H&N NEO-COMBAT XL: Neoadjuvant XL-092 (Zanzalintinib) and Pembrolizumab (Keytruda) in Surgically Resectable, HPV Negative Oral Cavity Squamous Cell Carcinoma (OCSCC)

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07484139
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XL092 — DRUG
    60 mg oral once a day
  • Pembrolizumab — DRUG
    200 mg intravenous for 30 minutes in every 21 days for

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Locally advanced oral cavity squamous cell carcinoma
    Locally advanced oral cavity squamous cell carcinoma (OCSCC) with surgically resectable disease.

Primary Outcome Measure

Rate of pathologic response [ Time Frame: Up to 66 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Nikki C Schmitt
[email protected]
Nikki C Schmitt, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Siddharth Sheth, MD
[email protected]
Rose Hall, MSW
[email protected]
984-974-8440
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in Atlanta, GA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Emory University· Atlanta, GAUniversity of North Carolina at Chapel Hill· Chapel Hill, NCThomas Jefferson University· Philadelphia, PA

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