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Checkpoint Inhibitor

Pembrolizumab for Prostate Cancer (PERSEUS1 Trial)

Phase 2
Recruiting
Led By Johann de Bono
Research Sponsored by Institute of Cancer Research, United Kingdom
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first decline by at least 50% until the time time there is an increase of 25% of psa nadir or date of death from any cause, whichever came first, assessed up to 100 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

PERSEUS1 is an open-label, single arm, phase II trial evaluating the efficacy of Pembrolizumab in metastatic castration resistant prostate cancer (mCRPC) patients (Part A) with a biomarker enrichment stage (Part B) if efficacy is shown in part A.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first decline by at least 50% until the time time there is an increase of 25% of psa nadir or date of death from any cause, whichever came first, assessed up to 100 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first decline by at least 50% until the time time there is an increase of 25% of psa nadir or date of death from any cause, whichever came first, assessed up to 100 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate tumour response
Secondary study objectives
Duration of PSA response
Overall survival
Progression free survival
+4 more
Other study objectives
Exploratory: Immune cell genomics including T-cell receptor sequencing
Exploratory: Immunophenotyping endpoint
Exploratory: next generation sequencing data
+2 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
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Pneumonia aspiration
3%
Sepsis
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: PembrolizumabExperimental Treatment1 Intervention
Pembrolizumab will be given at a dose of 200mg IV every 3 weeks for a maximum of two years
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Institute of Cancer Research, United KingdomLead Sponsor
164 Previous Clinical Trials
132,525 Total Patients Enrolled
27 Trials studying Prostate Cancer
77,134 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,981 Previous Clinical Trials
5,177,909 Total Patients Enrolled
28 Trials studying Prostate Cancer
17,397 Patients Enrolled for Prostate Cancer
Johann de BonoPrincipal InvestigatorThe Institute of Cancer Research/The Royal Marsden NHSFT
2 Previous Clinical Trials
748 Total Patients Enrolled
~15 spots leftby Oct 2025
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