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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

Study Summary

This trial is testing 3 different combinations of drugs to see which is most effective at treating men with metastatic prostate cancer that has progressed after other treatments.

Eligible Conditions
  • Castration-resistant 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiographic progression-free survival (rPFS) assessed by blinded independent central review (BICR) per Prostate Cancer Working Group 3 (PCWG3)
Secondary outcome measures
Duration of response per Prostate Cancer Working Group 3 (DOR-PCWG3) as determined by BICR
Number of deaths
Number of participants with adverse events (AEs)
+5 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

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
~5620
BMS-986218
2022
Completed Phase 2
~10
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,504 Total Patients Enrolled
42 Trials studying Prostate Cancer
5,447 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

Frequently Asked Questions

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

How many participants are enrolled in this trial?

"This medical trial requires 204 voluntary participants that qualify for the inclusion criteria. Intending volunteers can take part from various sites, such as University of Texas MD Anderson Cancer Center in Columbia, Maryland and Willamette Valley Cancer Institute And Research Center in Tampa, Florida."

Answered by AI

How is the medication Docetaxel most commonly utilized?

"Docetaxel is predominantly employed to address cancerous neoplasms, but can also be utilized for treating a multitude of other illnesses such as unresectable melanoma, squamous cell carcinoma and sarcoma."

Answered by AI

What is the ultimate objective of this research endeavor?

"This trial, which entails a 4 year period of observation and monitoring, aims to measure the frequency of adverse events (AEs). Secondary objectives include measuring AEs leading to discontinuation as classified in Part 2, duration of response per Prostate cancer Working Group 3 (DOR-PCWG3) as stipulated in Part 2, and death rate according to Part 2."

Answered by AI

Has the FDA sanctioned Docetaxel for therapeutic applications?

"There is some evidence of the safety profile for Docetaxel, so it has been assigned a score of 2. In this Phase 2 clinical trial, efficacy data remains absent."

Answered by AI

How many centers are currently conducting this research project?

"Across the United States, 33 clinical trial sites are recruiting patients to participate in this research. Prominent locations include University of Texas MD Anderson Cancer Center (Columbia), Willamette Valley Cancer Institute and Research Centre (Tampa), and Texas Oncology (Marietta)."

Answered by AI

Have prior experiments been conducted using Docetaxel?

"Currently, there are 1,016 clinical trials studying the effects of Docetaxel. Specifically, 201 live studies in Phase 3 have been documented with 61190 locations running experiments on this drug located predominantly in Fuzhou, Fujian."

Answered by AI

Is there availability for prospective participants in this experiment?

"As per clinicaltrials.gov, this trial is recruiting participants as of now. The listing was initially posted on February 14th 2022 and changed most recently on August 1st 2022."

Answered by AI
~3 spots leftby Apr 2025