Head and Neck CancerPhase 2NCT06145412
A Study of Xevinapant With Cisplatin and Radiation Therapy After Surgery in People With Head and Neck Cancer
A Phase 2 study testing Xevinapan, Cisplatin and External beam in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to test whether treatment with Xevinapant added to standard chemoradiation after surgery is an effective treatment for people with high-risk head and neck cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Xevinapan, Cisplatin and External beam
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Nov 2023to 4 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 on the day of signing of the consent form
- ECOG 0-1
- Able to swallow liquids or has an adequately functioning feeding tube, gastrostomy, or jejunostomy placed
- Squamous cell carcinoma of the head and neck (excluding lip) *
- o Eligible primary tumor sites will include the maxillary sinus, oral cavity, HPV-negative oropharynx, larynx, and hypopharynx.
- Gross total resection of known disease at the time of surgery within 10 weeks of registration. All efforts will be made to begin treatment within 6 weeks of surgery.
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- At least one of the following criteria
- Close surgical margin (<5mm) AND ≥2 additional intermediate risk factors (T3 or T4, multiple lymph nodes, LVI, PNI)
- Positive margins not eligible for re-resection (defined as <1mm)
- Extranodal extension
- Evidence of early gross recurrence on radiation planning scans after definitive intent surgical resection Patients with evidence of gross locoregional disease at the time of radiation are strongly advised to have biopsy confirmation. This requirement may be waived by the PI or the co-PIs. If a biopsy is not performed, patients must meet one of the other entry criteria (close surgical margin and 2 or more additional intermediate risk factors; positive margins not eligible for re-resection; extranodal extension).
- Adequate hematologic, renal, and hepatic function as indicated by:
- Absolute neutrophil count ≥ 1 500 cells/μL
- Platelets ≥ 100 000 cells/μL
- Hemoglobin ≥ 9.0 g/dL (blood transfusions during screening are permitted)
- AST and ALT ≤ 3.0 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 × ULN (up to 2.0 × ULN is allowed if the direct bilirubin level is normal, and the elevation is limited to indirect bilirubin).
- Adequate renal function within 30 days prior to registration, defined as follows:
- Creatinine clearance (CC) ≥ 60 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula:
- CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)]
- CCr female = 0.85 x (CrCl male) Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group) must have a negative serum pregnancy test at screening and must not be breastfeeding.
- Women of childbearing potential must agree to use highly effective contraceptive method(s). from ICF signature to 6 months after the last administration of chemotherapy or 3 months after last dose of xevinapant, whichever is the latest.
- Non-sterilized males who are sexually active with a female partner of childbearing potential must agree to use condom and spermicide from ICF signature to 6 months after the last administration of chemotherapy or 3 months after the last dose of xevinapant, whichever is the latest.
- Because male condom and spermicide is not a highly effective contraception method, it is required that female partners of a male study subject use highly effective contraceptive method(s) throughout this period.
- Male subjects must refrain from donating sperm during the clinical study and for 6 months after the last administration of chemotherapy or 3 months after the last dose of xevinapant, whichever is the latest.
- If not done previously, cryopreservation of sperm prior to receiving chemotherapy or xevinapant is advised to male patients with a desire to have children.
Who cannot join
- Metastatic disease
- Prior head and neck radiation
- Peripheral Neuropathy ≥ grade 2
- Hearing Impairment ≥ grade 2
- On-going wound infection, fistula, flap failure
- Use within 14 days prior to randomization or requirement for ongoing treatment with any drug(s) on the prohibited medication list (see below).
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- Known history of infection with HIV. If unknown history of HIV, an HIV screening test is to be performed and subjects with positive serology for HIV-1/2 must be excluded.
- Known chronically active HBV or HCV infection. If unknown status, the following tests are to be performed and subjects with positive serology must be excluded:
- HBV screening tests: both HBV sAg and Anti-HepB core IgG.
- HCV screening tests: both HCV-antibody and positive viral load HCV-RNA by PCR.
- Other infections (viral and/or bacterial and/or mycotic) requiring systemic treatment.
- Live-attenuated vaccinations within 30 days prior to first investigational treatment administration.
- Ongoing uncontrolled infection requiring intravenous antibiotic therapy within 1 week prior to randomization.
- Documented weight loss of >10% during the last 4 weeks prior to randomization (unless adequate measures are undertaken for nutritional support), OR plasmatic albumin <3.0 g/dL. No albumin transfusions are allowed within 2 weeks before randomization.
