Prostate CancerEarly Phase 1NCT02113657
T-Cell Responses to Neoantigens Post Treatment With Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer
A Early Phase 1 study testing Ipilimumab in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to study the impact of ipilimumab on the immune system of patients currently receiving hormone therapy. The safety of these drug combinations will also be studied. This is an investigational study. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2014to 4 Nov 2019
- Phase
- Early 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written Informed Consent for this protocol.
- Agreed to participate in laboratory protocol PA13-0291 for the testing of biomarkers as described in this clinical protocol.
- Patients included in the study must be >/= 18 years old.
- Histologically or cytologically confirmed carcinoma of the prostate.
- Subjects must have metastatic prostate cancer mass tissue collection within 3 months of study entry.
- Evidence of metastatic disease on previous bone scan, CT scan and/or MRI.
Show all 11Show fewer
- Asymptomatic or minimally symptomatic.
- Tumor progression while on hormone therapy with castrate levels serum testosterone (</= 1.7 nmol/L or 50 ng/dL) defined as biopsy-proven, PSA and/or radiographic criteria according to the Prostate Cancer Working Group 2 (PCWG2).Castrate levels of testosterone must be maintained by surgical or medical means throughout the conduct of the study.
- ECOG performance status </= 1.
- Patients must have normal organ and marrow function as defined below: a) WBC >/= 2500/uL.; b) ANC >/= 1000/uL.; c) Platelets >/= 75 x 10^3/uL.; d) Hemoglobin >/= 9 g/dL.; e) Creatinine </= 2.5 x ULN.; f) ALT </= 2.5 x ULN for patients without liver metastases. For patients with liver metastasis ALT </= 5 x ULN is allowed.; g) Bilirubin </= 2.5 x ULN (except for patients with Gilbert's Syndrome, who must have a total bilirubin </= 3mg/dL).
- Patient agrees to use adequate contraception (barrier method of birth control) prior to study entry, during therapy and up to 3 months after last dose of ipilimumab.
Who cannot join
- Treatment with any of the following medications or interventions concomitantly or within 28 days of starting ipilimumab: a.) Systemic corticosteroids. Use of inhaled, intranasal, intra-articular and topical steroids is acceptable, as is a short course (i.e. </= 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans.; b.) External beam radiation therapy or major surgery requiring general anesthetic.; c.) Any systemic therapy for prostate cancer (with the exception of bisphosphonates and RANK-ligand inhibitors for bone metastases which are allowed) including chemotherapy, secondary hormonal therapies (such as megestrol acetate, diethylstilbestrol, ketoconazole, abiraterone, enzalutamide) and non-steroidal anti-androgens (such as bicalutamide, flutamide or nilutamide).; d.) Immune modulators, cytokines or vaccines for the management of cancer or non-cancer-related illnesses.;
- (Exclusion Criteria #2 Cont.): e.) Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month before any dose of ipilimumab).; f.) Any other investigational product.
- Use of controlled schedule III controlled substances for cancer-related pain control.
- Autoimmune disease: Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus or autoimmune vasculitis [e.g., Wegener's Granulomatosis] are excluded from this study.
- Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
- Patients with known brain metastases.
Show all 11Show fewer
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known HIV, Hepatitis B, or Hepatitis C.
- Untreated symptomatic spinal cord compressions.
- Other malignancies requiring active therapy or known to be associated with altered immune response.
- Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Feasibility Study To Determine T-cell Responses To Neoantigens Following Treatment With Ipilimumab In Men With Metastatic Castration-Resistant Prostate Carcinoma
The goal of this clinical research study is to study the impact of ipilimumab on the immune system of patients currently receiving hormone therapy. The safety of these drug combinations will also be studied.
This is an investigational study. Ipilimumab is FDA approved and commercially available for the treatment of melanoma. Its use to treat prostate cancer is investigational.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive ipilimumab by vein over about 90 minutes at Weeks 1, 4, 7, and 10. Your blood pressure will be measured every 30 minutes during the infusion, as well as an hour after you are finished receiving the study drug.
You will continue to receive your current hormone therapy as scheduled.
You will be given standard drugs (such as steroids) to help decrease severe side effects. You may ask the study staff for information about how the drugs are given and their risks.
