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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 and 12 months post-randomization

Awards & highlights

SKYSCRAPER-04 Trial 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.Check my eligibility

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.See study design

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.

SKYSCRAPER-04 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My cervical cancer has returned or persisted after 1-2 chemotherapy treatments and cannot be cured with surgery, more chemo, or radiation.

Select...

I am fully active or can carry out light work.

SKYSCRAPER-04 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 and 12 months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 and 12 months post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 and 12 months post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)

Secondary outcome measures

Cmax of Atezolizumab

Cmin of Atezolizumab

IRC-Assessed Disease Control Rate (DCR)

+12 more

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%

Neuropathy peripheral

11%

Vomiting

11%

Stomatitis

10%

Arthralgia

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Peripheral sensory neuropathy

Pain in extremity

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Respiratory tract infection

Musculoskeletal chest pain

Lower respiratory tract infection

Acute kidney injury

Depression

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

SKYSCRAPER-04 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

Atezolizumab

2017

Completed Phase 3

~5860

Tiragolumab

2020

Completed Phase 2

~460

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,089,714 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,431 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people with the condition still sign up for the trial?

"Unfortunately, this particular trial is no longer recruiting patients. Although the trial's latest update was on October 26th, 2022, it is no longer looking for participants. There are, however, 769 other trials that are currently seeking patients."

Answered by AI

How many willing participants are being enrolled in this clinical trial?

"This particular study is no longer admitting patients. The posting dates were from June 30th, 2020 to October 26th, 2020. However, there are currently 408 clinical trials actively searching for participants with cervical cancers and 361 trials for Tiragolumab admitting patients."

Answered by AI

For what condition is Tiragolumab most often prescribed?

"Tiragolumab is a medication that is often used to help small cell lung cancer patients (sclc), as well as those suffering from malignant neoplasms, non-small cell lung carcinoma, and postoperative conditions."

Answered by AI

Is this research being conducted extensively in North American hospitals?

"Currently, this clinical trial is being conducted at 11 different sites. These locations are in Barrie, London, Hamilton, and 11 other places. If you are selected to participate in this trial, it is important to choose the clinic that is closest to you to minimize travel requirements."

Answered by AI

What is the efficacy of Tiragolumab in other medical trials?

"Tiragolumab was first studied back in 2008 at National Cheng Kung Uni Hospital's Surgery department. Since then, there have been a total of 76 completed clinical trials. There are currently 361 active studies, with many of them taking place in Barrie, Ontario."

Answered by AI

Have there been other tests like this one in the past?

"Tiragolumab has been under medical scrutiny since 2008 when the first clinical trial, sponsored by Genentech, occurred. This first study had 720 participants and after its success, Tiragolumab received Phase 2 drug approval. As of now, there are 361 active studies being conducted in 74 different countries and across 1668 cities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer

2020. "A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04300647.

All > Cervical Cancer