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Hormone Therapy

Nivolumab + Radiation + Hormone Therapy for Prostate Cancer

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.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

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