Tiragolumab +/− Atezolizumab for Cervical Cancer

(SKYSCRAPER-04 Trial)

No longer recruiting at 130 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: 21

Duration: Up to 17 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of two treatments for cervical cancer that has spread or recurred after treatment: tiragolumab combined with atezolizumab (also known as Tecentriq, an immunotherapy drug) and atezolizumab alone. The focus is on patients with cervical cancer that tests positive for PD-L1, a protein that can help cancer cells evade the immune system. It targets those who have undergone one or two rounds of unsuccessful chemotherapy and still exhibit measurable signs of cancer. Participants should have a type of cervical cancer that no longer responds effectively to surgery, chemotherapy, or radiation. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking systemic immunosuppressive medications at least 1 week before starting and avoid systemic immunostimulatory agents for a certain period before joining. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of tiragolumab and atezolizumab was tested for safety, with no treatment-related deaths or new safety concerns reported. Some overlapping side effects have been observed, which is expected with these types of drugs. Atezolizumab alone has shown promise in improving outcomes for cervical cancer patients in other studies. However, many patients have experienced serious side effects. Considering both the potential benefits and risks is important when deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for cervical cancer, which often involve chemotherapy, radiation, or surgery, the trial is exploring the use of novel immunotherapies: Tiragolumab and Atezolizumab. Atezolizumab is a type of immunotherapy known as a checkpoint inhibitor, which helps the immune system recognize and attack cancer cells. Tiragolumab, also a checkpoint inhibitor, targets a different pathway, potentially enhancing the immune response even further. Researchers are excited about these treatments because they offer a new mechanism of action by engaging the body's immune system to specifically target cancer cells, which might lead to fewer side effects and improved outcomes for patients compared to traditional treatments.

What evidence suggests that this trial's treatments could be effective for cervical cancer?

Studies have shown that atezolizumab, a medication that blocks the PD-L1 protein, can help treat cervical cancer. Specifically, it completely eliminated cancer in 6% of patients and partially reduced it in 16% of patients with solid tumors. On average, patients taking atezolizumab experienced about 13.7 months before their cancer began growing again. In this trial, some participants will receive atezolizumab alone, while others will receive a combination of atezolizumab and tiragolumab. Previous studies suggest that the combination treatment delayed cancer growth for an average of 2.8 months, compared to 1.9 months with atezolizumab alone. This indicates that adding tiragolumab might offer some benefit, but the overall advantages remain uncertain. ^{1 3 4 6 7}

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

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.

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?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11200956/

Efficacy and Safety of Atezolizumab as a PD-L1 Inhibitor in ... Data indicated that atezolizumab provided a complete response of 6% in solid cancers and a partial response rate of 16% with a median ...

2. targetedonc.com targetedonc.com/view/atezolizumab-efficacy-in-cervical-cancer-consistent-irrespective-of-pd-l1

Atezolizumab Efficacy in Cervical Cancer Consistent ... The initial results demonstrated a median PFS of 13.7 months (95% CI, 12.3-16.6) in the atezolizumab arm compared with 10.4 months (95% CI, 9.7- ...

3. onclive.com onclive.com/view/pd-l1-cps-does-not-enrich-the-efficacy-of-atezolizumab-bevacizumab-and-chemo-in-advanced-cervical-cancer

PD-L1 CPS Does Not Enrich the Efficacy of Atezolizumab/ ... In patients with a CPS of less than 1, the median OS was 37.3 months with atezolizumab vs 19.2 months without (HR, 0.43; 95% CI, 0.24-0.77). “ ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.5538

Integrative analysis of VB10.16 and atezolizumab in ... Integrative analysis of VB10.16 and atezolizumab in advanced HPV16-positive cervical cancer: Linking biomarker insights to clinical outcomes.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24000203

A non-comparative, randomized, phase II trial of ... At 8.5 months' median follow-up, independent review committee-assessed progression-free survival was 2.8 months (95% CI 1.7 to 4.1) with tiragolumab plus ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38927498/

Efficacy and Safety of Atezolizumab as a PD-L1 Inhibitor in ... Conclusions: Atezolizumab demonstrates significant potential in improving PFS and OS in patients with cervical cancer, supporting its inclusion ...

7. jitc.bmj.com jitc.bmj.com/content/13/1/e010827

Safety and efficacy of the therapeutic DNA-based vaccine ... The therapeutic DNA-based vaccine VB10.16 combined with atezolizumab was safe and well tolerated showing a promising clinically meaningful efficacy with ...