Ipilimumab + Androgen Depravation Therapy in Prostate Cancer

NCT01377389 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2009-0378NCI-2011-01125
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Castrate sensitive prostate carcinoma; Metastatic prostate carcinoma; Androgen depravation therapy; ADT; Prostate-specific antigen; PSA; Ipilimumab; Yervoy; BMS-734016; MDX010; Leuprolide; Lupron Depot; Leuprolide Acetate; Goserelin; Zoladex; Degarelix; Firmagon

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Progressed After 7 Months of Being on Treatment

  Anti-tumor activity assessed through serial PSA measurements (blood tests) at 7 months on treatment. Progression defined as two consecutive PSA values increasing by at least 20% or more from the lowest PSA value for each patient.

  at the end of 7 months on treatment

Secondary Outcomes (5)

• The Number of Clonal Expansion of Cluster of Differentiation 8 (CD8) T-cells

  Each evaluable patient was followed from the time of their first dose until 30 days after their last dose of study drug

• Time to Testosterone Recovery (> 50ng/mL) in Patients Treated With Intermittent ADT Plus Ipilimumab.

  1 month up to 7 months.

• Time to Progression of Disease (PD) Off Androgen Depravation Therapy (ADT), After Treatment With Intermittent ADT Plus Ipilimumab.

  2 to 45 months

• The Total Number of Study Drug Related Events Indicated by the Participants

  From the first dose to the last follow-up, up to 60 months

• Overall Survival

  From the date of randomization until the date of first documented progression or date of death from any case, whichever came first, assessed up to 70 months.

Study Arms (1)

Ipilimumab + ADT

EXPERIMENTAL

Ipilimumab 10 mg/kg intravenous (IV) Weeks 5, 9, 13, and 17 plus Androgen Depravation 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; Drug: Leuprolide; Drug: Goserelin; Drug: Degarelix

Interventions

Ipilimumab DRUG

10 mg/kg by vein over 90 minutes once every 4 weeks, for 4 weeks.

Also known as: Yervoy, BMS-734016, MDX010

Ipilimumab + ADT

Leuprolide DRUG

7.5 mg intramuscular once a month for 8 months

Also known as: Leuprolide Acetate, Lupron Depot

Ipilimumab + ADT

Goserelin DRUG

3.6 mg subcutaneous once a month for 8 months

Also known as: Zoladex

Ipilimumab + ADT

Degarelix DRUG

80 mg subcutaneous once a month for 8 months

Also known as: Firmagon

Ipilimumab + ADT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

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

Ipilimumab; Leuprolide; Goserelin; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

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)

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

Results Point of Contact

• Title: Aparicio,Ana,M.D. / Genitourinary Medical Oncology
• Organization: UT MD Anderson Cancer Center

AAPARICIO@MDANDERSON.ORG

713-792-7734

Study Officials

• Ana M. Aparicio, MD

  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: June 17, 2011
• First Posted: June 21, 2011
• Study Start: June 17, 2011
• Primary Completion: April 7, 2017
• Study Completion: April 7, 2017
• Last Updated: September 29, 2023
• Results First Posted: October 9, 2019

Record last verified: 2023-09

Locations

US (1)