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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Ipilimumab + Androgen Depravation Therapy in Prostate Cancer

NCTNCT01377389 (opens ClinicalTrials.gov in a new tab)Other id2009-0378Other idNCI-2011-01125

Overview

Status
Terminated
Phase
Phase 2
Enrollment
30 participants (actual)
Sponsor
M.D. Anderson Cancer Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
17 Jun 2011
Primary completion
7 Apr 2017
Completion
7 Apr 2017
First posted
21 Jun 2011 (estimated)
Last update posted
29 Sept 2023
Conditions
Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201420162018
  1. Ph 2

    Ipilimumab + Androgen Depravation Therapy in Prostate Cancer

    NCT01377389

    17 Jun 2011 to 7 Apr 2017

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • IpilimumabDrug
  • LeuprolideDrug
  • GoserelinDrug
  • DegarelixDrug

Arms1

  • Experimental

    Ipilimumab + ADT

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants Who Progressed After 7 Months of Being on Treatment

    Time frame · at the end of 7 months on treatment

    Registry description

    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.

Secondary outcomes(5)
  1. The Number of Clonal Expansion of Cluster of Differentiation 8 (CD8) T-cells

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

    Registry description

    CD8 T-cells are known as cytotoxic T-cells or "killer" T-cells. When the resting CD8 T-cells are activated, the activated CD8 T-cells multiple to fight a specific target so creating a group of specifically activated T-cells. This test measured the minimal number of clonal expansions of CD8 T-cells that always preceded an adverse response to treatment that was due to increased activity in the immune system itself. The minimal number of clonal expansion points to what this increased activity in the immune system might look like.

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

    Time frame · 1 month up to 7 months.

    Registry description

    The presence of testosterone was followed in each patient from the start of treatment until the testosterone lab test was found to be at a value greater than 50ng/mL.

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

    Time frame · 2 to 45 months

    Registry description

    The number of months after the last ADT dose until the PSA progression

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

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

    Registry description

    The total number of adverse events which were related to one of the study drugs. Grade 1- Mild, asymptomatic of mild symptoms; clinical or diagnostic observation only; intervention not indicated. Grade 2- Moderate, minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental (daily living activities). Grate 3- Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care of daily life activities.

  5. Overall Survival

    Time frame · 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.

    Registry description

    Overall survival of patients treated with intermittent ADT and ipilimumab in months.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· at the end of 7 months on treatment

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

GroupValue (Participants)
Ipilimumab and Androgen Depravation6
Secondary and other outcome results(5)
Secondary outcomeNumber· Each evaluable patient was followed from the time of their first dose until 30 days after their last dose of study drug

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

GroupValue (clonal expansions)
Ipilimumab and Androgen Depravation55
Secondary outcomeMean· 1 month up to 7 months.

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

GroupValue (months)
Ipilimumab and Androgen Depravation3.4
Secondary outcomeMean· 2 to 45 months

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

GroupValue (months)
Ipilimumab and Androgen Depravation8.0
Secondary outcomeNumber· From the first dose to the last follow-up, up to 60 months

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

GroupValue (related events)
Ipilimumab and Androgen Depravation113
Secondary outcomeMean· 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.

Overall Survival

GroupValue (months)
Ipilimumab and Androgen Depravation36

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Ipilimumab and Androgen DepravationParticipants with castrate sensitive prostate carcinoma0 / 2710 / 2727 / 27

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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