Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head a… (NCT05784012) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma
Spain34 participantsStarted 2023-11-13
Plain-language summary
Multi-center, open-label, non-randomized, non-comparative two-cohort study for patients with locally-advanced squamous cell carcinoma arising from the larynx, hypopharynx, oropharynx (Stage III, IVA and IVB according to 8th TNM/AJCC ed.) and oral cavity (unresectable, stage IVB according to 8th TNM/ American Joint Committee on Cancer (AJCC) ed.) who are candidates for definitive radiotherapy plus cisplatin (Cohort A) or as single-modality (in cisplatin unfit patient population) (Cohort B) and will receive dostarlimab and niraparib in combination pre-, during and post- radiation.
Study has three parts:
1. Neoadjuvant phase (immune-conditioning phase): patients will receive 1 dose of dostarlimab day -21; niraparib from day -14 prior to radiotherapy (up to 48h prior to radiotherapy (RT) in Cohort A; Cohort B niraparib is uninterrupted until the end of study treatment).
2. Concurrent phase (radiosensitization): patients will receive definitive radiotherapy (70Gy in 35 fractions) with concurrent cisplatin (Cohort A) or with concurrent niraparib (Cohort B).
3. Maintenance: Following radiotherapy, patients will receive adjuvant dostarlimab plus niraparib until Cycle 14 day1(dostarlimab) and day21(niraparib).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed written and voluntary informed consent.
. Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
. Age ≥ 18 years, male or female.
. Have histologically confirmed new diagnosis of non-metastatic squamous cell carcinoma as assessed by the Investigator based on baseline imaging and clinical assessment that is either:
. Stage III HPV-related oropharyngeal carcinoma OR
. Stage III, IVA and IVB HPV-unrelated oropharyngeal, laryngeal or hypopharyngeal carcinomas. Stage IVB oral cavity squamous cell carcinomas may be eligible upon consultation with Sponsor if considered unresectable as per treating surgeon and multidisciplinary tumor board.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1-year disease free survival
Timeframe: 1 year after the start of the study treatment
Trial details
NCT IDNCT05784012
SponsorGrupo Español de Tratamiento de Tumores de Cabeza y Cuello
. Human papillomavirus (HPV)-relatedness in oropharyngeal primaries must be determined by positive p16 immunohistochemical staining on any tumor specimens and, if positive, confirmed by human papilloma virus (HPV) DNA testing by in situ hybridisation (ISH) or polymerase chain reaction (PCR). Positive p16 expression is defined as strong and diffuse nuclear and cytoplasmic staining in 70 % or more of the tumor cells. Local testing is acceptable.
. Patients must have positive PD-L1 expression (CPS ≥ 1) by central laboratory (using PD-L1 immunohistochemistry \[IHC\] 22C3 pharmDx assay) on archival tumor tissue.
Exclusion criteria
. Early stages, defined as stage I-II according to Union for International Cancer Control (UICC) / American Joint Committee on Cancer (AJCC) 8th Edition staging in any localization, and including HPV-related and non-related.
. Stage III-IVA oral cavity carcinoma considered resectable as per treating surgeon and/or multidisciplinary tumor board.
. Has cancer outside of the oropharynx, larynx, and hypopharynx and oral cavity.
. Current history of other head and neck malignancies.
. Any previous treatment for current head and neck cancer including systemic therapy, radiotherapy and/or surgery (except for a diagnostic biopsy) and no major surgery within 28 days prior to study treatment initiation.
. Any previous radiation to the head and neck region that would result in overlap of fields for the current study.
. Patients unable to swallow niraparib tablets.
. Documented weight loss of \>10 % during the last 4 weeks prior to study treatment initiation (unless adequate measures are undertaken for nutritional support), OR plasmatic albumin \< 3.0 g/dL. No albumin transfusions are allowed within 2 weeks before study treatment initiation.