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Monoclonal Antibodies

Tiragolumab +/− Atezolizumab for Cervical Cancer (SKYSCRAPER-04 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
Cervical cancer tissue for study analysis (archival or fresh biopsy specimen)
Histologically confirmed recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after progression on or after 1-2 lines of prior systemic chemotherapy in the metastatic/recurrent setting that is not amenable to curative treatment with systemic chemotherapy, surgery, and/or radiotherapy
Must not have
Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization
Active or untreated central nervous system (CNS) or brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new immunotherapy drug for cervical cancer. The drug will be given with or without another immunotherapy drug. The goal is to see if the new drug is safe and effective.

Who is the study for?
This trial is for women with PD-L1-positive cervical cancer that's spread or come back and can't be cured with standard treatments. They should have tried 1-2 chemotherapies, be expected to live at least 12 weeks, have a good performance status (able to carry out daily activities), and agree to use birth control. Women can't join if they've had certain immune therapies, brain metastases, autoimmune diseases, liver disease, are pregnant/breastfeeding or have severe infections.
What is being tested?
The study tests the effectiveness and safety of Tiragolumab combined with Atezolizumab versus Atezolizumab alone in treating advanced cervical cancer. Participants will receive one of these two treatment options to see which works better.
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in different parts of the body, infusion-related reactions like fever or chills during drug administration, fatigue, potential liver issues and an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can provide a sample of my cervical cancer tissue for the study.
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My cervical cancer has returned or persisted after 1-2 chemotherapy treatments and cannot be cured with surgery, more chemo, or radiation.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had any experimental treatments in the last 28 days.
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I have active or untreated brain metastases.
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I haven't taken any immune-weakening drugs in the last week and don't expect to need any during the study.
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I haven't taken any immune-boosting drugs in the last 4 weeks or longer.
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I am allergic to ingredients in tiragolumab or atezolizumab.
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I have previously been treated with specific immune therapies.
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I have active tuberculosis.
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I have a significant liver condition.

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%
Febrile neutropenia
6%
Pneumonia
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Tiragolumab plus AtezolizumabExperimental Treatment2 Interventions
Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Group II: AtezolizumabExperimental Treatment1 Intervention
Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tiragolumab
2019
Completed Phase 3
~1390
Atezolizumab
2016
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,456 Previous Clinical Trials
1,097,440 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,226 Previous Clinical Trials
896,206 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04300647 — Phase 2
Cervical Cancer Research Study Groups: Tiragolumab plus Atezolizumab, Atezolizumab
Cervical Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04300647 — Phase 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04300647 — Phase 2
~32 spots leftby Nov 2025
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