Who is sponsoring NCT04943445?

NCT04943445 is sponsored by Latin American Cooperative Oncology Group.

What drugs are being tested in NCT04943445?

Interventions in NCT04943445: carboplatin AUC of 6, paclitaxel 175 mg/m2, and pembrolizumab 200 mg, i.v. on day 1, every 21 days for 3 cycles, Concurrent radio-immunotherapy: radiation therapy given concurrently with pembrolizumab 200 mg i.v. on day 1, every 21 days for 3 cycles., Consolidation immunotherapy: pembrolizumab 200 mg i.v. on day 1, every 21 days for 11 doses..

What condition does NCT04943445 study?

NCT04943445 studies Squamous Cell Carcinoma of Larynx.

Is NCT04943445 still recruiting?

NCT04943445 is currently active, enrolled. Last updated 13 February 2025.

Last reviewed 2025-02-13 · How we verify

NCT04943445: SMART-KEY

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of a Pembrolizumab-based Organ Preservation Strategy for Locally Advanced Larynx Cancers

Active, enrolled Phase 2 Last updated 13 February 2025

What this trial tests

Phase 2 trial testing carboplatin AUC of 6, paclitaxel 175 mg/m2, and pembrolizumab 200 mg, i.v. on day 1, every 21 days for 3 cycles in Squamous Cell Carcinoma of Larynx in 43 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 February 2022

Primary endpoint
16 October 2025

16 October 2025

Quick facts

Lead sponsor	Latin American Cooperative Oncology Group
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	22 February 2022
Primary completion	16 October 2025
Estimated completion	16 October 2025
Sites	10 locations across Brazil

Drugs / interventions tested

carboplatin AUC of 6, paclitaxel 175 mg/m2, and pembrolizumab 200 mg, i.v. on day 1, every 21 days for 3 cycles
Concurrent radio-immunotherapy: radiation therapy given concurrently with pembrolizumab 200 mg i.v. on day 1, every 21 days for 3 cycles.
Consolidation immunotherapy: pembrolizumab 200 mg i.v. on day 1, every 21 days for 11 doses. — full drug profile →

Conditions studied

Squamous Cell Carcinoma of Larynx — all drugs for Squamous Cell Carcinoma of Larynx →

Sponsor

Latin American Cooperative Oncology Group

Who can join

18 and older, any sex, with Squamous Cell Carcinoma of Larynx. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Systemic therapy for laryngeal carcinoma.
Fuereder T, Kocher F, Vermorken JB. · · 2025 · cited 4× · PMID 40104492 · DOI 10.3389/fonc.2025.1541385
Is precision medicine the solution to improve organ preservation in laryngeal/hypopharyngeal cancer? A position paper by the Preserve Research Group.
Mattavelli D, Wichmann G, Smussi D, Paderno A, et al · · 2024 · cited 4× · PMID 39165689 · DOI 10.3389/fonc.2024.1433333
Releasing the brakes: the role of immune checkpoint inhibitors in laryngeal cancer.
Athanasopoulos M, Samara P, Agrogiannis G, Athanasopoulos I, et al · · 2025 · cited 3× · PMID 40061133 · DOI 10.37349/etat.2025.1002292
Safety and preliminary activity of pembrolizumab-carboplatin-paclitaxel in heavily pretreated and/or fragile patients with PDL1-positive recurrent/metastatic head and neck cancer.
Cabezas-Camarero S, Merino-Menéndez S, Cabrera-Martín MN, Sotelo MJ, et al · · 2023 · cited 3× · PMID 36589672 · DOI 10.3892/ol.2022.13623

Verify or expand the search:

Other recruiting trials for Squamous Cell Carcinoma of Larynx

Currently open trials in the same condition.

NCT05144698 — RAPA-201 Therapy of Solid Tumors · Phase 1, PHASE2 · recruiting

Other Latin American Cooperative Oncology Group trials

Trials by the same sponsor.

NCT07192991 — Neuroendocrine Carcinomas: Patient Journey And Treatment Outcomes In Latin America · not yet recruiting
NCT06822543 — A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastas · Phase 2 · recruiting
NCT06527690 — Race Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficien · Phase 2 · withdrawn
NCT06279442 — Adrenal Project: Clinical and Epidemiological Characterization of Adrenocortical Carcinoma in a Brazilian Cohort · recruiting
NCT06014580 — Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04943445 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Latin American Cooperative Oncology Group
Last refreshed: 13 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04943445.

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