ImmunoSarc: Sunitinib and/​or Nivolumab Plus Chemotherapy in Advanced Soft Tissue and Bone Sarcomas

Treatment of Sunitinib and/or Nivolumab Plus Chemotherapy in Advanced Soft Tissue and Bone Sarcomas

Agents: Sunitinib
Phase III
Status Recruiting
Sponsor Abbisko Therapeutics Co, Ltd

For further information please also consult ClinicalTrials.gov.

 

This is a Phase III Study of ABSK021 to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor

WHO is the trial for?
  • Age ≥ 18 years.
  • Confirmed Tenosynovial Giant Cell Tumor (TGCT) with unresectable status.
  • Presence of measurable disease as defined by RECIST 1.1, with at least one lesion of ≥ 2 cm.
  • Overall health must be good: ECOG PS of 0 or 1.
  • Adequate organ and bone marrow function.

Ineligible if the patient had :

  • Major surgery or previous anti-tumor therapy for TGCT within 4 weeks prior to randomization.
  • Additional malignancies requiring active treatment
  • Previous treatment with highly selective inhibitors targeting CSF-1/CSF-1R.

WHAT is the key question that this trial is attempting to answer?

 The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in patients with Tenosynovial Giant Cell Tumor (TGCT). The main questions it aims to answer are:

  • Whether the Pimicotinib(ABSK021) works well in patients with TGCT.
  • Whether the Pimicotinib(ABSK021) is safe in patients with TGCT.

WHY patients might want to participate?

 Participation in this clinical trial provides patients with the opportunity to potentially benefit from a novel treatment, contribute to medical research, and play a role in advancing the understanding of Pimicotinib in the context of Tenosynovial Giant Cell Tumor.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is being conducted in:

Canada,  China,  Netherlands,  Spain,  United States

For further information please check here.

  1. Contact: YUAN LU
    Phone Number:+86-21-68910052
    Email Address: clinical@abbisko.cn

STUDY DESIGN: What does the study look like?

 This study consists of part 1 and part 2. Part 1 is a double-blind phase, eligible patients will be randomized to Pimicotinib(ABSK021) treatment group or matching placebo group and will receive Pimicotinib(ABSK021) or matching placebo until completion of Part 1.

Part 2 is an open-label treatment phase, and all patients entering this phase will receive open-label Pimicotinib(ABSK021) until completion of 24 weeks of dosing or withdrawal from the study.

HOW do I get more information?

  ClinicalTrials.gov, cancer societies or cancer focused patient advocacy groups in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organizations that might be helpful. If there are no such organization in your country, please email us for
more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken