Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Cetuximab for Metastatic Head and Neck Squamous Cell Carcinoma

This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies.

Official registry: https://clinicaltrials.gov/study/NCT06589804 · National Cancer Institute (NCI) · enrollment listed as 158

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biospecimen Collection, Cetuximab, or Computed Tomography. The registry lists allocation as randomized. This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic).

They plan to enroll about 158 people at 202 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease

Interventions: Biospecimen Collection, Cetuximab, Computed Tomography, Magnetic Resonance Imaging, Pembrolizumab, Positron Emission Tomography

Primary outcome (registry wording): Overall survival (OS)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC)
  • Previously untreated for recurrent and/or metastatic disease incurable by local therapies
  • Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx
  • Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair
  • Measurable disease
  • Must have platinum-refractory disease defined as disease progression during or ≤ 29 weeks after completion of definitive therapy (chemoradiation therapy) or adjuvant (post-operative) therapy
  • Patient must have a combined positive score PD-L1 positive (CPS \>/= 1) tumor

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

202 listed

Related recruiting trials in this snapshot

RecruitingPhase 1 / Phase 2Duarte, California
Phase 1 / Phase 2: testing INBRX-106 - Hexavalent OX40 agonist antibody for Solid Tumor

This is a Phase 1/2, open-label, non-randomly assigned, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA.

NCT04198766 · Official ClinicalTrials.gov record · Inhibrx Biosciences, Inc

RecruitingPhase 2Phoenix, Arizona
Phase 2: testing Cabozantinib S-malate for Clinical Stage III Cutaneous Melanoma AJCC v8

This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT05136196 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingNot a traditional drug phaseBasking Ridge, New Jersey
Not a traditional drug phase: Neurocognitive Tests for Head and Neck Cancer

The researchers are doing this study to collect more information about if, and how, neurocognitive function may be affected in people being treated with radiation therapy for head and neck cancer. Part of this study is to see if patients diagnosed with head and neck cancer who are undergoing radiation therapy are able to complete neurocognitive testing and questionnaires at 3 times over a period of 1 year.

NCT05207098 · Official ClinicalTrials.gov record · Memorial Sloan Kettering Cancer Center

FAQ about this NCT record

Is NCT06589804 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06589804?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06589804?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary