Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03051906
Status:
NOT_YET_RECRUITING
Last Update Posted:
2017-11-22
First Post:
2017-02-06
Brief Title:
Durvalumab Cetuximab and Radiotherapy in Head Neck Cancer
Sponsor:
Azienda Ospedaliero-Universitaria Careggi
Organization:
Azienda Ospedaliero-Universitaria Careggi
Study Overview
Official Title:
Anti PD-L1 Durvalumab Combined With Cetuximab and Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck a Phase III Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DUCRO-HN
Brief Summary:
In over 60 of cases squamous cell carcinoma of the head and neck SCCHN is discovered at a loco-regionally advanced stage that requires a combined multimodal strategy in order to pursue a curative intent Bonner et al demonstrated that the combination of radiation RT with Cetuximab CTX a chimeric mouse IgG1 monoclonal anti-EGFR antibody results in better median locoregional control and overall survival compared with RT alone without an increased rate of G3 acute toxicity or detrimental effect on compliance and quality of life However subsequent negative trials RTOG 0522 led to the hypothesis that in unselected patient populations the benefit of CTX may be diluted due to the molecular heterogeneity of SSCHN Moreover the absence of biomarkers predictive of response to anti-EGFR treatment may in part be explained by the observation that other factors play a role in favoring its anticancer effect namely immunologic mechanisms It has been demonstrated that SCCHN is an immunosuppressive disease characterized by prominent immuno-escape mechanisms such as induction of a tumor-permissive cytokine profile and qualitativequantitative lymphocyte deficiencies occurrence of anergy in major immune effector cells and poor antigen presentation Given these observations it has been postulated that SCCHN may benefit from immunotherapeutic strategies primarily aimed at PD-L1PD1 checkpoint blockade Segal et al Asco 2015 reported preliminary results on the use of Durvalumab in pretreated patients with recurrentmetastatic SCCHN Durvalumab is a humanized monoclonal IgG1 antibody that blocks PD-L1 binding to PD-1 and CD80 with high affinity and selectivity thereby promoting activity of tumor-specific effector T cells and global anti-tumor immune response Out of 64 treated patients 51 patients were available for the preliminary efficacy analysis promisingly the overall response rate was 12 25 in PD-L1 positive patients To date no clinical trial specifically designed for SCCHN testing PD-L1 targeted agents has been completed nor have been initiated combination strategies of CTX RT and PD1PD-L1 antibodies in the curative setting Taken all data together a strong rationale may support the combination of Durvalumab anti-EGFR therapy such as CTX and RT in order to revert the SCCHN-induced immune suppression and maximize treatment efficacy ultimately through enhanced CTX-mediated immune mechanisms and maximized RT-specific cytotoxicity
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-004668-20 | EUDRACT_NUMBER | None | None |