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

NCT07876414 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: GORTEC 2026-022026-527587-32-00
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

Keywords

Bispecific Antibody (INCA33890)

Outcome Measures

Primary Outcomes (1)

• Major pathologic response (MPR)

  Major pathologic response (MPR) is defined as proportion of patients with ≤ 10 % residual viable tumor in the resected specimen (primary tumor and cervical lymph nodes) evaluated after three neoadjuvant cycles of INCA33890 or after 2 cycles of pembrolizumab.

  From enrollment to the end of treatment at 9 weeks or 6 weeks

Study Arms (2)

INCA33890 arm

EXPERIMENTAL

INCA33890 900 mg (9 vials of 100 mg) Q2W for 3 cycles as the investigational treatment of this trial.

Drug: INCA33890

Pembrolizumab arm

ACTIVE COMPARATOR

Pembrolizumab 200 mg Q3W for 2 cycles, standard of care treatment for the trial population.

Drug: Pembrolizumab

Interventions

INCA33890 DRUG

INCA33890 is administered IV Q2W on Day 1 of each cycle. INCA33890 is given at a fixed dose of 900 mg (9 vials of 100 mg) IV, q2w for 3 cycles. The dose formulation and concentration is a solution of 20mg/ml or 50mg/ml.

INCA33890 arm

Pembrolizumab DRUG

Pembrolizumab (Keytruda®) is an antineoplastic agent for the treatment of patients with SCCHN

Pembrolizumab arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prior treatment for H\&N cancer, metastatic disease, cardiovascular disease, pulmonary comorbidities, central nervous system disorders, corticoids treatment, active uncontrolled inflammatory disease, history of organ transplant or active autoimmune disease.

Sponsors & Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou: lead
• Incyte Biosciences International Sàrl: collaborator

MeSH Terms

Interventions

pembrolizumab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share