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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

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.

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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