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Monoclonal Antibodies
Tiragolumab + Atezolizumab for Advanced Solid Cancer (SKYSCRAPER-11 Trial)
Phase 2
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months
Awards & highlights
SKYSCRAPER-11 Trial Summary
This trial is to test the safety and effectiveness of a new IV treatment for people with advanced and metastatic solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors that are PD-L1 positive and have not been treated with checkpoint inhibitors before. They should be in good health overall, have a life expectancy of at least 12 weeks, and no severe autoimmune diseases or infections. Women must test negative for pregnancy and agree to contraception; men also need to use birth control.Check my eligibility
What is being tested?
The study tests a combination of two drugs, Tiragolumab and Atezolizumab, given together intravenously (IV) to see how safe they are, how the body processes them, and if they cause an immune response against certain types of tumors.See study design
What are the potential side effects?
Possible side effects include reactions related to the infusion process itself, increased risk of infection due to immune system changes caused by the drugs, potential inflammation in various organs like lungs (pneumonitis), liver issues as well as other common drug-related adverse events.
SKYSCRAPER-11 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Adverse Events (AEs)
Secondary outcome measures
AUC of Atezolizumab
Area Under the Concentration Time Curve (AUC) of Tiragolumab
Cmax of Atezolizumab
+3 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
SKYSCRAPER-11 Trial Design
1Treatment groups
Experimental Treatment
Group I: Tiragolumab and Atezolizumab IV FDCExperimental Treatment1 Intervention
Participants will receive tiragolumab and atezolizumab as an intravenous fixed dose combination (IV FDC) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,431 Previous Clinical Trials
1,090,008 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,880 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from side effects of my last treatment, except for hair loss.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I haven't taken any immune-weakening drugs in the last 2 weeks.I agree to use contraception.I have a history of lung conditions.My blood and organs are functioning well.My Type 2 diabetes is not well-managed.I am fully active or can carry out light work.I have a serious liver condition.I have a serious heart condition.I don't have any health issues that prevent me from taking new medications.I haven't had severe infections or taken antibiotics in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Tiragolumab and Atezolizumab IV FDC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities at present to enroll in this clinical experiment?
"Indeed, clinicaltrials.gov's data suggests that this medical research is still recruiting participants. It was initially made public on February 1st 2023 and its most recent update occurred January 13th of the same year. The study necessitates 60 subjects to be recruited from a single site."
Answered by AI
Is intravenous administration of Tiragolumab and Atezolizumab generally considered to be secure for people?
"Due to its Phase 2 status, our team assesses Tiragolumab and Atezolizumab IV FDC as having a safety rating of 2. This is because there are some data points indicating it can be safe but no proof of efficacy has yet been established."
Answered by AI
How many test subjects are participating in this experiment?
"Affirmative, the public data available from clinicaltrials.gov reveals that this trial is presently seeking participants. This research was originally published on February 1st 2023 and underwent a recent revision on January 13th of the same year. 60 volunteers are required for this study at just one site."
Answered by AI
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