Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638931
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Agnostic Therapy in Rare Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Basket Study to Evaluate the Tissue-agnostic Efficacy of Anti-Programmed Cell Death Protein 1 Anti-PD1 Monoclonal Antibody in Patients With Advanced Rare Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANTARES
Brief Summary:
The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody nivolumab in patients with advanced or metastatic rare tumors
The study aims to treat rare malignancies with PD-L1 expression CPS 10 regardless of the tumors tissue type or location Patients who have not responded to standard treatments will be included and treatment will last for up to 12 months The study will assess objective response progression-free survival and biomarkers such as PD-L1 ctDNA and microvesicles in a multicenter collaborative effort to provide innovative therapeutic options for this underrepresented population
The study aims to treat rare malignancies with PD-L1 expression CPS 10 regardless of the tumors tissue type or location Patients who have not responded to standard treatments will be included and treatment will last for up to 12 months The study will assess objective response progression-free survival and biomarkers such as PD-L1 ctDNA and microvesicles in a multicenter collaborative effort to provide innovative therapeutic options for this underrepresented population
Detailed Description:
The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody nivolumab in patients with advanced or metastatic rare tumors A basket trial is an innovative type of clinical trial where patients with different types of cancers but sharing a common molecular feature in this case PD-L1 expression are treated with the same therapy regardless of the tumors site of origin This approach allows for the evaluation of treatments targeting specific molecular characteristics independent of the primary cancer type
Rare tumors as defined by the World Health Organization WHO have an incidence of fewer than six cases per 100000 people per year Although each rare cancer type is individually uncommon collectively they account for 25-30 of all malignancies and are often underrepresented in clinical trials due to recruitment challenges and limited funding As a result patients with rare cancers generally have a poorer prognosis compared to those with more common tumors
In this study patients with advanced or refractory rare malignancies expressing PD-L1 with a combined positive score CPS of 10 will be treated with nivolumab Treatment will be administered until disease progression or for a maximum duration of 12 months aiming to assess the efficacy and safety of this tissue-agnostic immunotherapy approach Efficacy will be measured according to RECIST v11 criteria with objective response as the primary endpoint Additionally the study will assess response biomarkers including PD-L1 circulating tumor DNA ctDNA and microvesicles to better understand the correlation between biomarker expression and clinical outcomes
This multicenter trial with an estimated duration of four years will be conducted at Institute of Cancer of the State of São Paulo ICESP and other partner institutions The study aims to overcome existing barriers in rare cancer treatment by offering an innovative approach that explores the potential of personalized therapies based on molecular characteristics rather than the tumors primary site
Rare tumors as defined by the World Health Organization WHO have an incidence of fewer than six cases per 100000 people per year Although each rare cancer type is individually uncommon collectively they account for 25-30 of all malignancies and are often underrepresented in clinical trials due to recruitment challenges and limited funding As a result patients with rare cancers generally have a poorer prognosis compared to those with more common tumors
In this study patients with advanced or refractory rare malignancies expressing PD-L1 with a combined positive score CPS of 10 will be treated with nivolumab Treatment will be administered until disease progression or for a maximum duration of 12 months aiming to assess the efficacy and safety of this tissue-agnostic immunotherapy approach Efficacy will be measured according to RECIST v11 criteria with objective response as the primary endpoint Additionally the study will assess response biomarkers including PD-L1 circulating tumor DNA ctDNA and microvesicles to better understand the correlation between biomarker expression and clinical outcomes
This multicenter trial with an estimated duration of four years will be conducted at Institute of Cancer of the State of São Paulo ICESP and other partner institutions The study aims to overcome existing barriers in rare cancer treatment by offering an innovative approach that explores the potential of personalized therapies based on molecular characteristics rather than the tumors primary site
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None