Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer

NCT03637543 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: 18-249
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (5)

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

  2 years

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

  2 years

• Median Time to Radiographic Progression to Metastatic Disease

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

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

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

• Number of Participants With Treatment Related Grade ≥3 Adverse Events

  2 years

Study Arms (2)

PD-L1 Negative

EXPERIMENTAL

-Nivolumab will be given on day 1 of a 28-day cycle intravenously

Drug: Nivolumab

PD-L1 Positive

EXPERIMENTAL

-Nivolumab will be given on day 1 of a 28-day cycle intravenously

Drug: Nivolumab

Interventions

Nivolumab DRUG

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

Also known as: Opdivo

PD-L1 Negative; PD-L1 Positive

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Bristol-Myers Squibb: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (5)

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

DFCI South Shore

South Weymouth, Massachusetts, 02190, United States

Location

DFCI Londonderry

Londonderry, New Hampshire, 03053, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: David Einstein
• Organization: BIDMC

deinstei@bidmc.harvard.edu

6176672100

Study Officials

• David J. Einstein, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 20, 2018
• Study Start: October 18, 2018
• Primary Completion: September 30, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 8, 2026
• Results First Posted: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)