A Single-arm, Multi-institutional, Phase 2 Study of a Pembrolizumab-based Organ Preservation Strategy for Locally Advanced Larynx Cancers

Who is this study for? Patients with locally advanced larynx cancers
What treatments are being studied? Pembrolizumab
Status: Active_not_recruiting
Location: See all (10) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

• A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.

• Female participants:

• A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:

⁃ 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.

• If available, provision of an archived tumor tissue block (or at least 20 newly cut unstained slides) where such samples exist in a quantity sufficient to allow for analysis. A recent (≤3 months) tumor biopsy prior to treatment initiation is an optional requirement, provided that a biopsy procedure is technically feasible, and the procedure is not associated with unacceptable clinical risk. For patients without an available archival sample and who decline a new biopsy prior to study entry, enrolment without tissue provision will be allowed.

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

• Have adequate organ function

Locations
Other Locations
Brazil
Hospital de Amor de Barretos
Barretos
CRIO - Centro Regional Integrado de Oncologia
Fortaleza
Liga Norte Riograndense Contra o Câncer
Natal
CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
Porto Alegre
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto
INCA - Instituto Nacional de Câncer
Rio De Janeiro
FUNFARME - Hospital de Base de São José do Rio Preto
São José Do Rio Preto
A.C. Camargo Cancer Center
São Paulo
BP - A Beneficência Portuguesa de São Paulo
São Paulo
ICESP - Instituto do Câncer do Estado de São Paulo
São Paulo
Time Frame
Start Date: 2022-02-22
Completion Date: 2025-10-16
Participants
Target number of participants: 43
Treatments
Experimental: Treatment: Single Arm
Induction chemo-immunotherapy:~Carboplatin AUC of 6, paclitaxel 175 mg/m2, and pembrolizumab 200 mg, i.v. on day 1, every 21 days for 3 cycles. Patients without disease progression will proceed to the concurrent radioimmunotherapy phase of the trial.~Concurrent radio-immunotherapy:~Radiation therapy given concurrently with pembrolizumab 200 mg i.v. on day 1, every 21 days for 3 cycles. Patients without disease progression will proceed to the consolidation immunotherapy phase of the trial.~Consolidation immunotherapy:~Pembrolizumab 200 mg i.v. on day 1, every 21 days for 11 doses.
Authors
William William
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Latin American Cooperative Oncology Group

This content was sourced from clinicaltrials.gov