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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose to the date of death due to any cause (assessed up to approximately 61 months)

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%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Nasopharyngitis

Lacrimation increased

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Chills

Hyperkalaemia

Bronchitis

Hypertension

Dehydration

Blood alkaline phosphatase increased

Hyperglycaemia

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Hypotension

Pain

Malaise

Musculoskeletal chest pain

Rash maculo-papular

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Cancer pain

Pneumothorax

Atrial flutter

Bone pain

Small intestinal haemorrhage

Confusional state

Bronchial obstruction

Femur fracture

Hypercalcaemia

Syncope

Neoplasm progression

Pericardial effusion malignant

Circulatory collapse

Superior vena cava syndrome

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

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

~2620

Cabazitaxel

2014

Completed Phase 3

~1290

Nivolumab

2014

Completed Phase 3

~4750

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,647 Previous Clinical Trials

4,130,938 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people can enroll in this research project?

"Although this study is not recruiting at the moment, it was last updated on November 15th, 2022. There are presently 1366 clinical trials actively recruiting patients with prostate cancer and 1142 trials for Nivolumab actively recruiting patients."

Answered by AI

In how many distinct places is this research being conducted?

"There are 37 sites running this clinical trial, including Local Institution - 0074 in Tucson, Arizona, Comprehensive Cancer Center Of Nevada in Las Vegas, Nevada and Minnesota Oncology Hematology (Minneapolis) - USOR in Minneapolis, Minnesota."

Answered by AI

Could you please list other research that has been published on Nivolumab?

"There are currently 1142 ongoing Nivolumab trials worldwide, with 178 of them in Phase 3. Though the majority of these studies originate from Pittsburgh, PA, there are 58497 locations conducting research for this medication."

Answered by AI

Are there any empty slots in this experiment that individuals could participate in?

"Currently, this clinical trial is not enrolling patients. Although, it was first posted on March 26th 2017 and last edited on November 15th 2022. There are 1,366 other trials for prostate cancer and 1142 for Nivolumab that are currently looking for participants."

Answered by AI

What are the government's thoughts on Nivolumab?

"Nivolumab's safety is based on data from Phase 2 trials, meaning that while there is evidence of its safety, there is currently no clinical data to support efficacy."

Answered by AI