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Neoadjuvant Ipilimumab in Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01194271
Recruitment Status : Completed
First Posted : September 2, 2010
Results First Posted : September 3, 2020
Last Update Posted : September 3, 2020
Bristol-Myers Squibb
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Leuprolide Acetate Drug: Ipilimumab Procedure: Radical Prostatectomy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Neoadjuvant Phase IIa Study of Ipilimumab {Formerly Known as MDX-010 (BMS-734016)} Plus Hormone Ablation in Men With Prostate Cancer Followed by Radical Prostatectomy.
Study Start Date : September 2010
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Neoadjuvant Ipilimumab
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
22.5 mg administered as a single intramuscular 3 month depot.
Other Name: Lupron Depot

Drug: Ipilimumab
10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy.
Other Names:
  • BMS-734016
  • MDX010

Procedure: Radical Prostatectomy
Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.

Primary Outcome Measures :
  1. Immunologic Response: Number of Participants With Immune Response [ Time Frame: Baseline to Week 8 ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Willing and able to give written informed consent;
  2. 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.
  3. 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.
  4. Determination of high-risk status: Patients must have either: 1) a Prostate biopsy Gleason sum >/= 8 OR 2) PSA >/= 20.
  5. 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.
  6. 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.
  7. ECOG performance status of 0 or 1;
  8. 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;
  9. Men >/= 18 years of age
  10. Patients must agree to practice barrier birth control methods while on therapy, prior to surgery.

Exclusion Criteria:

  1. 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.
  2. 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]).
  3. Known HIV or chronic hepatitis.
  4. 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.
  5. 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.
  6. Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab.
  7. 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);
  8. Previous treatment with other investigational products within 30 days;
  9. Previous enrollment in another MDX-010 (BMS-734016) clinical trial or prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist
  10. Concurrent use of 5-alpha-reductase inhibitors (finasteride, dutasteride).
  11. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194271

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Bristol-Myers Squibb
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Principal Investigator: Padmanee Sharma, MD, PHD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01194271    
Other Study ID Numbers: 2009-0135
NCI-2010-01974 ( Registry Identifier: NCI CTRP )
First Posted: September 2, 2010    Key Record Dates
Results First Posted: September 3, 2020
Last Update Posted: September 3, 2020
Last Verified: September 2020
Keywords provided by M.D. Anderson Cancer Center:
Hormone Ablation
Prostate adenocarcinoma
Radical prostatectomy
Leuprolide Acetate
Lupron Depot
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal