Efficacy Comparison of Zanzalintinib (XL092) and Pembrolizumab Versus Pembrolizumab Monotherapy in PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of cancer known as recurrent or metastatic head and neck squamous cell carcinoma. This is a condition where cancer cells form in the tissues of the head and neck and have either returned after treatment or spread to other parts of the body. The study will explore the effectiveness of a new treatment combination involving two medications: zanzalintinib (XL092) and pembrolizumab. Pembrolizumab is already used in cancer treatment, while zanzalintinib is being tested for its potential benefits when used together with pembrolizumab.

The purpose of the study is to compare how well the combination of zanzalintinib and pembrolizumab works against using pembrolizumab alone in treating this type of cancer. Participants in the study will be randomly assigned to receive either the combination treatment or pembrolizumab by itself. Some participants may receive a placebo, which looks like the real medication but does not contain the active drug. The study will involve regular check-ups and monitoring to assess the treatment’s effects and any side effects experienced by the participants.

The study will take place over several months, with participants receiving treatment and being monitored for changes in their condition. The goal is to determine if the combination of zanzalintinib and pembrolizumab can improve outcomes for patients with this type of cancer. Participants will be closely observed by medical professionals throughout the study to ensure their safety and to gather important data on the treatment’s effectiveness.

Who Can Join the Study?

  • You must have head and neck squamous cell carcinoma (a type of cancer that starts in the skin or cells of the head and neck area) that has returned or spread to other parts of the body, and which cannot be cured by local treatments like surgery or radiation.
  • The cancer must be located in the oropharynx (the back of the throat), oral cavity (the mouth), hypopharynx (the lower part of the throat), or larynx (the voice box).
  • You must not have received any systemic therapy (medicine that travels through the whole body, such as chemotherapy) to treat the cancer after it returned or spread.
  • If you received treatment for advanced cancer in the past, it must have been completed more than 6 months before joining this study.
  • Your tumor must show a PD-L1 expression level (a protein on certain cells) with a Combined Positive Score (CPS) of 1 or higher.
  • If your cancer is in the oropharynx, you must have a test result showing your HPV status (testing for the Human Papillomavirus) using p16 testing.
  • A doctor must be able to measure your cancer using specific rules called RECIST 1.1 (a standard method used to measure how much tumor is present).
  • Any side effects from previous treatments must have improved to a Grade 1 severity (mild symptoms) or returned to your normal baseline state.
  • You must be at least 18 years old or the legal age of adulthood in your country.
  • Your ECOG performance status must be 0 or 1, which means you are generally able to carry out most daily activities and are physically active.
  • You must have adequate organ and marrow function (your vital organs and the part of your bone marrow that makes blood cells must be working well).

Who Cannot Join the Study?

