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Checkpoint Inhibitor

pTVG-HP + Nivolumab 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

Must not have

Serum testosterone at screening < 50 ng/dL

Evidence of bone metastases or lymph node involvement as determined by imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My blood, kidney, and liver tests are normal.

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My prostate cancer has returned, is not spread, and my PSA levels are rising quickly.

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I finished my surgery and any follow-up radiation for cancer over 3 months ago, with all visible cancer removed.

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My scans show no signs of cancer spread to my abdomen, pelvis, or bones.

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I am over 18 and have been diagnosed with prostate cancer.

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I can perform daily activities and am expected to live more than a year.

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I have had surgery to remove my prostate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My testosterone levels are below 50 ng/dL.

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My cancer has spread to my bones or lymph nodes.

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I have previously received a DNA vaccine for prostate cancer.

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I have been treated with hormonal therapies before.

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My prostate cancer is of a specific type, not the most common one.

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I have not taken immunosuppressive drugs in the last 3 months.

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I am currently taking medications or supplements that affect hormones.

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I do not have any severe or unstable health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Who Experienced Adverse Events Grade 3 or Higher

Prostate-Specific Antigen (PSA) Complete Response (CR) Rate

Secondary study objectives

Median Radiographic Progression-free Survival

Metastasis-free Survival Rate

Number of Participants Receiving GM-CSF as an Adjuvant After Week 4

+2 more

Side effects data

From 2020 Phase 2 trial • 99 Patients • NCT01341652

69%

Injection site reaction

35%

Fatigue

22%

Headache

22%

Back pain

18%

Pain

18%

Hypertension

16%

Arthralgia

16%

Myalgia

14%

Dizziness

12%

Flu like symptoms

12%

Chills

10%

Pruritus

10%

Bone pain

10%

Malaise

10%

Skin and subcutaneous tissue disorders - Other, specify

Rash maculo-papular

Respiratory, thoracic and mediastinal disorders - Other, specify

Vomiting

Fever

Diarrhea

Edema limbs

Aspartate aminotransferase increased

Bruising

Nausea

Investigations - Other, specify

Hot flashes

Lymphocyte count decreased

Gastrointestinal disorders - Other, specify

Cholesterol high

Sinusitis

Flatulence

Urinary tract infection

Renal and urinary disorders - Other, specify

Urinary frequency

Urinary incontinence

Sinus disorder

Erythema multiforme

General disorders and administration site conditions - Other, specify

Chest wall pain

Vasovagal reaction

Neutrophil count decreased

Weight loss

Depression

Gastroesophageal reflux disease

White blood cell decreased

Allergic reaction

Cough

Dysphasia

Peripheral motor neuropathy

Generalized muscle weakness

Nervous system disorders - Other, specify

Presyncope

Neuralgia

Platelet count decreased

Photosensitivity

Ankle fracture

Constipation

Dry mouth

Non-cardiac chest pain

Rash pustular

Tooth infection

Cardiac disorders

Infections and infestations - Other, specify

Nervous system disorders - other, specify

Mucositis oral

Rectal hemorrhage

Memory impairment

Alanine aminotransferase increased

Blood bilirubin increased

Peripheral sensory neuropathy

Spasticity

Syncope

Insomnia

Psychiatric disorders - Other, specify

Bladder spasm

Hematuria

Epistaxis

Nasal congestion

Palpitations

Cataract

Gait disturbance

Chest pain - cardiac

Upper respiratory infection

Cardiac disorders - Other, specify

Colitis

Facial pain

Pain in extremity

Musculoskeletal and connective tissue disorder - Other, specify

Urine discoloration

Aortic valve disease

Tinnitus

Gum infection

Hyperglycemia

Serum amylase increased

Cognitive disturbance

Pharyngolaryngeal pain

Eye pain

Eye disorders - Other, specify

Abdominal pain

Bladder infection

Dysarthria

Dyspnea

Dry skin

Neck pain

Paresthesia

Pelvic pain

Sinus pain

Tremor

100%

80%

60%

40%

20%

Study treatment Arm

GM-CSF Alone

pTVG-HP Vaccine With GM-CSF

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5220