- Active uncontrolled inflammatory disease (including rheumatoid arthritis, systemic lupus erythematosus, Sjögren syndrome, severe extensive psoriasis, and other autoimmune diseases) requiring ongoing treatment with anti-TNF medication.
- Any concomitant medication known to prolong the QT interval that cannot be discontinued or replaced by safe alternative medication within 7 days prior to start of treatment.
- Known allergy to Xevinapant or any excipient known to be present in the formulation.
- Non-compensated or symptomatic liver cirrhosis (Child-Pugh score: B or C).
- Treatment with an investigational agent or use of an investigational device within 4 weeks of the first dose of study treatment.
- Known gastrointestinal disorder with clinically established malabsorption syndrome and major gastrointestinal surgery that may limit oral absorption.
- Active gastrointestinal bleeding, or any other uncontrolled bleeding requiring more than 2 red blood cell transfusions or 4 units of packed red blood cells within 4 weeks prior to randomization.
- Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
- Ongoing or history of uncontrolled or symptomatic ischemic myocardiopathy within 6 months prior to randomization.
- Known left ventricular ejection fraction < 50%).
- History of myocardial infarction, or severe/unstable angina, within 6 months prior to randomization.
- New York Heart Association grade ≥ 3 congestive heart failure.
- Congenital long QT syndrome.
- Family history of long QT syndrome.
- Symptomatic pulmonary embolism within 6 months prior to randomization.
- Ongoing or known history of transient ischemic attacks or stroke within 6 months prior to randomization.
- QTc using Fridericia's formula (QTcF) interval > 450 ms for males and > 470 ms for females Symptomatic pulmonary disease requiring continuous or intermittent oxygen supply.
- History of another malignancy within the last 3 years prior to randomization, with the exception of completely resected non-melanoma cell skin cancer outside the head and neck area or completely resected stage I breast cancer, or completely resected in-situ non-muscular invasive bladder, cervix and/or uterine carcinomas.
- Any ongoing condition or disorder, before randomization, including drug(s) or alcohol abuse, which in the judgment of the Investigator would make the patient inappropriate for entry into the study or precluding his/her ability to comply with study procedures.
- Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Suffolk - Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
East White Plains, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: A Phase II Trial of Xevinapant in Combination With Post-Operative Cisplatin and Radiotherapy for High Risk Head and Neck Cancer
The purpose of this study is to test whether treatment with Xevinapant added to standard chemoradiation after surgery is an effective treatment for people with high-risk head and neck cancers.
- Conditions
- Head and Neck Cancer
- Being tested
- Xevinapan, Cisplatin, External beam
- Keywords
- Xevinapant, Cisplatin, Radiotherapy, 23-044
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XevinapanDrug
Xevinapant (oral dose of 200mg per day on days 1-14 every 21 days for 3 cycles)
CisplatinDrug
Cisplatin (2-3 cycles, with 100mg/m2 per cycle q3 weeks)
External beamRadiation
60 - 66 Gy in 2 Gy fractions for patients without gross disease and 70 Gy for patients with early recurrence) with concurrent cisplatin (40 mg/m2 once weekly)
| Study group | Role | What they receive |
|---|---|---|
| Xevinapant in Combination with Post-Operative Cisplatin and Radiotherapy | Experimental | The study will consist of three phases: 2) concurrent radiation, cisplatin, and xevinapant, and 3) adjuvant xevinapant. Concurrent Chemoradiation Subjects will undergo FDG PET/CT simulation and standard radiation treatment planning. FDG PET/CT (Simulation or diagnostic) will also be utilized to rule out distant metastases. Subjects who meet criteria for the treatment phase will undergo standard of care adjuvant radiation (60-70 Gy administered in 2 Gy fractions) with concurrent cisplatin (2-3 cycles, with 100mg/m2 per cycle q3 weeks), and xevinapant (oral dose of 200mg per day on days 1-14 every 21 days for 3 cycles) Adjuvant Phase After completion of concurrent chemoradiation, patients will undergo an additional 3 cycles of xevinapant (oral dose of 200mg per day on days 1-14 every 21 days for 3- cycles) Receives: Drug: Xevinapan; Drug: Cisplatin; Radiation: External beam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression free survival will be defined as the time from the start of treatment to biopsyproven locoregional recurrence, distant tumor recurrence, or death. For patients without evidence of gross disease at registration, any locoregional progression will be considered a PFS event. For patients with gross disease at registration, progression-free survival will be determined based upon RECIST 1.1 criteria.
