A number of late-phase studies in colorectal cancer have opened in recent months. Could one of your patients benefit from being enrolled?
Metastatic colorectal cancer. Patients with colorectal cancer whose condition has progressed with or has demonstrated intolerance to first-line therapy for metastatic disease are sought for a trial of the use of a circulating-tumor DNA test called Signatera for guiding management in comparison with conventional imaging. As the disease progresses, all patients will receive the same prespecified sequence of US Food and Drug Administration–approved medications for up to 1 year. The study opened October 1 at the University of Florida, in Gainesville, Florida, and aims to enroll 78 participants. The primary endpoint is overall survival (OS). Quality of life (QoL) is not being tracked. More details are available at clinicaltrials.gov.
This study is “not a breakthrough,” comments Medscape Medical News contributor John Marshall, MD, professor and chief of the Division of Hematology/Oncology at Georgetown University, Washington, DC. However, the results could be helpful, he said.
Colorectal cancer, liver metastases, and oligometastatic disease. Adult patients with colorectal cancer and suspected liver metastases are being recruited for a trial comparing the performance of the MRI contrast agent gadobenate dimeglumine (MultiHance) with the current standard, gadoxetate disodium (Eovist). Over 1 month, patients will undergo two MRI scans, one with each agent. The trial began recruiting on June 22 at the University of Colorado Hospital, in Aurora, Colorado. Neither OS nor overall QoL will be assessed. The amount of time patients spend undergoing each procedure will be measured. More details are available at clinicaltrials.gov.
This is an “interesting and potentially impactful” study, says Marshall.
Stage IV colorectal cancer. Patients with high-frequency microsatellite-instability (MSI-H) or mismatch-repair-deficient (dMMR) stage IV colorectal cancer can join a study testing pembrolizumab (Keytruda) or a new combination of pembrolizumab and quavonlimab (MK-1308A). Patients will be treated for “up to approximately 2 years,” according to study sponsors. The study aims to recruit 240 people globally. US sites are in Florida and Georgia. The primary endpoint is objective response. OS is a secondary endpoint. QoL is not being assessed. More details are available at clinicaltrials.gov.
“This trial is trying to improve [treatment] in the MSI-H space where drugs are already approved,” Marshall commented.
In recent years, tumors with MSI-H or dMMR have been shown to respond particularly well to immunotherapy.
Pembrolizumab was approved for first-line use for patients with unresectable or metastatic colorectal cancer with such tumors (found in 4% to 5% of patients with advanced disease).
Immunotherapy with nivolumab (Opdivo), with or without ipilimumab (Yervoy), is also approved for use in patients with metastatic colorectal cancer with MSI-H or dMMR tumors.
MSS metastatic colorectal cancer. A new trial is exploring the use of nivolumab for patients who do not have MSI-H or dMMR disease but instead have microsatellite-stable (MSS) tumors.
Patients with MSS colorectal cancer that is refractory to standard treatment are being recruited for a study of the use of cabozantinib (Cabometyx) in combination with nivolumab. Patients will receive therapy for up to 2 years. The study opened on June 23 at five sites in Colorado. Disease control rate is the primary outcome measure. OS is a secondary measure. QoL will not be tracked. More details are available at clinicaltrials.gov.
Microsatellite-stable metastatic colorectal cancer. The STIMVAX study has started recruiting patients with metastatic colorectal cancer and microsatellite-stable tumors whose condition has progressed after two lines of chemotherapy (one containing oxaliplatin the other containing irinotecan). It will be testing a new “off the shelf” living immune cell product, AlloStim, made from the blood of healthy donors. The product is designed to modify and train the host immune system to kill tumors and prevent tumor growth and spread. This study will examine whether it will improve OS. Patients will be treated for up to 16 weeks. QoL will not be measured. The trial is running in New York and Texas. More details are available at clinicaltrials.gov.
Metastatic colorectal cancer with RAS. Patients with previously treated advanced or metastatic colorectal cancer and RAS mutations are being recruited for a trial of selinexor (Xpovio) with or without pembrolizumab. Participants will be treated for up to 3 years until study withdrawal, disease progression, or death, whichever occurs first. Progression-free survival is the primary endpoint. OS over 3 years is a secondary outcome. QoL will not be measured. Study sites are in Florida and California. More details are available at clinicaltrials.gov.
Marshall expressed doubts that any of these three trials in patients with metastatic disease will show efficacy. However, if one of the studies did show positive results, “it would be huge,” he commented.
All trial information is from the US National Library of Medicine (online at clinicaltrials.gov). Marshall has a regular Medscape column, Marshall on Oncology. He has served as speaker or as a member of a speakers’ bureau for Genentech, Amgen, Bayer, Celgene Corp, and Caris Life Sciences.
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