Neoadjuvant Ipilimumab in Prostate Cancer

NCT01194271 | Completed Phase 2 Results

• 2 other identifiers: 2009-0135NCI-2010-01974
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn how ipilimumab in combination with Lupron (leuprolide acetate) affects the body's own defense (immune) system before having surgery to remove prostate cancer. The safety of the drug combination will also be studied.

Conditions

Prostate Cancer

Keywords

Hormone Ablation; Prostate adenocarcinoma; Radical prostatectomy; Leuprolide Acetate; Lupron Depot; Ipilimumab; BMS-734016; MDX010

Outcome Measures

Primary Outcomes (1)

• Immunologic Response: Number of Participants With Immune Response

  Immunological response assays were measured at several time points starting at baseline until the eighth week after starting the medicine for each participant. The immunological responses measured were Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Inducible T-cell Costimulatory (ICOS) markers. T-cells with the CD4 marker help coordinate the immune system response to an invader. Killer T-cells have the CD8 marker and are responsible for killing the invader. ICOS is a molecule which stimulates the activity of the immune response of the killer T-Cells and memory T cells. Participants with at least a 2 fold increase in the presence of CD4, CD8, or ICOS markers from the participant's baseline measure were considered a responder for that marker.

  Baseline to Week 8

Study Arms (1)

Neoadjuvant Ipilimumab

EXPERIMENTAL

Leuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.

Drug: Leuprolide Acetate; Drug: Ipilimumab; Procedure: Radical Prostatectomy

Interventions

Leuprolide Acetate DRUG

22.5 mg administered as a single intramuscular 3 month depot.

Also known as: Lupron Depot

Neoadjuvant Ipilimumab

Ipilimumab DRUG

10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy.

Also known as: BMS-734016, MDX010

Neoadjuvant Ipilimumab

Radical Prostatectomy PROCEDURE

Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.

Neoadjuvant Ipilimumab

Eligibility Criteria

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

You may qualify if:

• Willing and able to give written informed consent;
• Histologic Documentation: Histologic documentation of prostatic adenocarcinoma. Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible. All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration.
• Locally Resectable Disease: Patients must have disease (localized or locally advanced) which is deemed by the surgeon to be resectable. Lymph node metastasis or lymph nodes suspicious of harboring metastasis should be deemed surgically resectable by the surgeon.
• Determination of high-risk status: Patients must have either: 1) a Prostate biopsy Gleason sum \>/= 8 OR 2) PSA \>/= 20.
• Prior Treatment: No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy. Patients who have initiated leuprolide acetate within 1 week of signing consent will be eligible.
• Patients must be appropriate candidates for radical prostatectomy. Evidence of underlying cardiac disease should be evaluated prior to enrollment to ensure that patients are not at high risk of cardiac complications.
• ECOG performance status of 0 or 1;
• Required values for initial laboratory tests: a) WBC \>/= 3000/uL; b) ANC \>/= 1500/uL, c) Platelets \>/= 100 x 10\^3/uL; d) Hemoglobin \>/= 9 g/dL; e) Creatinine \</= 2.0 x ULN; f) AST \</= 2.5 x ULN; g) Bilirubin 0 - 1.0 mg/dL, except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/mL;
• Men \>/= 18 years of age
• Patients must agree to practice barrier birth control methods while on therapy, prior to surgery.

You may not qualify if:

• Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer.
• Autoimmune disease: Patients with a history of Inflammatory Bowel Disease (including Crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], Systemic Lupus Erythematosus, autoimmune vasculitis \[e.g., Wegener's Granulomatosis\]).
• Known HIV or chronic hepatitis.
• Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea.
• Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis which are known risks factors for bowel perforation, should be excluded from the study.
• Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab.
• Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses);
• Previous treatment with other investigational products within 30 days;
• Previous enrollment in another MDX-010 (BMS-734016) clinical trial or prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist
• Concurrent use of 5-alpha-reductase inhibitors (finasteride, dutasteride).
• Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled in this study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; Ipilimumab

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)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Padmanee Sharma, Professor, Genitourinary Medical Oncology
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-2830

Study Officials

• Padmanee Sharma, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 2, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 6, 2024
• Results First Posted: September 3, 2020

Record last verified: 2023-09

Locations

US (1)