XL092 + Pembrolizumab for Oral Squamous Cell Carcinoma

(NEO COMBAT XL Trial)

Not yet recruiting at 2 trial locations
RH
SW
Overseen ByShamina Williams
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: UNC Lineberger Comprehensive Cancer Center
Must be taking: Pembrolizumab
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for oral squamous cell carcinoma. Researchers aim to determine if adding the experimental drug XL092 to the existing treatment pembrolizumab enhances tumor shrinkage before surgery. They seek participants with surgically removable tumors who meet specific health criteria, such as having a tumor marker of PD-L1 CPS ≥ 1. The goal is to assess whether this combination leads to better outcomes than the standard treatment. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to advancements in cancer therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of XL092 and pembrolizumab has been tested for safety in other studies. Pembrolizumab alone treats various cancers and is generally well-tolerated. Common side effects include fatigue, skin rash, and mild digestive issues, while more serious side effects occur less frequently.

Studies have found that combining XL092 with pembrolizumab remains safe, with side effects similar to those of pembrolizumab alone. However, there may be a higher risk of liver-related problems, so trials often monitor liver function.

These findings come from clinical trials testing the combination in patients with different types of cancer. This suggests the combination is generally tolerable, but individual experiences can vary. Discuss potential risks and benefits with a doctor before joining a trial.12345

Why are researchers excited about this study treatment for oral squamous cell carcinoma?

Researchers are excited about XL092 combined with pembrolizumab for treating oral squamous cell carcinoma because this combination offers a new approach to tackling the cancer. Pembrolizumab is an immunotherapy that helps the immune system recognize and attack cancer cells, while XL092 is a novel tyrosine kinase inhibitor that targets specific proteins involved in cancer cell growth. This dual-action strategy could potentially enhance treatment effectiveness compared to traditional chemotherapy and radiation, which are the standard of care. By combining these mechanisms, the treatment has the potential to improve outcomes for patients with surgically resectable oral cavity squamous cell carcinoma.

What evidence suggests that XL092 + Pembrolizumab might be an effective treatment for oral squamous cell carcinoma?

Research has shown that pembrolizumab may effectively treat oral cavity squamous cell carcinoma (OCSCC), particularly in patients who respond well to it. Studies have found that pembrolizumab can significantly reduce tumors in some cases. This trial tests a combination of XL092 (zanzalintinib) and pembrolizumab to see if it can further improve results. Early studies suggest that this combination might enhance pembrolizumab's effectiveness in shrinking tumors. The goal is to achieve a higher rate of complete response (no cancer left) or major response (less than 10% of cancer remaining) before surgery.12345

Who Is on the Research Team?

SS

Siddharth Sheth, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with HPV-negative, locally advanced oral cavity squamous cell carcinoma that can be removed by surgery. Participants must have measurable disease, good physical health, and tumors showing a certain protein (PD-L1 CPS ≥ 1).

Inclusion Criteria

* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) within 30 days prior to treatment .
* 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.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive neoadjuvant XL-092 and pembrolizumab to assess safety and pathologic response rates

Up to 66 days

Surgery

Participants undergo surgery following the completion of neoadjuvant therapy

Immediate post-treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pathologic response and survival outcomes

Up to 15 months

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • XL092

Trial Overview

The study tests the safety and effectiveness of giving XL092 plus pembrolizumab before surgery in people with oral cavity cancer. All participants receive both drugs; there is no placebo or comparison group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Locally advanced oral cavity squamous cell carcinomaExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

Exelixis

Industry Sponsor

Trials
126
Recruited
20,500+
Michael M. Morrissey profile image

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman profile image

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Citations

NCT06082167 | Study of Zanzalintinib (XL092) + ...

This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched ...

XL092 + Pembrolizumab for Oral Squamous Cell ...

The study will assess the combination of neoadjuvant XL092 and pembrolizumab for safety and improvement of pathologic response rates compared to historical ...

Efficacy and Safety of Pembrolizumab Monotherapy for ... - PMC

Our study suggests that pembrolizumab is beneficial to the most responsive patients with R/U/M OSCC in our single-center study and may shed light on the ...

Study of Zanzalintinib (XL092) + Pembrolizumab vs ...

This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched ...

Neoadjuvant XL-092 (Zanzalintinib) and Pembrolizumab ...

The study will assess the combination of neoadjuvant XL092 and pembrolizumab for safety and improvement of pathologic response rates compared to historical ...