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NCT07876414Not yet recruitingPhase 2

A Clinical Trial Comparing an Antibody (INCA33890) Versus Pembrolizumab for Squamous Cell Carcinoma of the Head and Neck.

A Randomized Phase 2 Trial of Anti Bispecific Antibody (INCA33890) Versus Pembrolizumab for Resectable Locally Advanced Squamous Cell Carcinoma of the Head and Neck (TRACE)

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

The objective of this research is to evaluate the efficacy of the new drug INCA33890 compared to the standard reference treatment, pembrolizumab. The study treatment is INCA33890. The reference treatment is pembrolizumab. Two-thirds of participants will receive INCA33890, and one-third will receive pembrolizumab. The details for the different treatment groups are as follows: * Group A: You will receive INCA33890 (900 mg) every two weeks for 3 cycles. * Group B: You will receive pembrolizumab (200 mg) every three weeks for 2 cycles. Following these treatments, you will undergo surgery. This surgical procedure will be performed in accordance with the hospital's standard care practices. After surgery, you will be offered one of the following standard additional treatments: * (Chemo)radiotherapy within 6 to 8 weeks after surgery. The adjuvant (chemo)radiotherapy will be tailored based on microscopic findings from the analysis of the resected tumor. * Immunotherapy: pembrolizumab (200 mg) administered intravenously every 3 weeks until disease progression or the occurrence of unacceptable toxicity.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
78 (estimated)
First submitted
9 Oct 2026
Start date
Feb 2027
Primary completion date
Feb 2030
Lead sponsor
Groupe Oncologie Radiotherapie Tete et Cou
NCT number
NCT07876414
EU CT number
2026-527587-32-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 78
  • From Feb 2027 to the primary completion date, Feb 2030
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment for H\&N cancer,

Other illness

  • metastatic disease,
  • cardiovascular disease,
  • central nervous system disorders,
  • active uncontrolled inflammatory disease,
  • history of organ transplant or active autoimmune disease.

Other

  • pulmonary comorbidities,
  • corticoids treatment,

Who the study is looking for

  • Patients with confirmed diagnosis in previously untreated LA-SCCHN patients suitable for definitive surgery
  • 18-75 years
  • CPS ≥1

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.