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)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07876414

Acronym

TRACE

Enrollment

Registered

2026-10-15

Start date

2027-02-01

Completion date

2030-12-01

Last updated

2026-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer Squamous Cell Carcinoma

Keywords

resectable, locally advanced

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.

Interventions

DRUGINCA33890

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.

DRUGPembrolizumab

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Major pathologic response (MPR)	From enrollment to the end of treatment at 9 weeks or 6 weeks	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 23, 2026