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New combo therapy shows promise for tough prostate cancer

NCT ID NCT03338790

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the immunotherapy drug nivolumab (Opdivo) combined with one of three other drugs (rucaparib, docetaxel, or enzalutamide) in 292 men with advanced prostate cancer that had spread and stopped responding to hormone therapy. The goal was to see if these combinations could shrink tumors or lower PSA levels. Results from this completed Phase 2 trial will help decide which combinations to test further.

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) combined with either rucaparib, docetaxel, or enzalutamide
What this could lead to
If successful, this could point toward effective combination therapies for advanced prostate cancer that has stopped responding to standard hormone therapy.
What could go wrong
This is a completed Phase 2 trial, so results are preliminary and may not confirm benefit in larger studies. Side effects from combining these drugs could be significant.

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

292 people

The number who actually took part.

Started

Dec 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: * Histologic confirmation of adenocarcinoma of the prostate * Evidence of stage IV disease on previous bone, CT, and/or MRI scan * Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy * Mandatory plasma and fresh or archival tumor tissue must be submitted Exclusion Criteria: * Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast * Participants with active brain metastases * Participants must have recovered from the effects of major surgery requiring general anesthesia or significant traumatic injury at least 14 days before treatment arm assignment Other protocol defined inclusion/exclusion criteria could apply

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Conditions

The condition(s) this trial relates to.

castration-resistant 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

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Local Institution - 0001

    Essen, 45122, Germany

  • Local Institution - 0002

    Jena, 07747, Germany

  • Local Institution - 0004

    Heidelberg, D-69120, Germany

  • Local Institution - 0006

    Göttingen, 37075, Germany

  • Local Institution - 0007

    Koblenz, 56068, Germany

  • Local Institution - 0009

    Marietta, Georgia, 30060, United States

  • Local Institution - 0010

    Rancho Mirage, California, 92270, United States

  • Local Institution - 0011

    St Louis, Missouri, 63110, United States

  • Local Institution - 0012

    Detroit, Michigan, 48201, United States

  • Local Institution - 0013

    Heidelberg, Victoria, 3084, Australia

  • Local Institution - 0014

    South Brisbane, Queensland, 4101, Australia

  • Local Institution - 0015

    Camperdown, New South Wales, 2050, Australia

  • Local Institution - 0016

    Elizabeth Vale, South Australia, 5112, Australia

  • Local Institution - 0017

    Westmead, New South Wales, 2145, Australia

  • Local Institution - 0018

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Local Institution - 0019

    Rio de Janeiro, Rio de Janeiro, 22793-080, Brazil

  • Local Institution - 0020

    Belo Horizonte, Minas Gerais, 30110-022, Brazil

  • Local Institution - 0021

    Porto Alegre, Rio Grande do Sul, 90035001, Brazil

  • Local Institution - 0022

    Campinas, São Paulo, 13075-460, Brazil

  • Local Institution - 0024

    Portland, Oregon, 97225, United States

  • Local Institution - 0025

    Culiacán, Sinaloa, 80230, Mexico

  • Local Institution - 0026

    Medellín, 0, Colombia

  • Local Institution - 0027

    Montería, Departamento de Córdoba, 0, Colombia

  • Local Institution - 0029

    Villejuif, 94800, France

  • Local Institution - 0030

    Marseille, 13273, France

  • Local Institution - 0031

    Lyon, 69008, France

  • Local Institution - 0032

    Clermont-Ferrand, 63000, France

  • Local Institution - 0033

    Besançon, 25030, France

  • Local Institution - 0034

    Santiago, Santiago Metropolitan, 8420383, Chile

  • Local Institution - 0035

    Omaha, Nebraska, 68130, United States

  • Local Institution - 0036

    Daphne, Alabama, 36526, United States

  • Local Institution - 0037

    Miami, Florida, 33176, United States

  • Local Institution - 0038

    Albany, New York, 12208, United States

  • Local Institution - 0039

    Fairfax, Virginia, 22031, United States

  • Local Institution - 0040

    Rockville, Maryland, 20850, United States

  • Local Institution - 0041

    Durham, North Carolina, 27710, United States

  • Local Institution - 0042

    Capital Federal, Buenos Aires, 1426, Argentina

  • Local Institution - 0043

    CABA, 1199, Argentina

  • Local Institution - 0044

    Buenos Aires, Distrito Federal, C1280, Argentina

  • Local Institution - 0045

    Madrid, 28041, Spain

  • Local Institution - 0046

    Pamplona, 31008, Spain

  • Local Institution - 0047

    Seville, 41013, Spain

  • Local Institution - 0048

    Guadalajara, Jalisco, 44280, Mexico

  • Local Institution - 0049

    New Haven, Connecticut, 06520, United States

  • Local Institution - 0050

    Clayton, Victoria, 0, Australia

  • Local Institution - 0051

    Viña del Mar, Valparaiso, 2540364, Chile

  • Local Institution - 0052

    CABA, Buenos Aires, 1426, Argentina

  • Local Institution - 0053

    Allentown, Pennsylvania, 18103, United States

  • Local Institution - 0054

    León, Guanajuato, 37000, Mexico

  • Local Institution - 0055

    Hamilton, Ontario, L8V 5C2, Canada

  • Local Institution - 0056

    Québec, Quebec, G1J 1Z4, Canada

  • Local Institution - 0059

    Moncton, New Brunswick, E1C 6Z8, Canada

  • Local Institution - 0061

    Guadalajara, Jalisco, 44130, Mexico

  • Local Institution - 0062

    Villa Siburu, Córdoba Province, 5003, Argentina

  • Local Institution - 0064

    München, 81675, Germany

  • Local Institution - 0065

    Louisville, Kentucky, 40207, United States

  • Local Institution - 0066

    Montreal, Quebec, H2X 0C1, Canada

  • Local Institution - 0067

    Kelowna, British Columbia, V1Y 5L3, Canada

  • Local Institution - 0068

    New York, New York, 10032, United States

  • Local Institution - 0069

    Jackson, Mississippi, 39202, United States

  • Local Institution - 0071

    São Paulo, São Paulo, 05652-900, Brazil

  • Local Institution - 0073

    São Paulo, São Paulo, 01308-050, Brazil

  • Local Institution - 0074

    Belo Horizonte, Minas Gerais, 30130-090, Brazil

  • Local Institution - 0075

    Curitiba, Paraná, 81480-580, Brazil

  • Tulane University

    New Orleans, Louisiana, 70112, United States

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