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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 belowSelect...
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.
Select...
My prostate cancer has spread and is resistant to hormone therapy, but it hasn't spread to my internal organs.
Select...
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 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)
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 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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%
Hypoalbuminaemia
10%
Muscular weakness
10%
Dry skin
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%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hyperkalaemia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
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%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Bronchial obstruction
1%
Femur fracture
1%
Syncope
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Circulatory collapse
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
1,104 Previous Clinical Trials
1,782,497 Total Patients Enrolled
8 Trials studying Prostate Cancer
5,349 Patients Enrolled for Prostate Cancer
Benjamin Maughan, MD, PharmDPrincipal InvestigatorHuntsman Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using or will use effective birth control during and for 7 months after the study.You have had a very bad allergic reaction in the past to the study drug or any of its ingredients.My liver is functioning properly.My kidneys are functioning well enough for treatment.My prostate cancer was confirmed through a tissue examination.I have not received any live vaccines within the last 4 weeks.I have recovered from previous cancer treatment side effects, or they are minor and stable.I have another type of cancer, but it won't affect this trial's treatment.I have stopped taking certain medications as required before starting treatment.I have hepatitis B or C with a detectable virus level, or it's undetectable.My kidney function is within normal ranges.I am not on immunosuppressive drugs, except for low-dose or topical steroids.I am a man aged 18 or older.My prostate cancer has spread and is resistant to hormone therapy, but it hasn't spread to my internal organs.I do not have serious heart conditions such as recent heart attacks, unstable angina, severe heart failure, or dangerous arrhythmias.I can take care of myself but might not be able to do heavy physical work.My bilirubin levels are within normal range, or I have Gilbert's syndrome.My organs are functioning well.My testosterone levels are below 50 ng/dL.My doctor says my cancer has spread to my bones and is causing symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment: all patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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