Measured: 12 months
Secondary outcomes (1)
Overall survival
Overall survival will be defined as the time from treatment start to the time of death from any cause.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start16 Nov 2023
- Primary completion4 Aug 2026
- Study completion4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm phase II.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yao Yu, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145412
- Sponsor's protocol ID
- 23-044
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Xevinapant in Combination With Post-Operative Cisplatin and Radiotherapy for High Risk Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT06145412
- Acronym / sponsor ID
- 23-044
- Conditions
- Head and Neck Cancer
- Keywords
- Xevinapant, Cisplatin, Radiotherapy, 23-044
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 4 Aug 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether treatment with Xevinapant added to standard chemoradiation after surgery is an effective treatment for people with high-risk head and neck cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm phase II.
| Arm | Type | Receives |
|---|---|---|
| Xevinapant in Combination with Post-Operative Cisplatin and Radiotherapy | Experimental | Drug: Xevinapan, Drug: Cisplatin, Radiation: External beamThe study will consist of three phases: 2) concurrent radiation, cisplatin, and xevinapant, and 3) adjuvant xevinapant. Concurrent Chemoradiation Subjects will undergo FDG PET/CT simulation and standard radiation treatment planning. FDG PET/CT (Simulation or diagnostic) will also be utilized to rule out distant metastases. Subjects who meet criteria for the treatment phase will undergo standard of care adjuvant radiation (60-70 Gy administered in 2 Gy fractions) with concurrent cisplatin (2-3 cycles, with 100mg/m2 per cycle q3 weeks), and xevinapant (oral dose of 200mg per day on days 1-14 every 21 days for 3 cycles) Adjuvant Phase After completion of concurrent chemoradiation, patients will undergo an additional 3 cycles of xevinapant (oral dose of 200mg per day on days 1-14 every 21 days for 3- cycles) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Age ≥ 18 on the day of signing of the consent form
- ECOG 0-1
- Able to swallow liquids or has an adequately functioning feeding tube, gastrostomy, or jejunostomy placed
- Squamous cell carcinoma of the head and neck (excluding lip) *
- o Eligible primary tumor sites will include the maxillary sinus, oral cavity, HPV-negative oropharynx, larynx, and hypopharynx.
Key exclusion criteria (34 listed)
- Metastatic disease
- Ongoing uncontrolled infection requiring intravenous antibiotic therapy within 1 week prior to randomization.
- Documented weight loss of >10% during the last 4 weeks prior to randomization (unless adequate measures are undertaken for nutritional support), OR plasmatic albumin <3.0 g/dL. No albumin transfusions are allowed within 2 weeks before randomization.
- Active uncontrolled inflammatory disease (including rheumatoid arthritis, systemic lupus erythematosus, Sjögren syndrome, severe extensive psoriasis, and other autoimmune diseases) requiring ongoing treatment with anti-TNF medication.
- Any concomitant medication known to prolong the QT interval that cannot be discontinued or replaced by safe alternative medication within 7 days prior to start of treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XevinapanXevinapant (oral dose of 200mg per day on days 1-14 every 21 days for 3 cycles) | Drug | Xevinapant in Combination with Post-Operative Cisplatin and Radiotherapy |
| CisplatinCisplatin (2-3 cycles, with 100mg/m2 per cycle q3 weeks) | Drug | Xevinapant in Combination with Post-Operative Cisplatin and Radiotherapy |
| External beam60 - 66 Gy in 2 Gy fractions for patients without gross disease and 70 Gy for patients with early recurrence) with concurrent cisplatin (40 mg/m2 once weekly) | Radiation | Xevinapant in Combination with Post-Operative Cisplatin and Radiotherapy |
Primary outcome
Progression Free Survival
Time frame: 12 months
Progression free survival will be defined as the time from the start of treatment to biopsyproven locoregional recurrence, distant tumor recurrence, or death. For patients without evidence of gross disease at registration, any locoregional progression will be considered a PFS event. For patients with gross disease at registration, progression-free survival will be determined based upon RECIST 1.1 criteria.
1 secondary outcome
Overall survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao Yu, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xevinapan, Cisplatin and External beam in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.