  • Cancer located in the nasopharynx (the upper part of the throat behind the nose), salivary glands, or an occult primary site (a cancer where the original starting location cannot be clearly found).
  • Having had major surgery, such as surgery on the gastrointestinal tract (the digestive system) or the removal/biopsy of brain metastasis (cancer that has spread to the brain), within 8 weeks before being assigned to the study. All wounds must be fully healed.
  • An electrocardiogram (a test that records the electrical activity of the heart) showing a corrected QT interval (a measurement of the time it takes for the heart muscle to recharge between beats) greater than 480 ms.
  • Being pregnant or lactating (breastfeeding).
  • Receiving a live, attenuated vaccine (a type of vaccine that uses a weakened form of the germ) within 30 days before joining the study.
  • Having cancer that can be treated with local therapy (treatment focused on one specific area, like surgery or radiation) with the goal of curative intent (aiming to completely cure the disease).
  • Having previously used certain types of systemic immunotherapy (treatments that help the immune system fight cancer), such as zanzalintinib or drugs targeting PD-1, PD-L1, PD-L2, CTLA-4, OX-40, or CD137, unless specific timing rules regarding surgery are met.
  • Having a life expectancy (how long a person is expected to live) of less than 3 months or having rapidly progressing disease (cancer that is growing or spreading very quickly, such as causing uncontrolled pain).
  • Having progressive disease (cancer that is growing or spreading) within 6 months of finishing previous systemic treatment (medicine that travels through the whole body, like chemotherapy) for head and neck cancer. This must be confirmed by radiographic (imaging like X-rays or CT scans) evidence.
  • Having received radiation therapy for bone metastases (cancer that has spread to the bones) within 2 weeks, or any other radiation within 4 weeks before starting the study.
  • Having ongoing complications from past radiation, such as radiation pneumonitis (inflammation of the lung tissue caused by radiation) or fistulation (the formation of an abnormal connection between organs).
  • Having known brain metastases (cancer that has spread to the brain) or cranial epidural disease (cancer near the protective lining of the brain) unless it has been treated and has been stable (not changing or growing) for at least 4 weeks.
  • Testing positive for the hepatitis B surface antigen, which indicates a hepatitis B infection.
  • Testing positive for the hepatitis C virus antibody, which indicates a hepatitis C infection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Orszagos Onkologiai Intezet Budapest Hungary
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Grand Hopital De Charleroi Charleroi Belgium
Vitaz Sint-Niklaas Belgium
Fakultna Nemocnica Trnava Trnava Slovakia
Radiotherapy Center Cluj S.R.L. Floresti Romania
Hopital De Libramont Libramont-Chevigny Belgium
Vychodoslovensky Onkologicky Ustav a.s. Kosice Slovakia
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu Torun Poland
Spitalul Municipal Ploiesti Ploiesti Romania
Complex Oncology Center Ruse EOOD Ruse Bulgaria
Policlinica CCBR S.R.L. Bucharest Romania
Bioclinic S.A. Thessaloniki Greece
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Tolna Vármegyei Balassa János Kórház Szekszard Hungary
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Oncomed S.R.L. Timisoara Romania
Justus-Liebig-Universitaet Giessen Giessen Germany
University Hospital Olomouc Olomouc Czechia
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Fakultni Thomayerova nemocnice Prague Czechia
Provita Centrum Medyczne Sp. z o.o. Tomaszow Mazowiecki Poland
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Centro Oncologico De Galicia A Coruna Galicia Spain
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Ccdzbkspa Uxgupjmdhwwqcg Sklolxtmj Woluwe-Saint-Lambert Belgium
Criexi Lpnc Bpcltq Lyon France
Ongchtgyvzfymn Lbvt Grkh Linz Austria
Dklaggqjhtmg Ckyxyza Ojgrgpgyu Pabniboymwml I Humhwiorvop Wroclaw Poland
Ndtpek Vwtjtweyu Sznls Llcwl Kyqnnu Salgotarjan Hungary
Bdrjrwnuzeg Vovtoqpbu Olbjrtxruivo Kecskemet Hungary
Fjkrefcz naososrjc Mzoyt a Hzpuiit Prague Czechia
Azcojpgxmw Pebgquku Htlealmr Dq Mrsbfsflh Marseille France
Ndqimrfu Ifdqhnco Osgoawnqc Ioj Mfzwu Salfzbzjeelowwusohfczmfhyjug Ifrkgfyk Bzscjdou Cracow Poland
Hkhppheb Dq Ly Sqqvr Cztc I Sypb Pji Barcelona Spain
Febxmtgsf Pqch Lq Idlunpkjccabq Bcbcqmble Dlw Hsvuazzs Usecttmmzkquy Ls Pfm Madrid Spain
Cpr Cfinb Repfqnvkelw Lyon France
Cmlzdg Ojvbn Ldwwgmh Lille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.04.2024
Belgium Belgium
Not recruiting
01.04.2024
Bulgaria Bulgaria
Not recruiting
01.04.2024
Czechia Czechia
Not recruiting
01.04.2024
France France
Not recruiting
01.04.2024
Germany Germany
Not recruiting
01.04.2024
Greece Greece
Not recruiting
01.04.2024
Hungary Hungary
Not recruiting
01.04.2024
Italy Italy
Not recruiting
01.04.2024
Poland Poland
Not recruiting
01.04.2024
Romania Romania
Not recruiting
01.04.2024
Slovakia Slovakia
Not recruiting
01.04.2024
Spain Spain
Not recruiting
01.04.2024

Trial locations

XL092 is an experimental oral tablet being studied for its ability to treat cancer.

Pembrolizumab is an intravenous medication that helps the body’s immune system recognize and attack cancer cells.

Recurrent or metastatic head and neck squamous cell carcinoma – This is a type of cancer that begins in the squamous cells lining the head and neck area. It often develops in the mouth, throat, or larynx. The disease is considered recurrent if it returns in the same location after a period of being undetectable. It is considered metastatic when the cancer cells spread from the original site to other parts of the body. This progression involves cells breaking away from the primary tumor and traveling through the blood or lymph system.

Trial ID:
2023-506308-24-00
Protocol code:
XL092-305
NCT ID:
NCT06082167
Trial Phase:
Therapeutic use (Phase IV)

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