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Prostate CancerPhase 2NCT03637543

Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer

A Phase 2 study testing Nivolumab in people with Prostate Cancer, run by Beth Israel Deaconess Medical Center at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This research study is studying an immune-based cancer drug as a possible treatment for prostate cancer. The drug involved in this study is: -Nivolumab Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
5 sitesUnited States
Study dates
18 Oct 2018to 31 Dec 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 33Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • DFCI Londonderry

    Londonderry, New Hampshire, 03053

  • DFCI South Shore

    South Weymouth, Massachusetts, 02190

Other trials in United States

About this study

Official title: A Phase 2 Study of Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer

This research study is studying an immune-based cancer drug as a possible treatment for prostate cancer.

The drug involved in this study is:

-Nivolumab

Read the detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved nivolumab for this specific disease but it has been approved for other uses. Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer.

In this research study, the investigators are investigating whether nivolumab has any activity in patients who have a rising PSA (prostate specific antigen) after previously undergoing surgery or radiation for prostate cancer. Although nivolumab was previously not found to have significant effect in advanced prostate cancer after all other therapies had failed, based on new research, the investigators are testing whether nivolumab could have a greater effect earlier in the disease course and before patients receive hormone therapies.

Conditions
Prostate Cancer
Being tested
Nivolumab
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called Opdivo

    Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer

Study groups in NCT03637543
Study groupRoleWhat they receive
PD-L1 NegativeExperimental-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Receives: Drug: Nivolumab
PD-L1 PositiveExperimental-Nivolumab will be given on day 1 of a 28-day cycle intravenously
Receives: Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Control Rate at 12 Weeks

    Proportion of patients with high-risk biochemically-recurrent (BCR) prostate cancer (PCa) who achieve disease control at 12 weeks, defined as a decline or stabilization in prostate-specific antigen (PSA) levels without symptomatic or radiographic progression, following 12 weeks of nivolumab treatment.

    Measured: 12 weeks

Secondary outcomes (5)

  1. Number of Participants With Maximal Change in Prostate Specific Antigen (PSA) During Nivolumab Treatment

    Maximum percent change in prostate-specific antigen (PSA) from baseline observed at any time during nivolumab treatment, defined as the greatest decrease or increase in PSA relative to baseline. Participants are categorized based on maximum percent change in PSA as <10% or ≥10% change.

    Measured: 2 years

  2. Change in PSA Doubling Time (PSADT) Prior to End of Treatment Relative to Baseline

    Pre-treatment PSA doubling time (PSADT) was calculated using at least three PSA values obtained prior to treatment initiation. On-treatment PSADT required three consecutive PSA values ≥ 0.2 ng/mL, with the first and last measurements occurring within 12 months. End-of-treatment (EOT) PSADT was calculated using the three PSAs obtained immediately prior to EOT; it was not calculated for patients who discontinued treatment before cycle 4. PSADT was estimated using a linear regression model of the natural logarithm of PSA over time, following PCWG3 recommendations and the MSKCC calculator.

    Measured: 2 years

  3. Median Time to Radiographic Progression to Metastatic Disease

    Time to radiographic progression to metastatic disease was defined as the interval from treatment initiation to the first documentation of radiographic disease progression to metastatic disease per RECIST v1.1 criteria and Prostate Cancer Working Group (PCWG) guidelines, or censored at the date of last imaging assessment.

    Measured: From initiation of nivolumab treatment until the date of first documented disease progression, assessed up to the end of the study.

  4. Median Time to Initiation of Androgen Deprivation Therapy (ADT) After Nivolumab

    Time to initiation of ADT was defined as the interval from initiation of nivolumab to the start of systemic ADT. Participants who did not initiate ADT were censored at the date of last follow-up.

    Measured: From the first dose of nivolumab to initiation of ADT, assessed through end of study follow-up.

  5. Number of Participants With Treatment Related Grade ≥3 Adverse Events

    The number of participants experiencing treatment-related adverse events of Grade 3 or higher that were assessed as definitely or probably related to study treatment, graded according to CTCAE v5.0.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2018
  2. Study start18 Oct 2018
  3. Primary completion30 Sep 2023
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03637543
Sponsor's protocol ID
18-249
Status last verified
Apr 2026
First submitted
16 Aug 2018
Last updated
8 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab in people with Prostate Cancer, run by Beth Israel Deaconess Medical Center at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate at 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03637543.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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