Apply to Trial

Compensation: Varies

Number of Visits: 21

Duration: Up to 17 months

172 Participants Needed

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 GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

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

What You Need to Know Before You Apply

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).

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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

See 4 more

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.

See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tiragolumab plus atezolizumab or atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit

Up to 17 months

Visits every 21 days for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 36 months

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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.

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

Find a Clinic Near You

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

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