A Phase 2 interventional study of INCA33890 and Pembrolizumab in Head and Neck Cancer Squamous Cell Carcinoma, sponsored by Groupe Oncologie Radiotherapie Tete et Cou. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Groupe Oncologie Radiotherapie Tete et Cou · Phase 2, Interventional, and Treatment
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:
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:
Groupe Oncologie Radiotherapie Tete et Cou is the lead sponsor of 33 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
INCA33890 900 mg (9 vials of 100 mg) Q2W for 3 cycles as the investigational treatment of this trial.
Drug: INCA33890
Pembrolizumab 200 mg Q3W for 2 cycles, standard of care treatment for the trial population.
Drug: Pembrolizumab
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.
Pembrolizumab (Keytruda®) is an antineoplastic agent for the treatment of patients with SCCHN
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.
Time frame: From enrollment to the end of treatment at 9 weeks or 6 weeks
No study locations are listed for this record.
Plan to share: Yes — A single, secure database will be used, and pseudonymized participant data will be shared among the partners.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Anti-PD-1/Anti-TGFbRII Bispecific Antibody INCA33890
Groupe Oncologie Radiotherapie Tete et Cou