Phase 2
N=71
Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer
Prostate Cancer · Neoplasm Metastasis
Bottom Line
View on ClinicalTrials.gov: NCT00323882 ↗Enrolled (actual)
71
Serious AEs
49.3%
Results posted
Aug 2014
Primary outcome: Primary: Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants — 3; 2; 9; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MDX-010 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants |
3; 2; 9; 2; 19; 2 | — |
| PRIMARY Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants |
0; 0; 1; 0; 1; 1 | — |
| SECONDARY Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants |
0; 0; 1; 0; 2; 2 | — |
| SECONDARY Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85 |
1.41; 1.54; 1.4; 1.1; 1.1 | — |
| SECONDARY Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy |
12.5; 0; 0 | — |
| SECONDARY PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy |
18.8; 9.5; 15.4; 25.0; 9.5; 15.4 | — |
| SECONDARY Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants |
5; 4; 7; 3; 18; 37 | — |
| SECONDARY Overall Survival at Completion of Follow Up Period - Treated Participants |
22.5; 36.3; 26.6; 18.2; 9.7; 17.4 | — |
| SECONDARY Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants |
0; 0; 0; 1; 2; 0 | — |
| SECONDARY Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants |
0; 2; 7; 2; 10; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants |
0; 0; 2; 0; 0; 0 | — |
| SECONDARY Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants |
0; 0; 0; 0; 0 | — |
Summary
Multicenter study in which patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010 every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be enrolled in each dosage level. Patients who tolerated and responded to treatment or who had stable disease for 3 months or longer and who subsequently progressed during the follow up phase of the study had the option to receive additional treatment with MDX-010, up to 4 cycles. Patients were followed in the study for response up to 2 years and were followed for survival status for up to 5 years after enrollment.
Eligibility Criteria
Inclusion Criteria
- Histologic diagnosis of adenocarcinoma of the prostate
- Metastatic prostate cancer (positive bone scan or measurable disease)
- Total testosterone of less than 50 ng/dL, except for patients with prior orchiectomy, where testosterone does not need to be measured.
- Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen and completion of a washout period and then observe disease progression.
- Patients must stop using any herbal product known to decrease PSA levels (eg., saw palmetto and PC-SPES) or any systemic or topical corticosteroid at least 4 weeks prior to screening. Progressive disease must be documented after discontinuation of these products.
- Progressive disease after androgen deprivation (or hormone therapy). For patients with measurable disease, progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For patients with progression in, or without any measurable disease, a positive bone scan and elevated PSA will be required.
- Patients receiving bisphosphate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment.
- No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).
- Prior radiation therapy completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
Exclusion Criteria
- Bone pain due to metastatic bone disease severe enough to require routine narcotic analgesic use.
- History of severe hypersensitivity reactions to drugs formulated with polysorbate 80.
- Patients with active autoimmune disease or a history of autoimmune disease that required systemic steroids or immunosuppressive medications, except for patients with vitiligo.
- Prior therapy with any anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) antibody.
- Active infection requiring therapy.
- Concurrent medical condition requiring the use of systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is acceptable.
Data sourced from ClinicalTrials.gov (NCT00323882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.