Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer
Active, enrolledPhase 2Results postedLast updated 23 January 2026
What this trial tests
Phase 2 trial testing Cabozantinib in Metastatic Head and Neck Carcinoma in 36 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, any sex, with Metastatic Head and Neck Carcinoma or Paranasal Sinus Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR)Primary· Up to 2 years after treatment start
Will assess the proportion of subjects with partial response or complete response as defined by Response Evaluation Criteria in Solid Tumors version 1.1 response criteria. ORR will be calculated with 95% confidence interval by binomial distribution. The ability of biomarkers to predict ORR will be estimated by chi-square test and/or logistic regression model.
Group
Value
95% CI
Treatment (Pembrolizumab, Cabozantinib)
52
Progression Free Survival (PFS)Secondary· Duration from date of treatment start to the date of objectively documented progression or death due to any cause, whichever status is recorded first, assessed up to 2 years
The median PFS will be estimated by Kaplan-Meier method along with 95% confidence interval. The biomarker association with PFS will be assessed by the Kaplan-Meier method, log-rank test, and Cox model.
Group
Value
95% CI
Treatment (Pembrolizumab, Cabozantinib)
54
31.5 – 72
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well pembrolizumab and cabozantinib in treating patients with head and neck squamous cell cancer that has come back or spread to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the pathways needed for cell growth. Giving pembrolizumab and cabozantinib may improve the chances of tumor response in patients with head and neck squamous cell cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07293351 — A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Caboz
· Phase 1, PHASE2
· recruiting
NCT07187869 — Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell
· Phase 1
· not yet recruiting
NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
· Phase 3
· recruiting
NCT06900595 — Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescent
· Phase 2
· recruiting
Other recruiting trials for Metastatic Head and Neck Carcinoma
Currently open trials in the same condition.
NCT06572423 — Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy for Palliative Head and Neck Cancer Treatment (PULS-Pa
· NA
· recruiting
NCT04514484 — Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and
· Phase 1
· active not recruiting
NCT05075993 — Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metast
· Phase 1
· active not recruiting
NCT04140526 — Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
· Phase 1, PHASE2
· active not recruiting
NCT03010150 — Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastati
· recruiting
Other Emory University trials
Trials by the same sponsor.
NCT06143345 — HIIT in Isolated IFG: A Proof-of-Concept Study
· NA
· withdrawn
NCT07189819 — Innovative Closed-loop Functional Electrical Stimulation Control System for Augmenting Post-stroke Gait
· NA
· not yet recruiting
NCT06451055 — Low-calorie Diet in Isolated Impaired Fasting Glucose
· NA
· not yet recruiting
NCT07405476 — Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative I
· Phase 2
· recruiting
NCT06708351 — Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya, the ENHANCE LINKAge Trial
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 23 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03468218.