Prostate CancerPhase 2NCT03600350
pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer
A Phase 2 study testing pTVG-HP, Nivolumab and GM-CSF in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with nivolumab, and the efficacy of this combination in decreasing serum Prostate-Specific Antigen (PSA) in patients with non-metastatic… 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?
- pTVG-HP, Nivolumab and GM-CSF
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2018to Dec 2027
- 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 be at least 18 years of age with a histologic diagnosis of adenocarcinoma of the prostate
- Patients must have undergone radical prostatectomy
- Patients must have completed local therapy by surgery and any adjuvant/salvage radiation therapy at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement.
- Patients must have biochemically recurrent, non-metastatic (by CT and bone scan) clinical stage D0/M0 disease defined by the following:
- Patients must have evidence of detectable serum PSA with at least 4 serum PSA measurements available, from the same clinical laboratory, at least two weeks apart up to one year, and the final serum PSA value must be > 2.0 ng/mL.
- PSA doubling time, calculated from most recent 4 serum PSA values (collected up to one year prior to enrollment, at least 2 weeks apart, and all from the same clinical laboratory), must be a positive number (i.e. evidence of PSA rise over time).
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- PSA doubling time will be calculated using the Memorial Sloan-Kettering Cancer Center nomogram (http://www.mskcc.org/applications/nomograms/prostate/PsaDoublingTime.aspx).
- Patients must not have definitive evidence of metastases as determined by CT of the abdomen/pelvis and bone scintigraphy (bone scan). Note: patients with lesions detectable by highly sensitive methods (e.g. NaF PET imaging or PSMA PET imaging) will be considered eligible as long as these lesions do not meet size criteria on CT imaging (visceral lesions suspicious for metastases or lymph node > 15 mm in short axis) and/or are not independently observed on bone scan
- Patients with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years. There will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, or other in situ carcinoma that has been adequately treated.
- Patients who are sexually active must use a reliable form of contraception while on study and for 4 weeks after the last immunization.
- ECOG performance score < 2 and life expectancy of at least 12 months.
- Patients must have normal hematologic, renal and liver function as defined by: WBC > 3000/mm3, hematocrit > 30%, platelet count > 100,000/mm3, serum creatinine < 1.5 mg/dl or a calculated creatinine clearance > 60 cc/min, AST or ALT < 3.0x ULN, and serum bilirubin < 2.0 mg/dl(except participants with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL), within 4 weeks prior to first immunization.
- Patients must be informed of the experimental nature of the study and its potential risks and must sign an IRB-approved written informed consent form indicating such an understanding.
- Willingness to provide blood samples for immune studies, per study calendar, up to one year after study, even if off study treatment.
Who cannot join
- Small cell or other variant prostate cancer histology
- Patients cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy or chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), within 3 months of the first vaccination.
- Seropositive for HIV, hepatitis B (HBV) or hepatitis C (HCV) per patient history due to the immunosuppressive features of these diseases.
- Prior treatment with an LHRH agonist or nonsteroidal antiandrogen, except in the following circumstances: Neoadjuvant/adjuvant androgen deprivation therapy administered with radiation therapy or at the time of prostatectomy is acceptable, provided that there was no evidence of PSA progression while on treatment. In this situation, patients must not have received more than 24 months of androgen deprivation treatment. Other treatment with androgen deprivation therapy is prohibited.
- Serum testosterone at screening < 50 ng/dL.
- Patients must not be concurrently taking other medications or supplements with known hormonal effects, including PC-SPES, megestrol acetate, finasteride, ketoconazole, estradiol, or Saw Palmetto. All other medications with possible anticancer effects must be discussed with the PI prior to study entry.
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- Patients previously treated with herbal supplements as described in 5.B.6 or other potential or experimental therapies for prostate cancer must have discontinued these treatments and completed at least a 4 week washout prior to beginning treatment.
- Patients must not have evidence of bone metastases or lymph node involvement as determined by bone scan or CT scan of the abdomen and pelvis within 4 weeks of study registration. Note: Advanced imaging modalities (such as NaF-PET/CT, choline PET/CT, fluciclovine, or PSMA PET scans) will NOT be used to determine evidence of metastases for eligibility purposes or for defining disease progression.
- Patients must not have been treated with a prior DNA vaccine therapy for prostate cancer.
- Patients must not have known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol.
- Patients must not have known allergic reactions to GM-CSF.
- Patients with unstable or severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the PI, excess risk associated with study participation or study agent administration.
