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

NCT05582031 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-06-07

No results posted yet for this study

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.

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

COMBINATION_PRODUCT

Regorafenib in combination with Tislelizumab

Regorafenib 30 mg/tablet + Tislelizumab 100 mg/10 ml vial

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • Translational Research in Oncology

    lead OTHER

Principal Investigators

  • Josep Tabernero · Medical Oncology Department, Vall d'Hebron Institute of Oncology, CIBERONC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05582031 on ClinicalTrials.gov