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Phase I Clinical Trial for Patients with Muscle Invasive Bladder Cancer

By David M. Waterhouse, MD, MPH, medical oncologist and co-director of research, OHC, For Physicians, 0 comments
July 22, 2016

Clinical Trials, Oncology Hematology Care, OHC, Cancer Treatment, Cincinnati Cancer Treatment, cancer, cancer help, cancer care

By David M. Waterhouse, M.D., M.P.H.
OHC Chair & Principal Investigator OHC Clinical Research

OHC’s Research Department’s complex clinical trial menu provides an opportunity for patients in and around the Tri-State to participate in innovative studies which include targeted and immunotherapies.

In order to obtain FDA approval, all drugs (and combinations of drugs) must be rigorously tested in the clinical trial setting. Such new drug development occurs in “Phases.” For example, a Phase I clinical trial is the initial step towards investigating the safety and efficacy of a new treatment or combination of treatments. Currently, OHC is enrolling patients to nine Phase I Clinical Trials.

OHC’s GU 118 study is a Phase 1 study for patients with Muscle Invasive Bladder Cancer who have progressed on prior treatment. Patients may be second- or third-line but prior immunotherapy is not allowed. Tumor tissue is required baseline. There are four treatment groups:

  1. AZD4547 (FGFR inhibitor) alone or in combination with durvalumab (PD-L1 inhibitor) in patients with FGFR mutations or fusions.
  2. Durvalumab in combination with olaparib (Parp inhibitor) in patients with mutations in a homologous recombination repair gene panel.
  3. Durvalumab in combination with AZD1775 (WEE1 inhibitor) in patients with mutations in genes involved in cell cycle regulation.
  4. Durvalumab monotherapy for patients that do not qualify for groups A-C.

This exciting clinical trial follows in the footsteps of the first immunotherapy approved for the treatment of metastatic bladder cancer. Atezolizumab, recently FDA approved, is a member of a class of drugs that is commonly referred to as “Immune Checkpoint Inhibitors.” Immune therapy is different than chemotherapy in its mechanism of action and side-effect profile. Atezolizumab is a monoclonal antibody designed to bind with a protein called PD-L1 which is over expressed on tumor cells. By inhibiting PD-L1, the patient’s own T cells can then be recruited to fight against their cancer. Atezolizumab received approval for patients with urothelial cancer refractory to platinum-based therapy.

OHC is proud to have played a role in the development of this important advance.

OHC’s research menu has continued to evolve in order to accommodate the many disease types that are seen daily in our clinics. By participating in these trials, we are offering our patients a chance to try the newest, most promising investigational products for their disease.

To obtain further OHC Clinical Research Trial information, please contact:

Lynnetta Hart, BS, M.Ed, CCRC
OHC Research Program Director



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