Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Immunotherapy duo takes on Hard-to-Treat prostate cancer

NCT ID NCT02985957

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested whether combining two immunotherapy drugs, nivolumab and ipilimumab, could shrink tumors or slow progression in men with metastatic castration-resistant prostate cancer. 351 participants received either the combination, ipilimumab alone, or the chemotherapy cabazitaxel. The study measured tumor response and progression-free survival to see if the immune-boosting approach offers a new treatment path.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nivolumab (Opdivo) and ipilimumab (Yervoy)
What this could lead to
If successful, this could provide a new immunotherapy option for men with advanced prostate cancer that has stopped responding to hormone therapy.
What could go wrong
This is a phase 2 trial, so results are still early. Immunotherapies can cause serious immune-related side effects, and not all patients may benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

351 people

The number who actually took part.

Started

Mar 2017

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * 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 a surgical/medical castration with testosterone level of ≤1.73nmol/L (50ng/dL) For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: * Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization Exclusion Criteria: * Presence of visceral metastases in the liver * Active brain metastases or leptomeningeal metastases * Active, known, or suspected autoimmune disease or infection * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways For crossover phase for participants originally randomized to Arm D3 or Arm D4 only: * Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab * Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel) Other protocol-defined inclusion/exclusion criteria apply

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic castration resistant prostate cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Local Institution - 0001

    New York, New York, 10029, United States

  • Local Institution - 0002

    Houston, Texas, 77030, United States

  • Local Institution - 0003

    Villejuif, 94805, France

  • Local Institution - 0004

    Marseille, 13273, France

  • Local Institution - 0005

    Lyon, 69008, France

  • Local Institution - 0008

    St Louis, Missouri, 63110, United States

  • Local Institution - 0009

    Clermont-Ferrand, 63000, France

  • Local Institution - 0010

    Philadelphia, Pennsylvania, 19104, United States

  • Local Institution - 0011

    Chicago, Illinois, 60637, United States

  • Local Institution - 0017

    Jena, 07747, Germany

  • Local Institution - 0018

    Münster, 48149, Germany

  • Local Institution - 0019

    Herne, 44625, Germany

  • Local Institution - 0020

    Madrid, 28007, Spain

  • Local Institution - 0021

    Madrid, 28041, Spain

  • Local Institution - 0022

    Madrid, Sede Madrid, 28027, Spain

  • Local Institution - 0023

    Santiago Compostela, 15706, Spain

  • Local Institution - 0024

    Málaga, 29010, Spain

  • Local Institution - 0025

    Barcelona, 08003, Spain

  • Local Institution - 0026

    Badajoz, 06006, Spain

  • Local Institution - 0027

    Gosford, New South Wales, 2250, Australia

  • Local Institution - 0028

    Southport, Queensland, 4215, Australia

  • Local Institution - 0029

    Westmead, New South Wales, 2145, Australia

  • Local Institution - 0030

    Elizabeth Vale, South Australia, 5112, Australia

  • Local Institution - 0031

    Clayton, Victoria, 3168, Australia

  • Local Institution - 0032

    Dresden, 01307, Germany

  • Local Institution - 0033

    Tübingen, 72076, Germany

  • Local Institution - 0034

    Munich, 81377, Germany

  • Local Institution - 0035

    Wesel, 46483, Germany

  • Local Institution - 0036

    Rostock, 18107, Germany

  • Local Institution - 0037

    Nuremberg, 90419, Germany

  • Local Institution - 0038

    Göttingen, Lower Saxony, 37075, Germany

  • Local Institution - 0041

    Braunschweig, 38114, Germany

  • Local Institution - 0042

    Nürtingen, 72622, Germany

  • Local Institution - 0043

    Woolloongabba, Queensland, 4012, Australia

  • Local Institution - 0044

    Montreal, Quebec, H2X 0A9, Canada

  • Local Institution - 0046

    Marietta, Georgia, 30060, United States

  • Local Institution - 0047

    Allentown, Pennsylvania, 18105, United States

  • Local Institution - 0048

    Vienna, 1090, Austria

  • Local Institution - 0051

    Terni, 05100, Italy

  • Local Institution - 0052

    Milan, 20133, Italy

  • Local Institution - 0053

    Naples, 80131, Italy

  • Local Institution - 0054

    Warsaw, 02-781, Poland

  • Local Institution - 0055

    Krakow, Lesser Poland Voivodeship, 30-688, Poland

  • Local Institution - 0059

    Wahroonga, New South Wales, 2076, Australia

  • Local Institution - 0060

    Odense, 5000, Denmark

  • Local Institution - 0061

    København Ø, 2100, Denmark

  • Local Institution - 0062

    Aalborg, 9000, Denmark

  • Local Institution - 0063

    Aarhus N, Central Jutland, 8200, Denmark

  • Local Institution - 0065

    Lake Success, New York, 11042, United States

  • Local Institution - 0066

    Koszalin, 75-581, Poland

  • Local Institution - 0067

    Charleston, South Carolina, 29425, United States

  • Local Institution - 0071

    Arezzo, 52100, Italy

  • Local Institution - 0072

    Parma, 43100, Italy

  • Local Institution - 0074

    Tucson, Arizona, 85711, United States

  • Local Institution - 0075

    Las Vegas, Nevada, 89169, United States

  • Local Institution - 0076

    Minneapolis, Minnesota, 55404, United States

  • Local Institution - 0077

    Tigard, Oregon, 97223, United States

  • Local Institution - 0078

    Albany, New York, 12208, United States

  • Local Institution - 0079

    Austin, Texas, 78731, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.