What is the mechanism of action of this treatment?

The most common treatments for solid tumors often involve immune checkpoint inhibitors, which enhance the body's immune response against cancer cells. Anti-PD-L1 antibodies like Atezolizumab block the interaction between PD-L1 on tumor cells and PD-1 on T cells, preventing the 'off' signal that stops T cells from attacking the tumor. Anti-TIGIT antibodies like Tiragolumab target the TIGIT protein, another immune checkpoint, to further stimulate T cell activity. This dual inhibition can lead to a stronger and more sustained immune response, which is particularly important for solid tumor patients as it may improve the effectiveness of the treatment and lead to better clinical outcomes.

What side effects are associated with this type of intervention?

Treatments for solid tumors using immune checkpoint inhibitors like Atezolizumab (anti-PD-L1) and potentially Tiragolumab (anti-TIGIT) commonly cause immune-related adverse events (irAEs). These include fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, and pyrexia. More severe side effects can include pneumonitis, colitis, hepatitis, endocrinopathies, and severe hypersensitivity reactions such as anaphylactic shock. Management typically involves immunosuppressive therapies like glucocorticoids.

What prior FDA approvals exist?

Atezolizumab, an anti-PD-L1 antibody, has received FDA approval for the treatment of various solid tumors, including non-small cell lung cancer (NSCLC) and breast cancer. It is often used in combination with chemotherapy or other immunotherapies. For instance, atezolizumab in combination with nab-paclitaxel has been approved for the treatment of metastatic triple-negative breast cancer. Additionally, atezolizumab combined with platinum-based chemotherapy has shown improved overall survival in extensive-stage small cell lung cancer (SCLC). While tiragolumab, an anti-TIGIT antibody, is still under investigation, its combination with atezolizumab aims to enhance anti-tumor efficacy by targeting different immune checkpoints.

What other types of research exist?

Promising novel alternatives to Tiragolumab and Atezolizumab for solid tumors include Pembrolizumab (anti-PD-1 antibody), Nivolumab (anti-PD-1 antibody), and Camrelizumab (anti-PD-1 antibody). These therapies have demonstrated efficacy in various solid tumors and are being actively studied in clinical trials. Additionally, bispecific antibodies like ABT-122 and COVA322, which target multiple pathways, are emerging as potential treatments for solid tumors.

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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 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs given through an IV to help the immune system fight advanced or hard-to-treat solid tumors. The drugs work by making it easier for immune cells to find and destroy cancer cells. The combination of ipilimumab and nivolumab is frequently investigated to improve cancer treatment outcomes, especially in patients who do not benefit from single-drug treatments.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Dysgeusia

Headache

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors often involve immune checkpoint inhibitors, which enhance the body's immune response against cancer cells. Anti-PD-L1 antibodies like Atezolizumab block the interaction between PD-L1 on tumor cells and PD-1 on T cells, preventing the 'off' signal that stops T cells from attacking the tumor. Anti-TIGIT antibodies like Tiragolumab target the TIGIT protein, another immune checkpoint, to further stimulate T cell activity. This dual inhibition can lead to a stronger and more sustained immune response, which is particularly important for solid tumor patients as it may improve the effectiveness of the treatment and lead to better clinical outcomes.

Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.Dual Targeting Autoimmunity and Cancer: From Biology to Medicine.