Study of Xevinapant With Radiation and Chemotherapy for Patients With Head and Neck Cancer
NCT ID: NCT06110195
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
42 participants
INTERVENTIONAL
2024-01-24
2027-10-31
Brief Summary
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The main question\[s\] it aims to answer are:
* what is the maximum safe dose that can be given
* what dose should be used in subsequent (phase 2) trials
Participants will receive xevinapant in combination with paclitaxel and carboplatin chemotherapy and radiation. Treatment will be given in 3-week cycles for 3 cycles.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Escalation Group Dose Level -1
Participants assigned to this cohort will receive xevinapant 50 mg for 2 out of every 3 weeks (Daily on days 1-14 of a 21-day cycle). They will also receive carboplatin and paclitaxel weekly for 7 doses with radiation (chemoRT).
An additional 3 cycles of xevinapant will be given after completion of chemoRT.
Xevinapant
Given orally during study treatment on days 1-14 of a 21-day treatment cycles. It will be given continuously during treatment with carboplatin, paclitaxel, and radiation (chemoRT). After completely of the chemoRT dosing, an additional 3 cycles of Xevinapant along will be given.
Carboplatin
Given with radiation weekly for 7 doses.
Paclitaxel
Given with radiation weekly for 7 doses.
Radiation Therapy
Radiation will be given together with paclitaxel and carboplatin for 7 weeks.
Escalation Group Dose Level 0
Participants assigned to this cohort will receive xevinapant 100 mg for 2 out of every 3 weeks (Daily on days 1-14 of a 21-day cycle). They will also receive carboplatin and paclitaxel weekly for 7 doses with radiation (chemoRT).
An additional 3 cycles of xevinapant will be given after completion of chemoRT.
Xevinapant
Given orally during study treatment on days 1-14 of a 21-day treatment cycles. It will be given continuously during treatment with carboplatin, paclitaxel, and radiation (chemoRT). After completely of the chemoRT dosing, an additional 3 cycles of Xevinapant along will be given.
Carboplatin
Given with radiation weekly for 7 doses.
Paclitaxel
Given with radiation weekly for 7 doses.
Radiation Therapy
Radiation will be given together with paclitaxel and carboplatin for 7 weeks.
Escalation Group Dose Level 1
Participants assigned to this cohort will receive xevinapant 150 mg for 2 out of every 3 weeks (Daily on days 1-14 of a 21-day cycle). They will also receive carboplatin and paclitaxel weekly for 7 doses with radiation (chemoRT).
An additional 3 cycles of xevinapant will be given after completion of chemoRT.
Xevinapant
Given orally during study treatment on days 1-14 of a 21-day treatment cycles. It will be given continuously during treatment with carboplatin, paclitaxel, and radiation (chemoRT). After completely of the chemoRT dosing, an additional 3 cycles of Xevinapant along will be given.
Carboplatin
Given with radiation weekly for 7 doses.
Paclitaxel
Given with radiation weekly for 7 doses.
Radiation Therapy
Radiation will be given together with paclitaxel and carboplatin for 7 weeks.
Escalation Group Dose Level 2
Participants assigned to this cohort will receive xevinapant 200 mg for 2 out of every 3 weeks (Daily on days 1-14 of a 21-day cycle). They will also receive carboplatin and paclitaxel weekly for 7 doses with radiation (chemoRT).
An additional 3 cycles of xevinapant will be given after completion of chemoRT.
Xevinapant
Given orally during study treatment on days 1-14 of a 21-day treatment cycles. It will be given continuously during treatment with carboplatin, paclitaxel, and radiation (chemoRT). After completely of the chemoRT dosing, an additional 3 cycles of Xevinapant along will be given.
Carboplatin
Given with radiation weekly for 7 doses.
Paclitaxel
Given with radiation weekly for 7 doses.
Radiation Therapy
Radiation will be given together with paclitaxel and carboplatin for 7 weeks.
Dose Expansion
Participants assigned to this cohort will receive xevinapant at the dose found during escalation phase of study for 2 out of every 3 weeks (Daily on days 1-14 of a 21-day cycle). They will also receive carboplatin and paclitaxel weekly for 7 doses with radiation (chemoRT).
An additional 3 cycles of xevinapant will be given after completion of chemoRT.
