A Trial of Regorafenib Plus Lorigerlimab as Neoadjuvant Therapy for Patients With pMMR/MSS, Resec… (NCT07137390) | Clinical Trial Compass
WithdrawnPhase 1/2
A Trial of Regorafenib Plus Lorigerlimab as Neoadjuvant Therapy for Patients With pMMR/MSS, Resectable, Lung-limited Metastatic Colorectal Cancer
Stopped: 0 participants enrolled
0Started 2025-09-03
Plain-language summary
To apply its findings as rationale needed for a subsequent registration trial towards a novel indication for systemic treatment of resectable, lung-limited metastatic CRC.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age .18 years at the time of informed consent.
* Histologically or cytologically confirmed adenocarcinoma of colon or rectum.
* MSS or pMMR status as tested according to institutional standard practice. For example, pMMR status can be determined by intact expression by immunohistochemistry of all 4 mismatch repair proteins (MLH1, MSH2, MSH6, and PMS2) while microsatellite instability can be determined by polymerase chain reaction (PCR) or next generation sequencing (NGS). Note: methodologies (e.g., ddPCR, NGS) to determine microsatellite instability on ctDNA are acceptable for study eligibility evaluation.
* Lung-limited metastatic disease (i.e., no other secondary organ involvement outside of the lung) as determined by the treating provider or PI.
Note: lesions previously treated with loco-regional approaches (e.g., radiotherapy) with clinical or radiological evidence of progression at the time of study enrolment will be considered evaluable.
* Willing to undergo pretreatment biopsy of a lung metastasis that can be both safely and effectively biopsied at the discretion of the interventional radiology team.
* Identification of the subject as a medically appropriate candidate for surgical resection of the lung metastasis (or metastases) with or without the primary tumor according to the surgeon(s), and the ability to tolerate surgical resection with acceptable operative risk as deemed by surgeon(s) based on performance status and medical comorbiditi…
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year