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

Part of paid clinical trials in Miami Beach, Florida.

Sponsor
Calliditas Therapeutics Suisse SA
Study ID
NCT05323656
Phase
PHASE2
Status
Completed

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Setanaxib — DRUG
    Oral tablets, 400 mg per tablet
  • Pembrolizumab — BIOLOGICAL
    200 mg IV infusion
  • Placebo — DRUG
    Oral tablets

Study Details

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.

Key Dates

Start date
Apr 6, 2022
Status verified
Aug 2025
Primary completion
Feb 18, 2024
Completion
Aug 21, 2025

Study Design

Enrollment
55 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Setanaxib 1600 mg and Pembrolizumab 200 mg
    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.
  • Active Comparator: Placebo and Pembrolizumab 200 mg
    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.

Primary Outcome Measure

Best Percentage Change in Tumour Size [ Time Frame: Baseline to at least 15 weeks and up to 51 weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
Siteman Cancer Center - St. PetersCity of Saint PetersMissouri63376-
Siteman Cancer Center - West CountyCreve CoeurMissouri63141-
Siteman Cancer Center - North CountyFlorissantMissouri63031-
Washington University School of Medicine Center for Advanced MedicineSt LouisMissouri63110-

Related coverage on Hipa.ai

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By research site
Mount Sinai Comprehensive Cancer Center· Miami Beach, FLSiteman Cancer Center - St. Peters· City of Saint Peters, MOSiteman Cancer Center - West County· Creve Coeur, MOSiteman Cancer Center - North County· Florissant, MOWashington University School of Medicine Center for Advanced Medicine· St Louis, MO

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