(Goodyear, Arizona - June 26, 2015) - Cancer Treatment Centers of America® (CTCA) at Western Regional Medical Center (Western) in Goodyear, Arizona, has begun a new Phase Ib/II clinical trial using a new immunotherapy treatment for patients with advanced kidney, non-small cell lung cancer, pancreatic cancer and colorectal carcinoma.
This "NivoPlus" clinical trial combines an immunotherapy drug (nivolumab) with already FDA-approved chemotherapy drugs (temsirolimus, irinotecan, and a combination of irinotecan and capecitabine).
The addition of nivolumab is intended to activate the body's own immune system to improve on the results that otherwise might not be achieved from chemotherapy alone. This combination of chemotherapy and immunotherapy drugs is investigational in this study and is the third such combination clinical trial launched in the past year by CTCA® at Western.
There are anticipated to be up to 49 patients enrolled on the multi-arm NivoPlus study. The first patient received treatment on this study earlier this month.
"Some of these drug combinations are not available elsewhere, giving CTCA patients additional treatment options," said Dr. Glen Weiss, Director of Clinical Research and Medical Oncologist, CTCA at Western. "Our ultimate goal is to evaluate if these combinations yield improved results for our patients."
Nivolumab works by inhibiting a protein called PD-1, which otherwise blocks the body's immune system from attacking cancerous cells.
Nivolumab was approved by the Food and Drug Administration in December 2014 for the treatment of advanced melanoma and on March 4, 2015, for patients with previously treated metastatic squamous non-small cell lung cancer.
"Patients with these types of advanced-stage cancers have tumors that may be challenging to treat," said Dr. Vivek Khemka, Medical Oncologist, CTCA Western and NivoPlus Principal Investigator. "We are investigating whether combining nivolumab with these chemotherapy drugs will be a more powerful approach against their disease."
Recent data reported in the New England Journal of Medicine(1),(2) and Lancet(3) demonstrates promising results with antibody-based immunostimulatory therapy in treating melanoma, renal cell carcinoma, non-small cell lung cancer and colorectal cancer. Data has also shown synergetic effects of utilizing cytotoxic chemotherapy in combination with immunostimulatory therapy. NivoPlus will build upon this data, extending treatment options to additional cancer types.
CTCA investigators have been actively researching the impact of immunotherapy, a topic prominently highlighted this year at the annual conferences of both the American Association for Cancer Research (AACR) and the American Society of Clinical Oncologists (ASCO).
At AACR, physicians described immunotherapy as now being considered an integral part of cancer biology and cancer treatment, and recent clinical successes were described as "stunning" and "unprecedented" in their ability to improve the care of cancer patients.
At ASCO, a full press briefing was devoted to the subject of immunotherapy, which was described by doctors as "one of the most exciting advances in oncology," enabling the body's own immune system to target cancer tumors and key to helping accelerate the pace of progress "and ultimately achieve cures for cancer."
Additionally, in 2013, Science magazine named cancer immunotherapy the scientific breakthrough of the year.
CTCA physicians are committed to bringing the latest technologies and advanced treatment options to their patients as quickly as possible. At the same time, CTCA patients are supported with therapies to reduce side effects, boost energy levels and keep them strong during treatment.
For more information or to enroll in the NivoPlus clinical trial or other CTCA trials currently available, visit http://www.cancercenter.com/clinical-trials/, email WesternTrials@ctca-hope.com or call 888-841-9129.
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References:
(1). Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 2012;366(26):2443-54.
(2). Le DT, Uram JN, Wang H, et al. PD-1 Blockade in Tumors with Mismatch-Repair Deficiency. N Engl J Med. 2015 May 30. [Epub ahead of print]
(3). Robert C, Ribas A, Wolchok JD, et al. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. Lancet 2014;384(9948):1109-17.
About Cancer Treatment Centers of America®
Cancer Treatment Centers of America, Inc. (CTCA) is a national network of five hospitals that specialize in the treatment of patients fighting complex cancer. CTCA offers an integrative approach to cancer treatment that combines surgery, radiation, and chemotherapy with nutritional counseling, naturopathic medicine, mind-body therapy, and spiritual support to enhance quality of life and minimize side effects during treatment. The company serves patients from all 50 states at hospitals located in Atlanta, Chicago, Philadelphia, Phoenix and Tulsa. Known for delivering the Mother Standard® of care and Patient Empowerment Medicine®, CTCA provides patients with comprehensive information about their treatment options so they can participate in their treatment decisions. For more information about CTCA, go to http://www.cancercenter.com.