Head and Neck Cancer Squamous Cell CarcinomaPhase 2TRACENCT07876414

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

A Phase 2 study testing INCA33890 and Pembrolizumab in people with Head and Neck Cancer Squamous Cell Carcinoma, run by Groupe Oncologie Radiotherapie Tete et Cou.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Head and Neck Cancer Squamous Cell Carcinoma
What is being tested?: INCA33890 and Pembrolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: No sites listed yet
Study dates: Feb 2027to Dec 2030
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

About this study

Official title: 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)

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: Head and Neck Cancer Squamous Cell Carcinoma
Being tested: INCA33890, Pembrolizumab
Keywords: resectable, locally advanced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INCA33890Drug
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.
PembrolizumabDrug
Pembrolizumab (Keytruda®) is an antineoplastic agent for the treatment of patients with SCCHN

Study groups in NCT07876414
Study group	Role	What they receive
INCA33890 arm	Experimental	INCA33890 900 mg (9 vials of 100 mg) Q2W for 3 cycles as the investigational treatment of this trial. Receives: Drug: INCA33890
Pembrolizumab arm	Active comparator	Pembrolizumab 200 mg Q3W for 2 cycles, standard of care treatment for the trial population. Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2027Dec 2030

First posted15 Oct 2026
Study startFeb 2027 (estimated)
Primary completionFeb 2030 (estimated)
Study completionDec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Head and Neck Cancer Squamous Cell CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 78 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07876414
Sponsor's protocol ID: GORTEC 2026-02
Other IDs: 2026-527587-32-00
Acronym: TRACE
Status last verified: Oct 2026
First submitted: 9 Oct 2026
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: A single, secure database will be used, and pseudonymized participant data will be shared among the partners.

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
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Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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Phase 1 Study of STRO-006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic
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