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Monoclonal Antibodies

Pembrolizumab for Prostate Cancer

Phase 1 & 2
Waitlist Available
Led By Douglas G McNeel, MD PhD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying a combination of two different treatments- a vaccine and an antibody- to see if they are more effective at treating hormone-resistant prostate cancer that has metastasized than either treatment alone.

Eligible Conditions
  • Prostate Cancer
  • Bone Metastasis
  • Prostate Adenocarcinoma
  • Soft Tissue Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
6-month Progression Free Survival Rate
Incidence of Adverse Events, Using the National Cancer Common Terminology Criteria, Version 4
Median Time to Radiographic Progression
+2 more
Secondary outcome measures
PAP-specific Immune Response
PAP-specific T-cell Response
PD-1 Expression
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

4Treatment groups
Experimental Treatment
Group I: Extended Treatment Arm IVExperimental Treatment2 Interventions
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) every 2 weeks, for a maximum of 24 doses Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 4 weeks, for a maximum of 12 doses, beginning on day 1 after the first pTVG-HP vaccination
Group II: Extended Treatment Arm IIIExperimental Treatment2 Interventions
pTVG-HP (100 μg) with rhGM-CSF (208 μg) administered intradermally (i.d.) every 3 weeks, for a maximum of 16 doses. Pembrolizumab 2 mg/kg, with a maximum dose of 200 mg, administered intravenously every 3 weeks, for a maximum of 16 doses, beginning on day 1 after the first pTVG-HP vaccination.
Group III: Arm II (pTVG-HP plasmid DNA vaccine, sequential pembrolizumab)Experimental Treatment2 Interventions
Patients receive pTVG-HP plasmid DNA vaccine ID as in Arm I and pembrolizumab IV over 30 minutes every 3 weeks on days 85, 106, 127, and 148.
Group IV: Arm I (pTVG-HP plasmid DNA vaccine, concurrent pembrolizumab)Experimental Treatment2 Interventions
Patients receive pTVG-HP plasmid DNA vaccine ID every other week on days 1, 15, 29, 43, 57, and 71 and pembrolizumab IV over 30 minutes every 3 weeks on days 1, 22, 43, and 64.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
pTVG-HP Plasmid DNA Vaccine
2015
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,180 Previous Clinical Trials
3,592,284 Total Patients Enrolled
34 Trials studying Prostate Cancer
8,966 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,714 Total Patients Enrolled
28 Trials studying Prostate Cancer
1,930 Patients Enrolled for Prostate Cancer
Madison Vaccines, IncUNKNOWN
2 Previous Clinical Trials
120 Total Patients Enrolled
2 Trials studying Prostate Cancer
120 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ailments does Pembrolizumab typically alleviate?

"Pembrolizumab is primarily used to battle malignant neoplasms, yet it can be utilized for other ailments such as advanced melanoma, microsatellite instability-high conditions, and post-chemotherapy progression."

Answered by AI

What is the enrollment capacity for this experiment?

"As of November 8th 2022, this trial is no longer actively recruiting. Initially posted on July 1st 2015, the study has since concluded its recruitment phase. However, 5932 trials for adenocarcinoma and 961 studies involving Pembrolizumab are presently seeking participants to join their medical research."

Answered by AI

What additional investigations into Pembrolizumab have been done?

"Currently, Pembrolizumab is the subject of 961 active trials. Out of those studies, 122 are in Phase 3. Though Houston Texas has a high number of these tests running, there are 35 731 different locations that offer this medication's clinical trial worldwide."

Answered by AI

What potential benefits is the research team hoping to glean from this trial?

"The primary research goal of this trial, which will span six months or so, is to catalogue the frequency and type of adverse events with the National Cancer Common Terminology Criteria, Version 4. Secondary objectives pertain to PAP-specific T-cell Response (Number and frequencies), PAP-Specific Immune Response (quantity from immunization) , and PD-1 Expression (PD-1/PDL1 expression levels). A linear regression model or a negative binomial regression model will be utilized to evaluate effects of schedule on PD-1 expression in terms of circulating cells."

Answered by AI

Is this trial currently open to enrollment?

"Sadly, clinicaltrials.gov specifies that this medical trial is not currently seeking patient participants. Although the protocol was first published on July 1st 2015 and last updated on November 8th 2022, there are 6893 other studies recruiting patients presently."

Answered by AI
~7 spots leftby Apr 2025