Study of a Pembrolizumab-based Organ Preservation Strategy for Locally Advanced Larynx Cancers (NCT04943445) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of a Pembrolizumab-based Organ Preservation Strategy for Locally Advanced Larynx Cancers
Brazil43 participantsStarted 2022-02-22
Plain-language summary
This a prospective, single-arm, multi-institutional, open label, phase 2 trial evaluating the effects of induction chemo-immunotherapy, followed by radioimmunotherapy, followed by consolidation immunotherapy in patients with locally advanced squamous cell carcinoma of the larynx who are candidates for organ preservation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At least 18 years of age on the day of signing informed consent
✓. Histologically or cytologically confirmed new diagnosis of squamous cell carcinoma of the larynx (glottic or supraglottic).
✓. Stages III, IVA, or IVB according to the AJCC (American Joint Cancer Committee) staging manual, 8th edition
✓. Male participants:
✓. Female participants:
✓. Not a woman of childbearing potential (WOCBP) OR
✓. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
✓. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Exclusion criteria
✕. Large volume T4 disease, defined as invasion through the cartilage or extension \> 1 cm to the base of the tongue
✕. T1 disease, defined as tumor limited to one subsite of the supraglottis or limited to the vocal cords, with normal vocal-cord mobility, according to the TNM staging system.
✕. Contra indication, in the opinion of the treating physician, for radiotherapy, carboplatin or paclitaxel.
✕. A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment initiation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.
✕. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
✕. Has received any prior systemic anti-cancer therapy for management of the participant's current cancer, including investigational agents prior to allocation.