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Checkpoint Inhibitor
pTVG-HP for Prostate Cancer
Phase 2
Waitlist Available
Led By Hamid Emamekhoo
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have normal hematologic, renal and liver function
Patients must have biochemically recurrent, non-metastatic clinical stage D0/M0 disease with detectable serum PSA and a PSA doubling time calculated using the Memorial Sloan-Kettering Cancer Center nomogram
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will test a new vaccine for prostate cancer in combination with nivolumab, to see if it is safe and effective in lowering PSA levels.
Who is the study for?
Men over 18 with non-metastatic, PSA-recurrent prostate cancer after surgery and possible radiation therapy. They should have a rising PSA level, be in good physical condition (ECOG score < 2), expect to live at least another year, and have normal blood counts and organ function. No recent immunosuppressants or other cancer treatments are allowed, except certain hormone therapies under specific conditions.Check my eligibility
What is being tested?
The trial is testing the safety of pTVG-HP, a DNA vaccine targeting prostate acid phosphatase (PAP), combined with Nivolumab, an immune checkpoint inhibitor. The goal is to see if this combination can lower serum Prostate-Specific Antigen (PSA) levels in patients whose prostate cancer has returned but hasn't spread.See study design
What are the potential side effects?
Possible side effects include typical immune-related reactions such as fatigue, skin issues or rashes; flu-like symptoms from the vaccine like fever and chills; injection site reactions; potential liver enzyme changes due to Nivolumab; and allergic responses to GM-CSF.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood, kidney, and liver tests are normal.
Select...
My prostate cancer has returned, is not spread, and my PSA levels are rising quickly.
Select...
I finished my surgery and any follow-up radiation for cancer over 3 months ago, with all visible cancer removed.
Select...
My scans show no signs of cancer spread to my abdomen, pelvis, or bones.
Select...
I am over 18 and have been diagnosed with prostate cancer.
Select...
I can perform daily activities and am expected to live more than a year.
Select...
I have had surgery to remove my prostate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Who Experienced Adverse Events Grade 3 or Higher
Prostate-Specific Antigen (PSA) Complete Response (CR) Rate
Secondary outcome measures
Median Radiographic Progression-free Survival
Metastasis-free Survival Rate
Number of Participants Receiving GM-CSF as an Adjuvant After Week 4
+2 moreSide effects data
From 2020 Phase 2 trial • 99 Patients • NCT0134165269%
Injection site reaction
35%
Fatigue
22%
Back pain
22%
Headache
18%
Pain
18%
Hypertension
16%
Arthralgia
16%
Myalgia
14%
Dizziness
12%
Flu like symptoms
12%
Chills
10%
Bone pain
10%
Pruritus
10%
Malaise
10%
Skin and subcutaneous tissue disorders - Other, specify
8%
Respiratory, thoracic and mediastinal disorders - Other, specify
8%
Rash maculo-papular
8%
Vomiting
8%
Fever
8%
Diarrhea
6%
Aspartate aminotransferase increased
6%
Edema limbs
6%
Bruising
6%
Nausea
6%
Investigations - Other, specify
6%
Hot flashes
6%
Lymphocyte count decreased
6%
Gastrointestinal disorders - Other, specify
4%
Urinary tract infection
4%
Sinusitis
4%
Flatulence
4%
Renal and urinary disorders - Other, specify
4%
Urinary frequency
4%
Urinary incontinence
4%
Sinus disorder
4%
Erythema multiforme
4%
General disorders and administration site conditions - Other, specify
4%
Cholesterol high
4%
Chest wall pain
4%
Vasovagal reaction
4%
Neutrophil count decreased
4%
Weight loss
4%
Depression
4%
Gastroesophageal reflux disease
4%
White blood cell decreased
4%
Allergic reaction
4%
Cough
2%
Dysphasia
2%
Presyncope
2%
Rash pustular
2%
Infections and infestations - Other, specify
2%
Ankle fracture
2%
Platelet count decreased
2%
Nervous system disorders - Other, specify
2%
Constipation
2%
Non-cardiac chest pain
2%
Cardiac disorders
2%
Dry mouth
2%
Tooth infection
2%
Photosensitivity
2%
Nervous system disorders - other, specify
2%
Mucositis oral
2%
Rectal hemorrhage
2%
Memory impairment
2%
Alanine aminotransferase increased
2%
Blood bilirubin increased
2%
Generalized muscle weakness
2%
Neuralgia
2%
Peripheral motor neuropathy
2%
Peripheral sensory neuropathy
2%
Spasticity
2%
Syncope
2%
Insomnia
2%
Psychiatric disorders - Other, specify
2%
Bladder spasm
2%
Hematuria
2%
Epistaxis
2%
Nasal congestion
2%
Palpitations
2%
Cataract
2%
Gait disturbance
2%
Chest pain - cardiac
2%
Upper respiratory infection
2%
Cardiac disorders - Other, specify
