Comparison · NCT01560923-2bcff9b1
Sipuleucel-T + Placebo vs Sipuleucel-T + Oral Indoximod: Number of Participants With Progression Free Survival at 6 Months
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Sipuleucel-T + Placebo vs Sipuleucel-T + Oral Indoximod: Number of Participants With Progression Free Survival at 6 Months. Trial comparisons, record NCT01560923-2bcff9b1. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01560923-2bcff9b1
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.25 | 0.12 | 0.449 | wilson | |
| Risk in group 2 | 0.5 | 0.307 | 0.693 | wilson | |
| Risk difference, group 1 minus group 2 | -0.25 | -0.483 | 0.0271 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.5 | 0.223 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 0.333 | 0.0959 | 1.16 | log | |
| Number needed to treat, for one fewer participant with the outcome on Sipuleucel-T + Placebo than on Sipuleucel-T + Oral Indoximod | 4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Sipuleucel-T + Placebo | Placebo is identical-looking to Indoximod and provided in the same manner.~Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).~Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth. | 6 | 24 | OG000 |
| Group 2 | Sipuleucel-T + Oral Indoximod | Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.~Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.~Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday). | 11 | 22 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Progression Free Survival at 6 Months
- Description
Progression free survival (PFS) is a composite endpoint defined as disease progression in bone or soft tissues, PSA progression, worsening pain, or death. PFS will be measured in months from the time of study enrollment until the date of disease progression.~Progression is evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) \[Eur J Ca 45:228-247, 2009\]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
- Time frame
- 6 Months
- Population
Source ClinicalTrials.gov
Trial
- Title
- Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer
- NCT number
- NCT01560923
- Phases
- PHASE2
- Conditions
- Metastatic Prostate Cancer
- Interventions
- Indoximod, Sipuleucel-T, Placebo
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Results first posted
- 2020-04-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01560923?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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