Finding More Ways for Bladder Cancer Patients to Keep Their Bladders Through Clinical Trials

ADAPT—Immunotherapy for Non-Muscle Invasive Bladder Cancer (NMIBC)

Each year, about 80,470 adults in the US are diagnosed with bladder cancer, and about 17,670 die. New interventions such as immunotherapy are continuously being investigated, but a large proportion of patients with NMIBC have been left out. “Intravesical immunotherapy is a good option for patients with NMIBC, but for patients with recurrent disease or very high risk NMIBC, bladder removal is still the standard of care for patients with a high risk of recurrence,” said Daniel M. Geynisman, MD, Department of Hematology/Oncology.

“Many patients with NMIBC are at high risk of recurrence, and don’t respond to available medications. Everyone would like to avoid bladder removal. The goal of the ADAPT trial is to see if we can eliminate or control NMIBC without surgery,” Geynisman said.

ADAPT is a Phase I/II study for adults with BCG-unresponsive intermediate or high-risk NMIBC. All patients will receive immunotherapy with durvalumab, and some will receive radiation or BCG, depending on the trial phase and study group. “The point is to try and stimulate the immune system to destroy the tumors. If it is effective, it will be an exciting new option to reduce the number of patients who need bladder removal. It would also help avoid continuing to place potentially ineffective medications in the bladder, as well as progression to muscle-invasive bladder cancer,” Geynisman said.

Physicians can reach out to see if ADAPT may be right for their patients with NMIBC that is unresponsive to intravesical therapy with BCG, which is a live attenuated Mycobacterium bovis. It is the only agent approved in the US for primary therapy of cancer confined to the bladder.

RETAIN—Bladder-sparing Therapy for Muscle Invasive Bladder Cancer (MIBC)

Fox Chase is enrolling patients who have MIBC for the RETAIN trial. “The disease is more advanced, and treatment is more urgent. Aggressive treatment has been the norm. It is standard care to give chemotherapy followed by surgery to remove the bladder,” Geynisman said. The goal of RETAIN is to find out if some patients can be spared from bladder removal by using chemotherapy alone.

“In RETAIN, we take tumor tissue for molecular testing to see which patients are likely to respond well to chemotherapy alone. We believe some patients have tumors with specific mutations that make them more responsive to chemotherapy, and that chemotherapy alone may destroy these tumors,” Geynisman said. Patients with one of the key mutations who are candidates for chemotherapy and respond well can continue with surveillance alone, without further therapy.

Clinical trials like RETAIN are a valuable option for patients with MIBC.

Is ADAPT or RETAIN right for your patients?

• ADAPT is for patients with NMIBC.
• RETAIN is for patients who have MIBC.
• It is not obvious whether a clinical trial will be right for a specific patient.
  • Physicians are encouraged to reach out to ask about these clinical trials and about treatment options other than standard of care.

“At Fox Chase we are more than happy to answer questions. It’s not necessary for patients to be treated at Fox Chase—we want to partner with physicians to find the best care for their patients,” Geynisman said.

To find out more about enrolling in these trials contact the clinical trials office or call 215-214-1515.