NCT05582031

Regorafenib With Tislelizumab in Patients With Selected Mismatch Repair-Proficient/Microsatellite Stable Cancers

An Open-label, Phase II, Multi-cohort, 2-stage Trial to Evaluate the Efficacy and Safety of Regorafenib in Combination With Tislelizumab in Patients With Selected Mismatch Repair-Proficient/Microsatellite Stable Pretreated Solid Cancers

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Translational Research in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

REFIT-MSS is a non-randomized, multicenter, open-label, multi-cohort, 2-stage, phase II trial to evaluate the efficacy and safety of regorafenib in combination with tislelizumab (referred as Rego-Tisle) in adult patients with select advance, previously treated, Mismatch Repair-Proficient/Microsatellite (pMMR/MSS) stable solid cancers. The multi-cohort design will allow for the examination of 8 separate cohorts of different cancers to determine whether further examination may be warranted in the individual indications.

Detailed description

This is a non-randomized, multicenter, open-label, multi-cohort, phase II trial to evaluate the efficacy and safety of Rego-Tisle in adult patients with solid tumors that are advanced, pretreated and refractory to standard therapy. Approximately 322 evaluable patients (between 15 and 82 per cohort) in around 65 sites will be enrolled to power the trial efficiently to measure the primary endpoint, Progression Free Survival at 6 months (PFS-6). Patients should have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors guidelines version 1.1 (RECIST 1.1), an Eastern Cooperative Oncology Group Performance Scale (ECOG PS) 0-1, and adequate organ function. The trial will include patients who had been diagnosed with a histologically or cytologically confirmed solid tumor belonging to any of the types in the cohorts to be enrolled. To be eligible, patient must meet the criteria for tumor type, stage and prior anti-cancer therapy according to inclusion criteria.

Conditions

• Anal Squamous Cell Carcinoma
• Colorectal Neoplasms
• Soft Tissue Sarcoma
• Malignant Pleural Mesothelioma
• Small Cell Lung Carcinoma
• Castrate Resistant Prostate Cancer
• Neuroendocrine Carcinoma of Prostate
• Gastroenteropancreatic Neuroendocrine Neoplasm

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Regorafenib in combination with Tislelizumab	Regorafenib 30 mg/tablet + Tislelizumab 100 mg/10 ml vial

Timeline

• Start date: 2023-04-30
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2022-10-17
• Last updated: 2023-06-07

Regulatory

• FDA-regulated drug study