H&N NEO-COMBAT XL: Neoadjuvant XL-092 (Zanzalintinib) and Pembrolizumab (Keytruda) in Surgically Resectable, HPV Negative Oral Cavity Squamous Cell Carcinoma (OCSCC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XL092, Pembrolizumab.
- Who it may be relevant to
- Registry conditions: Oral Cavity Squamous Cell Carcinoma, Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This is a multicenter, single arm Phase 2B study in subjects with locally advanced oral cavity squamous cell carcinoma (OCSCC) with surgically resectable disease. The study will assess the combination of neoadjuvant XL092 and pembrolizumab for safety and improvement of pathologic response rates compared to historical standard of care with perioperative pembrolizumab. The primary objective is to estimate the pathologic response rate defined as either pathological complete response (pCR), which is the absence of residual viable tumor, or major pathologic response (MPR), which is \<10% of residual tumor following the completion of neoadjuvant therapy and surgery. The study will be conducted in two stages. Per Simon's Stage 1, 11 patients will be enrolled. Simon Stage 2 will be gated on multiple factors. If ≥2 pathologic response is observed (pCR or MPR), the trial will proceed with cohort expansion and enroll an additional 15 patients for a total of 26 patients.
Interventions
- Drug XL092
60 mg oral once a day - Drug Pembrolizumab
200 mg intravenous for 30 minutes in every 21 days for
Primary outcome measures
- Rate of pathologic response [Time frame: Up to 66 days]
Secondary outcome measures (5)
- Neoadjuvant Adverse Events [Time frame: Up to 66 days]
- Events Free Survival (EFS) [Time frame: Up to 15 months]
- Objective response rate (ORR) [Time frame: Up to 15 months]
- Time to surgery [Time frame: Up to 66 days]
- Overall survival (OS) [Time frame: Up to 15 months]
Eligibility criteria
Inclusion criteria
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- Age ≥ 18 years at the time of consent.
- Tumors must have PD-L1 Combined Positive Score (CPS) ≥ 1.
- ECOG or Karnofsky Performance Status of 0-1
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) within 30 days prior to treatment .
Exclusion criteria
- Known HPV-positive cancer
- Active infection requiring systemic therapy.
- Prior treatment with XL-092
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Emory University — Atlanta
- University of North Carolina at Chapel Hill — Chapel Hill
- Thomas Jefferson University — Philadelphia
Identifiers
NCT: NCT07484139 · LCCC2517