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Hormone Therapy
Nivolumab + Radiation + Hormone Therapy for Prostate Cancer
Tampa, FL
Phase 1 & 2
Waitlist Available
Led By Kosj Yamoah, M.D., Ph.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status: 0-1
Diagnosed with Grade Group 5 prostate cancer (PCa): Gleason grade 9 (4+5 or 5+4) or 10 (5+5) with >30% of cores involved; Any PSA or T-stage
Must not have
History of allergy or hypersensitivity to any of the study drugs or study drug components
Uncontrolled intercurrent illnesses including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer drug combination to see if it is safe, works well, and delays prostate cancer progression.
See full description
Who is the study for?
Men over 18 with advanced prostate cancer (Grade Group 5, Gleason grade 9 or 10) who are receiving their first treatment and have a good performance status. They must be able to follow the study procedures for its duration, have normal organ function, agree to use contraception if necessary, and not donate sperm during the study.Check my eligibility
What is being tested?
The trial is testing how safe and effective nivolumab (Opdivo™) is when combined with high-dose radiation therapy and hormone therapy in delaying prostate cancer progression. Participants will receive this combination as part of their initial treatment.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in various organs, skin reactions, hormonal gland problems like thyroid issues, fatigue, infusion reactions similar to allergic responses, lung issues like coughing or shortness of breath.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My prostate cancer is aggressive (Grade Group 5) with a high Gleason score.
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I have a confirmed diagnosis of prostate cancer and am starting my first treatment.
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I am a man aged 18 or older.
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I am eligible for specific radiation therapy and hormone treatment.
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My organs are functioning normally while I'm on nivolumab.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not allergic to any of the drugs or their components used in this study.
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I do not have any uncontrolled illnesses like infections or heart problems.
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I have lung disease that causes symptoms or could affect lung-related side effects from treatment.
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I have tested positive for HIV/AIDS.
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My blood, liver, or pancreas functions are not normal.
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I have previously received treatments targeting the immune system.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1: Safety Run In - Rate of Dose Limiting Toxicity (CTCAE V5.0)
Phase II: Relapse Free Survival Rate
Secondary study objectives
Time to PSA Nadir
Side effects data
From 2024 Phase 3 trial • 529 Patients • NCT0201771770%
Fatigue
50%
Headache
45%
Confusional state
45%
Cough
40%
Malignant neoplasm progression
35%
Hemiparesis
35%
Diarrhoea
30%
Gait disturbance
30%
Nausea
30%
Pruritus
25%
Urinary tract infection
25%
Fall
25%
Hyperglycaemia
25%
Muscular weakness
25%
Rash
20%
Constipation
20%
Vomiting
20%
Lethargy
20%
Memory impairment
20%
Urinary incontinence
20%
Dizziness
20%
Nasal congestion
15%
Abdominal pain
15%
Alanine aminotransferase increased
15%
Lymphocyte count decreased
15%
Platelet count decreased
15%
Decreased appetite
15%
Arthralgia
15%
Cognitive disorder
10%
Aspartate aminotransferase increased
10%
Oedema peripheral
10%
Facial paresis
10%
Pyrexia
10%
Candida infection
10%
Depressed level of consciousness
10%
Syncope
10%
Pulmonary embolism
10%
Anaemia
10%
Sinus tachycardia
10%
Anal incontinence
10%
Asthenia
10%
Tooth infection
10%
Upper respiratory tract infection
10%
Lipase increased
10%
Paraesthesia
10%
Psychomotor skills impaired
10%
Seizure
10%
Agitation
10%
Anxiety
10%
Disorientation
10%
