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Chemotherapy Agent

Nivolumab Combinations for Prostate Cancer (CheckMate 9KD 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
Evidence of stage IV disease on previous bone, CT, and/or MRI scan
Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

CheckMate 9KD Trial Summary

This trial is testing nivolumab in combination with other drugs to see if it is safe and effective in treating prostate cancer that has spread and is resistant to hormone therapy.

Who is the study for?
This trial is for men with advanced prostate cancer that has spread and doesn't respond to hormone therapy. They must have evidence of stage IV disease, provide tissue samples, and continue hormone treatments like GnRH or surgery. Men with active brain tumors, recent major surgeries, or other cancers within the last 3 years are excluded.Check my eligibility
What is being tested?
The study tests how safe and effective Nivolumab is when combined with Rucaparib, Docetaxel, or Enzalutamide in treating metastatic castration-resistant prostate cancer. It aims to find better treatment options by mixing these drugs.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs (like lungs or intestines), fatigue, skin issues, hormonal changes due to enzalutamide, chemotherapy effects from docetaxel such as hair loss and nausea, and potential blood cell count changes.

CheckMate 9KD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My scans show my cancer is stage IV.
Select...
I am currently on hormone therapy for cancer or have had surgery to remove my testicles.
Select...
I can provide samples of my blood and either a new or stored sample of my tumor.
Select...
My prostate cancer is confirmed to be adenocarcinoma.

CheckMate 9KD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 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 Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
Prostate-Specific Antigen Response Rate (RR-PSA)
Secondary outcome measures
Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3)
Number of Deaths
Number of Participants With Adverse Events (AEs)
+7 more

Side effects data

From 2021 Phase 3 trial • 1844 Patients • NCT03068455
38%
Fatigue
37%
Diarrhoea
37%
Pruritus
29%
Headache
28%
Rash
24%
Hypothyroidism
24%
Nausea
20%
Hyperthyroidism
18%
Arthralgia
18%
Cough
18%
Asthenia
15%
Alanine aminotransferase increased
13%
Pyrexia
13%
Lipase increased
12%
Constipation
12%
Aspartate aminotransferase increased
12%
Decreased appetite
12%
Nasopharyngitis
11%
Abdominal pain
11%
Dry mouth
11%
Vomiting
11%
Myalgia
10%
Back pain
10%
Insomnia
10%
Hypophysitis
9%
Amylase increased
8%
Dyspnoea
8%
Upper respiratory tract infection
7%
Dizziness
6%
Adrenal insufficiency
6%
Abdominal pain upper
6%
Infusion related reaction
6%
Hyperglycaemia
6%
Oropharyngeal pain
6%
Blood creatine phosphokinase increased
6%
Influenza like illness
5%
Vitiligo
5%
Hypertension
5%
Pain in extremity
3%
Anxiety
3%
Colitis
2%
Immune-mediated enterocolitis
2%
Autoimmune hepatitis
2%
Basal cell carcinoma
2%
Malignant neoplasm progression
1%
Autoimmune colitis
1%
Squamous cell carcinoma
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Erysipelas
1%
Pneumonia
1%
Melanoma recurrent
1%
Pneumonitis
1%
Sarcoidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nivo + Ipi
Arm B: Nivo

CheckMate 9KD Trial Design

3Treatment groups
Experimental Treatment
Group I: nivolumab + rucaparibExperimental Treatment2 Interventions
Specified dose on specified days
Group II: nivolumab + enzalutamideExperimental Treatment2 Interventions
Specified dose on specified days
Group III: nivolumab + docetaxel + prednisoneExperimental Treatment3 Interventions
Specified dose on specified days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nivolumab
2016
Completed Phase 3
~4960
docetaxel
2015
Completed Phase 3
~7230
enzalutamide
2017
Completed Phase 4
~4530
rucaparib
2016
Completed Phase 2
~50
prednisone
1999
Completed Phase 3
~10920

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,629 Previous Clinical Trials
4,126,024 Total Patients Enrolled
41 Trials studying Prostate Cancer
5,155 Patients Enrolled for Prostate Cancer
Clovis Oncology, Inc.Industry Sponsor
63 Previous Clinical Trials
9,879 Total Patients Enrolled
2 Trials studying Prostate Cancer
19 Patients Enrolled for Prostate Cancer
Astellas Pharma IncIndustry Sponsor
689 Previous Clinical Trials
219,747 Total Patients Enrolled
35 Trials studying Prostate Cancer
8,350 Patients Enrolled for Prostate Cancer

Media Library

Docetaxel (Chemotherapy Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03338790 — Phase 2
Prostate Cancer Research Study Groups: nivolumab + rucaparib, nivolumab + docetaxel + prednisone, nivolumab + enzalutamide
Prostate Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT03338790 — Phase 2
Docetaxel (Chemotherapy Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03338790 — 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 facilities are facilitating this trial?

"This clinical trial can be found at Maryland Oncology Hematology, P.A. in Rockville, Maryland; Local Institution - 0068 in New york City and Local Institution - 0038 in Albany, Mississippi as well another 42 research sites throughout the country."

Answered by AI

Are there any vacancies for participants in this research program?

"Unfortunately, clinicaltrials.gov states that this trial is not currently recruiting patients to participate. The first posting of the study occurred on December 19th 2017 and it was last updated on October 4th 2022. Nevertheless, there are a multitude of other medical studies seeking volunteers presently with 2745 trials open for enrollment at present."

Answered by AI

What is the recruitment rate for this clinical research program?

"Unfortunately, this research project has already stopped recruitment. Initial postings for the trial were made on December 19th 2017 and it was last updated on October 4th 2022. For those seeking alternate trials, there are currently 1,321 prostate cancer studies and 1,424 clinical tests involving nivolumab that are actively enrolling participants."

Answered by AI

What health conditions has nivolumab been found to effectively address?

"Nivolumab is a popular treatment for thyroiditis, as well as unresectable melanoma and squamous cell carcinomas. This medication can also be used to manage ulcerative colitis symptoms."

Answered by AI

Has nivolumab been used in any other scientific research?

"Presently, there are 1424 ongoing clinical investigations exploring nivolumab with 309 of these in the third phase. Most of these trials are based out of Columbus, Ohio however over seventy-nine thousand locations worldwide have studies for this drug running."

Answered by AI

Could you elucidate the risks of using nivolumab as a treatment option?

"A score of 2 was assigned to nivolumab due to the lack of clinical efficacy data, although there is evidence which suggests it has a positive safety profile."

Answered by AI
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~40 spots leftby Mar 2025