Trials / Withdrawn

WithdrawnNCT07137390

A Trial of Regorafenib Plus Lorigerlimab as Neoadjuvant Therapy for Patients With pMMR/MSS, Resectable, Lung-limited Metastatic Colorectal Cancer

Phase Ib/II Trial of Regorafenib Plus Lorigerlimab as Neoadjuvant Therapy for Patients With pMMR/MSS, Resectable, Lung-limited Metastatic Colorectal Cancer

Status: Withdrawn
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives: * To evaluate safety and tolerability (NCI-CTCAE v5.0) of neoadjuvant regorafenib plus lorigerlimab in patients with pMMR/MSS, resectable, lung-limited mCRC. * To assess the major pathological response (MPR) rate following neoadjuvant regorafenib plus lorigerlimab and surgical resection in patients with pMMR/MSS, resectable, lunglimited mCRC. MPR is defined as residual (viable) invasive cancer cells of 0 - 49% within the resected specimen at the time of surgical resection. Secondary Objectives: * To estimate objective response rate (RECIST 1.1) and immune-related objective response rate (irRECIST) following neoadjuvant regorafenib plus lorigerlimab in patients with pMMR/MSS, resectable, lung-limited mCRC. * To describe the complete resection rate (as defined in Section 9.4) following neoadjuvant regorafenib plus lorigerlimab and surgical resection in patients with pMMR/MSS, resectable, lung-limited mCRC. Note: if a staged resection is performed, the overall outcome will be assessed after completion of all surgical stages. * To summarize pathological response (% tumor viability) at the time of surgical resection following neoadjuvant regorafenib plus lorigerlimab in patients with pMMR/MSS, resectable, lung-limited mCRC.

Conditions

Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Regorafenib	Given Orally
DRUG	Lorigerlimab	Given Orally

Timeline

Start date: 2025-09-03
Primary completion: 2026-01-22
Completion: 2026-01-22
First posted: 2025-08-22
Last updated: 2026-03-11

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07137390. Inclusion in this directory is not an endorsement.