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Checkpoint Inhibitor

PROSTVAC-V/F + Nivolumab for Prostate Cancer

Phase 1 & 2
Waitlist Available
Led By James L Gulley, M.D.
Research Sponsored by National Cancer Institute (NCI)
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 3-5 years
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of the combination of PROSTVAC and nivolumab for people with castration resistant prostate cancer and then for other people with localized prostate cancer who are candidates for surgical removal of the prostate.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-5 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
Evaluate changes in T-cell infiltration in the tumor after neoadjuvant treatment
Safety - lead-in mCRPC cohort
Secondary outcome measures
Determine the change in peripheral PSA-specific T cells in participants treated with PROSTVAC and nivolumab
Document any MRI changes secondary to treatment
Document any PSA changes secondary to vaccination, including rate of biochemical recurrence after prostatectomy
+7 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Chills
7%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Small intestinal haemorrhage
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Circulatory collapse
1%
Hypercalcaemia
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Neoadjuvant CohortExperimental Treatment2 Interventions
PROSTVAC-V on week 0 followed by booster injection called PROSTVAC-F on 2, 4 and 8 weeks. When administered on the same day, the preferred order of administration is PROSTVAC first followed by nivolumab. Participants will undergo prostatectomy on week 9.
Group II: Lead-in mCRPC CohortExperimental Treatment2 Interventions
PROSTVAC-V on week 0 followed by booster injection called PROSTVAC-F every 2 weeks. When administered on the same day, the preferred order of administration is PROSTVAC first followed by nivolumab. Participants will undergo sigmoidoscopies on week 9 and restaging scans on week 12. If no PD, option to continue treatment every 2 weeks until intolerance or progression. Option to extend nivolumab interval to 4 weeks after 1 year
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,662 Previous Clinical Trials
40,925,861 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,075 Patients Enrolled for Prostate Cancer
James L Gulley, M.D.Principal InvestigatorNational Cancer Institute (NCI)
19 Previous Clinical Trials
35,766 Total Patients Enrolled
6 Trials studying Prostate Cancer
25,246 Patients Enrolled for Prostate Cancer

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02933255 — Phase 1 & 2
Prostate Cancer Research Study Groups: Lead-in mCRPC Cohort, Neoadjuvant Cohort
Prostate Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT02933255 — Phase 1 & 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02933255 — Phase 1 & 2

Frequently Asked Questions

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

What goals is the trial hoping to achieve?

"This clinical trial, with a timeline of 10 participants, is aiming to understand how neoadjuvant treatment can alter T-cell infiltration in the tumor. Secondary objectives include surveying changes in soluble immune mediators, such as cytokines; documenting intraprostatic Treg cell infiltration utilizing CD4+FOX-P3staining; and measuring circulating tumor cells levels (for mCRPCcohort only)."

Answered by AI

How many individuals are actively involved in this research project?

"Affirmative. The clinical trials database reveals that recruitment for this medical test is still ongoing, having first been posted on April 18th 2017 and last updated on November 19th 2022. Currently, 29 patients are required from a single site."

Answered by AI

What conditions can be ameliorated through the administration of Nivolumab?

"Nivolumab is an effective therapy for treating malignant neoplasms, as well as conditions such as unresectable melanoma, squamous cell carcinoma of the head and neck, and metastatic esophageal adenocarcinoma."

Answered by AI

Is this a pioneering research endeavor?

"Currently, there are 717 ongoing clinical trials for Nivolumab spread across 49 countries and 2356 individual cities. The initial research study was initiated by Ono Pharmaceutical Co. Ltd in 2012 with 659 participants; since then 252 studies have reached completion of their Phase 1 & 2 evaluation stages."

Answered by AI

Could you provide an overview of investigations that have involved Nivolumab?

"Currently, there are 82 Phase 3 studies and 717 trials in total concerning Nivolumab. Of these, 40281 locations have been identified as hosting clinical trial experiments related to this drug. Notably, a handful of these laboratories can be found near Zürich, BE."

Answered by AI

Has recruitment for this clinical trial been open to participants yet?

"Affirmative. Clinicaltrials.gov has data that supports this trial's search for participants, beginning on April 18th 2017 and last amended on November 19th 2022. The research endeavour is looking to recruit 29 individuals from a single centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer
2017. "PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02933255.
~2 spots leftby Apr 2025
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