Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Rare Diseases

Carcinoma

Pancreatic Neoplasms

Melanoma

Sarcoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Thymoma

Thymus Neoplasms

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Endocrine System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Thoracic Neoplasms

Lymphatic Diseases

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Regorafenib 160 mg (40 mg tablets), po, every day for 3 weeks of every 4 week cycle

Regorafenib

Armando Santoro, MD

This is a single arm, single-stage, phase II trial to evaluate the activity of Regorafenib in patients with metastatic solid tumors (pancreatic cancer, ovarian cancer, melanoma, sarcoma, thymoma (type B2 - B3) and thymic carcinoma, who have progressed after standard therapy.

Each tumour will be assessed by itself. Regorafenib 40 mg tablets will be used in the study. Subjects will receive 160 mg regorafenib po every day (qd) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off).

Subjects will continue on treatment until at least one of the following occurs (main criteria):

* Progressive Disease (PD) by radiological assessments or clinical progression
* Death
* Unacceptable toxicity
* Subject withdraws consent
* Treating physician determines discontinuation of treatment is in the subject's best interest
* Substantial non-compliance with the protocol

Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy

An Open-label Phase II Study of Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy - RESOUND

to evaluate activity of regorafenib, in terms of 2-months progression free survival rate

to explore the prognosis in terms of progression-free survival calculated from the first day of regorafenib treatment to the date of tumor progression or death, whichever occurs first.

to explore overall survival (OS) measured from the first day of regorafenib treatment until the date of death from any cause or the date of the last contact, at which the patients will be censored

to assess the safety profile of regorafenib according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3

Istituto Clinico Humanitas

Neoplasms, Glandular and Epithelial

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Lenvatinib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Pembrolizumab 200 mg will be administered to patients as 30-minute IV infusion every 3 weeks (a window of -5 minutes and +10 minutes is permitted).

Lenvatinib 20 mg (2 capsules of 10 mg) will be administered daily at the same time, with or without food. At the day 1 of each cycle, lenvatinib will be administered within 4 hours after finishing pembrolizumab (lenvatinib after pembrolizumab). Lenvatinib cannot be chewed

Pembrolizumab 200 mg will be administered to patients as 30-minute intravenous infusion (a window of -5 minutes and +10 minutes is permitted) every 3 weeks.

Lenvatinib 20 mg (2 capsules of 10 mg) will be administered daily at the same time, with or without food. At the day 1 of each cycle, lenvatinib will be administered within 4 hours after finishing pembrolizumab (lenvatinib after pembrolizumab)

Lenvatinib 10 mg

Jordi Remon, MD, PhD

Benjamin Besse, MD, PhD

This is a multicentric, open-label, single arm phase II study to evaluate the efficacy and safety of the combination of pembrolizumab and lenvatinib in pre-treated thymic carcinoma patients who have progressed after at least one line of platinum-based chemotherapy for advanced disease without having received any previous immunotherapy (previous bevacizumab allowed, but not sunitinib), and not amenable to curative-intent radical surgery and/or radiotherapy, regardless of PD-L1 status.

Men and women aged ≥ 18 years old diagnosed with B3-thymoma or metastatic thymic carcinoma who have progressed after at least one line of platinum-based chemotherapy for advanced disease without having received any previous immunotherapy (previous bevacizumab allowed, but not sunitinib), and not amenable to curative-intent radical surgery and/or radiotherapy, regardless of PD- L1 status. Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1 criteria. Patients are not eligible if they are candidates for a local treatment with a curative intention. Patients must present Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 and with adequate organ function.

Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents

A Multicentric, Open-Label, Single Arm Phase II Study To Evaluate The Efficacy And Safety Of The Combination Of PEmbrolizumab And Lenvatinib In Pre-Treated Thymic Carcinoma PaTIents. PECATI.

PFS rate at 5 months, defined as the percentage of patients with B3-Thymoma and Thymic Carcinoma without disease progression at 5 months after starting the treatment combination.

Grade 3 and 4 AEs and serious adverse events (SAEs) will be assessed, according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v.5.0), to determine the safety and tolerability of the combination.

Merck Sharp & Dohme LLC

MedSIR

Immunomodulating Agents

Nivolumab

Patients will be centrally registered and will receive nivolumab 240 mg IV every 2 weeks

Nicolas Girard

Solange Peters

The aim of the phase II Nivothym study is to collect data on activity and toxicity of nivolumab therapy in patients with thymic carcinoma or type B3 thymoma that previously received a first platinum-based chemotherapy.

Nivolumab in Patients With Type B3 Thymoma and Thymic Carcinoma (NIVOTHYM)

Single-arm, Multicentre, Phase II Study of Immunotherapy in Patients With Type B3 Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy

This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, for adverse event reporting.

Overall Response Rate (ORR) will be measured according to RECIST 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Regorafenib in Patients With Metastatic Solid Tumors Who Have Progressed After Standard Therapy	NCT02307500	Pancreas Cancer Ovarian Cancer Melanoma Sarcoma Thymoma Type B3 Thymoma Type B2 Thymic Carcinom...	Regorafenib	18 Years -	Istituto Clinico Humanitas
Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents	NCT04710628	Metastatic Thym... Thymoma Type B3	Pembrolizumab Lenvatinib 10 m...	18 Years -	MedSIR
Nivolumab in Patients With Type B3 Thymoma and Thymic Carcinoma (NIVOTHYM)	NCT03134118	Thymoma Type B3 Thymic Carcinom...	Nivolumab	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for thymoma type b3