- Patients cannot have concurrent enrollment on other phase I, II, or III investigational therapeutic treatment studies.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
About this study
Official title: Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and Nivolumab in Patients With Non-Metastatic, PSA-Recurrent Prostate Cancer
The purpose of this study is to evaluate the safety of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with nivolumab, and the efficacy of this combination in decreasing serum Prostate-Specific Antigen (PSA) in patients with non-metastatic, non-castrate prostate cancer (clinical stage D0/M0).
- Conditions
- Prostate Cancer
- Being tested
- pTVG-HP, Nivolumab, GM-CSF
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pTVG-HPBiological
Plasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP)
NivolumabDrug
Also called Opdivo
Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
GM-CSFDrug
Also called Leukine, Sargramostim
Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that supports the survival, clonal expansion and differentiation of hematopoietic progenitor cells including dendritic antigen presenting cells.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | * Nivolumab 240 mg IV every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* pTVG-HP (100 µg) administered intradermally (i.d.) every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12
* rhGM-CSF (208 µg) administered intradermally (i.d.) every two weeks x 4 beginning week 4, then every four weeks x 9 beginning week 12 NOTE: Only administered to patients for whom serum PSA obtained week 4 > serum PSA obtained at day 1. Receives: Biological: pTVG-HP; Drug: Nivolumab; Drug: GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Adverse Events Grade 3 or Higher
Subjects will be evaluated at each visit by a review of systems based on the most recent version of the NCI common toxicity criteria. Safety and Tolerability of this intervention is defined as following: a toxicity rate p0 of at most 15% of Grade ≥ 3 toxicity events (CTCAE v.4.0) will be considered as acceptable while a toxicity rate p1=35% or more will be considered as unacceptably high. See Adverse Events Section for full summary of data.
Measured: up to 48 weeks
Prostate-Specific Antigen (PSA) Complete Response (CR) Rate
A PSA CR will be defined as the percentage of participants with a serum PSA <0.2 ng/mL and confirmatory PSA <0.2 ng/mL at least 4 weeks later, as per Prostate Cancer Working Group 2 (PCWG2) recommendations. To qualify as a PSA CR, there must be no evidence of radiographic progression.
Measured: up to 48 weeks
Secondary outcomes (5)
Metastasis-free Survival Rate
The 5-year metastasis-free survival will be determined by investigator review of radiographic studies (CT/MRI and bone scintigraphy) performed 5 years after study initiation in subjects who have not already met criteria for radiographic progression.
Measured: Up to 5 years
Median Radiographic Progression-free Survival
All participants will undergo radiographic imaging prior to treatment and at 6-month intervals (or as clinically required). The appearance of lesions consistent with metastatic disease will be used to define radiographic progression.
Measured: Up to 5 years
PSA Doubling Time
Post-treatment doubling time will be calculated from: 1) All PSA values obtained from the same clinical laboratory using the same PSA assay beginning with the PSA value at day 1 (week 0) and continuing until the end-of study (or month 24) value (PSADT 0-24). 2) All PSA values obtained from the same clinical laboratory using the same PSA assay beginning with the PSA value at day 85 (month 3) to the day 253 (month 9) value (PSADT 3-9).
Measured: Up to 2 years
PSA Response Rate (</= 50% of Baseline)
The percentage of participants with PSA values less than or equal to their baseline value after 2 year.
Measured: Up to 2 years
Number of Participants Receiving GM-CSF as an Adjuvant After Week 4
GM-CSF is used as an adjuvant if the PSA at week 4 is higher than baseline.
Measured: up to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start10 Sep 2018
- Primary completion7 Nov 2022
- Study completionDec 2027 (estimated)
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 (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, single-institution, two-stage phase II trial
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Madison Vaccines Inc. (MVI), AIQ Solutions
- Responsible party
- Sponsor
- Investigators
- Hamid Emamekhoo, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600350
- Sponsor's protocol ID
- UW18008
- Other IDs
- 2018-0418, A534260, SMPH/MEDICINE/HEM-ONC, NCI-2018-01474, Protocol Version 4/15/2024
- Status last verified
- May 2026
- First submitted
- 11 Jul 2018
- Last updated
- 1 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
McNeel DG, Emamekhoo H, Eickhoff JC, Kyriakopoulos CE, Wargowski E, Tonelli TP, Johnson LE, Liu G. Phase 2 trial of a DNA vaccine (pTVG-HP) and nivolumab in patients with castration-sensitive non-metastatic (M0) prostate cancer. J Immunother Cancer. 2023 Dec 14;11(12):e008067. doi: 10.1136/jitc-2023-008067.
