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Monoclonal Antibodies

BMS-986218 + Nivolumab + Docetaxel for Prostate Cancer

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing different combinations of a chemotherapy drug and immune-boosting medications in men with advanced prostate cancer that hasn't improved with other treatments. The goal is to see if these combinations can better fight the cancer. One drug is already known to be effective in patients who haven't had chemotherapy before, while another drug is used for those who have already received the first drug.

Eligible Conditions
  • Castration-resistant Prostate Cancer
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of deaths
Number of participants with adverse events (AEs)
Radiographic progression-free survival (rPFS) assessed by blinded independent central review (BICR) per Prostate Cancer Working Group 3 (PCWG3)
Secondary study objectives
Duration of response per Prostate Cancer Working Group 3 (DOR-PCWG3) as determined by BICR
Objective response rate per Prostate Cancer Working Group 3 (ORR-PCWG3)
Overall survival (OS)
+3 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%
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Arm 2D (Optional Crossover): BMS-986218 + NivolumabExperimental Treatment2 Interventions
Group II: Arm 2C: Docetaxel + BMS-986218 + NivolumabExperimental Treatment3 Interventions
Group III: Arm 2B: Docetaxel + BMS-986218Experimental Treatment2 Interventions
Group IV: Arm 2A: DocetaxelExperimental Treatment1 Intervention
Group V: Arm 1B: Docetaxel + BMS-986218 + NivolumabExperimental Treatment3 Interventions
Group VI: Arm 1A: Docetaxel + BMS-986218Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~6550
BMS-986218
2022
Completed Phase 2
~10
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,688 Previous Clinical Trials
4,096,797 Total Patients Enrolled
42 Trials studying Prostate Cancer
5,483 Patients Enrolled for Prostate Cancer

Media Library

BMS-986218 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05169684 — Phase 2
Prostate Cancer Research Study Groups: Arm 1A: Docetaxel + BMS-986218, Arm 2C: Docetaxel + BMS-986218 + Nivolumab, Arm 2B: Docetaxel + BMS-986218, Arm 1B: Docetaxel + BMS-986218 + Nivolumab, Arm 2A: Docetaxel, Arm 2D (Optional Crossover): BMS-986218 + Nivolumab
Prostate Cancer Clinical Trial 2023: BMS-986218 Highlights & Side Effects. Trial Name: NCT05169684 — Phase 2
BMS-986218 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05169684 — Phase 2
~3 spots leftby Nov 2025
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