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Chemotherapy

Nivolumab + Docetaxel for Advanced Prostate Cancer (CheckMate 7DX Trial)

Phase 3
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
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)
Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization to the date of psa progression per pcwg3, approximately 31 months
Awards & highlights

CheckMate 7DX Trial Summary

This trial is testing nivolumab with docetaxel in men with advanced prostate cancer who have not responded to other treatments.

Who is the study for?
Men with advanced castration-resistant prostate cancer who have not had chemotherapy for this condition, but may have received hormonal therapies. They must show evidence of metastatic disease, be in good physical condition (ECOG 0-1), and continue androgen deprivation therapy. Men should agree to contraception if applicable and provide tumor tissue samples.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Nivolumab combined with Docetaxel versus a placebo with Docetaxel in treating men whose prostate cancer has worsened after hormonal treatments. The goal is to see if Nivolumab can improve outcomes.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in various organs, skin rash, endocrine problems like thyroid dysfunction, fatigue, and infusion reactions. Docetaxel can cause hair loss, nail changes, nausea, neutropenia which increases infection risk.

CheckMate 7DX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My scans show cancer has spread to my bones or soft tissues.
Select...
I am currently on hormone therapy for cancer.
Select...
I am fully active or can carry out light work.
Select...
My prostate cancer is confirmed to be adenocarcinoma without small cell features.

CheckMate 7DX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization to the date of psa progression per pcwg3, approximately 31 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization to the date of psa progression per pcwg3, approximately 31 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
Overall Survival (OS)
Radiographic progressive free survival (rPFS) assessed by Blinded Independent Central Review (BICR) per Prostate Cancer Working Group (PCWG3)
Secondary outcome measures
Duration of Response (DOR) per PCWG3 determined by BICR
Incidence of AEs leading to discontinuation
Incidence of Adverse Events (AEs)
+17 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

CheckMate 7DX Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A: Nivolumab + docetaxel + prednisoneExperimental Treatment3 Interventions
Group II: Arm B: Placebo + docetaxel + prednisonePlacebo Group3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Prednisone
2014
Completed Phase 4
~2370
Docetaxel
1995
Completed Phase 4
~5620

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,127,530 Total Patients Enrolled
41 Trials studying Prostate Cancer
4,463 Patients Enrolled for Prostate Cancer

Media Library

Docetaxel (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04100018 — Phase 3
Prostate Cancer Research Study Groups: Arm B: Placebo + docetaxel + prednisone, Arm A: Nivolumab + docetaxel + prednisone
Prostate Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT04100018 — Phase 3
Docetaxel (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04100018 — Phase 3

Frequently Asked Questions

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

Does Docetaxel present serious risks to human health?

"Docetaxel is considered safe based on its Phase 3 status and available data, scoring a 3 on our team's safety scale."

Answered by AI

Are we still enrolling people to participate in this research?

"The clinical trial is currently looking for participants, as seen on clinicaltrials.gov. The posting date was February 6th, 2020, and the most recent edit was on September 13th, 2020."

Answered by AI

What is the precedent for using Docetaxel in medical treatment?

"There are currently 1388 clinical trials researching the efficacy of Docetaxel. Of those, 293 have reached Phase 3. While the majority of these studies' locations are in Mexico City and Maryland, there are 75401 total sites running these trials."

Answered by AI

For what purpose is Docetaxel most frequently prescribed?

"Docetaxel is most commonly given to patients with thyroiditis, however, it has also been shown to help manage symptoms of unresectable melanoma, squamous cell carcinoma, and ulcerative colitis."

Answered by AI

Who else is applying?

What site did they apply to?
UCLA Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
2020. "A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04100018.
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~310 spots leftby Apr 2026
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