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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
Must not have
Treatment with systemic immunostimulatory agents or systemic immunosuppressive medication
Grade >=2 unresolved toxicity related to surgery or other prior therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My cancer in the throat area is recurring or has spread and cannot be cured with surgery or radiation.
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I haven't had systemic therapy for my metastatic or recurrent head and neck cancer.
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I know my HPV status for throat cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking or have recently taken drugs that affect my immune system.
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I have lasting side effects from past treatments or surgeries.
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I have had lung conditions like pulmonary fibrosis or pneumonitis, or my CT scan shows active pneumonitis.
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I have previously been treated with specific immune therapies.
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I have brain metastases that are untreated or getting worse.
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I have had cancer spread to the lining of my brain and spinal cord.
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I have or had an autoimmune disease or immune deficiency.
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My condition can be treated with the goal of curing it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Pneumonia
6%
Febrile neutropenia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

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
2016
Completed Phase 3
~5860
Tiragolumab
2019
Completed Phase 3
~1390

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,452 Previous Clinical Trials
1,096,180 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,221 Previous Clinical Trials
895,870 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04665843 — Phase 2
~26 spots leftby Nov 2025
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