Clinical trial · Interventional
Phase 1 Trial of Ipilimumab and GVAX in Patients With Metastatic Castration-resistant Prostate Cancer
A Phase 1 Dose Escalation Trial of Ipilimumab in Combination With CG1940 and CG8711 in Patients With Metastatic Hormone-Refractory Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated because Cell Genesys stopped all activities for GVAX.
Summary
Brief summary (as posted)
Ipilimumab, an antibody that blocks cytotoxic T-lymphocyte antigen 4, and GVAX have demonstrated anti-tumor activity in prostate cancer. Pre-clinical studies with this combination have demonstrated potent synergy. The purpose of this study is to investigate, using a phase-I 3+3 dose escalation design followed by an expansion cohort, the safety and efficacy of combined treatment with GVAX and ipilimumab in castration-resistant metastatic prostate cancer (CRPC) patients.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GVAX and ipilimumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ipilimumab and GVAX
- interventionNames
- Drug: GVAX and ipilimumab
Primary outcomes (1)
- measure
- Number of patients with adverse events
- timeFrame
- 7 months
Secondary outcomes (3)
- measure
- number of patients that have a tumor/PSA response
- timeFrame
- 7 months
- measure
- number of patients that will develop a tumor-specific (e.g. PSMA, NY-ESO) antibody response as measured by ELISA
- timeFrame
- 7 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Males age 18-80 years * Histologic diagnosis of adenocarcinoma of the prostate * Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy * Detectable metastases by bone scan, CT scan or MRI * Two consecutive rising PSA values obtained at least two weeks apart and both obtained at least 4-6 weeks after discontinuation of hormone therapy. Second PSA value must be \> 5.0 ng/mL. LHRH agonist should not be discontinued. * Testosterone \< 50 ng/dL. Must have had orchiectomy or is currently receiving an LHRH agonist. * WBC \> 3.0 x 109/L, ANC \> 1.5 x 109/L, hemoglobin \> 6.2 mmol/L, and platelets \> 100 x 109/L * Serum creatinine \< 177 umol/L Bilirubin \< 1.5 times the upper limit of normal AST \< 3 times the upper limit of normal * ECOG performance status 0-2 * Life expectancy of at least 6 months * If sexually active, willing to use barrier contraception during the treatment phase of the protocol * The ability to understand and willingness to sign a written informed consent Exclusion Criteria: * Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer * Bone pain severe enough to require routine narcotic analgesia use * Clinical evidence of brain metastases or history of brain metastases * Seropositive for HIV, Hepatitis B antigen positive and/or Hepatitis C viremic * Prior chemotherapy or immunotherapy for prostate cancer * Radiation therapy within 4 weeks of the first treatment * Surgery within 4 weeks of the first treatment. Must have recovered from all side effects. * Flutamide within 4 weeks of the first treatment Megesterol acetate (Megace), finasteride (Proscar), bicalutamide (Casodex),nilutamide, aminoglutethimide, ketoconazole or diethylstilbestrol within 6 weeks of the first treatment. * Systemic corticosteroid use within 4 weeks of the first treatment * History of autoimmune disease * History of another malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage I or II cancer currently in complete remission or any other cancer that has been in complete remission for at least 5 years
References
Publications (1)
- DERIVEDvan den Eertwegh AJ, Versluis J, van den Berg HP, Santegoets SJ, van Moorselaar RJ, van der Sluis TM, Gall HE, Harding TC, Jooss K, Lowy I, Pinedo HM, Scheper RJ, Stam AG, von Blomberg BM, de Gruijl TD, Hege K, Sacks N, Gerritsen WR. Combined immunotherapy with granulocyte-macrophage colony-stimulating factor-transduced allogeneic prostate cancer cells and ipilimumab in patients with metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial. Lancet Oncol. 2012 May;13(5):509-17. doi: 10.1016/S1470-2045(12)70007-4. Epub 2012 Feb 10. PMID 22326922