A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer

NCT01981122 | Completed Phase 2 Results DMC

• 1 other identifier: P12-2
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 19

Brief Summary

This is a randomized, open-label study designed to assess the effects of sipuleucel-T when administered concurrently or sequentially with enzalutamide.

Conditions

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).

  PA2024-specific T cell proliferation responses over time will be compared between the concurrent arm and sequential arm using a repeated measurement mixed model analysis. The unit of analysis for the T cell proliferation data is the stimulation index, defined as the median 3H uptake of 3 wells exposed to antigen divided by the median 3H thymidine uptake of 3 wells exposed to media. The stimulation index will be log-transformed prior to analysis.

  Each patient was followed for up to 52 weeks after the first dose of sipuleucel-T. Immune sample draws during the treatment period (Week 0 through Week 4) were to be performed at the patient's pre-leukapheresis visits (Pre-Leuk 2 and Pre-Leuk 3).

Study Arms (2)

Concurrent Arm

EXPERIMENTAL

Subjects will receive sipuleucel-T concurrently with enzalutamide (160 mg orally once daily). Enzalutamide treatment will start 2 weeks prior to the first leukapheresis and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.

Biological: sipuleucel-T; Drug: enzalutamide

Sequential Arm

EXPERIMENTAL

Subjects will receive sipuleucel-T followed by enzalutamide (160 mg orally once daily). Enzalutamide treatment will start approximately 10 weeks after the first infusion of sipuleucel-T and continue for 52 weeks or until disease progression or unacceptable toxicity, whichever occurs first.

Biological: sipuleucel-T; Drug: enzalutamide

Interventions

sipuleucel-T BIOLOGICAL

Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

Also known as: PROVENGE(R), APC8015

Concurrent Arm; Sequential Arm

enzalutamide DRUG

Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily.

Also known as: Xtandi

Concurrent Arm; Sequential Arm

Eligibility Criteria

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

You may qualify if:

• Written informed consent provided prior to the initiation of study procedures.
• Age ≥ 18 years.
• Histologically documented adenocarcinoma prostate cancer confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen.
• Metastatic disease as evidenced by bone metastasis or lymph node metastasis.
• Castrate-resistant prostate cancer as demonstrated by one of the following:
• Prostate specific antigen progression.
• Progression of measurable disease.
• Progression of non-measurable disease by soft tissue disease or bone disease.
• Castration levels of testosterone (≤ 50 ng/dL) achieved via medical or surgical castration.
• Serum PSA (Prostate specific antigen) ≥ 2.0 ng/mL.
• Screening ECOG (The Eastern Cooperative Oncology Group )performance status ≤ 1
• Adequate screening hematologic, renal, and liver function as evidenced by laboratory test results obtained ≤ 28 days prior to registration.
• Negative serology test for human immunodeficiency virus 1 and 2.
• Resides within driving distance (round trip within 1 day) of the clinical trial site for the duration of the active phase.

You may not qualify if:

• The presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites.
• Spinal cord compression, imminent long bone fracture, or any other condition that is likely to require radiation therapy and/or steroids for pain control during the active phase.
• History of stage 3 or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease free at the time of registration. Subjects with a history of stage 1 or 2 cancer must have been adequately treated and been disease free for ≥ 3 years at the time of registration.
• History of seizures or of predisposing factors for seizures.
• Child-Pugh Class C hepatic insufficiency.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T, GM-CSF or granulocyte colony stimulating factor (G-CSF).
• Previous treatment with sipuleucel-T or enrollment in a sipuleucel-T trial, regardless of whether the subject received sipuleucel-T or control.
• Previous treatment with enzalutamide.
• Previous treatment with abiraterone acetate.
• Previous treatment with ipilimumab.
• Previous treatment with ketoconazole other than topical use or for treatment of infections (e.g., oral thrush); most recent use must have been ≥ 7 days prior to registration.
• Previous treatment with any immunotherapy or investigational vaccine.
• A requirement for ongoing systemic immunosuppressive therapy. Use of inhaled, intranasal, intra-articular, and topical steroids is allowed. Oral or IV steroids to prevent or treat IV contrast reactions are allowed.
• Previous treatment with chemotherapy for mCRPC, or chemotherapy for any reason ≤ 2 years prior to registration.
• Use of concomitant medications that may lower the seizure threshold or the use of antiseizure medications ≤ 1 year prior to registration.

Sponsors & Collaborators

• Dendreon: lead

Study Sites (19)

Urological Associates of Southern Arizona, P.C.

Tucson, Arizona, 85741, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

H. Lee Moffitt Cancer and Research Center

Tampa, Florida, 33612, United States

Location

Uro Partners/ RMD Clinical Research

Melrose Park, Illinois, 60160, United States

Location

Fort Wayne Medical Oncology and Hematology, Lutheran Hospital, Parkview Regional Medical Center

Fort Wayne, Indiana, 46804, 46845, United States

Location

Johns Hopkins Medicine - Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

GU Research Network

Omaha, Nebraska, 68130, United States

Location

North Shore Hematology/Oncology Associates, P.C.

East Setauket, New York, 11733, United States

Location

Associated Medical Professionals of New York, PLLC

Syracuse, New York, 13210, United States

Location

Raleigh Hematology Oncology Associates, D.B.A. Cancer Centers of North Carolina

Raleigh, North Carolina, 27607, United States

Location

Cleveland Clinic - Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology Associates, PC

Nashville, Tennessee, 37209, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

Virginia Mason Medical Center, Virginia Mason Hospital

Seattle, Washington, 98101, United States

Location

Northwest Medical Specialties, Rainier Physicians

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• Antonarakis ES, Subudhi SK, Pieczonka CM, Karsh LI, Quinn DI, Hafron JM, Wilfehrt HM, Harmon M, Sheikh NA, Shore ND, Petrylak DP. Combination Treatment with Sipuleucel-T and Abiraterone Acetate or Enzalutamide for Metastatic Castration-Resistant Prostate Cancer: STAMP and STRIDE Trials. Clin Cancer Res. 2023 Jul 5;29(13):2426-2434. doi: 10.1158/1078-0432.CCR-22-3832.

  PMID: 37058234 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sipuleucel-T; enzalutamide

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Shabnam Vaziri
• Organization: Dendreon

svaziri@Dendreon.com

206.455.2323

Study Officials

• Bruce Brown, MD

  Dendreon Pharmaceuticals, LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 11, 2013
• Study Start: September 1, 2013
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: October 24, 2018
• Results First Posted: September 25, 2018

Record last verified: 2018-09

Locations

US (19)