Who is sponsoring NCT05582031?

NCT05582031 is sponsored by Translational Research in Oncology.

What drugs are being tested in NCT05582031?

Interventions in NCT05582031: Regorafenib in combination with Tislelizumab.

What condition does NCT05582031 study?

NCT05582031 studies 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.

Is NCT05582031 still recruiting?

NCT05582031 is currently withdrawn. Last updated 7 June 2023.

Last reviewed 2023-06-07 · How we verify

NCT05582031: REFIT-MSS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Withdrawn Phase 2 Last updated 7 June 2023

What this trial tests

Phase 2 trial testing Regorafenib in combination with Tislelizumab in Anal Squamous Cell Carcinoma. Withdrawn.

Timeline

30 April 2023

Primary endpoint
30 April 2025

30 April 2025

Quick facts

Lead sponsor	Translational Research in Oncology
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	30 April 2023
Primary completion	30 April 2025
Estimated completion	30 April 2025

Drugs / interventions tested

Regorafenib in combination with Tislelizumab

Conditions studied

Anal Squamous Cell Carcinoma — all drugs for Anal Squamous Cell Carcinoma →
Colorectal Neoplasms — all drugs for Colorectal Neoplasms →
Soft Tissue Sarcoma — all drugs for Soft Tissue Sarcoma →
Malignant Pleural Mesothelioma — all drugs for Malignant Pleural Mesothelioma →

Sponsor

Translational Research in Oncology — full company profile →

Who can join

18 and older, any sex, with Anal Squamous Cell Carcinoma or Colorectal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Lineage plasticity and treatment resistance in prostate cancer: the intersection of genetics, epigenetics, and evolution.
Imamura J, Ganguly S, Muskara A, Liao RS, et al · · 2023 · cited 34× · PMID 37455903 · DOI 10.3389/fendo.2023.1191311
The Current Therapeutic Landscape for Metastatic Prostate Cancer.
Bernal A, Bechler AJ, Mohan K, Rizzino A, et al · · 2024 · cited 18× · PMID 38543137 · DOI 10.3390/ph17030351
New Insights into Potential Therapeutic Targets for Neuroendocrine Prostate Cancer: From Bench to Clinic.
Cai M, Zheng F, Ren YZ, Zhen C, et al · · 2025 · cited 2× · PMID 40746825 · DOI 10.34133/research.0791
A Complete Response to Combined Immunotherapy in a Patient with an ATM plus SF3B1 Mutation and a Moderate Tumor Mutational Burden with a High-Grade Treatment-Emergent Neuroendocrine Prostate Cancer: Case Report and Review of the Literature.
Ferreira Bruzzi Porto H, C K Lopes G, B V Bekierman H, Altino De Almeida S, et al · · 2024 · PMID 39474562 · DOI 10.1159/000540573

Verify or expand the search:

Other recruiting trials for Anal Squamous Cell Carcinoma

Currently open trials in the same condition.

NCT07217171 — A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial · Phase 1 · recruiting
NCT06050707 — MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach · Phase 2 · recruiting
NCT05328765 — A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection · recruiting
NCT05838391 — Adaptive Radiation in Anal Cancer · NA · recruiting
NCT04929028 — Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer · Phase 2 · active not recruiting

Other Translational Research in Oncology trials

Trials by the same sponsor.

NCT04777851 — Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7 · Phase 3 · terminated
NCT04261218 — Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of Tomivosertib Combined With Paclitaxel in Advanced Breast Can · Phase 1 · completed
NCT03004534 — A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide · EARLY_PHASE1 · completed
NCT02900560 — Study of Pembrolizumab With or Without CC-486 in Patients With Platinum-resistant Ovarian Cancer · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05582031 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Translational Research in Oncology
Last refreshed: 7 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05582031.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing