CTCA initiates New Clinical Study of Immunotherapy Combined With Chemotherapy

CTCA initiates New Clinical Study of Immunotherapy Combined With Chemotherapy

Cancer Treatment Centers of America (CTCA) recently announced it will begin a Phase Ib/II clinical trial using a novel immunotherapy for the treatment of patients with advanced kidney, pancreatic, colorectal carcinoma and non-small cell lung cancer.

The “NivoPlus” study combines nivolumab (an immunotherapy drug) with the FDA-approved irinotecan, temsirolimus, and a combination of capecitabine and irinotecan (all chemotherapy drugs).

The combination of chemotherapeutic agents with nivolumab intends to stimulate the patient’s immune system to improve the results that would not be achieved using chemotherapy alone. This is the first time that this combination of immunotherapy and chemotherapy is being investigated and is the third combination study launched since last year by CTCA at the Western Regional Medical Center (Western) in Goodyear, Arizona

The company aims to enroll 49 patients on the multi-arm NivoPlus clinical trial, and has already announced the first patient already received treatment.

“Some of these drug combinations are not available elsewhere, giving CTCA patients additional treatment options,” said in a recent news release 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 inhibits the PD-1 protein, which otherwise blocks the body’s immune system from attacking tumor cells.

On March 4, 2015 the FDA approved the use of Nivolumab for the treatment of patients with  advanced melanoma and for those 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 in the news release 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 studies published in The Lancet journal and in the New England Journal of Medicine showed encouraging results concerning the use of antibody-based immunostimulatory therapy for renal cell carcinoma, melanoma, colorectal cancer and non-small cell lung cancer. Data from these studies also demonstrated a synergetic effect of using cytotoxic chemotherapy with immunostimulatory drugs.

The current NivoPlus clinical trial was built upon this data, extending treatment options to other types of cancer. CTCA researchers have been working on the impact of immunotherapy, a theme recently highlighted during the annual conferences of both the American Society of Clinical Oncologists (ASCO) and American Association for Cancer Research (AACR).

During the AACR, doctors mentioned that immunotherapy is now an integral part of cancer treatment and biology, with recent clinical achievements being described as “stunning” and “unprecedented” in their ability to improve cancer patients’ care.

During ASCO, a full press briefing was devoted to the subject of immunotherapy, which was explained by clinicians 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”.

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