Immunotherapy and Chemotherapy Trial Arm for Sarcoma Commences

Glen Weiss, MD, MBA

Glen Weiss, MD, MBA

A sarcoma study arm of the phase II portion of the multiarm PembroPlus clinical trial that combines immunotherapy with chemotherapy has commenced at Cancer Treatment Centers of America (CTCA), Western Regional Medical Center, Goodyear, Arizona. The clinical trial is the first of its kind to use pembrolizumab, a programmed cell death-1 (PD-1) inhibitor, combined with chemotherapy in patients who have advanced small cell lung cancer, pancreatic cancer, and sarcomas.^1,2

The purpose of this arm was to target sarcomas, and the multifaceted study was named in accordance with the usage of chemotherapy plus pembrolizumab. Other chemotherapies used in combination with pembrolizumab in PembroPlus include gemcitabine, docetaxel, nab-paclitaxel, vinorelbine, and irinotecan.¹

“There is growing evidence that the use of immunotherapies, like those in our PembroPlus clinical trials, could enhance the ability to fight cancers," said Glen Weiss, MD, MBA, director of clinical research and a medical oncologist at CTCA at Western, in a press release.²“We will be testing this new arm for sarcoma patients to determine its effectiveness and safety.”

By using pembrolizumab, CTCA Western investigators hope to activate the body’s immune system, in order to combat sarcomas and test whether or not results can be improved with the combination treatment, as opposed to using chemotherapy alone.

The study authors plan to enroll around 140 patients who meet the clinical trial criteria.²Patients must be at least 18 years old, with definitive histologically or cytologically confirmed metastatic solid tumor, as well as one or more metastatic tumors measurable by CT scan—or PET/CT, if the patient is allergic to CT contrast media. Additionally, investigators will assign patients to the appropriate treatment arm with the following requirements: patients must not have had prior progression or intolerance on the single agent chemotherapy and then enrolled on an arm that has the same single agent chemotherapy plus pembro, and chemotherapy on the arm selected must be considered standard of care or listed within the NCCN guidelines (www.nccn.org) for that cancer type. Lastly, the patient enrolled must have recovered from acute toxicities of previous treatment.³

Patients who have metastatic sarcoma will be enrolled in the non-randomized and open label clinical trial within the following four arms: pembro plus gemcitabine, pembro plus gemcitabine and docetaxel, pembro plus gemcitabine and vinorelbine, and pembro plus liposomal doxorubicin. Those with metastatic pancreatic adenocarcinoma will be enrolled in the pembro plus gemcitabine and nab-paclitaxel arm. Patients who have extensive-stage small cell lung cancer will be enrolled in the pembro plus irinotecan arm.³

Outcome measures include frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03, response rate by irRC and response evaluation criteria in solid tumors (RECIST), characterization of changes in circulating tumor DNA in enrolled patients, and textural changes identified on imaging that is completed per routine practice.³Study authors plan to determine the overall survival (OS) and progression-free survival (PFS) as well.³

Vivek Khemka, MD

Vivek Khemka, MD

On April 23, a patient with triple-negative breast cancer was the first to receive treatment in the clinical trial.¹

“Each year, nearly 14,000 Americans are newly diagnosed with some form of sarcoma, which are often difficult to treat, especially in advanced stages," said Vivek Khemka, MD, medical oncologist, CTCA Western and PembroPlus Principal Investigator, in a press release.²“We believe that, even though these types of cancer pose a significant challenge, researchers are developing powerful new tools that eventually may give cancer patients additional answers and renewed hope.”

References:

1. Cancer Treatment Centers of America. Cancer Treatment Centers of America at Western Regional Medical Center launches phase II of innovative ‘PembroPlus’ clinical trial.http://www.cancercenter.com/press-center/press-releases/ctca/2015/04/Cancer-Treatment-Centers-of-America-at-Western-Regional-Medical-Center-Launches-Phase-II-of-Innovative-PembroPlus-Clinical-Trial/. Accessed on September 23, 2015.

2. Cancer Treatment Centers of America. Cancer Treatment Centers of America at Western Regional Medical Center launches next phase of immunotherapy clinical trial aimed at soft-tissue cancers.http://www.cancercenter.com/press-center/press-releases/ctca/2015/09/Western-Regional-Medical-Center-Launches-next-phase-of-immunoterapy-clinical-trial-aimed-at-soft-tissue-cancers/. Accessed on September 23, 2015.

3. ClinicalTrials.gov. ClinicalTrials.gov Identifier: NCT02331251.