Could an immunotherapy drug replace hormone therapy for some prostate cancers?

NCT ID NCT04019964

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This phase 2 trial tested the immunotherapy drug nivolumab (Opdivo) in 8 men whose prostate cancer had returned after surgery or radiation, shown by rising PSA levels. The men had specific genetic changes (MMR deficiency or CDK12 alteration) that might make their cancers more sensitive to this type of drug. The goal was to see if nivolumab could lower PSA levels without using standard hormone therapy, which has significant side effects.

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)
What this could lead to
If it works, this could offer a non-hormonal treatment option for men with certain genetic types of recurrent prostate cancer.
What could go wrong
This was a very small, early-phase trial with only 8 participants. The results may not apply to all patients, and nivolumab can cause immune-related side effects.

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

8 people

The number who actually took part.

Started

Jan 2020

Finished

Jul 2025

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: * Willing and able to provide signed informed consent and HIPAA authorization for the release of personal health information * Males aged 18 years and above * Prior local therapy with prostatectomy or EBRT/brachytherapy is required * Prior salvage or adjuvant radiation therapy is allowed but not mandated. Radiation therapy must have been completed for at least 6 months. * Absolute PSA \>=1.0 ng/mL at screening * Must have at least one of the following genetic alterations identified using archival tissue (i.e. prostate needle biopsy prior to radiation therapy or prostatectomy specimen): * Microsatellite instability (MSI-high) status by clinical grade testing * MMR protein loss (MSH2, MSH6, MLH1, PMS2) by immunohistochemistry * Inactivating mutation of MSH2, MSH6, MLH1 or PSM2 by clinical grade genomic testing * Tumor mutational burden \>= 20 mutations/megabase (TMB \>=20 muts/Mb) by clinical grade testing * Inactivating mutation (at least monoallelic of CDK12 by clinical grade testing * Serum testosterone \>= 150 ng/dL * No radiographic evidence of metastatic disease by CT scan and bone scan, performed within the prior 4 weeks. * Karnofsky Performance Status (KPS) \>= 70% within 14 days before start of study treatment (ECOG \<=1) * Participants must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below: * Hemoglobin \>= 9.0 g/dL with no blood transfusion in the past 28 days * Absolute neutrophil count (ANC) \>= 1.0x10\^9 / L * Platelet count \>= 100 x 10\^9 /L * Total bilirubin within institutional upper limit of normal (ULN) (in patients with Gilbert's syndrome, total bilirubin \<1.5x institutional ULN will be acceptable) * Aspartate aminotransferase (AST), Serum Glutamic Oxaloacetic Transaminase (SGOT) / Alanine aminotransferase (ALT), Serum Glutamic Pyruvate Transaminase (SGPT) within institutional ULN * Participants must have creatinine clearance estimated using the Cockcroft-Gault equation of \>=40 mL/min: Estimated creatinine clearance = \[(140 - age (years)) x weight (kg)\] / \[serum creatinine (mg/dL) x 72\] * Participants must have a life expectancy of \>= 6 months * Male participants and their partners who are sexually active and of childbearing potential must agree to the use of two highly effective forms of contraception in combination, throughout the period of taking study treatment and for 7 months after the last dose of nivolumab to prevent pregnancy in a partner. * No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin) Exclusion Criteria: * Metastatic disease or currently active second malignancy * Prior androgen deprivation therapy (ADT) in the past 6 months. Prior ADT in context of neoadjuvant/adjuvant primary; prior ADT for biochemical recurrence is allowed, as long as no ADT has been administered in past 6 months and testosterone has recovered (\>150 ng/dL) * Prior oral anti-androgen (e.g. bicalutamide, nilutamide, enzalutamide, apalutamide), or androgen synthesis inhibitor (e.g. abiraterone, orteronel) within the past 2 weeks is not permitted. 5-alpha reductase inhibitor therapy (e.g. finasteride, dutasteride) is allowed, as long as subject has been stable on medication for past 6 months. * Involvement in the planning and/or conduct of the study (applies to both BMS staff and/or staff at the study site) * Participation in another clinical study with an investigational product during the last 4 weeks/28 days * Patients should be excluded if they have had prior systemic treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways * Patients should be excluded if they have an active, known or suspected autoimmune disease (e.g. inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, lupus, celiac disease). Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recure in the absence of an external trigger. * Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone daily equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \>10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease * Permitted therapies include topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \> 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g. contrast dye allergy) or for treatment of nonautoimmune conditions (e.g. delayed-type hypersensitivity reaction caused by contact allergen) is permitted. * As there is potential for hepatic toxicity with nivolumab, drugs with a predisposition to hepatotoxicity should be used with caution in patients treated with nivolumab-containing regimen. * Patients should be excluded if they have a positive test for hepatitis B virus surface antigen (HBVsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection * Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). * History of allergy to study drug components * History of severe hypersensitivity reaction to any monoclonal antibody * Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to: * Any uncontrolled major infection * Cardiac failure NYHA (New York Heart Association) III or IV * Crohn's disease or ulcerative colitis * Bone marrow dysplasia * Known allergy to any of the compounds under investigation * Unmanageable fecal incontinence * Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease, or any psychiatric disorder that prohibits obtaining informed consent.

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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

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287, United States

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