Xevinapant
Given orally during study treatment on days 1-14 of a 21-day treatment cycles. It will be given continuously during treatment with carboplatin, paclitaxel, and radiation (chemoRT). After completely of the chemoRT dosing, an additional 3 cycles of Xevinapant along will be given.
Carboplatin
Given with radiation weekly for 7 doses.
Paclitaxel
Given with radiation weekly for 7 doses.
Radiation Therapy
Radiation will be given together with paclitaxel and carboplatin for 7 weeks.
Interventions
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Xevinapant
Given orally during study treatment on days 1-14 of a 21-day treatment cycles. It will be given continuously during treatment with carboplatin, paclitaxel, and radiation (chemoRT). After completely of the chemoRT dosing, an additional 3 cycles of Xevinapant along will be given.
Carboplatin
Given with radiation weekly for 7 doses.
Paclitaxel
Given with radiation weekly for 7 doses.
Radiation Therapy
Radiation will be given together with paclitaxel and carboplatin for 7 weeks.
Eligibility Criteria
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Inclusion Criteria
* Patients with oropharynx cancer need p16 determination by immunohistochemistry (where positive is defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells).
* Oral cavity, larynx, hypopharynx, or p16-negative oropharynx cancer must be stages T1-2N1-3 or T3-4N0-3 (AJCC 8th edition). Sinus primary must be T4bN0-3 not amenable to surgical resection.
* P16-positive oropharynx cancer patients, stages T1-2N1-3 or T3-4N0-3 (AJCC 8th edition staging).
2. The patient has unresected, measurable disease as defined by the presence of at least one measurable lesion per RECIST 1.1.
3. Age \>= 18 years of age
4. Patients must have a contraindication to cisplatin
5. Performance Status of 0-2
6. Adequate hematologic function
* White Blood Cell Count (WBC) \>= 2000 cells/mm3
* Absolute neutrophil count (ANC) \>= 1,500 cells/mm3
* Platelets \>= 100,000 cells/mm3
* Hemoglobin \>= 9.0 g/dL
7. Adequate renal function was defined as follows: Creatinine clearance (CrCl) \> 30 mL/min
8. Adequate hepatic function
* Total bilirubin \<= 1.5 x upper limit of normal (ULN) (except patients with Gilbert Syndrome who can have total bilirubin \< 3.0 mg/dL)
* aspartate aminotransferase (AST) and alanine transaminase (ALT) \<= 2.5 x upper limit of normal (ULN)
9. For women of childbearing potential (e.g. uterus present and menstruating), a negative serum pregnancy test within 14 days prior to registration.
10. Willingness to agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of joining the study until 6 months after completing chemotherapy treatment or 3 months after last dose of xevinapant, whichever is the latest.
11. Patients with a history of hepatitis B or C infection are eligible if they have an undetectable viral load.
12. Ability to understand and the willingness to sign a written informed consent document.
13. Availability of tumor tissue for research analysis. Patients who do not have adequate tissue available will need to undergo a new biopsy prior to enrollment on study.
Exclusion Criteria
2. Carcinoma of the neck of unknown primary site of origin
3. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if not within \< 3 years
4. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
5. Severe, active co-morbidity defined as follows:
* History of bone marrow transplant and organ transplant, including allogeneic stem cell transplantation.
* Unstable angina requiring hospitalization in the last 6 months.
* New York Heart Association Functional Classification III/IV.
* Myocardial infarction within the last 6 months.
* Persistent Grade 3-4 electrolyte abnormalities that cannot be reversed despite as indicated by repeat testing.
* Ongoing active infection associated with symptoms and/or requires antibiotic therapy at the time of initiation of treatment.
6. Pregnancy and nursing females, if applicable.
7. Receipt of live vaccinations within 28 days prior to study start.
8. Patients who are receiving any other investigational agents.
9. Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
10. History of allergic reactions attributed to compounds of similar chemical or biologic composition to xevinapant, carboplatin, or paclitaxel.
11. Patients taking prohibited medications and those requiring close monitoring.
18 Years
ALL
No
Sponsors
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EMD Serono
INDUSTRY
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Ari Rosenberg, ND
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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IRB23-0294
Identifier Type: -
Identifier Source: org_study_id
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