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New treatment option for Head and Neck Squamous Cell Carcinoma
Official title Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC
ClinicalTrials.gov ID: NCT04681469
What this study is testing
What is Niraparib?
Niraparib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for head and neck squamous cell carcinoma.
Also referred to as Dostarlimab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients of both genders, aged ≥18 years;
- Signed written informed consent;
- Primary histologically proven p16 negative squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx amenable to surgery with...
- Clinical stage III-IV(M0) according to the VIII edition of AJCC staging system; recurrent/metastatic HNSCC, or previously treated HNSCC with local or...
- Performance status ECOG 0-1;
You likely can't join if
- Patient has recurrent/metastatic disease;
- Patient with locally advanced disease not amenable of surgery with curative intent;
- Patient has received prior local or systemic treatment for HNSCC;
- Patient with p16/HPV positive HNSCC;
- Patient with sinonasal, nasal cavity or nasopharyngeal cancer;
- Patient with SCC on neck disease with unknown primary tumor site;
See the full eligibility criteria
Who can join
- Patients of both genders, aged ≥18 years;
- Signed written informed consent;
- Primary histologically proven p16 negative squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx amenable to surgery with curative intent. p16 status will be assessed as surrogate marker for HPV...
- Clinical stage III-IV(M0) according to the VIII edition of AJCC staging system; recurrent/metastatic HNSCC, or previously treated HNSCC with local or systemic therapies, are not eligible for this study.
- Performance status ECOG 0-1;
- Availability of fresh tumor tissue via biopsy and provided for study purposes;
- Willing to provide blood and saliva samples for study purposes;
- Absence of a second malignancy (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, oesophageal, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete...
- Patient has adequate organ and marrow function (absolute neutrophil count ≥ 1500, hemoglobin ≥ 9.0 gram/deciliter (g/dL), platelet count ≥ 100,000, total bilirubin ≤1.5 times institution's upper limit of normal...
- Patient must be able to swallow study drug;
- Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment;
- Female participant has a negative serum pregnancy test within 72 hours prior to taking study treatment if of childbearing potential and agrees to use an adequate method of contraception from screening through 180 days...
- ≥45 years of age and has not had menses for \>1 year
- Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
- Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal...
- Participant must agree to not breastfeed during the study or for 90 days after the last dose of study treatment;
- Male participant agrees to use an adequate method of contraception (Section 3.3 for a list of acceptable birth control methods) starting with the first dose of study treatment through 180 days after the last dose of...
- Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
What rules you out
- Patient has recurrent/metastatic disease;
- Patient with locally advanced disease not amenable of surgery with curative intent;
- Patient has received prior local or systemic treatment for HNSCC;
- Patient with p16/HPV positive HNSCC;
- Patient with sinonasal, nasal cavity or nasopharyngeal cancer;
- Patient with SCC on neck disease with unknown primary tumor site;
- Patient must not be simultaneously enrolled in an treatment clinical trial;
- Patient must not have had major surgery ≤3 weeks prior to initiating protocol therapy and patient must have recovered from any surgical effects;
- Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy;
- Participant has had radiation therapy encompassing \>20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy;
- Participant must not have a known hypersensitivity to niraparib and TSR-042 components or excipients;
- Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy;
- Participant must not have received colony stimulating factors (eg, granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating...
- Participant has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \> 4 weeks and was related to the most recent treatment;
- Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
- Participant must not have a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia...
- Participant must not have known, symptomatic brain or leptomeningeal metastases;
- Patient experienced ≥ Grade 3 immune-related adverse event with prior immunotherapy, with the exception of non-clinically significant lab abnormalities;
- Participant has a diagnosis of immunodeficiency or has received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy;
- Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment;
- people with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, oesophageal, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete...
- people with an active, known or suspected autoimmune disease. people with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not...
- people with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids...
- people with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity;
- Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial;
- Known active Hepatitis B infection (defined as presence of HBsAg and/or HBV DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV). Patients with HIV who...
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 72 hours before treatment start. Both men and women enrolled in this trial must use adequate...
- Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results;
- History or current evidence of any condition that, in the opinion of the treating investigator, might interfere with the subject's participation for the full duration of the trial.
- Participant has received a live vaccine within 14 days of initiating protocol therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Brescia, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brescia, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.