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Checkpoint Inhibitor

Nivolumab + Radium-223 for Prostate Cancer (Rad2Nivo Trial)

Phase 1 & 2
Recruiting
Led By Benjamin Maughan, MD, PharmD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula: Males: ((140-age)×weight[kg])/(serum creatinine [mg/dL]×72)
Histologically confirmed adenocarcinoma of the prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between baseline and c4d15 (about 5 months)
Awards & highlights

Rad2Nivo Trial 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.

Who is the study for?
This trial is for men over 18 with advanced prostate cancer that has spread to the bones but not to other organs. They must have a certain white blood cell count, hemoglobin level, and liver function; no severe side effects from previous treatments; controlled testosterone levels; and be in fairly good health overall. Men who can father children must use effective birth control.Check my eligibility
What is being tested?
The study tests Nivolumab combined with Radium-223 in an open-label setup where everyone knows what treatment they're getting. It starts with a safety check phase followed by a larger test phase to see how well it works for bone metastasis in prostate cancer.See study design
What are the potential side effects?
Potential side effects of Nivolumab may include immune system reactions affecting different parts of the body, fatigue, skin issues, digestive problems, and infusion-related reactions. The specific side effects related to Radium-223 are not listed but typically could include nausea, diarrhea, or bone marrow suppression.

Rad2Nivo Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidneys are functioning well enough for treatment.
Select...
My prostate cancer was confirmed through a tissue examination.
Select...
I am a man aged 18 or older.
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My prostate cancer has spread and is resistant to hormone therapy, but it hasn't spread to my internal organs.
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I can take care of myself but might not be able to do heavy physical work.
Select...
My testosterone levels are below 50 ng/dL.
Select...
My doctor says my cancer has spread to my bones and is causing symptoms.

Rad2Nivo Trial 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%
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%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
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%
Small intestinal haemorrhage
1%
Syncope
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
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

Rad2Nivo 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
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,653 Total Patients Enrolled
8 Trials studying Prostate Cancer
5,349 Patients Enrolled for Prostate Cancer
Benjamin Maughan, MD, PharmDPrincipal InvestigatorHuntsman 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.
~0 spots leftby Apr 2024
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