Dehydration
10%
Hypoalbuminaemia
10%
Hypokalaemia
10%
Hyponatraemia
10%
Aphasia
10%
Dysarthria
10%
Dyspnoea
10%
Rash maculo-papular
5%
Dermatitis acneiform
5%
Dysphagia
5%
Oedema
5%
Pain
5%
Cardio-respiratory arrest
5%
Autoimmune thyroiditis
5%
Pneumonia
5%
Hip fracture
5%
White blood cell count decreased
5%
Enterocolitis infectious
5%
Tumour flare
5%
Brain oedema
5%
Cerebrovascular accident
5%
Ischaemic stroke
5%
Mental status changes
5%
Aspiration
5%
Herpes zoster
5%
Haemorrhage intracranial
5%
Hypoxia
5%
Pneumonitis
5%
Respiratory distress
5%
Atrial fibrillation
5%
Cushingoid
5%
Hyperthyroidism
5%
Hypothyroidism
5%
Dry eye
5%
Eyelid ptosis
5%
Visual field defect
5%
Visual impairment
5%
Dyspepsia
5%
Oral candidiasis
5%
Stomatitis
5%
Chills
5%
Amylase increased
5%
Blood alkaline phosphatase increased
5%
Blood bilirubin increased
5%
Weight decreased
5%
Weight increased
5%
Tremor
5%
Vasogenic cerebral oedema
5%
Depression
5%
Insomnia
5%
Pollakiuria
5%
Hypocalcaemia
5%
Proteinuria
5%
Back pain
5%
Myalgia
5%
Amnesia
5%
Ataxia
5%
Balance disorder
5%
Dysphonia
5%
Dry skin
5%
Deep vein thrombosis
5%
Hypertension
5%
Hypotension
5%
Colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1b: Arm N3+I1
Cohort 1: Arm N3
Cohort 1: Arm N1+I3
Cohort 2: Arm N3
Part A Cohort 1c: Arm N3+RT+TMZ
Cohort 2: Arm B
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Part A Cohort 1d: Arm N3+RT
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: Combination TherapyExperimental Treatment4 Interventions
Post androgen deprivation therapy (ADT), participants will receive nivolumab, HDR brachytherapy and external beam radiation therapy, followed by a 2 year follow-up period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brachytherapy
2007
Completed Phase 3
~2140
External Beam Radiation Therapy
2006
Completed Phase 3
~3300
Nivolumab
2014
Completed Phase 3
~3880
Androgen Deprivation Therapy
2008
Completed Phase 2
~110
Find a Location
Closest Location:H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
575 Previous Clinical Trials
144,976 Total Patients Enrolled
27 Trials studying Prostate Cancer
3,645 Patients Enrolled for Prostate Cancer
Bristol-Myers SquibbIndustry Sponsor
2,730 Previous Clinical Trials
4,129,059 Total Patients Enrolled
41 Trials studying Prostate Cancer
5,439 Patients Enrolled for Prostate Cancer
Kosj Yamoah, M.D., Ph.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
2 Previous Clinical Trials
300 Total Patients Enrolled
2 Trials studying Prostate Cancer
300 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.My prostate cancer is aggressive (Grade Group 5) with a high Gleason score.I have a confirmed diagnosis of prostate cancer and am starting my first treatment.I am not allergic to any of the drugs or their components used in this study.I do not have any uncontrolled illnesses like infections or heart problems.I do not have active autoimmune diseases except for controlled type I diabetes, hypothyroidism, or certain skin conditions.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.I am a man aged 18 or older.I have cancer spread to 3 or fewer places and/or in pelvic lymph nodes, and am being treated to cure it.I agree to use contraception during and after the study for a total of 31 weeks if I'm sexually active with women who can get pregnant. I won't donate sperm during this time.I am receiving radiation therapy at Moffitt Cancer Center.I have lung disease that causes symptoms or could affect lung-related side effects from treatment.I had cancer before, but it's been in complete remission for over 2 years and I don't need treatment now.I tested positive for HCV antibodies but do not currently have an active infection.I have tested positive for HIV/AIDS.My blood, liver, or pancreas functions are not normal.I am eligible for specific radiation therapy and hormone treatment.My organs are functioning normally while I'm on nivolumab.I have recovered from major surgery or significant injury for at least 14 days before starting prostate radiation.I have previously received treatments targeting the immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Therapy
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.