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Chemotherapy

Nivolumab + Ipilimumab for Prostate Cancer (CheckMate 650 Trial)

Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI).
Must not have
Active, known, or suspected autoimmune disease or infection
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose to the date of death due to any cause (assessed up to approximately 61 months)
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new cancer treatment involving two drugs, to see if it is effective, safe, and tolerable for patients with mCRPC.

Who is the study for?
Men with advanced prostate cancer that has spread and is resistant to hormone therapy can join. They should be relatively healthy (ECOG 0-1) and on hormone-blocking treatment with low testosterone levels. Men who've had certain recent treatments, active autoimmune diseases, liver metastases, brain tumors, or previous immunotherapy are excluded.
What is being tested?
The trial tests the effectiveness of Nivolumab followed by Ipilimumab versus each drug alone or Cabazitaxel in treating metastatic castration-resistant prostate cancer. It aims to see which combination is safer and more tolerable for patients.
What are the potential side effects?
Nivolumab and Ipilimumab might cause immune system-related side effects like inflammation in various organs, skin rash, endocrine issues (like thyroid problems), fatigue, and flu-like symptoms. Cabazitaxel can lead to blood cell count changes, allergic reactions during infusion, nausea, hair loss, and nerve pain.

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 scans show cancer has spread to my bones or soft tissues.
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I am on hormone therapy for cancer and my testosterone is very low.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an autoimmune disease or a current infection.
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I have been treated with specific immune system targeting drugs before.
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My cancer has spread to my liver.
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I have active brain or spinal cord cancer spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to the date of death due to any cause (assessed up to approximately 61 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to the date of death due to any cause (assessed up to approximately 61 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
Objective Response Rate (ORR) Cohort D
Objective Response Rate (ORR) Cohorts B and C Per BICR
Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR
+1 more
Secondary study objectives
Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D
Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C
Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D
+24 more

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%
0%
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

7Treatment groups
Experimental Treatment
Group I: Cohort D (Arm D4)Experimental Treatment2 Interventions
Group II: Cohort D (Arm D3)Experimental Treatment1 Intervention
Group III: Cohort D (Arm D2)Experimental Treatment2 Interventions
Group IV: Cohort D (Arm D1)Experimental Treatment2 Interventions
Group V: Cohort C (Arm C)Experimental Treatment2 Interventions
Group VI: Cohort B (Arm B)Experimental Treatment2 Interventions
Group VII: Cohort A (Arm A)Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~3140
Cabazitaxel
2014
Completed Phase 3
~1290
Prednisone
2014
Completed Phase 4
~2500
Nivolumab
2014
Completed Phase 3
~5220

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,681 Previous Clinical Trials
4,124,633 Total Patients Enrolled
41 Trials studying Prostate Cancer
5,132 Patients Enrolled for Prostate Cancer

Media Library

Cabazitaxel (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02985957 — Phase 2
Prostate Cancer Research Study Groups: Cohort D (Arm D4), Cohort D (Arm D3), Cohort C (Arm C), Cohort D (Arm D1), Cohort A (Arm A), Cohort D (Arm D2), Cohort B (Arm B)
Prostate Cancer Clinical Trial 2023: Cabazitaxel Highlights & Side Effects. Trial Name: NCT02985957 — Phase 2
Cabazitaxel (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02985957 — Phase 2
~41 spots leftby Nov 2025
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