Trial · NCT01560923
Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer
NCT01560923, Phase 2, Completed, Masonic Cancer Center, University of Minnesota; results first posted 2020-04-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer. Trials, record NCT01560923. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01560923
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer
- NCT number
- NCT01560923
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Metastatic Prostate Cancer
- Interventions
- Indoximod, Sipuleucel-T, Placebo
- First posted
- 2012-03-22
- Last updated
- 2020-04-03
- Results first posted
- 2020-04-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Immune Response to Sipuleucel-T | 14 Weeks from First Leukapheresis | Assess the augmentation of immune response (PA2024) to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo. The frequency of antigen specific, cytokine producing cells will be determined by an ELISPOT assay. ELISPOT assay will use whole PBMC to assess interferon gamma production in response to the immunizing protein PA2024. Increase in number of ELISPOT responses to PBMC in patients in the treatment arm will be compared to those in control arm. |
| Secondary | Number of Participants With Progression Free Survival at 6 Months | 6 Months | 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. |
| Secondary | Objective Response Rate | 4 weeks | rate as defined by Prostate Cancer Working Group -2 (PCWG2). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST)(version 1.1) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesion. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Overall Survival | 2 years | To evaluate 2 year overall survival |
| Secondary | Quality of Life Scale Results | 6 Months | measured by the performance status with scale of 0-5 0 being 'normal activity' and 5 'being dead' |
| Secondary | Ratio of Antibodies to PA2024 | 14 Weeks from First Leukapheresis | Assess the augmentation of immune response (PA2024) to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo. The frequency of antigen specific, cytokine producing cells will be determined by an ELISPOT assay. ELISPOT assay will use whole PBMC to assess interferon gamma production in response to the immunizing protein PA2024. Antibodies to PA2024 is measured by ELISA. The ratio of antibodies to ELISPOT responses to PBMC in patients in the treatment arm will be compared to those in control arm. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Immune Response to Sipuleucel-T | 14 Weeks from First Leukapheresis | Spots per ml | GEOMETRIC_MEAN | |
| SECONDARY | Number of Participants With Progression Free Survival at 6 Months | 6 Months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Objective Response Rate | 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Quality of Life Scale Results | 6 Months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Ratio of Antibodies to PA2024 | 14 Weeks from First Leukapheresis | Ratio | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Immune Response to Sipuleucel-T | Sipuleucel-T + Placebo | 29.6 | 95% Confidence Interval 4.86 to 180.37 | Spots per ml | |
| Immune Response to Sipuleucel-T | Sipuleucel-T + Oral Indoximod | 25.45 | 95% Confidence Interval 2.92 to 222.12 | Spots per ml | |
| Number of Participants With Progression Free Survival at 6 Months | Sipuleucel-T + Placebo | 6 | Participants | ||
| Number of Participants With Progression Free Survival at 6 Months | Sipuleucel-T + Oral Indoximod | 11 | Participants | ||
| Objective Response Rate | Sipuleucel-T + Placebo | Partial response (PR) | 1 | Participants | |
| Objective Response Rate | Sipuleucel-T + Oral Indoximod | Partial response (PR) | 0 | Participants | |
| Objective Response Rate | Sipuleucel-T + Placebo | Not Evaluable | 0 | Participants | |
| Objective Response Rate | Sipuleucel-T + Oral Indoximod | Not Evaluable | 2 | Participants | |
| Objective Response Rate | Sipuleucel-T + Placebo | Stable Disease (SD) | 5 | Participants | |
| Objective Response Rate | Sipuleucel-T + Oral Indoximod | Stable Disease (SD) | 11 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sipuleucel-T + Placebo | 24 | |
| Overall Study | STARTED | Sipuleucel-T + Oral Indoximod | 22 | |
| Overall Study | COMPLETED | Sipuleucel-T + Placebo | 24 | |
| Overall Study | COMPLETED | Sipuleucel-T + Oral Indoximod | 22 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T + Placebo | 0 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T + Oral Indoximod | 0 |
Source ClinicalTrials.gov
Adverse events222
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Positive ANA panel 1:320 | Blood and lymphatic system disorders | Sipuleucel-T + Indoximod | 1 | 22 | 1 |
| other | Positive ANA panel 1:320 | Blood and lymphatic system disorders | Sipuleucel-T + Placebo | 0 | 24 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Sipuleucel-T + Indoximod | 1 | 22 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Sipuleucel-T + Placebo | 1 | 24 | 1 |
| other | Lymph node pain (bilateral inguinal) | Blood and lymphatic system disorders | Sipuleucel-T + Indoximod | 1 | 22 | 1 |
| other | Lymph node pain (bilateral inguinal) | Blood and lymphatic system disorders | Sipuleucel-T + Placebo | 0 | 24 | 0 |
| other | White blood cell count decreased | Blood and lymphatic system disorders | Sipuleucel-T + Indoximod | 0 | 22 | 0 |
| other | White blood cell count decreased | Blood and lymphatic system disorders | Sipuleucel-T + Placebo | 1 | 24 | 1 |
| other | Atrial flutter | Cardiac disorders | Sipuleucel-T + Indoximod | 1 | 22 | 1 |
| other | Atrial flutter | Cardiac disorders | Sipuleucel-T + Placebo | 0 | 24 | 0 |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sipuleucel-T + Indoximod | 5 | 22 |
| Total, all-cause mortality | Sipuleucel-T + Placebo | 6 | 24 |
| Total, other adverse events | Sipuleucel-T + Indoximod | 20 | 22 |
| Total, other adverse events | Sipuleucel-T + Placebo | 21 | 24 |
| Total, serious adverse events | Sipuleucel-T + Indoximod | 2 | 22 |
| Total, serious adverse events | Sipuleucel-T + Placebo | 1 | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sipuleucel-T + Placebo vs Sipuleucel-T + Oral Indoximod: Number of Participants With Progression Free Survival at 6 Months | Trial comparisons |
| Sipuleucel-T + Placebo vs Sipuleucel-T + Oral Indoximod: Overall Survival | Trial comparisons |
| Sipuleucel-T + Indoximod vs Sipuleucel-T + Placebo: deaths from any cause | Trial comparisons |
| Sipuleucel-T + Indoximod vs Sipuleucel-T + Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01560923
GET https://conductscience.org/api/trials/v1/NCT01560923/results?page=2