HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions
Brief summary
Efficacy: Rate of Major Pathological Response (MPR, i.e. less than 10% viable tumor cells identified on routine hematoxylin and eosin staining in pathological surgical specimen) in patients with locally advanced HNSCC treated with Niraparib + Dostarlimab (TSR-042) in the WoO setting.
Detailed description
Safety: Safety stopping rule: the first 6 patients will be evaluated for surgical toxicities graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 and documented over the 4 weeks period following surgery in order to determine if preoperative study protocol is safe., Once the safety is established total planned enrolment will be completed. Surgical safety in the whole population will be evaluated up to 4 weeks after surgery considering the following: a) postoperative bleeding requiring surgical revision b) delayed wound healing or wound dehiscence c) wound infection d) fistula e) need for secondary surgical interventions (not considered part of institutional standard of care) f) skin loss/flap necrosis including partial or total flap as applicable., • Two-year DFS of the patients enrolled in the trial, defined as the time from treatment assignment to cancer recurrence, second cancer or death from any cause. • radiological response after 6 weeks of treatment evaluated at MRI prior to surgery by: a) RECIST v1.1 using conventional MRI imaging b) Diffusion Weighted Imaging Magnetic Resonance Imaging (DWI MRI), • Safety of the whole treatment and safety of each phase (induction and maintenance) as evaluated in a separate way • correlation between radiological and pathological response; • evaluation of predictive role of baseline genomic expression, salivary markers and radiomic characteristics on response to induction therapy; • change in gene expression in tumor samples after induction therapy;
Interventions
DRUGJEMPERLI 500 mg concentrate for solution for infusion
Sponsors
Gruppo Oncologico Del Nord Ovest
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Rate of Major Pathological Response (MPR, i.e. less than 10% viable tumor cells identified on routine hematoxylin and eosin staining in pathological surgical specimen) in patients with locally advanced HNSCC treated with Niraparib + Dostarlimab (TSR-042) in the WoO setting. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Safety stopping rule: the first 6 patients will be evaluated for surgical toxicities graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 and documented over the 4 weeks period following surgery in order to determine if preoperative study protocol is safe., Once the safety is established total planned enrolment will be completed. Surgical safety in the whole population will be evaluated up to 4 weeks after surgery considering the following: a) postoperative bleeding requiring surgical revision b) delayed wound healing or wound dehiscence c) wound infection d) fistula e) need for secondary surgical interventions (not considered part of institutional standard of care) f) skin loss/flap necrosis including partial or total flap as applicable., • Two-year DFS of the patients enrolled in the trial, defined as the time from treatment assignment to cancer recurrence, second cancer or death from any cause. • radiological response after 6 weeks of treatment ev | — |
Countries
Italy
Outcome results
None listed