Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

pMMRMSSAdvanced solid tumorsMKIPD-1 inhibitors

Outcome Measures

Primary Outcomes (1)

Progression Free Survival at 6 months (PFS-6) as per Investigator Assessment
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.
6 Months

Secondary Outcomes (7)

Overall Response Rate
24 Months
Disease Control Rate (DCR)
24 Months

Study Arms (1)

Regorafenib 90 mg + Tislelizumab 300 mg (Rego-Tisle)

EXPERIMENTAL

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).

Combination Product: Regorafenib in combination with Tislelizumab

Interventions

Regorafenib in combination with TislelizumabCombination product

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

Regorafenib 90 mg + Tislelizumab 300 mg (Rego-Tisle)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Regorafenib in combination with Tislelizumab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed and dated PICF obtained prior to any trial-specific procedure that is not part of standard patient care.
Patient is ≥ 18 years-old at the time of PICF signature (or the legal age of consent in the jurisdiction in which the trial is taking place).

Sponsors & Collaborators

Translational Research in Oncology
Otherlead
Novartis
Industrycollaborator
Bayer

MeSH Terms

Conditions

Anus NeoplasmsColorectal NeoplasmsSarcomaMesothelioma, MalignantSmall Cell Lung Carcinoma

Interventions

regorafenibtislelizumab

Condition Hierarchy (Ancestors)

Rectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System Diseases

Study Officials

Josep Tabernero
Medical Oncology Department, Vall d'Hebron Institute of Oncology, CIBERONC
STUDY CHAIR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 17, 2022

You may not qualify if:

Prior treatment with regorafenib.
Prior treatment with a PD1, PD-L1/PD-L2, or CTLA-4 inhibitor, or any other drug or antibody targeting T-cell co-stimulation or checkpoint pathways, except in patients that meet all the following criteria:
Patient received a PD1, PD-L1/PD-L2, or CTLA-4 inhibitor, or any other drug or antibody targeting T-cell co-stimulation or checkpoint pathways in either:
Neoadjuvant and/or adjuvant setting and had no relapse within 12 months of completing immunotherapy
Advanced disease setting and had no progression during immunotherapy
Patient tolerated immunotherapy and did not need to discontinue treatment due to intolerable toxicity
Evidence of progressive or symptomatic CNS metastases. Patients with treated CNS metastases are eligible if they meet all the following criteria:
Minimal neurologic symptoms
Evidence of stable disease (for at least 2 weeks prior to enrollment) or response on a follow-up scan performed after CNS treatment completion
Require corticosteroids at a dose ≤ 10 mg daily of prednisone or equivalent
Previous treatment with live vaccine within 28 days of planned start of trial drugs (seasonal flu vaccines that do not contain a live virus are permitted).
Concurrent participation in another clinical study, unless it is: (a) an observational (noninterventional) study, or (b) the follow-up period of an interventional trial and patient did not receive an investigational agent/device within 28 days before enrollment (or within 5 half-lives of the drug).
Major surgical procedure, open biopsy, significant traumatic injury, radiation therapy and/or systemic anti-cancer therapy ≤28 days prior to enrollment. Patients must have recovered adequately from the toxicity and/or complications from these interventions before enrollment. Radiation therapy given with palliative intent is allowable if finalized ≥ 14 days prior to enrollment.
Known hypersensitivity to any of the trial drugs or its formulation components.
Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids.
+16 more criteria

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Regorafenib 90 mg + Tislelizumab 300 mg (Rego-Tisle)

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Regorafenib 90 mg + Tislelizumab 300 mg (Rego-Tisle)

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record