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Study to evaluate the efficacy and safety of petosemtamab compared to the investigator's monotherapy of choice in patients with incurable and previously treated metastatic/recurrent metastatic/recurrent head and neck squamous cell carcinoma.

THE AIMS OF THIS STUDY ARE TO: - TO COMPARE THE EFFECT OF PETOSEMTAMAB ON REDUCING THE AMOUNT OF CANCER PRESENT IN THEIR BODY WITH THAT OF THE REFERENCE TREATMENT. - TO COMPARE THE EFFECT OF PETOSEMTAMAB ON SURVIVAL WITH THAT OF THE REFERENCE TREATMENT. - TO ASSESS THE SAFETY OF PETOSEMTAMAB AND HOW WELL YOU TOLERATE IT. - ASSESS THE EFFECT PETOSEMTAMAB MIGHT HAVE ON YOUR QUALITY OF LIFE. - DETERMINE HOW YOUR BODY PROCESSES THE STUDY DRUG (CALLED "PHARMACOKINETICS"). - DETERMINE HOW THE STUDY DRUG AFFECTS YOUR BODY (CALLED "PHARMACODYNAMICS").

Status
In recruitment
headquarters
Pamplona

Technical Summary

  • OPEN-LABEL, RANDOMIZED, CONTROLLED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PETOSEMTAMAB COMPARED TO THE INVESTIGATOR'S MONOTHERAPY OF CHOICE IN PATIENTS WITH INCURABLE AND PREVIOUSLY TREATED METASTATIC/RECURRENT METASTATIC/RECURRENT HEAD AND NECK SQUAMOUS CELL CARCINOMA. IMMUNOTHERAPY.
  • Code EudraCT: 2023-510322-32
  • Protocol number: MCLA-158-CL02
  • Promoter: Merus N.V.
  • Molecule/Drug: petosemtamab

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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