Study Visits:
You will have a study visit before each dose of ipilimumab, then every 4 weeks for a total of 3 visits after the last dose of ipilimumab. At each of these visits, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 3 tablespoons) and urine will be collected for routine tests. This blood will also be used and to measure your protein, PSA levels.
- Blood (up to 7 tablespoons) and urine will be collected to test for biomarkers. (Weeks 7, 14, and 22 only)
- Blood (about 1½ teaspoons) will be drawn to check your testosterone level. (Week 10 only)
- Blood (up to 10 tablespoons) will be drawn to test your immune system. You will sign a separate consent form for this blood draw.
At Weeks 14 and 22, the following tests and procedures will be performed to check the status of the disease:
- You may have a chest x-ray.
- You will have CT scans or MRIs of the abdomen, pelvis. If the doctor thinks it is needed, you will also have a CT scan of the chest. If a CT scan of the chest is done, a chest x-ray is not required.
- You will have a bone scan.
If the study doctor thinks it is needed, you may have additional bone scans or CT scans or MRIs of the abdomen, pelvis, or chest to check the status of the disease.
Length of Study:
You may receive the study drug for up to 10 weeks. You will remain on study (receiving your standard hormone therapy) for up to a total of 22 weeks. You will be taken off study treatment if you have intolerable side effects, if the disease gets worse, or if you are unable to follow study directions. If you develop certain side effects or have certain side effects for a long period of time, you may be taken off study. The study doctor will let you know if you need to be taken off study.
- Conditions
- Prostate Cancer
- Being tested
- Ipilimumab
- Keywords
- Prostate cancer, Castration-resistant prostate cancer, CRPC, Metastatic, Hormone therapy treatment, Androgen deprivation therapy, gonadotropin-releasing hormone, GnRH, Ipilimumab, Yervoy, BMS-734016, MDX010
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Also called Yervoy, BMS-734016, MDX010
3 mg/kg by vein once every 3 weeks for a total of 4 doses.
| Study group | Role | What they receive |
|---|---|---|
| Ipilimumab | Experimental | Ipilimumab administered by vein at a dose of 3 mg/kg once every 3 weeks for a total of 4 doses. Receives: Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Ipilimumab on T Cell Responses to prostate cancer neoantigens in both primary tumor and metastatic sites in men with metastatic CRPC
T-cell response to neoantigens defined as: At least a 2-fold increase compared to the response seen against irrelevant control targets, and activating at least 0.1% of cells tested, or at least a 2-fold increase compared to baseline.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study start20 Aug 2014
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Stand Up To Cancer, High Impact Clinical Research Support Program
- Responsible party
- Sponsor
- Investigators
- Padmanee Sharma, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113657
- Sponsor's protocol ID
- 2013-0444
- Other IDs
- NCI-2014-01205, SUC2CR-AACR-DT10
- Status last verified
- May 2024
- First submitted
- 8 Apr 2014
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study To Determine T-cell Responses To Neoantigens Following Treatment With Ipilimumab In Men With Metastatic Castration-Resistant Prostate Carcinoma
- ClinicalTrials.gov ID
- NCT02113657
- Acronym / sponsor ID
- 2013-0444
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Castration-resistant prostate cancer, CRPC, Metastatic, Hormone therapy treatment, Androgen deprivation therapy, gonadotropin-releasing hormone, GnRH
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Stand Up To Cancer, High Impact Clinical Research Support Program
- Study start
- 20 Aug 2014 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 14 Apr 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.
The goal of this clinical research study is to study the impact of ipilimumab on the immune system of patients currently receiving hormone therapy. The safety of these drug combinations will also be studied.
This is an investigational study. Ipilimumab is FDA approved and commercially available for the treatment of melanoma. Its use to treat prostate cancer is investigational.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive ipilimumab by vein over about 90 minutes at Weeks 1, 4, 7, and 10. Your blood pressure will be measured every 30 minutes during the infusion, as well as an hour after you are finished receiving the study drug.
You will continue to receive your current hormone therapy as scheduled.
You will be given standard drugs (such as steroids) to help decrease severe side effects. You may ask the study staff for information about how the drugs are given and their risks.
