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Monoclonal Antibodies

Pembrolizumab for Prostate Cancer

Phase 2

Waitlist Available

Led By Julie Graff

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

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

Must have

Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale

Have a PSA or radiographic progression on enzalutamide; PSA progression is defined as two consecutive increases in PSA with the second level obtained at least 3 weeks after the first, and the second level of at least 0.5 ng/mL; soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or >= 2 new lesions on bone scan

Must not have

Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)

Has had chemotherapy for castration-resistant disease; chemotherapy for castration-sensitive disease is permitted

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies pembrolizumab to treat prostate cancer that has spread and is still growing despite reduced testosterone. Pembrolizumab is a monoclonal antibody that may help to block tumor growth.

Who is the study for?

This trial is for men with prostate cancer that has spread and doesn't respond to low testosterone or enzalutamide treatment. They must have good blood counts, liver and kidney function, be willing to use contraception, and not have had certain other treatments recently.

What is being tested?

The study tests pembrolizumab's effectiveness in patients whose prostate cancer continues to grow after enzalutamide treatment. Pembrolizumab is a monoclonal antibody designed to block tumor growth by targeting specific cells.

What are the potential side effects?

Pembrolizumab may cause immune system reactions affecting organs, fatigue, infusion-related symptoms, skin rashes, digestive issues like diarrhea or constipation, hormone gland problems (like thyroid), and can increase infection risk.

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 restricted in physically strenuous activity but can do light work.

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My prostate cancer has worsened on enzalutamide, shown by PSA or scans.

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I have had surgical castration or am on hormone therapy to lower my testosterone and will continue it during the study.

Select...

My bilirubin levels are within the normal range.

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My cancer has spread to other parts of my body.

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I have a cancer spread that can be sampled through a biopsy.

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My prostate cancer is spreading and no longer responds to enzalutamide.

Exclusion Criteria

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

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I have been diagnosed with HIV.

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I've had chemotherapy for cancer that didn't respond to hormone therapy.

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I haven't had cancer treatment in the last 2 weeks or have recovered from its side effects.

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I have cancer that has spread to my brain or its coverings.

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I have been treated with specific immune-targeting drugs before.

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I have had pneumonitis treated with steroids or have it now.

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I plan to receive specific cancer treatments during the study.

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I have had seizures in the past.

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I am currently being treated for an infection with medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 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

PSA response, defined by a PSA decrease of at least 50% confirmed by a second measurement at least 3 weeks later

Secondary study objectives

Changes in T cell activation as measured in whole blood

Changes in T cell numbers as measured in whole blood

Changes in T cell phenotype as measured in whole blood

+7 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

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: Treatment (pembrolizumab)Experimental Treatment3 Interventions

INITIAL TREATMENT PHASE: Patients who are progressing on enzalutamide will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily. MONITORING PHASE: After completion of the initial treatment phase, patients continue to receive standard of care enzalutamide PO daily for the duration of the trial. RETREATMENT PHASE: Patients with disease response or stability after the initial treatment phase will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for an additional 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily for the duration of the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

Enzalutamide

2014

Completed Phase 4

~3820