What side effects are associated with this type of intervention?

PD-1 inhibitors like Nivolumab, used in prostate cancer treatment, are associated with immune-related toxicities. These can include pneumonitis, colitis, hepatitis, endocrinopathies (such as thyroid dysfunction), and skin reactions. Other common treatments for prostate cancer, such as androgen deprivation therapy (ADT), can cause hot flashes, decreased libido, fatigue, and osteoporosis. Chemotherapy may lead to nausea, hair loss, and increased risk of infection. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including immunotherapies similar to Nivolumab, a PD-1 inhibitor. One notable example is Pembrolizumab, another PD-1 inhibitor, which has been approved for certain cases of prostate cancer with specific genetic markers. Additionally, Sipuleucel-T, an autologous cellular immunotherapy, has been approved for metastatic castration-resistant prostate cancer (CRPC). These treatments represent a shift towards leveraging the body's immune system to combat cancer, similar to the approach being studied with Nivolumab.

What other types of research exist?

Promising novel alternatives to Nivolumab for prostate cancer patients in 2024 include therapies targeting prostate specific membrane antigen (PSMA) and the manipulation of target receptors. These approaches are being explored to improve response rates and outcomes in clinical trials.

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Checkpoint Inhibitor

Nivolumab for Prostate Cancer

Q: What is the mechanism of action of this treatment?

Prostate cancer treatments often target the androgen receptor pathway or the immune system. Androgen deprivation therapy (ADT) reduces androgen levels, which prostate cancer cells rely on for growth. Androgen receptor signaling inhibitors, like enzalutamide and abiraterone, block the androgen receptor or inhibit androgen production, respectively. Immune checkpoint inhibitors, such as Nivolumab (a PD-1 inhibitor), enhance the immune system's ability to recognize and attack cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. These mechanisms are crucial as they offer different strategies to control cancer progression, providing options for personalized treatment plans based on the patient's specific tumor characteristics and treatment response.

Phase 2

Waitlist Available

Led By David J. Einstein, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

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

Must have

PSA doubling time (PSADT) <10 months --PSADT: calculated as per Prostate Cancer Working Group 3 (PCWG3) and the Memorial Sloan Kettering Cancer Center calculator: (https://www.mskcc.org/nomograms/prostate/psa_doubling_time)

Following primary RP: Any detectable rising PSA after RP (or after salvage RT if performed), minimum PSA 1.0 at time of screening

Must not have

Concurrent medical condition requiring use of systemic corticosteroids with prednisone >10 mg per day or equivalent. Use of inhaled, nasal, and topical steroids (applied to small body areas) is allowed.

Major surgery or radiation therapy within 14 days of starting study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing nivolumab, a drug that helps the immune system fight cancer, in prostate cancer patients with rising PSA levels. The goal is to see if it works better when used earlier in the disease. Nivolumab is an immunotherapy drug that has been tested in various cancers, including prostate cancer, often in combination with other treatments like ipilimumab.

Who is the study for?

This trial is for men over 18 with high-risk prostate cancer that's come back, shown by rising PSA levels after surgery or radiation. They must have no metastases on scans, a fast PSA doubling time (<10 months), and good organ function. Participants need to understand the study and consent to it, agree to use contraception if necessary, and not be on certain other treatments or have serious health issues.

What is being tested?

The trial is testing Nivolumab, an immune-based cancer drug for treating prostate cancer that has returned biochemically but hasn't spread. It aims to see how well this drug can manage such cases in patients who meet specific criteria regarding their PSA levels and overall health.

What are the potential side effects?

Nivolumab may cause side effects related to the immune system like inflammation of organs, potential autoimmune reactions, fatigue, skin conditions or digestive problems. The severity of these side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My PSA levels double in less than 10 months.

Select...

My PSA levels are rising and are above 1.0 after prostate surgery.

Select...

- You must have tissue samples available for testing, either from a prostatectomy or biopsy. - You must consent to genetic testing performed on this tissue. - You must be at least 18 years old and have adequate organ and marrow function. - You must have a certain level of blood counts and normal kidney and liver function. - You must have a testosterone level of at least 100 ng/dL. - You must have recovered from any toxicity related to prior treatment or have no treatment-related toxicity greater than grade 2. - Having a history of other cancer is not a problem as long as it's stable and doesn't require treatment. - You must be able to understand and follow study procedures. - Male patients with female partners of reproductive potential must agree to use contraception during the trial period.

Select...

I am fully active or can carry out light work.

Select...

I am 18 years old or older.

Select...

I agree to use contraception during the trial if my partner can become pregnant.

Select...

I had prostate cancer confirmed by biopsy and treated with surgery or radiation.

Select...

My biopsy showed cancer in at least 3 tissue samples.

Select...

My kidney function is within the required range.

Exclusion Criteria

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

Select...

I am taking more than 10 mg of prednisone or equivalent daily for another health issue.

Select...

I have not had major surgery or radiation within the last 2 weeks.

Select...

I haven't taken any prohibited medications, including cancer treatments, in the last 4 weeks.

Select...

I am currently using or plan to use hormone therapy for my cancer during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease Control

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

2Treatment groups

Experimental Treatment

Group I: PD-L1 PositiveExperimental Treatment1 Intervention

-Nivolumab will be given on day 1 of a 28-day cycle intravenously

Group II: PD-L1 NegativeExperimental Treatment1 Intervention

-Nivolumab will be given on day 1 of a 28-day cycle intravenously

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments often target the androgen receptor pathway or the immune system. Androgen deprivation therapy (ADT) reduces androgen levels, which prostate cancer cells rely on for growth. Androgen receptor signaling inhibitors, like enzalutamide and abiraterone, block the androgen receptor or inhibit androgen production, respectively. Immune checkpoint inhibitors, such as Nivolumab (a PD-1 inhibitor), enhance the immune system's ability to recognize and attack cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. These mechanisms are crucial as they offer different strategies to control cancer progression, providing options for personalized treatment plans based on the patient's specific tumor characteristics and treatment response.