18 and older, male only, with Metastatic Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Immune Response to Sipuleucel-TPrimary· 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.
Group
Value
95% CI
Sipuleucel-T + Placebo
29.6
4.86 – 180.37
Sipuleucel-T + Oral Indoximod
25.45
2.92 – 222.12
Number of Participants With Progression Free Survival at 6 MonthsSecondary· 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
Group
Value
95% CI
Sipuleucel-T + Placebo
6
Sipuleucel-T + Oral Indoximod
11
Objective Response RateSecondary· 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
Group
Value
95% CI
Sipuleucel-T + Placebo
1
Sipuleucel-T + Oral Indoximod
0
Sipuleucel-T + Placebo
0
Sipuleucel-T + Oral Indoximod
2
Sipuleucel-T + Placebo
5
Sipuleucel-T + Oral Indoximod
11
Sipuleucel-T + Placebo
3
Sipuleucel-T + Oral Indoximod
1
Overall SurvivalSecondary· 2 years
To evaluate 2 year overall survival
Group
Value
95% CI
Sipuleucel-T + Placebo
18
Sipuleucel-T + Oral Indoximod
17
Quality of Life Scale ResultsSecondary· 6 Months
measured by the performance status with scale of 0-5 0 being 'normal activity' and 5 'being dead'
Baseline Performance Status Score
Group
Value
95% CI
Sipuleucel-T + Placebo
19
Sipuleucel-T + Oral Indoximod
15
Sipuleucel-T + Placebo
5
Sipuleucel-T + Oral Indoximod
7
Sipuleucel-T + Placebo
0
Sipuleucel-T + Oral Indoximod
0
Post Treatment performance Status Score
Group
Value
95% CI
Sipuleucel-T + Placebo
7
Sipuleucel-T + Oral Indoximod
9
Sipuleucel-T + Placebo
10
Sipuleucel-T + Oral Indoximod
3
Sipuleucel-T + Placebo
7
Sipuleucel-T + Oral Indoximod
10
Ratio of Antibodies to PA2024Secondary· 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
PA2024 IGG ratio (wk14/baseline)
Group
Value
95% CI
Sipuleucel-T + Placebo
13.05
5.05 – 33.72
Sipuleucel-T + Oral Indoximod
9.19
3.04 – 27.8
PA2024 IGGIGM ratio (wk14/baseline)
Group
Value
95% CI
Sipuleucel-T + Placebo
104.39
33.88 – 321.66
Sipuleucel-T + Oral Indoximod
111.43
35.49 – 349.89
Adverse events — posted to ClinicalTrials.gov
Time frame: 28 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Sipuleucel-T + Indoximod
Serious: 2/22 (9%)
Deaths: 5/22
Sipuleucel-T + Placebo
Serious: 1/24 (4%)
Deaths: 6/24
Serious adverse events (3 terms)
Reaction
System
Sipuleucel-T + Indoximod
Sipuleucel-T + Placebo
Urinary tract obstruction
Renal and urinary disorders
—
—
Sepsis
Infections and infestations
—
—
Flank pain
Musculoskeletal and connective tissue disorders
—
—
Other adverse events (108 terms — click to expand)
This is a randomized, double blind, multi-institutional phase II therapeutic study of Indoximod or placebo after the completion of standard of care sipuleucel-T (Provenge®) in men with asymptomatic or minimally symptomatic metastatic prostate cancer that is castration resistant (hormone refractory). Patients are randomized to receive either twice daily oral Indoximod or placebo for 6 months beginning the day after the third and final sipuleucel-T infusion.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05106296 — Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer
· Phase 1
· recruiting
NCT04049669 — Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG
· Phase 2
· active not recruiting
NCT03301636 — A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma
· Phase 2
· terminated
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Currently open trials in the same condition.
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Other Masonic Cancer Center, University of Minnesota trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota
Last refreshed: 3 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01560923.