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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
Must not have
Active brain metastases
Active, known, or suspected autoimmune disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to 1st pain symptoms at their worst over the last 24 hours (up to approximately 31 months
Awards & highlights
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active cancer spread to my brain.
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I have an autoimmune disease.
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I have previously been treated with specific immunotherapy drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to 1st pain symptoms at their worst over the last 24 hours (up to approximately 31 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to 1st pain symptoms at their worst over the last 24 hours (up to approximately 31 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
Overall Survival (OS)
Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3)
Secondary study objectives
Duration of Response Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
Number of Participants With Adverse Events
Number of Participants With Adverse Events Leading to Discontinuation
+11 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%
Alanine aminotransferase increased
13%
Neurotoxicity
13%
Cough
13%
Vomting
9%
Musculoskeletal pain
9%
Headache
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
2015
Completed Phase 3
~4010
Prednisone
2014
Completed Phase 4
~2500
Docetaxel
1995
Completed Phase 4
~6550

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,098,041 Total Patients Enrolled
41 Trials studying Prostate Cancer
4,453 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
~177 spots leftby Dec 2025
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