD-1 mAb (CT-011) and Low Dose Cyclophosphamide in Men With Advanced Castrate-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01420965
- Acronym / sponsor ID
- 11C0231
- Conditions
- Prostatic Neoplasms
- Keywords
- Anti PD-1 Monoclonal Antibody, Vaccine, Autologous Cellular Immunotherapy, Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug supply issues
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Posted 10 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Sipuleucel-T is a new treatment for advanced stage prostate cancer. It takes cells from a person with prostate cancer and treats them in the laboratory. Then it returns the cells to the person to help the immune system fight the cancer. Sipuleucel-T may be combined with the drug CT-011 to boost its ability to kill cancer cells. The chemotherapy drug cyclophosphamide will also be given, either before or after the cells are collected at the start of the treatment.
Objectives:
- To test the effectiveness of Sipuleucel-T, CT-011, and cyclophosphamide for prostate cancer.
Eligibility:
- Men at least 18 years of age who have advanced prostate cancer.
Design:
- Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies.
- This study has two parts, with different participants in each part. All participants will be monitored with frequent blood tests and imaging studies.
- Part I:
- Participants will provide cells for the Sipuleucel-T treatment three times. The first time will be 3 days before the chemotherapy. The second time will be 10 days after chemotherapy. The third time will be 24 days after chemotherapy.
- Participants will have one dose of cyclophosphamide the day before the first dose of Sipuleucel-T.
- Participants will have Sipuleucel-T about 3 days after each cell donation.
- Part II:
- Participants will be in three groups: Sipuleucel-T given alone, given with CT-011, or given with both cyclophosphamide and CT-011.
- Participants will provide cells for the Sipuleucel-T treatment three times, as in Part I.
- Participants will have Sipuleucel-T about 3 days after each cell donation, and will receive treatment with the other drugs as directed by the study doctors.
Detailed description
Background:
- Prostate cancer is the most common cancer and the second leading cause of cancer deaths among males in most Western countries.
- Sipuleucel-T, a recently FDA approved treatment for prostate cancer, is designed to induce an immune response targeted against PAP, an antigen expressed in most prostate cancers. .
- Blockade of PD-1/PD-L1 has been shown to enhance the therapeutic efficacy of peptide cancer vaccines in pre-clinical animal models. CT-011 is a humanized IgG1 kappa recombinant monoclonal antibody against PD-1 receptor that blocks the interaction of PD-L1 with PD-1.
- Preclinical studies demonstrated that CT-011 when administered with low dose cyclophosphamide led to synergistic antitumor effects when combined with HPV16 E749-57 peptide vaccine.
- Given the role CT-011 plays in down-regulating peripheral tolerance and the synergistic relationship it has with cyclophosphamide in doing so, in this study we propose to treat patients with advanced, castrate-resistant disease with CT-011 and low-dose cyclophosphamide as adjuvants in combination with Provenge(Trademark) activated cell vaccine.
Objectives:
- To assess the feasibility of administration of Sipuleucel-T (Provenge(Trademark)) autologous active cellular immunotherapy in combination with low dose cyclophosphamide in men with advanced castrate-resistant (hormone refractory) prostate cancer.
- To determine the immune efficacy of Sipuleucel-T (Provenge(Trademark)) autologous active cellular immunotherapy alone vs. Sipuleucel-T (Provenge(Trademark)) in combination with CT- 011 vs. Sipuleucel-T (Provenge(Trademark)) in combination with low-dose cyclophosphamide and CT-011 on the change in PA2024-specific IFN-? ELISPOT responses in men with advanced, castrate-resistant prostate cancer.
- Secondary objectives will determine the tolerability and toxicities of the combination of low-dose cyclophosphamide/CT-011/ Sipuleucel-T (Provenge(Trademark)) and determine in a preliminary fashion whether this regimen correlates with increased progression-free survival (PFS) and overall survival (OS) in patients and with growth rate in an exploratory fashion.
Eligibility:
- Males greater than or equal to 18 years old with chemotherapy na ve metastatic progressive castrate-resistant prostate cancer defined as progressive disease (two consecutively rising PSA values at a minimum of 1-week intervals (2.0 ng/mL is the minimum starting value for PSA), appearance of one or more new lesions on bone scans, progressive disease by Recist 1.1).
- Must meet minimum organ safety requirements and length of time since prior therapy.
- May not have active infections, autoimmune disease or require immunosuppressive therapies.
