Clinical trial · Interventional
Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
A Phase III Randomized, Open-Label Study of Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation.
Summary
Brief summary (as posted)
The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy (docetaxel and prednisone) | Drug | — | UNRESOLVED |
| Immunotherapy allogeneic GM-CSF secreting cellular vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
- type
- OTHER
- label
- 2
- interventionNames
- Drug: Chemotherapy (docetaxel and prednisone)
Primary outcomes (1)
- measure
- Survival
- timeFrame
- 0
Secondary outcomes (1)
- measure
- Time to disease progression. Time to pain progression.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate * Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy * Detectable metastases * ECOG performance status ≤2 (Performance status of 3 if due to bone pain) * Any Gleason score * Only one prior treatment with systemic chemotherapy * No prior treatment with gene therapy * No prior immunotherapy for prostate cancer * Taxane naïve * Experiencing cancer-related pain
References
Publications (1)
- DERIVEDMichael BD, Syndikus I, Clark A, Baborie A. Diffuse primary leptomeningeal melanocytosis in a patient receiving a novel cancer cell vaccine for prostate cancer. BMJ Case Rep. 2010 May 4;2010:bcr11.2009.2495. doi: 10.1136/bcr.11.2009.2495. PMID 22736604