A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

NCT05323656 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: GSN000400
• Study Type: interventional
• Target: 55
• Locations: 7 countries
• Sites: 24

Brief Summary

The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab.

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

Squamous Cell Carcinoma of Head and Neck; Setanaxib; Pembrolizumab; SCCHN; Keytruda

Outcome Measures

Primary Outcomes (1)

• Best Percentage Change in Tumour Size

  Defined as the best percentage change from Baseline in the sum of diameters of target lesions, as assessed by RECIST v1.1.

  Baseline to at least 15 weeks and up to 51 weeks

Secondary Outcomes (20)

• Progression Free Survival (PFS)

  Baseline up to approximately 21 months

• Change From Baseline in Cancer-associated Fibroblasts (CAFs) Level in Tumour Tissue

  Baseline up to approximately 9 weeks

• Change From Baseline in the Number of Cluster of Differentiation 8 (CD8+) Tumour Infiltrating Lymphocytes (TILs) in Tumour Tissue

  Baseline up to approximately 9 weeks

• Change From Baseline in the Number of Regulatory T-cells in Tumour Tissue

  Baseline up to approximately 9 weeks

• Overall Response Rate (ORR)

  Baseline up to approximately 12 months

Study Arms (2)

Setanaxib 1600 mg and Pembrolizumab 200 mg

EXPERIMENTAL

Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period. Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.

Drug: Setanaxib; Biological: Pembrolizumab

Placebo and Pembrolizumab 200 mg

ACTIVE COMPARATOR

Participants will be administered placebo for the up to 24-month double-blind treatment period. Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.

Biological: Pembrolizumab; Drug: Placebo

Interventions

Setanaxib DRUG

Oral tablets, 400 mg per tablet

Setanaxib 1600 mg and Pembrolizumab 200 mg

Pembrolizumab BIOLOGICAL

200 mg IV infusion

Also known as: Keytruda

Placebo and Pembrolizumab 200 mg; Setanaxib 1600 mg and Pembrolizumab 200 mg

Placebo DRUG

Oral tablets

Placebo and Pembrolizumab 200 mg

Eligibility Criteria

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

You may qualify if:

• Male or female patients aged ≥18 years, inclusive, at the time of informed consent.
• Willing and able to give informed consent and to comply with the requirements of the study.
• Histologically- or cytologically-confirmed diagnosis of SCCHN that is recurrent or metastatic with or without nodal involvement, and with or without metastatic spread, and is not eligible for surgical resection.
• Candidates for first-line treatment for pembrolizumab for recurrent or metastatic SCCHN, at the discretion of the investigator.
• A positive CAFs level (defined as CAFs level in tumours ≥5%), performed at a central laboratory, with fresh tumour biopsy taken during or within 30 days prior to the Screening Period. If available, suitable archival tissue (taken within 6 months prior to the Screening Visit and where the patient has received no further anti-cancer therapy during this 6-month period) can be used to assess tumour CAFs level and determine patient eligibility.
• Measurable disease, in accordance with RECIST v1.1, and with tumour accessible and of sufficient volume for pre-treatment and on-treatment biopsy.
• Combined positive score (CPS) ≥1, as determined on the archival or fresh tumour biopsy taken during or within 30 days prior to the Screening Period.
• HPV status known at randomisation.
• Life expectancy of at least 6 months in the judgment of the investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ and bone marrow function within 35 days of starting study treatment. Criteria "a" to "c" cannot be met in patients with ongoing or recent (within 14 days of screening test) transfusions or who require ongoing growth factor support:
• Absolute neutrophil count ≥1,000/mm3 (≥ 1.0×109/L).
• Platelet count ≥100,000/mm3 (≥ 100×109/L).
• Haemoglobin ≥9 g/dL, in the absence of transfusions for at least 2 weeks. Patients requiring ongoing transfusions or growth factor support to maintain haemoglobin ≥ 9g/dL are not eligible.
• Total bilirubin ≤1.5×upper limit of normal (ULN) (if associated with liver metastases or Gilbert's disease, ≤3×ULN).

You may not qualify if:

• Diagnosis of immunosuppression or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent. Steroids as premedication for hypersensitivity reactions due to radiographic contrast agents are allowed.
• Anti-cancer mAb treatment within 4 weeks prior to study Day 1.
• Chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 (radiation therapy can be allowed for palliative therapy of bone metastasis only).
• Not recovered from AEs Grade 2 or greater (except for alopecia) due to previously administered agents.
• Treatment with any investigational agent within 12 weeks of Screening Visit or 5 half-lives of the IMP (if known), whichever is longer, or current enrolment in an interventional clinical study.
• Prior treatment with setanaxib or participation in a previous setanaxib clinical study.
• Prior treatment with pembrolizumab.
• Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer that has undergone potentially curative therapy, or malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IMP and of low potential risk for recurrence.
• Known active central nervous system metastases and/or carcinomatous meningitis.
• Active autoimmune disease requiring systemic treatment within the past 3 months or documented history of clinically severe autoimmune disease, or syndrome that requires systemic steroids or immunosuppressive agents. The following are exceptions to this criterion:
• Patients with vitiligo or alopecia.
• Any chronic skin condition that does not require systemic therapy.
• Patients with coeliac disease controlled by diet alone.
• Any evidence of current interstitial lung disease or pneumonitis, or a prior history of interstitial lung disease or non-infectious pneumonitis requiring high-dose glucocorticoids.
• Active infection requiring systemic therapy.

Sponsors & Collaborators

• Calliditas Therapeutics Suisse SA: lead

Study Sites (24)

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Siteman Cancer Center - St. Peters

City of Saint Peters, Missouri, 63376, United States

Location

Siteman Cancer Center - West County

Creve Coeur, Missouri, 63141, United States

Location

Siteman Cancer Center - North County

Florissant, Missouri, 63031, United States

Location

Washington University School of Medicine Center for Advanced Medicine

St Louis, Missouri, 63110, United States

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, Grand Est, 54519, France

Location

Centre de Lutte contre le Cancer - Centre Oscar Lambret

Lille, Hauts-de-France, 59000, France

Location

Centre Hospitalier Universitaire Amiens-Picardie - Site Sud

Amiens, Picardie, 80054, France

Location

Ramsay Health Clinic Belharra

Bayonne, 64100, France

Location

Hôpital Saint-André

Bordeaux, 33000, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Hôpital de la Timone

Marseille, 13005, France

Location

Institut Régional du Cancer de Montpellier

Montpellier, 34298, France

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Azienda Socio-Sanitaria Territoriale Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario

Milan, Milan, 20142, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-792, Poland

Location

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie-Państwowy Instytut Badawczy O. w Gliwicach

Gliwice, Silesian Voivodeship, 44-102, Poland

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

The Royal Marsden Hospital - London

London, England, SW3 6JJ, United Kingdom

Location

The Royal Marsden Hospital Head and Neck Unit

Sutton, England, SM5 5PT, United Kingdom

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

setanaxib; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Head of Clinical Operations
• Organization: Calliditas Therapeutics AB

info@calliditas.com

+4684113005

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 12, 2022
• Study Start: April 6, 2022
• Primary Completion: February 18, 2024
• Study Completion: August 21, 2025
• Last Updated: September 2, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-08

Locations

US (5); PL (2); ES (4); FR (8); DE (1); IT (2); GB (2)