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New combo aims to tackle tough prostate cancer

NCT ID NCT04109729

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tests two drugs together—nivolumab (Opdivo) and Radium-223 (Xofigo)—in 39 men with metastatic castration-resistant prostate cancer that has spread to the bones. The main goals are to check safety and see if the combination can reduce tumor DNA in the blood. It is not yet known if this approach will work better than current treatments.

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 Radium-223 (Xofigo)
What this could lead to
If it works, this could point toward a new combination treatment for advanced prostate cancer that has spread to the bones.
What could go wrong
This is a very early phase 1 trial with only 39 men, so it is primarily checking safety and dosing. The combination may cause serious side effects or fail to shrink tumors.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 39 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Male subject aged ≥ 18 years. * Histologically confirmed adenocarcinoma of the prostate. * Diagnosis of metastatic, castration-resistant prostate cancer without evidence of visceral metastasis. * Symptomatic bone metastasis as determined by the treating physician. * Castrate levels of testosterone as defined as \< 50 ng/dL. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2. * Adequate organ function as defined as: * Hematologic: * White blood cell count (WBC) ≥ 2000/mm3 * Absolute neutrophil count (ANC) ≥ 1500/mm3 * Platelet count ≥ 100,000/mm3 * Hemoglobin ≥ 10g/dL * Hepatic: * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) unless there is a known history of Gilbert's syndrome. * Aspartate aminotransferase (AST)(SGOT)/Alanine aminotransferase (ALT)(SGPT) ≤ 5 × institutional ULN * Renal: * Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula: * Males: ((140-age)×weight\[kg\])/(serum creatinine \[mg/dL\]×72) * Highly effective contraception throughout the study and for at least 6 months after last study treatment administration if the risk of conception exists. * Recovery to baseline or ≤ Grade 1 CTCAE v 5.0 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy as determined by the treating physician. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. Exclusion Criteria: * Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, hypo-or hyperthyroid disease or other autoimmune diseases in the opinion of the treating physician that is clinically insignificant or not requiring systemic immunosuppressive treatment are eligible. * Current use of immunosuppressive medication at the time of study enrollment, EXCEPT for the following permitted steroids: * Intranasal, inhaled, topical steroids, eye drops or local steroid injection (eg, intra-articular injection); * Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; * Steroids as premedication for hypersensitivity reactions (eg, computed tomography (CT) scan premedication). * Prior or concurrent malignancy (other than adenocarcinoma of the prostate). --Note: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial as approved by the Principle Investigator. * The subject has uncontrolled, significant intercurrent or recent illness that would preclude safe study participation. * Clinically significant cardiovascular disease: myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (\> New York Heart Association Classification Class IIB) or a serious cardiac arrhythmia requiring medication. * Known HIV infection with a detectable viral load at the time of screening. --Note: Patients on effective antiretroviral therapy with an undetectable viral load at the time of screening are eligible for this trial. * Known chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with a detectable viral load. --Note: Patients with an undetectable HBV viral load are eligible. Patients with an undetectable HCV viral load are eligible. * Live attenuated vaccinations within 4 weeks of the first dose of radium-223 and while on trial is prohibited. * Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3). * Subjects taking prohibited medications as described in Section 6.4.1. A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur prior to the start of treatment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112, United States

More trials for these conditions

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