Checkpoint Inhibitor

Nivolumab for Prostate Cancer

Huntsman Cancer Institute at University of Utah, Salt Lake City, UT
NivolumabPhase 1 & 2RecruitingLed by Benjamin Maughan, MD, PharmDResearch Sponsored by University of Utah

Study Summary

This trial is testing a new safety drug in two phases. First, a small group of people will test it to make sure it's safe. If it is, then a larger group of people will use it.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have bone metastasis that is causing symptoms, as decided by your doctor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between baseline and c4d15 (about 5 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and between baseline and c4d15 (about 5 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase II: To assess the ctDNA reduction after 6 weeks of nivolumab treatment.
Phase Ib:To assess the safety of nivolumab in combination w Radium-223 in patients w metastatic castrate resistant prostate cancer.
Secondary outcome measures
To assess PSA progression free survival defined by the Prostate Cancer Working Group 3 (PCWG3).
To assess correlation of bone metabolism markers with clinical response.
To assess radiographic progression-free survival as defined by the PCWG3 criteria.
+2 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%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
14%
Rash
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
12%
Pruritus
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Muscular weakness
10%
Productive cough
10%
Alopecia
10%
Dry skin
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
9%
Abdominal pain upper
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
7%
Hypertension
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
5%
Rash maculo-papular
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Atrial fibrillation
2%
Cardiac failure
2%
Adrenal insufficiency
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Embolism
1%
Pancytopenia
1%
Atrial flutter
1%
Pericardial effusion
1%
Colitis
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal haemorrhage
1%
Small intestinal obstruction
1%
Performance status decreased
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Confusional state
1%
Bronchial obstruction
1%
Pneumothorax
1%
Respiratory tract infection
1%
Respiratory failure
1%
Superior vena cava syndrome
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Cancer pain
1%
Lung cancer metastatic
1%
Ataxia
1%
Seizure
1%
Syncope
1%
Circulatory collapse
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

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: all patientsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Find a site

Who is running the clinical trial?

University of UtahLead Sponsor
1,049 Previous Clinical Trials
1,704,728 Total Patients Enrolled
8 Trials studying Prostate Cancer
5,349 Patients Enrolled for Prostate Cancer
Benjamin Maughan, MD, PharmDPrincipal Investigator
Huntsman Cancer Institute

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04109729 — Phase 1 & 2
Prostate Cancer Research Study Groups: Treatment: all patients
Prostate Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04109729 — Phase 1 & 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04109729 — 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 is the total enrollment capacity for this medical experiment?

"Affirmative. Clinicaltrials.gov details indicate that this trial was launched on August 25 2020 and is currently seeking volunteers. 36 participants need to be enrolled at a single clinical site."

Answered by AI

Are there any openings left for this clinical trial?

"Affirmative. As confirmed by clinicaltrials.gov, the medical study is still recruiting participants as of April 21st 2022; it was first advertised on August 25th 2020. The research project demands 36 volunteers from 1 site to partake in the trial."

Answered by AI

Is this research unprecedented in its approach?

"Research surrounding Nivolumab began in 2012, when Ono Pharmaceutical Co. Ltd sponsored its initial study involving 659 patients. This led to the drug receiving Phase 1 and 2 approval, sparking a wave of clinical trials around the world with 723 active studies occurring across 2357 cities and 49 countries today."

Answered by AI

In what medical scenarios is Nivolumab typically prescribed?

"Nivolumab has been found to have positive effects in treating malignant tumours, unresectable melanoma, and squamous cell carcinomas."

Answered by AI

Can you please provide an overview of the prior research on Nivolumab?

"Currently, 723 trials are actively researching Nivolumab with 83 Phase 3 studies. The medication is being investigated in 40342 different areas of the globe, including Basel, BE."

Answered by AI

What is the aim of this experiment?

"The primary objective of this medical trial, anticipated to last 30 months, is the assessment of nivolumab's safety when combined with Radium-223 in patients with metastatic castrate resistant prostate cancer. Additionally, researchers will evaluate radiographic progression-free survival according to PCWG3 criteria and PSA progression free survival using Prostate Cancer Working Group 3 (PCWG3). Lastly, there will be a correlation analysis between bone metabolism markers and clinical response."

Answered by AI
~5 spots leftby Apr 2024