LEAP-009 : A Phase 2, Randomized, Open-label Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) That Have Progressed After Platinum Therapy and Immunotherapy (PD-1/PD-L1 Inhibitors)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Head and Neck<br/>CancersCancer LocationHead and Neck
Cancers

Systemic therapy,Treatment | Head and neckHead and neck,Oral cavity,Oropharynx,Throat (hypopharynx),Voice box (larynx)

Trial Overview Read MoreRead more

This phase II trial will test the safety and effectiveness of a targeted cancer drug, alone and in combination with immunotherapy, to see if it is better than standard of care chemotherapy in patients with head and neck cancers that have spread, come back and/or gotten worse after treatment.
 

This trial is treating patients with squamous cell carcinoma of the head and neck.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 2, Randomized, Open-label Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) That Have Progressed After Platinum Therapy and Immunotherapy (PD-1/PD-L1 Inhibitors)

Commercial Sponsor

Merck

Summary

Pembrolizumab + Lenvatinib : Participants will be treated with the combination of pembrolizumab (200 mg 30-minute intravenous (IV) infusion on day 1 of each 21-day cycle for 35 cycles), plus lenvatinib (once daily 20 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met. Participants may receive up to an additional 17 cycles of pembrolizumab as Second Course treatment, with or without lenvatinib. Drug: Pembrolizumab : 200 mg 30-minute IV infusion on day 1 of each 21-day cycle

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
Lung and Head & Neck Research Study Coordinator
lung.oncresearch@monashhealth.org
0417607146

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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