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Monoclonal Antibodies

Atezolizumab + Tiragolumab for Head and Neck Cancer (SKYSCRAPER-09 Trial)

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Histologically or cytologically confirmed recurrent/metastatic SCCHN involving the oropharynx, oral cavity, larynx, or hypopharynx, that is considered incurable by local therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6, month 12

Awards & highlights

SKYSCRAPER-09 Trial Summary

This trial is testing two different combinations of drugs to see which is more effective in treating squamous cell carcinoma of the head and neck.

Who is the study for?

This trial is for adults with recurrent or metastatic PD-L1 positive squamous cell carcinoma of the head and neck. Participants must have measurable disease, an ECOG status of 0 or 1, a life expectancy of at least 12 weeks, and no prior systemic therapy for their condition. They cannot join if they are pregnant, breastfeeding, have certain lung conditions or other cancers within the last five years, untreated brain metastases, rapid disease progression or recent immunotherapy.Check my eligibility

What is being tested?

The study tests how well Atezolizumab combined with Tiragolumab works compared to Atezolizumab with a placebo in treating this type of cancer as a first-line treatment. It measures the rate at which tumors respond to these treatments and also looks into safety and how the body processes these drugs.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs (like lungs), infusion-related reactions where the drug enters your body, fatigue, potential liver issues and possibly increased risk for infections.

SKYSCRAPER-09 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Select...

My cancer in the throat area is recurring or has spread and cannot be cured with surgery or radiation.

Select...

I haven't had systemic therapy for my metastatic or recurrent head and neck cancer.

Select...

I know my HPV status for throat cancer.

SKYSCRAPER-09 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6, month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Confirmed Objective Response Rate (ORR)

Secondary outcome measures

Cmax of Tiragolumab

Cmin of Tiragolumab

Duration of Response (DOR)

+10 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Neuropathy peripheral

11%

Vomiting

11%

Stomatitis

10%

Arthralgia

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Pain in extremity

Peripheral sensory neuropathy

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Respiratory tract infection

Musculoskeletal chest pain

Lower respiratory tract infection

Acute kidney injury

Depression

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

SKYSCRAPER-09 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Atezolizumab + TiragolumabExperimental Treatment2 Interventions

Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.

Group II: Atezolizumab + PlaceboPlacebo Group2 Interventions

Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

Tiragolumab

2020

Completed Phase 2

~350

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,931 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

888,379 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04665843 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still admitting participants?

"Presently, this trial is not in search of participants. The study was initially listed on March 2nd 2021 and has seen its most recent update November 11th 2022. If you are searching for other studies, 2676 trials with oral squamous cell carcinoma as the primary focus are presently enrolling patients and 351 medical experiments utilizing Atezolizumab have open recruitment slots."

Answered by AI

In what clinical settings is Atezolizumab typically employed?

"Atezolizumab is typically used to address small cell lung cancer (sclc), however, it can also be applied in the treatment of postoperative malignant neoplasms and non-small cell lung carcinoma."

Answered by AI

Are there any precedent experiments involving Atezolizumab?

"In 2008, SCRI Tennessee Oncology Chattanooga was the first to investigate atezolizumab. Since then, 18401 trials have been completed and there are 351 active clinical studies located primarily in Los Angeles, California."

Answered by AI

Is this endeavor pioneering in terms of its approach?

"First explored in 2008 by Hoffmann-La Roche, Atezolizumab was initially trialed on 720 patients. Following the successful Phase 2 drug approval, 351 studies have been conducted across 1646 cities and 74 countries."

Answered by AI

Is there a broad implementation of this study across the US healthcare system?

"The current medical trial is being conducted across 6 sites, including those in Los Angeles, Marietta and La Jolla. For convenience sake, it would be wise to select the location nearest you if deciding to partake."

Answered by AI

How many participants are currently receiving treatment within this investigation?

"Currently, no more patients are being accepted for this clinical trial. It was established on March 2nd 2021 and the last edit to its information occurred November 11th 2022. For alternative studies, 2676 trials focused on oral squamous cell carcinoma are currently recruiting as well as 351 which focus on Atezolizumab use."

Answered by AI

Is Atezolizumab sanctioned by the FDA for therapeutic use?

"There is limited evidence of Atezolizumab's safety, warranting a score of 2 on the rating scale. As this is only a Phase 2 trial, no studies have yet supported its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04665843.

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