Clinical Trials Logo
  1. Home
  2. Anal Squamous Cell Carcinoma
  3. NCT05582031

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

Colorectal Neoplasms Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05582031
Study type Interventional
Source Translational Research in Oncology
Contact
Status Withdrawn
Phase Phase 2
Start date April 30, 2023
Completion date April 30, 2025
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04552093 - Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT) Phase 2/Phase 3
Completed NCT04192565 - A Prospective Investigation of the ColubrisMX ELS System N/A
Completed NCT05178745 - A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
Recruiting NCT03561350 - Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
Recruiting NCT06128798 - Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery. N/A
Recruiting NCT03602677 - Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage N/A
Completed NCT03631407 - Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC) (MK-7690-046) Phase 2
Withdrawn NCT04192929 - Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy N/A
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT02889679 - Underwater Resection of Non-pedunculated Colorectal Lesions N/A
Terminated NCT02842580 - De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer Phase 2
Completed NCT02564835 - Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer N/A
Completed NCT02503696 - Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD) N/A
Completed NCT02149108 - Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1) Phase 3
Completed NCT02599103 - The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects N/A
Completed NCT01719926 - Phase I Platinum Based Chemotherapy Plus Indomethacin Phase 1
Completed NCT01669109 - Hatha Yoga for Patients With Colorectal Cancer N/A
Recruiting NCT01428752 - Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer N/A
Completed NCT01978717 - General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer N/A
Completed NCT01877018 - Colorectal Cancer Screening in Primary Care N/A