CYT107 After Vaccine Treatment (Provenge®) in Patients With Metastatic Castration-Resistant Prostate Cancer
CompletedPhase 2Results postedLast updated 9 July 2019
What this trial tests
Phase 2 trial testing Glycosylated Recombinant Human Interleukin-7 in Castration Levels of Testosterone in 54 participants. Completed in 2 January 2018.
18 and older, male only, with Castration Levels of Testosterone or Castration-Resistant Prostate Carcinoma. 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.
Quantification of T-cell Responses to Prostatic Acid Phosphatase Granulocyte-macrophage Colony-stimulating Factor (PAP-GM-CSF), Assessed by Quantification of Interferon Gamma Levels Measured Using Enzyme-linked Immunospot (ELISPOT)Primary· Day 70 (week 11)
The Mann-Whitney-Wilcoxon (MWW) test will be used as part of the statistical analysis to determine quantification of T-cell responses to prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (PAP-GM-CSF), as assessed by quantification of interferon gamma levels measured using enzyme-linked immunospot (ELISPOT). The power is roughly equivalent to that based on the t-test.
Group
Value
95% CI
Cohort I (no Therapy)
212.2
± 111.97
Cohort II (Glycosylated Recombinant Human Interleukin-7)
199.68
± 182.4
Change in Circulating Tumor CellsSecondary· Baseline to up to week 53
Enumerated by the approved Veridex assay.
Week 01
Group
Value
95% CI
Cohort I (no Therapy)
2.56
± 7.88
Cohort II (Glycosylated Recombinant Human Interleukin-7)
1.45
± 2.97
Week 53
Group
Value
95% CI
Cohort I (no Therapy)
2.63
± 5.97
Cohort II (Glycosylated Recombinant Human Interleukin-7)
0
± 0
Change in Number of Peripheral Blood Mononuclear Cell (PBMC) Subsets and T Lymphocyte SubsetsSecondary· Week 11
The absolute fold change from baseline of CD3+ cells
Week 06
Group
Value
95% CI
Cohort I (no Therapy)
1.05
± 0.29
Cohort II (Glycosylated Recombinant Human Interleukin-7)
2.33
± 1.02
Week 11
Group
Value
95% CI
Cohort I (no Therapy)
1.21
± 0.34
Cohort II (Glycosylated Recombinant Human Interleukin-7)
1.77
± 0.55
Change in Prostate Specific Antigen (PSA) Kinetics.Secondary· Baseline to up to week 53
The change in prostate specific antigen (PSA) kinetics will be evaluated according to the recommendations from PSA Working Group (PSAWG). Analysis of PSA doubling time
Group
Value
95% CI
Cohort I (no Therapy)
46.82
17.49 – 76.15
Cohort II (Glycosylated Recombinant Human Interleukin-7)
8.15
-18.79 – 35.09
Change in Vaccine-induced Antigen-specific Antibody Immune Response to Prostatic Acid Phosphatase (PAP)Secondary· Baseline to up to week 6
Will be measured by change in immunoglobulin G (IgG) and immunoglobulin M (IgM) levels quantified by standard enzyme-linked immunosorbent assay (ELISA). Fold change from baseline in week 6 titer
IgG-IgM levels
Group
Value
95% CI
Cohort I (no Therapy)
8
0.5 – 256
Cohort II (Glycosylated Recombinant Human Interleukin-7)
8
1 – 64
IgG levels
Group
Value
95% CI
Cohort I (no Therapy)
4
1 – 32
Cohort II (Glycosylated Recombinant Human Interleukin-7)
2
1 – 128
Overall SurvivalSecondary· Up to 5 years
Number of participants that have survived
Group
Value
95% CI
Cohort I (no Therapy)
22
Cohort II (Glycosylated Recombinant Human Interleukin-7)
25
Adverse events — posted to ClinicalTrials.gov
Time frame: 53 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort I (no Therapy)
Serious: 2/26 (8%)
Deaths: 4/26
Cohort II (Glycosylated Recombinant Human Interleukin-7)
This randomized phase II trial studies how well glycosylated recombinant human interleukin-7 (CYT107) after vaccine therapy works in treating patients with castration-resistant prostate cancer that has spread to other areas of the body or has not responded to at least one type of treatment. Biological therapies, such as glycosylated recombinant human interleukin-7, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. It is not yet known whether glycosylated recombinant human interleukin-7 works better with or without vaccine therapy in treating prostate cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of Glycosylated Recombinant Human Interleukin-7
Trials testing the same drug.
NCT03513952 — Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma
· Phase 2
· completed
Other recruiting trials for Castration Levels of Testosterone
Currently open trials in the same condition.
NCT03678025 — Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
· Phase 3
· recruiting
NCT03419234 — Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metast
· Phase 2
· active not recruiting
NCT02703623 — Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating P
· Phase 2
· active not recruiting
Other Fred Hutchinson Cancer Center trials
Trials by the same sponsor.
NCT07390968 — Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Pati
· Phase 2
· not yet recruiting
NCT07493252 — A Behavioral Application for Improving Smoking Cessation Among Smokers
· NA
· not yet recruiting
NCT07490860 — A Restorative Justice-Based Lung Cancer Screening Decision-Making Support Intervention Tailored for Black Individuals to
· NA
· not yet recruiting
NCT07194980 — Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small L
· Phase 2
· not yet recruiting
NCT07176000 — Tailored Patient Navigation to Improve the Uptake of Lung Cancer Screening in Tribal Communities in Western Washington S
· NA
· not yet recruiting
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 Fred Hutchinson Cancer Center
Last refreshed: 9 July 2019
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/NCT01881867.