Ipilimumab + Androgen Deprivation Therapy in Prostate Cancer
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ClinicalTrials.gov Identifier: NCT01377389 |
Recruitment Status
:
Completed
First Posted
: June 21, 2011
Last Update Posted
: April 12, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Drug: Ipilimumab Drug: Leuprolide Drug: Goserelin Drug: Degarelix | Phase 2 |

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 |

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.
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Drug: Ipilimumab
10 mg/kg by vein over 90 minutes once every 4 weeks, for 4 weeks.
Other Names:
Drug: Leuprolide
7.5 mg intramuscular once a month for 8 months
Other Names:
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
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed prostate carcinoma.
- Evidence of metastatic disease on previous bone scan and/or CT scan and/or MRI.
- 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).
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 1
- 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)
- Patients included in the study must be >/= 18 years old
- Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
- 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.
- 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.
- Patients with known brain metastases.
- Patients with small cell carcinoma of the prostate.
- 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.
- 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.
- Known HIV, Hepatitis B, or Hepatitis C.
- Untreated symptomatic spinal cord compressions.
- 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 participation in another ipilimumab clinical trial or prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist.
- History of acute diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation.
- Patients who do not agree to practice appropriate birth control methods while on therapy.
- Concurrent use of 5-alpha reductase inhibitors (finasteride or dutasteride).

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): NCT01377389
United States, Texas | |
University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Ana M. Aparicio, MD | M.D. Anderson Cancer Center |
Additional Information:
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov 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 |
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 ADT Prostate-specific antigen PSA Ipilimumab Yervoy |
BMS-734016 MDX010 Leuprolide Lupron Depot Leuprolide Acetate Goserelin Zoladex Degarelix Firmagon |
Additional relevant MeSH terms:
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Antibodies, Monoclonal Androgens Leuprolide |
Goserelin Immunologic Factors Physiological Effects of Drugs Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Fertility Agents, Female Fertility Agents Reproductive Control Agents Antineoplastic Agents, Hormonal Antineoplastic Agents |