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Immune drug nivolumab takes on returning prostate cancer

NCT ID NCT03637543

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 study tests nivolumab (Opdivo) in 29 men with high-risk prostate cancer that has returned after initial treatment, shown by rising PSA levels. The drug works by helping the immune system recognize and attack cancer cells. The main goal is to see if nivolumab can control the disease by lowering or stabilizing PSA without the cancer spreading.

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 point toward a new immune-based treatment option for men with prostate cancer that has returned after initial therapy.
What could go wrong
This is a small, early-phase trial with only 29 participants, so results may not apply to all patients. Nivolumab can cause immune-related side effects, and it may not effectively control PSA levels or slow cancer growth.

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

29 people

The number who actually took part.

Started

Oct 2018

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: * Patients must have signed an informed-consent form indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study. * Patients must have a history of prostate adenocarcinoma (adenocarcinoma must be the primary histology; secondary components of variant histologies are acceptable) confirmed on biopsy and treated with primary radical prostatectomy (RP) or definitive radiation (RT). Prior salvage RT is acceptable. * Patients must have experienced biochemical recurrence (BCR) plus have minimum PSA values noted below: * Following primary RP: Any detectable rising PSA after RP (or after salvage RT if performed), minimum PSA 1.0 at time of screening * Following primary RT: PSA rise to ≥2 ng/mL above the nadir * No evidence of metastases on conventional imaging (CT or MRI plus bone scan) * PSA doubling time (PSADT) \<10 months --PSADT: calculated as per Prostate Cancer Working Group 3 (PCWG3) and the Memorial Sloan Kettering Cancer Center calculator: (https://www.mskcc.org/nomograms/prostate/psa\_doubling\_time) With linear regression model of normal logarithm of PSA and time, based on: * At least 3 consecutive PSA values with each value ≥0.2 ng/mL * Interval between first and last PSA values is ≥8 weeks but ≤12 months. -Archival tissue is mandatory, either prostatectomy specimen or (in patients who received primary RT) diagnostic core biopsies. Patients must consent to next-generation sequencing performed on this tissue. * If diagnostic core biopsies are only available tissue, at least 3 cores must be involved by tumor * Easteron Cooperative Oncology Group (ECOG) performance status 0-1 * Age ≥18 years * Adequate organ and marrow function: * System Laboratory Value * Hematological * White blood cell (WBC) ≥ 2000/µL * Absolute Neutrophil Count (ANC) ≥ 1500/μL * Platelets (Plt) ≥ 100 x103/μL * Hemoglobin (Hgb) \> 9.0 g/dL (with or without transfusion) -Renal * Serum Creatinine ≤ 2 x ULN * Hepatic * Bilirubin1 ≤ 1.5× upper limit of normal (ULN) * Aspartate aminotransferase (AST) ≤ 3 × ULN * Alanine aminotransferase (ALT) ≤ 3 × ULN * Except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL * Baseline testosterone ≥100 ng/dL * Recovery from acute toxicity related to prior therapy, including surgery and radiation, or no treatment-related toxicity ≥ grade 2. * History of prior malignancy or concurrent separate malignancy is not an exclusion criterion so long as the non-prostate malignancy is stable and does not require any treatment. * Able to understand and sign informed consent and adhere to study procedures. * Male patients whose female partners are of reproductive potential must agree to use a contraception during the trial period Exclusion Criteria: * Current use of ADT or plan to initiate ADT during trial period * Major surgery or radiation therapy within 14 days of starting study treatment * Subjects with active autoimmune disease. Patients with a history of autoimmune disease that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system, heart, lungs, kidneys, skin, and gastrointestinal tract will be allowed. * Known history of immune deficiencies or chronic viral infections including HIV, hepatitis B (HBV), and hepatitis C (HCV) (patients with prior therapy for HBV or HCV is permitted if viral clearance was documented). * Concurrent medical condition requiring use of systemic corticosteroids with prednisone \>10 mg per day or equivalent. Use of inhaled, nasal, and topical steroids (applied to small body areas) is allowed. * Current use (within past 4 weeks) of other prohibited medications including anti-cancer therapies, hormonal therapies, 5-alpha reductase inhibitors, and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto). * Prior treatment with immune checkpoint inhibitors. (Prior cancer vaccines are allowed.) * Serious intercurrent medical or psychiatric illness that, in the judgment of the investigator, would interfere with patient's ability to carry out the treatment program

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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

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • DFCI Londonderry

    Londonderry, New Hampshire, 03053, United States

  • DFCI South Shore

    South Weymouth, Massachusetts, 02190, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135, United States

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