Study Visits:
You will have a study visit before each dose of ipilimumab, then every 4 weeks for a total of 3 visits after the last dose of ipilimumab. At each of these visits, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 3 tablespoons) and urine will be collected for routine tests. This blood will also be used and to measure your protein, PSA levels.
- Blood (up to 7 tablespoons) and urine will be collected to test for biomarkers. (Weeks 7, 14, and 22 only)
- Blood (about 1½ teaspoons) will be drawn to check your testosterone level. (Week 10 only)
- Blood (up to 10 tablespoons) will be drawn to test your immune system. You will sign a separate consent form for this blood draw.
At Weeks 14 and 22, the following tests and procedures will be performed to check the status of the disease:
- You may have a chest x-ray.
- You will have CT scans or MRIs of the abdomen, pelvis. If the doctor thinks it is needed, you will also have a CT scan of the chest. If a CT scan of the chest is done, a chest x-ray is not required.
- You will have a bone scan.
If the study doctor thinks it is needed, you may have additional bone scans or CT scans or MRIs of the abdomen, pelvis, or chest to check the status of the disease.
Length of Study:
You may receive the study drug for up to 10 weeks. You will remain on study (receiving your standard hormone therapy) for up to a total of 22 weeks. You will be taken off study treatment if you have intolerable side effects, if the disease gets worse, or if you are unable to follow study directions. If you develop certain side effects or have certain side effects for a long period of time, you may be taken off study. The study doctor will let you know if you need to be taken off study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ipilimumab | Experimental | Drug: IpilimumabIpilimumab administered by vein at a dose of 3 mg/kg once every 3 weeks for a total of 4 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written Informed Consent for this protocol.
- Agreed to participate in laboratory protocol PA13-0291 for the testing of biomarkers as described in this clinical protocol.
- Patients included in the study must be >/= 18 years old.
- Histologically or cytologically confirmed carcinoma of the prostate.
- Subjects must have metastatic prostate cancer mass tissue collection within 3 months of study entry.
Key exclusion criteria (11 listed)
- Treatment with any of the following medications or interventions concomitantly or within 28 days of starting ipilimumab: a.) Systemic corticosteroids. Use of inhaled, intranasal, intra-articular and topical steroids is acceptable, as is a short course (i.e. </= 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans.; b.) External beam radiation therapy or major surgery requiring general anesthetic.; c.) Any systemic therapy for prostate cancer (with the exception of bisphosphonates and RANK-ligand inhibitors for bone metastases which are allowed) including chemotherapy, secondary hormonal therapies (such as megestrol acetate, diethylstilbestrol, ketoconazole, abiraterone, enzalutamide) and non-steroidal anti-androgens (such as bicalutamide, flutamide or nilutamide).; d.) Immune modulators, cytokines or vaccines for the management of cancer or non-cancer-related illnesses.;
- (Exclusion Criteria #2 Cont.): e.) Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month before any dose of ipilimumab).; f.) Any other investigational product.
- Use of controlled schedule III controlled substances for cancer-related pain control.
- Autoimmune disease: Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus or autoimmune vasculitis [e.g., Wegener's Granulomatosis] are excluded from this study.
- Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
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 |
|---|---|---|
| IpilimumabAlso: Yervoy, BMS-734016, MDX0103 mg/kg by vein once every 3 weeks for a total of 4 doses. | Drug | Ipilimumab |
Primary outcome
Impact of Ipilimumab on T Cell Responses to prostate cancer neoantigens in both primary tumor and metastatic sites in men with metastatic CRPC
Time frame: 10 weeks
T-cell response to neoantigens defined as: At least a 2-fold increase compared to the response seen against irrelevant control targets, and activating at least 0.1% of cells tested, or at least a 2-fold increase compared to baseline.
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 24 May 2024.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Padmanee Sharma, MD,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ipilimumab in people with Prostate Cancer, run by M.D. Anderson Cancer Center 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 11 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 24 May 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Impact of Ipilimumab on T Cell Responses to prostate cancer neoantigens in both primary tumor and metastatic sites in men with metastatic CRPC (time frame: 10 weeks). 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 24 May 2024.