In the past 30 years, treatments for Stage 4 bladder cancer saw few advancements. This changed in early 2016, when the U.S. Food & Drug Administration (FDA) approved atezolizumab (Tecentriq), an anti-PD-L1 antibody. Since that time, the FDA has approved four more checkpoint inhibitors: pembrolizumab (Keytruda), nivolumab (Opdivo), avelumab (Bavencio) and durvalumab (Imfinzi), all of which are available at Montefiore.
Among the many ongoing Montefiore clinical trials is one evaluating atezolizumab in patients with recurrent, non-muscle-invasive bladder cancer in an effort to avoid the requirement for surgery to remove the bladder (WO29635).
Embrolizumab and nivolumab are among the FDA-approved immunotherapies available for a small group of colon cancer patients whose disease has progressed after chemotherapy treatment. This is due to an absence of certain proteins known as mismatch repair proteins—the patient's tumor is known as microsatellite instability or MSI-H.
Through a collaboration with our Pathology Department, the Cancer Center offers routine screening for MSI-H status. In addition, patients are also offered a trial studying pembrolizumab as a front-line therapy.
A vast range of clinical trials—including novel immunotherapy approaches for patients whose colon cancer is unresponsive to standard therapies—are also available through our Phase 1 program for early drug development.
These include targeting immune checkpoints beyond PD-1 and CTLA-4, and a study for a drug that targets the CD40 protein to stimulate and create an immune response to cancer.
Our team also has substantial experience with a cancer-destroying (oncolytic) reovirus and are currently working to better understand the anti-cancer activity and immune-stimulating effects of the reovirus.
Cellular immunotherapy has revolutionized the treatment of hematologic malignancies, the forms of cancer that begin in the cells of blood-forming tissue, such as the bone marrow, or in the cells of the immune system.
Montefiore Einstein Center for Cancer Care patients have access to early-stage studies of promising new immunotherapies, like chimeric antigen-receptor T-cell immunotherapy (CAR-Ts). This emerging immunotherapy removes blood cancer patients’ T-cells and engineers them to target the cancer before they are reinfused into the patient.
Our Cancer Center is one of only two centers in the New York metropolitan area to have FDA-approved CAR-T cells available to patients with refractory lymphoma. We’ve also been at the forefront of clinical trials demonstrating CAR-T cells’ effectiveness to treat lymphomas that have failed all other therapies.
We also developed a cellular immunotherapy program for solid tumors. Montefiore is one of only three medical centers in the New York metropolitan area accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) for the full spectrum of adult and pediatric stem cell transplant procedures.
Immunotherapy has been used to treat kidney cancer (or renal cell carcinoma) for several decades. Immunotherapy with high-dose interleukin-2 (IL-2) is offered to appropriate Montefiore Einstein Center for Cancer Care patients with stage 4 kidney cancer. The anti-PD-1 antibody nivolumab (Opdivo) is FDA-approved for stage 4 kidney cancer and is also available.
We are also participating in a number of clinical trials evaluating checkpoint inhibitors in kidney cancer, including those for patients who have undergone surgery to remove kidney cancer in which checkpoint inhibitors are being used in hopes of reducing the chance of cancer recurrence (KEYNOTE-564 and PROSPER). Montefiore is also participating in a clinical trial evaluating the combination of two immunotherapy drugs in patients with stage 4 kidney cancer (CHECKMATE 920).
Immunotherapy has taken center stage in the management of patients with advanced lung cancer and all FDA-approved medications, such as pembrolizumab (Keytruda), nivolumab (Opdivo) and atezolizumab (Tecentriq), are routinely used.
Montefiore Einstein Center for Cancer Care has also been one of the first centers in the tristate area to implement routine immune biomarker testing, such as PD-L1 testing that can help identify patients who can receive immunotherapy instead of chemotherapy in the first place.
Our thoracic clinical research group offers a range of exciting clinical studies looking at novel combinations of immunotherapies and the use of these agents for earlier stage patients.
Montefiore Einstein Center for Cancer Care is one of only a few centers in the region to offer high-dose interleukin-2 (IL-2) therapy as well as other immunotherapies for patients with metastatic melanoma, including checkpoint inhibitors ipilimumab (Yervoy), pembrolizumab (Keytruda) and nivolumab (Opdivo) and targeted therapies such as zelboraf (Vemurafenib), tafinlar (Dabrafenib) and mekinist (Trametinib). Our patients may also participate in early-stage studies, including the use of new biologic drugs to determine the effectiveness of new therapies.
Montefiore Einstein Center for Cancer Care has an open clinical trial of the checkpoint inhibitor PDR001 for most types of neuroendocrine tumors. This is an open-label phase II study to evaluate the efficacy and safety of PDR001 in patients with advanced or metastatic disease, including well-differentiated, non-functional neuroendocrine tumors of pancreatic, gastrointestinal or thoracic origin or poorly differentiated gastroenteropancreatic neuroendocrine carcinoma, that have progressed on prior treatment.
Immunotherapy with the prostate cancer vaccine sipuleucel-T (Provenge) has been offered to patients at Montefiore since it was approved for use by the FDA in 2010.
Checkpoint inhibitors are as of yet not FDA-approved for use in prostate cancer. However, Montefiore is participating in clinical trials of checkpoint inhibitors in prostate cancer, including KEYNOTE-199, in which pembrolizumab (Keytruda), an antibody targeting the PD-1 checkpoint molecule, is being evaluated in stage 4, castration-resistant prostate cancer.