Design:
Part 1: Initially the feasibility generating Sipuleucel-T after administration of low dose cyclophosphamide , and will be evaluated using a standard 3 + 3 design for doses of cyclophosphamide 250 mg/m2 or 125 mg/m2. Initially 3 patients will receive cyclophosphamide on day -1 of the first cycle (one day prior to the first infusion of Sipuleucel-T). All patients will receive Sipuleucel-T cell infusion on Day 0. The Sipuleucel-T cell infusion will be repeated every two weeks for a total of three cycles. If Sipuleucel-T active cellular immunotherapy from an apheresis obtained after infusion of cyclophosphamide, which meets the FDA approved Certificate of Analysis (COA) release criteria from Dendreon, cannot be generated, a second apheresis will be performed. Failure of two attempts to generate Sipuleucel-T product after two aphereses at either the 2nd or 3rd scheduled Sipuleucel-T infusion will be considered failure of one patient to meet release criteria .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Other: Sipuleucel-T (Provenge)Sipuleucel-T autologous active cellular immunotherapy only for 3 cycles (cycle = 14 days) |
| Arm B | Experimental | Drug: CT-011 (Anti-PD1 Antibody), Other: Sipuleucel-T (Provenge)Sipuleucel-T for 3 cycles (cycle = 14 days) + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion |
| Arm C | Experimental | Drug: CT-011 (Anti-PD1 Antibody), Other: Sipuleucel-T (Provenge), Drug: CyclophosphamideSipuleucel-T for 3 cycles (cycle = 14 days)+ cyclophosphamide (125 or 250mg/m2) IV [first cycle only] + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have histopathological documentation of prostate cancer prior to starting this study.
- Patients must have metastatic progressive castrate-resistant prostate cancer defined as progressive disease (see below) despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone. Criteria of progression for trial eligibility are defined from the Prostate Cancer Clinical Trials Working Group-253. Clinically progressive prostate cancer must be evidenced and documented by any of the following parameters:
- Two consecutively rising PSA values at a minimum of 1-week intervals (2.0 ng/mL is the minimum starting value for PSA)
- Appearance of one or more new lesions on bone scans
- Progressive measurable disease by RECIST 1.1
Key exclusion criteria (9 listed)
- Concurrent treatment with any other cancer therapies including radiation (except palliative radiation therapy for bone metastases), chemotherapy or other investigational agent(s). Androgen suppression therapy will be allowed.
- History of a second active malignancy in the last 2 years other than non-melanoma skin cancers.
- Patients who have active or history of autoimmune disease/symptom/conditions including: type I diabetes, rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis. Type II diabetes mellitus, vitiligo or stable hypothyroidism are not considered exclusion criteria.
- Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH).
- Concurrent use of systemic glucocorticoids within 4 weeks prior to trial entry
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 |
|---|---|---|
| CT-011 (Anti-PD1 Antibody)Also: Anti-PD1 AntibodyImmune Enhancer | Drug | Arm B, Arm C |
| Sipuleucel-T (Provenge)Also: ProvengeVaccine | Other | Arm A, Arm B, Arm C |
| CyclophosphamideAlso: CytoxanLow dose- Immune Enhancer | Drug | Arm C |
Primary outcome
Determine Feasibility of Provenge Plus Low-dose Cyclophosphamide as Well as the Immune Efficacy of Provenge Alone Versus Provenge Plus Low-dose Cyclophosphamide and Anti PD1 Monoclonal Antibodies (CT011) on the Change in Specific Immune Response.
Time frame: 2 years
1 secondary outcome
Determine Whether the Combination of Low Dose-Cyclophosphamide and Anti PD1 Monoclonal Antibodies (CT-011) With Provenge(tm) Lead to Improvement in Increase Progression Free Survival (PFS) and Overall Survival (OS) in Patients With Advanced, Min...
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20647400Jemal A, Center MM, DeSantis C, Ward EM. Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomarkers Prev. 2010 Aug;19(8):1893-907. doi: 10.1158/1055-9965.EPI-10-0437. Epub 2010 Jul 20.
- Background: PubMed 1985245Gittes RF. Carcinoma of the prostate. N Engl J Med. 1991 Jan 24;324(4):236-45. doi: 10.1056/NEJM199101243240406. No abstract available.
- Background: PubMed 2503724Crawford ED, Eisenberger MA, McLeod DG, Spaulding JT, Benson R, Dorr FA, Blumenstein BA, Davis MA, Goodman PJ. A controlled trial of leuprolide with and without flutamide in prostatic carcinoma. N Engl J Med. 1989 Aug 17;321(7):419-24. doi: 10.1056/NEJM198908173210702.
- Individual participant dataSharing planned: No
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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.
Samir N. Khleif, MD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT-011 (Anti-PD1 Antibody), Sipuleucel-T (Provenge) and Cyclophosphamide in people with Prostatic Neoplasms, run by Augusta University 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 14 inclusion and 9 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 10 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 10 Jul 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?
Determine Feasibility of Provenge Plus Low-dose Cyclophosphamide as Well as the Immune Efficacy of Provenge Alone Versus Provenge Plus Low-dose Cyclophosphamide and Anti PD1 Monoclonal Antibodies (CT011) on the Change in Specific Immune Response. (time frame: 2 years). 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 NCT01420965, 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 10 Jul 2019.