Tiragolumab +/− Atezolizumab for Cervical Cancer

(SKYSCRAPER-04 Trial)

Recruiting at 104 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must not be taking: Immunosuppressants, Immunostimulants

Disqualifiers: Autoimmune disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

172 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent).

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

Inclusion Criteria

I can provide a sample of my cervical cancer tissue for the study.

I am willing to use birth control during the trial.

Radiologically-measurable disease

Exclusion Criteria

I haven't had any experimental treatments in the last 28 days.

I have active or untreated brain metastases.

I haven't taken any immune-weakening drugs in the last week and don't expect to need any during the study.

Treatment Details

Interventions

• Atezolizumab
• Tiragolumab

Trial Overview 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.

Participant Groups

Group I: Tiragolumab plus Atezolizumab Experimental Treatment 2 Interventions

Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Group II: Atezolizumab Experimental Treatment 1 Intervention

Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University