PubMed 38101860
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and Nivolumab in Patients With Non-Metastatic, PSA-Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT03600350
- Acronym / sponsor ID
- UW18008
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Madison Vaccines Inc. (MVI), AIQ Solutions
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 6 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with nivolumab, and the efficacy of this combination in decreasing serum Prostate-Specific Antigen (PSA) in patients with non-metastatic, non-castrate prostate cancer (clinical stage D0/M0).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, single-institution, two-stage phase II trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: pTVG-HP, Drug: Nivolumab, Drug: GM-CSF* Nivolumab 240 mg IV every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12 * pTVG-HP (100 µg) administered intradermally (i.d.) every two weeks x 6 beginning day 1, then every four weeks x 9 beginning week 12 * rhGM-CSF (208 µg) administered intradermally (i.d.) every two weeks x 4 beginning week 4, then every four weeks x 9 beginning week 12 NOTE: Only administered to patients for whom serum PSA obtained week 4 > serum PSA obtained at day 1. |
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 be at least 18 years of age with a histologic diagnosis of adenocarcinoma of the prostate
- Patients must have undergone radical prostatectomy
- Patients must have completed local therapy by surgery and any adjuvant/salvage radiation therapy at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement.
- Patients must have biochemically recurrent, non-metastatic (by CT and bone scan) clinical stage D0/M0 disease defined by the following:
- Patients with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years. There will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, or other in situ carcinoma that has been adequately treated.
Key exclusion criteria (13 listed)
- Small cell or other variant prostate cancer histology
- Patients cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy or chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), within 3 months of the first vaccination.
- Seropositive for HIV, hepatitis B (HBV) or hepatitis C (HCV) per patient history due to the immunosuppressive features of these diseases.
- Prior treatment with an LHRH agonist or nonsteroidal antiandrogen, except in the following circumstances: Neoadjuvant/adjuvant androgen deprivation therapy administered with radiation therapy or at the time of prostatectomy is acceptable, provided that there was no evidence of PSA progression while on treatment. In this situation, patients must not have received more than 24 months of androgen deprivation treatment. Other treatment with androgen deprivation therapy is prohibited.
- Serum testosterone at screening < 50 ng/dL.
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 |
|---|---|---|
| pTVG-HPPlasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP) | Biological | Treatment Group |
| NivolumabAlso: OpdivoNivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer. | Drug | Treatment Group |
| GM-CSFAlso: Leukine, SargramostimGranulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that supports the survival, clonal expansion and differentiation of hematopoietic progenitor cells including dendritic antigen presenting cells. | Drug | Treatment Group |
Primary outcome
Number of Participants Who Experienced Adverse Events Grade 3 or Higher
Time frame: up to 48 weeks
Subjects will be evaluated at each visit by a review of systems based on the most recent version of the NCI common toxicity criteria. Safety and Tolerability of this intervention is defined as following: a toxicity rate p0 of at most 15% of Grade ≥ 3 toxicity events (CTCAE v.4.0) will be considered as acceptable while a toxicity rate p1=35% or more will be considered as unacceptably high. See Adverse Events Section for full summary of data.
Prostate-Specific Antigen (PSA) Complete Response (CR) Rate
Time frame: up to 48 weeks
A PSA CR will be defined as the percentage of participants with a serum PSA <0.2 ng/mL and confirmatory PSA <0.2 ng/mL at least 4 weeks later, as per Prostate Cancer Working Group 2 (PCWG2) recommendations. To qualify as a PSA CR, there must be no evidence of radiographic progression.
5 secondary outcomes
Metastasis-free Survival Rate
Time frame: Up to 5 years
Median Radiographic Progression-free Survival
Time frame: Up to 5 years
PSA Doubling Time
Time frame: Up to 2 years
PSA Response Rate (</= 50% of Baseline)
Time frame: Up to 2 years
Number of Participants Receiving GM-CSF as an Adjuvant After Week 4
Time frame: up to week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38101860McNeel DG, Emamekhoo H, Eickhoff JC, Kyriakopoulos CE, Wargowski E, Tonelli TP, Johnson LE, Liu G. Phase 2 trial of a DNA vaccine (pTVG-HP) and nivolumab in patients with castration-sensitive non-metastatic (M0) prostate cancer. J Immunother Cancer. 2023 Dec 14;11(12):e008067. doi: 10.1136/jitc-2023-008067.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
Hamid Emamekhoo principal investigator
University of Wisconsin, Madison
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 pTVG-HP, Nivolumab and GM-CSF in people with Prostate Cancer, run by University of Wisconsin, Madison 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 13 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. 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 6 Dec 2023). 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 Participants Who Experienced Adverse Events Grade 3 or Higher (time frame: up to 48 weeks). The study lists 2 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 NCT03600350, which also lists 1 linked publication.
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 1 Jun 2026.