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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic bone metastasis as determined by the treating physician

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbetween baseline and c4d15 (about 5 months)

Awards & highlights

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ between baseline and c4d15 (about 5 months)

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

Hypothyroidism

Mucosal inflammation

Upper respiratory tract infection

Peripheral sensory neuropathy

Abdominal pain upper

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Chills

Bronchitis

Blood alkaline phosphatase increased

Dehydration

Hyperglycaemia

Hyperkalaemia

Lymphocyte count decreased

Anxiety

Hypertension

Leukopenia

Hypophosphataemia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Dry mouth

Malaise

Pain

Musculoskeletal chest pain

Hypotension

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Rash maculo-papular

Fall

Pulmonary embolism

Myocardial infarction

Metastases to central nervous system

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Atrial fibrillation

Cardiac failure

Adrenal insufficiency

Sepsis

Malignant pleural effusion

General physical health deterioration

Embolism

Pancytopenia

Atrial flutter

Pericardial effusion

Colitis

Gastrointestinal haemorrhage

Ileus

Small intestinal haemorrhage

Small intestinal obstruction

Performance status decreased

Femur fracture

Hypercalcaemia

Bone pain

Neoplasm progression

Pericardial effusion malignant

Confusional state

Bronchial obstruction

Pneumothorax

Respiratory tract infection

Respiratory failure

Superior vena cava syndrome

Tumour pain

Appendicitis

Skin infection

Cancer pain

Lung cancer metastatic

Ataxia

Seizure

Syncope

Circulatory collapse

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met

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

Recent research and studies

clinicaltrials.govStudy

Study of Nivolumab in Combination w Radium-223 in Men w Metastatic Castration Resistant Prostate Cancer

2020. "Study of Nivolumab in Combination w Radium-223 in Men w Metastatic Castration Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04109729.