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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).
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

CheckMate 650 Trial 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.Check my eligibility
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.See study design
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.

CheckMate 650 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or can carry out light work.
Select...
My scans show cancer has spread to my bones or soft tissues.
Select...
I am on hormone therapy for cancer and my testosterone is very low.

CheckMate 650 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Dry skin
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hyperkalaemia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Bronchial obstruction
1%
Femur fracture
1%
Syncope
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Circulatory collapse
1%
Superior vena cava syndrome
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

CheckMate 650 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
Prednisone
2014
Completed Phase 4
~2370
Ipilimumab
2014
Completed Phase 3
~2610
Cabazitaxel
2014
Completed Phase 3
~1290
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,650 Previous Clinical Trials
4,130,481 Total Patients Enrolled
42 Trials studying Prostate Cancer
5,217 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
~43 spots leftby Jun 2025
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