Genitourinary Cancers Clinical Trials & Research at St. Joseph Health
Medical Group
St. Joseph Health Medical Group is currently enrolling patients for the
following genitourinary cancers clinical trials:
Cervical Cancer
Endometrial Cancer
Urothelial Cancer
Prostate Cancer
Renal Cell Cancer
Cervical Cancer
A Phase 1/2 Safety, Tolerability, Pharmacokinetics, Biological, and Clinical
Activity of AGEN1884 in Combination With AGEN2034 in Subjects With Metastatic
or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors
(Cervical) (JIT Agenus)
Phase Ib/II
This is an open-label, multi-arm study, of AGEN1884 in combination with
AGEN2034 in subjects with advanced solid tumors including cervical cancer
who have relapsed after a 1st line platinum doublet therapy. AGEN2034 is a novel, fully human monoclonal
immunoglobulin G4 (IgG4) antibody, designed to block program cell death-1
(PD-1). AGEN1884 is a novel, fully human monoclonal immunoglobulin G1
(IgG1) antibody, designed to block cytotoxic T lymphocyte antigen-4 (CTLA-4).
Treatment agent: AGEN1884 (CTLA-4 blocker) + AGEN2034 (PD-1 blocker)
PI:
Thomas Stanton, MD
Study Coordinator: Kim Young //
Kimberly.Young@stjoe.org // (707) 521-3814
Resources and Links:
clinicaltrials.gov NCT No: NCT03495882
Endometrial
A Phase 2, Single Arm, Two Period Study of Sodium Cridanimod in Conjunction
with Progestin Therapy in Patients with Endometrial Carcinoma (VX-EC-2-02)
Phase II
The study will investigate the efficacy of Sodium Cridanimod in conjunction
with progestin therapy in a population of subjects with recurrent or persistent
endometrial cancer, who have failed progestin monotherapy or who have
been identified as PrR negative. All patients must have endometrial cancer
PrR status determined from an archival sample at Screening. The PrR status
(positive or negative) will be determined by central laboratory by IHC testing.
Treatment agent: Sodium Cridanimod (PR modulator)
PI:
Sara Keck, MD
Study Coordinator: Camille Shaffer //
Camille.Shaffer@stjoe.org // (707) 521-3809
Resources and Links:
clinicaltrials.gov NCT No: NCT03077698
Urothelial
A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab
versus Standard of Care Chemotherapy in Participants with Previously Untreated
Unresectable or Metastatic Urothelial Cancer (CheckMate 901)
Phase III
The purpose of this study is to determine whether an investigational immunotherapy
nivolumab in combination with ipilimumab or in combination with standard
of care chemotherapy is more effective than standard of care chemotherapy
alone in treating patients with previously untreated inoperable or metastatic
urothelial cancer.
Treatment agent: Nivolumab + ipilimumab/SOC
PI:
Thomas Stanton, MD
Study Coordinator: Sabine Ucik //
Sabine.Ucik@stjoe.org // (707) 521-3830
Resources and Links:
clinicaltrials.gov NCT No: NCT03036098
An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab
Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies (STRONG)
Phase IIIb
This is an open-label study to determine the short and long-term safety
of fixed dose of durvalumab + tremelimumab combination therapy or durvalumab
in adult patients with urothelial and nonurothelial carcinoma of the urinary
tract that has progressed during or after previous platinum-based chemotherapy,
either for metastatic disease or progressive disease less than 12 months
after adjuvant or neo-adjuvant chemotherapy.
Treatment agent: Durvalumab
PI:
Ian Anderson, MD
Study Coordinator: Tracy Foster //
Tracy.Foster@stjoe.org // (707) 521-3836
Resources and Links:
clinicaltrials.gov NCT No: NCT03084471
Prostate
A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients with Metastatic
Castration-resistant Prostate Cancer Associated with Homologous Recombination
Deficiency (TRITON2)
Phase II
The purpose of this study is to evaluate the effectiveness of rucaparib
for the treatment of patients with metastatic castration-resistant prostate
cancer (mCRPC) whose tumors are associated with HRD. This study will enroll
mCRPC patients with mutations in BRCA1/2, ATM, or other HR genes. All
patients will be required to have progressed on prior AR-targeted therapy
after receiving treatment with at least 1, but no more than 2, of these
agents. Patients must also have progressed after one prior taxane-based
chemotherapy for mCRPC. Patients who received prior PARPi treatment, mitoxantrone,
cyclophosphamide or platinum-based chemotherapy will be excluded.
Treatment agent: Rucaparib (PARPi)
PI:
Thomas Stanton, MD
Study Coordinator: Teresa Lund //
Teresa.Lund@stjoe.org // (707) 521-3803
Resources and Links:
clinicaltrials.gov NCT No: NCT02952534
A Multicenter, Randomized, Open-label Phase 3 Study of Rucaparib versus
Physician’s Choice of Therapy for Patients with Metastatic Castration-resistant
Prostate Cancer Associated with Homologous Recombination Deficiency (TRITON3)
Phase III
The purpose of this study is to evaluate the effectiveness of rucaparib
versus physician’s choice of second-line AR-directed therapy or
docetaxel as treatment for metastatic castration-resistant prostate cancer
(mCRPC) patients who have progressed on one prior AR-directed therapy
and have not yet received chemotherapy in the castration-resistant setting.
Patients who received prior PARPi treatment will be excluded. This study
will enroll mCRPC patients with deleterious mutations in BRCA1/2 or ATM genes.
Treatment agent: Rucaparib (PARPi)
PI:
Thomas Stanton, MD
Study Coordinator: Teresa Lund //
Teresa.Lund@stjoe.org // (707) 521-3803
Resources and Links:
clinicaltrials.gov NCT No: NCT02975934
Renal Cell
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing
CB-839 in Combination with Cabozantinib (CB-Cabo) vs. Placebo with Cabozantinib
(Pbo-Cabo) in Patients with Advanced or Metastatic Renal Cell Carcinoma
(JIT Calithera)
Phase II
This study is an evaluation of CB-839 in combination with cabozantinib
versus placebo with cabozantinib in Renal Cell Carcinoma patients with
at least one and not more than 2 prior therapies in the advanced or metastatic setting.
Treatment agent: CB-839 (glutaminase inhibitor) +/- Cabozantinib
PI:
Thomas Stanton, MD
Study Coordinator: Teresa Lund //
Teresa.Lund@stjoe.org // (707) 521-3803
Resources and Links:
clinicaltrials.gov NCT No: NCT03428217