Spots Global Cancer Trial Database for Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.
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Trial Identification
Brief Title: Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.
Official Title: Open Label, Multicenter Phase II Study of the C5a Antibody IFX-1 Alone or IFX-1 + Pembrolizumab in Patients With PD-1 or PD-L1 Resistant/Refractory Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC)
Study ID: NCT04812535
Conditions
Study Description
Brief Summary: This is an open-label, "non comparative", non-randomized, Phase II study. Patients will be enrolled in 2 treatment arms
Detailed Description: This is an open-label, non-randomized, Phase II study. Patients will be enrolled in 2 treatment arms (Arm A: IFX-1 monotherapy; Arm B: IFX-1 + pembrolizumab combination therapy), both consisting of 2 stages whereas Arm B starts with a safety run in portion. Enrollment follows an optimal Simon's 2-stage design with an interim analysis of treatment response after Stage 1 prior to patient enrollment into Stage 2. Arm B will start after ≥3 patients have been treated in Arm A and no toxicity concerns have emerged. In a safety run-in part of Arm B, escalating doses of IFX-1 will be investigated in combination with pembrolizumab in order to identify the MTD or RP2D. Patients will be treated until progression, occurrence of unacceptable toxicity, or treatment discontinuation for any other reason.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UC San Diego Moores Cancer Center, La Jolla, California, United States
Anschutz Cancer Pavilion, Aurora, Colorado, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Orlando Health, Inc., Orlando, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
University Hospital Antwerp (UZA), Edegem, , Belgium
St. Augustinus Hospital, Wilrijk, , Belgium
University Hospital Center of Grenoble Alpes, Department of Dermatology, Grenoble, , France
South Lyon Hospital Center, Lyon, , France
CHU APHM la Timone / Aix Marseille University, Dermatology and Skin Cancer Department, Marseille, , France
St. Louis Hospital, Paris, , France
University Hospital Center of Poitiers, Department of Oncology, Poitiers, , France
University Hospital Erlangen, Department of Dermatology, Erlangen, , Germany
University Duisburg-Essen, University Hospital Essen, Department of Dermatology, Essen, , Germany
Frankfurt University Clinic, Department of Dermatology, Venereology and Allergology, Frankfurt, , Germany
University Hospital Hamburg-Eppendorf, Hamburg, , Germany
University Hospital Leipzig, Department of Dermatology, Venereology and Allergology, Leipzig, , Germany
University Hospital Regensburg, Clinic and Policlinic for Dermatology, Regensburg, , Germany
University Hospital Tuebingen, Department of Dermatology, Tuebingen, , Germany
University Hospital Vall d'Hebron, Barcelona, , Spain
ICO Hospitalet, Barcelona, , Spain
MD Anderson International Cancer Center Spain, Madrid, , Spain
Regional University Hospital of Malaga, Málaga, , Spain
University Clinical Hospital of Salamanca, Salamanca, , Spain
Contact Details
Name: Prof. Dr. D. Schadendorf, MD
Affiliation: University Hospital, Essen
Role: PRINCIPAL_INVESTIGATOR
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