NCT04665843 (SKYSCRAPER-09) is a Phase 2 clinical trial of Atezolizumab in Squamous Cell Carcinoma of Head and Neck, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT04665843?

NCT04665843 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT04665843?

Interventions in NCT04665843: Atezolizumab, Tiragolumab, Placebo.

What condition does NCT04665843 study?

NCT04665843 studies Squamous Cell Carcinoma of Head and Neck.

Is NCT04665843 still recruiting?

NCT04665843 is currently completed. Last updated 30 September 2025.

Last reviewed 2025-09-30 · How we verify

NCT04665843: SKYSCRAPER-09

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

A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

Completed Phase 2 Last updated 30 September 2025

What this trial tests

Phase 2 trial testing Atezolizumab in Squamous Cell Carcinoma of Head and Neck in 123 participants. Completed in 27 August 2025.

Timeline

2 March 2021

Primary endpoint
20 September 2023

27 August 2025

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	123
Start date	2 March 2021
Primary completion	20 September 2023
Estimated completion	27 August 2025
Sites	47 locations across France, Italy, New Zealand, Greece, Taiwan, United Kingdom, Hungary, Poland

Drugs / interventions tested

Atezolizumab (atezolizumab) — full drug profile →
Tiragolumab (tiragolumab) — full drug profile →
Placebo

Conditions studied

Squamous Cell Carcinoma of Head and Neck — all drugs for Squamous Cell Carcinoma of Head and Neck →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

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

Sponsor's own description

The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.

Publications & conference data

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

TIGIT, the Next Step Towards Successful Combination Immune Checkpoint Therapy in Cancer.
Ge Z, Peppelenbosch MP, Sprengers D, Kwekkeboom J. · · 2021 · cited 166× · PMID 34367161 · DOI 10.3389/fimmu.2021.699895
Co-inhibition of TIGIT and PD-1/PD-L1 in Cancer Immunotherapy: Mechanisms and Clinical Trials.
Chu X, Tian W, Wang Z, Zhang J, et al · · 2023 · cited 147× · PMID 37291608 · DOI 10.1186/s12943-023-01800-3
TIGIT/CD226 Axis Regulates Anti-Tumor Immunity.
Yeo J, Ko M, Lee DH, Park Y, et al · · 2021 · cited 98× · PMID 33670993 · DOI 10.3390/ph14030200
Blockade of novel immune checkpoints and new therapeutic combinations to boost antitumor immunity.
Archilla-Ortega A, Domuro C, Martin-Liberal J, Muñoz P. · · 2022 · cited 61× · PMID 35164813 · DOI 10.1186/s13046-022-02264-x
Novel Systemic Treatment Modalities Including Immunotherapy and Molecular Targeted Therapy for Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma.
Ghosh S, Shah PA, Johnson FM. · · 2022 · cited 47× · PMID 35887235 · DOI 10.3390/ijms23147889
Promising immunotherapy targets: TIM3, LAG3, and TIGIT joined the party.
Lu C, Tan Y. · · 2024 · cited 43× · PMID 38596295 · DOI 10.1016/j.omton.2024.200773
Immunotherapy Approaches in HPV-Associated Head and Neck Cancer.
Julian R, Savani M, Bauman JE. · · 2021 · cited 41× · PMID 34884999 · DOI 10.3390/cancers13235889
Current status and perspective of tumor immunotherapy for head and neck squamous cell carcinoma.
Yu C, Li Q, Zhang Y, Wen ZF, et al · · 2022 · cited 31× · PMID 36092724 · DOI 10.3389/fcell.2022.941750

Verify or expand the search:

Other trials of Atezolizumab

Trials testing the same drug.

NCT07388524 — Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer · Phase 3 · not yet recruiting
NCT07322341 — SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce · Phase 2 · recruiting
NCT07461675 — Effects of Neoadjuvant Immunotherapy on Anti-tumour Immunity in Hepatocellular Carcinoma Patients Undergoing Liver Resec · Phase 3 · not yet recruiting
NCT07291076 — A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants Wit · Phase 1, PHASE2 · recruiting

Other recruiting trials for Squamous Cell Carcinoma of Head and Neck

Currently open trials in the same condition.

NCT07455032 — Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous · Phase 1 · recruiting
NCT07219212 — A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck S · Phase 1 · recruiting
NCT07276399 — A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurre · Phase 3 · recruiting
NCT07063212 — A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC) · Phase 2 · recruiting
NCT06487403 — HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune R · NA · recruiting

Other Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · 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 NCT04665843 (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 Hoffmann-La Roche
Last refreshed: 30 September 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/NCT04665843.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing