Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Rare Diseases

Lung Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Prostatic Neoplasms

Colorectal Neoplasms

Neuroendocrine Tumors

Small Cell Lung Carcinoma

Carcinoma, Neuroendocrine

Sarcoma

Mesothelioma

Mesothelioma, Malignant

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplasms, Connective and Soft Tissue

Adenoma

Neoplasms, Mesothelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neuroendocrine Tumor

Small Cell Lung Cancer

Soft Tissue Sarcoma

Malignant Mesothelioma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Tislelizumab

Antineoplastic Agents, Immunological

The trial will include 8 cohorts of patients, with each cohort considered as a single-arm; all patients enrolled will be treated with regorafenib at a dose of 90 mg orally once daily, on days 1 to 21 of a 28 cycle in combination with tislelizumab 300 mg intravenously day 1 (of a 28 day cycle).

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

Regorafenib in combination with Tislelizumab

Josep Tabernero

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.

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.

The trial will include 8 cohorts of patients. Each cohort is considered as a single-arm activity-estimating sub-study with PFS-6 as the primary endpoint. A strong primary endpoint signal seen in a cohort may allow for expansion of the cohort, independently of the status of the other cohorts. Similarly, a cohort may be opened and/or closed for enrollment independently of others.

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

PFS-6 is defined as the proportion of patients who remained free of PFS event (disease progression or death) at 6 months from the date of enrollment.

Defined as the proportion of patients who have a complete response (CR) or partial response (PR) based on investigator assessment.

Defined as the proportion of patients who have CR, PR, or stable disease (SD) according to RECIST 1.1, as per investigator assessment.

Defined as the time (in months) from first documentation of response (PR or CR) to progressive disease (PD) or death, based on investigator assessment or death, in patients who had best overall response of CR or PR.

Defined as as the ratio of time to progression (TTP) with the nth line (TTP(n)) of therapy to the TTP(n)(-1) with the n-1th line.

Defined as time from date of enrollment to date of death due to any cause. Median OS, OS at 6 months (OS-6) and OS at 12 months (OS-12) will be evaluated.

In metastatic castration-resistant prostate cancer (mCRPC) cohort only; defined as the time from the date of enrollment to the date of PSA progression based on Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria

Frequency and severity of AEs and laboratory abnormalities

Bayer

Novartis

Translational Research in Oncology

Spots Global Cancer Trial Database for neuroendocrine carcinoma of prostate