Know Cancer

forgot password

A Phase 1 Dose Escalation Trial of Ipilimumab in Combination With CG1940 and CG8711 in Patients With Metastatic Hormone-Refractory Prostate Cancer

Phase 1
18 Years
80 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

A Phase 1 Dose Escalation Trial of Ipilimumab in Combination With CG1940 and CG8711 in Patients With Metastatic Hormone-Refractory Prostate Cancer

A promising immunotherapeutic approach in prostate cancer is whole-cell vaccination.
Irradiated allogeneic tumor cells expressing GM-CSF generate a long-lasting and specific
anti-tumor immunity in preclinical models. Results from several phase I and II trials showed
Prostate GVAX (GVAX) to be well tolerated and suggested improved survival. Cytotoxic
T-lymphocyte-associated antigen 4 (CTLA-4) is a crucial immune checkpoint molecule that
down-regulates T-cell activation and proliferation. Ipilimumab, a fully human monoclonal
antibody (IgG1) that blocks CTLA-4, promotes antitumor immunity, and has been demonstrated
in two phase III trials to improve overall survival in metastatic melanoma patients.
Pre-clinical studies of the anti-CTLA-4 antibody in combination with GM-CSF secreting tumor
cell vaccines demonstrated a potent synergy. In this phase I study the investigators examine
in CRPC patients whether ipilimumab can be safely combined with GVAX. In addition, the
investigators will treat an additional 16 patients at a dose level of 3•0 mg/kg to determine
the safety profile and antitumor effects of GVAX and ipilimumab in patients with CRPC.

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

- WBC > 3.0 x 109/L, ANC > 1.5 x 109/L, hemoglobin > 6.2 mmol/L, and platelets > 100 x

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients with adverse events

Outcome Time Frame:

7 months

Safety Issue:


Principal Investigator

Winald Gerritsen, Prof. MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

VU University Medical Center


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

November 2004

Completion Date:

November 2011

Related Keywords:

  • Prostate Cancer
  • GVAX
  • Ipilimumab
  • prostate cancer
  • Prostatic Neoplasms