2%
Colitis
2%
Facial pain
2%
Pain in extremity
2%
Musculoskeletal and connective tissue disorder - Other, specify
2%
Urine discoloration
2%
Aortic valve disease
2%
Tinnitus
2%
Gum infection
2%
Hyperglycemia
2%
Serum amylase increased
2%
Cognitive disturbance
2%
Pharyngolaryngeal pain
2%
Eye pain
2%
Eye disorders - Other, specify
2%
Abdominal pain
2%
Bladder infection
2%
Dysarthria
2%
Dyspnea
2%
Dry skin
2%
Neck pain
2%
Paresthesia
2%
Pelvic pain
2%
Sinus pain
2%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
GM-CSF Alone
pTVG-HP Vaccine With GM-CSF
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pTVG-HP
2011
Completed Phase 2
~100
Nivolumab
2014
Completed Phase 3
~4750
GM-CSF
2014
Completed Phase 4
~1340
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,495 Total Patients Enrolled
41 Trials studying Prostate Cancer
5,428 Patients Enrolled for Prostate Cancer
Madison Vaccines Inc. (MVI)UNKNOWN
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,368 Total Patients Enrolled
33 Trials studying Prostate Cancer
8,947 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My testosterone levels are below 50 ng/dL.My cancer has spread to my bones or lymph nodes.I have previously received a DNA vaccine for prostate cancer.I have been treated with hormonal therapies before.My prostate cancer is of a specific type, not the most common one.My blood, kidney, and liver tests are normal.I am willing to give blood samples for research for up to a year after the study ends.My prostate cancer has returned, is not spread, and my PSA levels are rising quickly.I had cancer before, was treated to cure it, and have been cancer-free for over 3 years.I will use reliable birth control during and for 4 weeks after the study.I finished my surgery and any follow-up radiation for cancer over 3 months ago, with all visible cancer removed.I have not taken immunosuppressive drugs in the last 3 months.My scans show no signs of cancer spread to my abdomen, pelvis, or bones.I am currently taking medications or supplements that affect hormones.I am over 18 and have been diagnosed with prostate cancer.I can perform daily activities and am expected to live more than a year.I have not used herbal supplements or experimental therapies for prostate cancer recently.I have had surgery to remove my prostate.I do not have any severe or unstable health conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent can pTVG-HP be considered a threat to human health?
"The safety of pTVG-HP has been evaluated as a 2 since this is Phase 2 trial and there exists some evidence for its safety but not effectiveness."
Answered by AI
What therapeutic purpose does pTVG-HP usually fulfill?
"Malignant neoplasms can generally be ameliorated with pTVG-HP. Additionally, this medication has been demonstrated to improve outcomes for patients receiving allogenic bone marrow transplantation therapy, those afflicted by unresectable melanoma and individuals suffering from squamous cell carcinoma."
Answered by AI
What is the ultimate purpose of this experiment?
"This medical trial's primary goal, which is evaluated within 48 weeks, examines the percentage of patients who remain within acceptable toxicity limits. Secondary endpoints include Median Radiographic Progression-free Survival (determined through imaging prior to treatment and at 6-month intervals), PSA Doubling Time (calculated from baseline and subsequent laboratory values) ,and PSA Response Rate (assessed by comparing pre-treatment levels with those after 2 years)."
Answered by AI
Are there still opportunities to take part in this investigation?
"As per the records on clinicaltrials.gov, this trial is not currently open to participants; it was first posted in September 2018 and last edited a few months ago in 2022. However, there are over 2000 other studies actively looking for enrollees at present."
Answered by AI
Is there evidence of prior experimentation using pTVG-HP?
"Currently, 756 clinical trials utilizing pTVG-HP are ongoing with 86 of these in the third phase. Basel, BE is home to several of these experiments while 41450 sites across the world host studies evaluating pTVG-HP's efficacy."
Answered by AI
How many applicants can be admitted to this research project?
"This study is no longer in the recruitment phase. According to its timeline, first posted on September 10th 2018 and last edited on September 1st 2022, it has concluded for now. But individuals with prostate cancer may be interested in the 1321 studies actively recruiting patients while those seeking pTVG-HP may look into one of the 756 active trials."
Answered by AI
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