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Ipilimumab + Androgen Deprivation Therapy in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01377389
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : April 12, 2018
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 if ipilimumab in combination with either Lupron® (leuprolide), Zoladex® (goserelin), or Firmagon® (degarelix) can affect prostate-specific antigen (PSA) levels in patients with prostate cancer. Researchers also want to learn if these drug combinations affect the body's immune system. The safety of these drug combinations will also be studied.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Ipilimumab Drug: Leuprolide Drug: Goserelin Drug: Degarelix Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Ipilimumab PLUS Androgen Deprivation Therapy in Castrate Sensitive Prostate Carcinoma
Actual Study Start Date : June 17, 2011
Actual Primary Completion Date : April 7, 2017
Actual Study Completion Date : April 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Ipilimumab + ADT
Ipilimumab 10 mg/kg intravenous (IV) Weeks 5, 9, 13, and 17 plus Androgen Deprivation Therapy (ADT) of either Leuprolide 7.5 mg intramuscular (IM) , Goserelin 3.6 mg subcutaneous (SQ) or Degarelix 80 mg SQ once a month for 8 months beginning Week 1.
Drug: Ipilimumab
10 mg/kg by vein over 90 minutes once every 4 weeks, for 4 weeks.
Other Names:
  • Yervoy
  • BMS-734016
  • MDX010

Drug: Leuprolide
7.5 mg intramuscular once a month for 8 months
Other Names:
  • Leuprolide Acetate
  • Lupron Depot

Drug: Goserelin
3.6 mg subcutaneous once a month for 8 months
Other Name: Zoladex

Drug: Degarelix
80 mg subcutaneous once a month for 8 months
Other Name: Firmagon

Primary Outcome Measures :
  1. Proportion of Participants achieving a PSA ≤ 0.2ng/mL at Month 7 [ Time Frame: Baseline to 7 months ]
    Prostate-specific antigen (PSA) conducted by the Simon's optimal two-stage design (Simon, 1989). Antitumor activity assessed through serial PSA measurements (blood tests) at pre-determined time points.

Information from the National Library of Medicine

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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. Histologically or cytologically confirmed prostate carcinoma.
  2. Evidence of metastatic disease on previous bone scan and/or CT scan and/or MRI.
  3. Castrate-sensitive disease. Patients already on ADT are eligible as long as the time from initiation of LHRH analog or antagonist is not greater than 1 month AND the total exposure time to the LHRH analog or antagonist will not exceed 8 months (i.e. the effectiveness of current depot LHRH analog or antagonist does not extend beyond 8 months since its initiation).
  4. Patients who have received prior hormonal therapy are allowed to participate as long as they have been off hormone ablation for 1.5 times as long as they were on it: e.g. 1) Patients who have received up to 4 months of hormonal ablation are eligible as long as they have been off hormonal ablation for >/= 6 months; 2) Patients who have received 1 year of hormonal ablation are eligible as long as they have been off hormone ablation for >/= 18 months; 3) Patients who have received up to 2 years of hormonal ablation are eligible as long as they have been off hormonal ablation for >/= 3 years have elapsed since its discontinuation.
  5. Eastern Cooperative Oncology Group (ECOG) performance status </= 1
  6. Patients must have normal organ and marrow function as defined below: a) white blood cell count (WBC) >/= 3000/uL; b) Absolute neutrophil count (ANC) >/= 1500/uL; c) Platelets >/= 100 x 10^3/uL; d) Hemoglobin >/= 9 g/dL; e) Creatinine </= 2mg/dL; f) ALT </= 2.5 x upper limit of normal (ULN) for patients without liver metastases. For patients with liver metastasis ALT </= 5 x ULN is allowed; g) Bilirubin </= 3 x ULN (except for patients with Gilbert's Syndrome, who must have a total bilirubin </= 3mg/dL)
  7. Patients included in the study must be >/= 18 years old
  8. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Autoimmune disease: Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus or autoimmune vasculitis [e.g., Wegener's Granulomatosis] are excluded from this study.
  2. Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs: e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficiencies.
  3. Patients with known brain metastases.
  4. Patients with small cell carcinoma of the prostate.
  5. History of other malignancies, other than nonmelanoma skin cancer or Ta or T1 (low grade) bladder carcinomas, unless in complete remission and off therapy for that disease for at least 5 years.
  6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  7. Known HIV, Hepatitis B, or Hepatitis C.
  8. Untreated symptomatic spinal cord compressions.
  9. Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab).
  10. 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).
  11. Previous participation in another ipilimumab clinical trial or prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist.
  12. History of acute diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation.
  13. Patients who do not agree to practice appropriate birth control methods while on therapy.
  14. Concurrent use of 5-alpha reductase inhibitors (finasteride or dutasteride).

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 identifier (NCT number): NCT01377389

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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: Ana M. Aparicio, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01377389     History of Changes
Other Study ID Numbers: 2009-0378
NCI-2011-01125 ( Registry Identifier: NCI CTRP )
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Prostate cancer
Castrate sensitive prostate carcinoma
Metastatic prostate carcinoma
Androgen deprivation therapy
Prostate-specific antigen
Lupron Depot
Leuprolide Acetate
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents