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

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