Actively Recruiting
Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC
Led by Gruppo Oncologico del Nord-Ovest · Updated on 2022-08-04
49
Participants Needed
1
Research Sites
381 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
We propose a window of opportunity trial to evaluate safety and efficacy of a short course of the study combination, composed by an Anti-PD-1 monoclonal antibody (Dostarlimab (TSR-042)) and a PARPi (Niraparib). The study population will be surgically resectable, HPV-negative (defined by p16 negative status) locally advanced HNSCC. Maintenance treatment will be then delivered, so to better integrate the therapeutic benefits of this drug combination. Response to neoadjuvant treatment will be evaluated by the rate of major pathologic response, morphologic, and functional imaging (MRI with functional evaluation -DWI). We anticipate that neoadjuvant and maintenance PARPi plus immunotherapy treatment could lead to a reduction of loco-regional recurrence (LRR) and distant metastasis (DM) rates in such a high-risk population. Furthermore, the window of opportunity portion of this trial will allow in vivo acquisition of valuable knowledge on mechanisms of action and primary resistance to Anti-PD-1 monoclonal antibody and PARPi in HNSCC. In this phase of the study, biological specimens will be collected (pre-treatment tumor biopsy, tissues from the surgical specimen, liquid biopsy, blood and saliva samples) as well as functional imaging (MRI).
CONDITIONS
Official Title
Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Signed written informed consent
- Primary histologically confirmed p16 negative squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or larynx suitable for curative surgery
- Clinical stage III-IV (M0) according to AJCC 8th edition
- ECOG performance status 0-1
- Fresh tumor tissue available via biopsy for study
- Willing to provide blood and saliva samples
- No second malignancy except certain in situ cancers or non-melanoma skin cancers unless in remission for 2+ years without ongoing therapy
- Adequate organ and marrow function as defined by specified blood counts and lab values
- Ability to swallow study drug
- Agreement not to donate blood during study or for 90 days after last treatment dose
- Women of childbearing potential must have negative pregnancy test within 72 hours before treatment and agree to use contraception through 180 days after last dose, or be of nonchildbearing potential
- Agreement not to breastfeed during study or for 90 days after last dose
- Men must agree to use contraception from first dose through 180 days after last dose
- Ability to understand study procedures and provide informed consent
You will not qualify if you...
- Recurrent or metastatic disease
- Locally advanced disease not suitable for curative surgery
- Prior local or systemic treatment for HNSCC
- p16/HPV positive HNSCC
- Sinonasal, nasal cavity, or nasopharyngeal cancer
- Squamous cell carcinoma of neck with unknown primary tumor
- Concurrent enrollment in another interventional trial
- Major surgery within 3 weeks before starting protocol therapy
- Recent investigational therapy within 4 weeks or less than 5 half-lives of agent
- Radiation therapy affecting >20% bone marrow within 2 weeks or any radiation within 1 week before protocol therapy
- Known hypersensitivity to niraparib or Dostarlimab components
- Recent blood transfusions or colony stimulating factors within 4 weeks
- Grade 3 or 4 anemia, neutropenia, or thrombocytopenia lasting more than 4 weeks from prior chemotherapy
- History of myelodysplastic syndrome or acute myeloid leukemia
- Serious uncontrolled medical conditions or active infections
- Known symptomatic brain or leptomeningeal metastases
- Prior severe immune-related adverse events from immunotherapy
- Immunodeficiency or recent systemic immunosuppressive therapy
- Concurrent cancer treatments
- Active autoimmune disease requiring systemic treatment except specified exceptions
- Interstitial lung disease with symptoms or interfering with drug toxicity detection
- Psychiatric or substance abuse disorders interfering with trial participation
- Active hepatitis B, hepatitis C, or HIV infection (except well-controlled HIV)
- Pregnant or breastfeeding women
- Medical conditions increasing study risks or interfering with safety interpretation
- History or current conditions interfering with full trial participation
- Live vaccine within 14 days before starting protocol therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Asst Degli Spedali Civili Di Brescia
Brescia, Italy, 25123
Actively Recruiting
Research Team
P
Paolo Bossi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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