Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SipT Treatment · 1 trial · 1 indication
Immune response will be tested using the single sample binomial exact test when induction therapy is completed. The Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibody responses to PAP and/or PA2024 will be assessed by ELISA assay at baseline and week 20 after start of sipT treatment (day 113 of study treatment). A positive response is defined as a titer \> 1:400. The positive immune percentage for both IgG and IgM antibodies to PAP and to PA2024 will be used to summarize the results for each study arm.
Immune Response Adverse Events (IRAEs) will be reported for each study arm by tabulating the frequency of the maximum grade occurring for each patient for each type of iRAE using NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0. IRAEs will be reported as a proportion of the participants in the treatment arm with the associated highest grade IRAE occurrences during protocol therapy.
| Arm | Type | Description |
|---|---|---|
| Immediate IpilimumabTreatment | EXPERIMENTAL | Arm 1 (Immediate Treatment) Ipilimumab Q3wks x 4 started 1 day following the final dose of SipT. |
| Delayed IpilimumabTreatment | EXPERIMENTAL | Arm 2 (Delayed Treatment) Ipilimumab Q3wks x 4 started 3 weeks following the final dose of SipT. |
| Name | Type | Description |
|---|---|---|
| SipT Treatment | DRUG | All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete. SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion. |
| Ipilimumab | DRUG | Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion. |
Inclusion Criteria: 1. Histologically confirmed, metastatic prostate adenocarcinoma (positive bone scan and/or measurable disease on CT scan and/or MRI of the abdomen and pelvis). 2. Progressive disease after androgen deprivation, as defined by Prostate Cancer Clinical Trials Working Group 2 (PCWG2...
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SipT Treatment is an investigational small molecule being studied for prostate cancer. It is being evaluated in a Phase 2 clinical trial that combines Sipuleucel-T with immediate versus delayed CTLA-4 blockade. The study enrolled 50 male participants aged 18 years and older in the United States.
SipT Treatment is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this investigational therapy for prostate cancer.
SipT Treatment is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial has been completed, and the drug is not currently in any active clinical trials.
SipT Treatment has one completed clinical trial, NCT01804465, titled "Sipuleucel-T With Immediate vs. Delayed Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Blockade for Prostate Cancer." This Phase 2 study enrolled 50 participants with prostate cancer in the United States.
Yes, the Phase 2 trial for SipT Treatment was randomized and controlled. It was not double-blind, and it used a controlled design. The trial also selected patients based on biomarkers.