Head and Neck Cancer
Conditions
Brief summary
The purpose of this study is to determine the best overall response of the combination of dostarlimab and niraparib in patients with recurrent and/or metastatic HNSCC patients.
Detailed description
Recurrent and/or metastatic HNSCC patients will be treated with combination of the PD-1 inhibitor (dostarlimab) and PARPi (niraparib) concurrently and ORR, PFS and OS will be determined.
Interventions
DRUGNiraparib
Niraparib \& Dostarlimab combination
DRUGDostarlimab
Niraparib \& Dostarlimab combination
Sponsors
Trisha Wise-Draper
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically, cytologically, or radiographically confirmed recurrent or metastatic non cutaneous HNSCC for which there are no surgical or radiation curative options. * ECOG performance status ≤2 * Patients must be able to swallow pills
Exclusion criteria
* Nasopharyngeal and salivary gland tumors * Patients who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia * Prior exposure to both immunotherapy drugs (PD-1, PDL-1, CTLA-4 inhibitors) and PARP inhibitors. Single exposure to either immunotherapy or PARP inhibitors is allowable. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to niraparib or dostarlimab. * Patients with uncontrolled intercurrent illness. * Requirement of any use of steroids greater than the equivalent of 10mg prednisone daily is not allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response | 8 weeks | Measured by assessing best overall response using RECIST 1.1 in subjects in recurrent and/or metastatic HNSCC patients receiving combination of niraparib and dostarlimab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 1 and 3 years | Measured using Kaplan Meier Curves from time of treatment start until time of progression |
| Overall Survival | Through study completion, an average of 10 months | Measured using Kaplan Meier Curves from diagnosis until time of death |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTrisha Wise-Draper, MD, PhD
University of Cincinnati
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.5 years |
| ECOG ECOG Score of 0 | 4 Participants |
| ECOG ECOG Score of 1 | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 10 |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 6 / 10 |
Outcome results
None listed