What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly those involving immune checkpoint inhibitors like Atezolizumab, include immune-related adverse events (irAEs) such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Severe adverse events can also occur, including pulmonary embolism, acute myocardial infarction, and sepsis. Management of these side effects often involves withholding the immunotherapy and administering immunosuppressive treatments.

What prior FDA approvals exist?

Atezolizumab, a PD-L1 inhibitor, has received FDA approval for treating several solid tumors, including non-small cell lung cancer (NSCLC) and metastatic renal cell carcinoma (RCC), showing improved overall survival and response duration. Pembrolizumab, a PD-1 inhibitor, is also approved for various solid tumors such as NSCLC and melanoma, demonstrating significant benefits in progression-free and overall survival. These approvals underscore the success of immune checkpoint inhibitors in managing solid tumors.

What other types of research exist?

Promising alternatives for solid tumor treatment in 2024 include: 1) Durvalumab (PD-L1 Inhibition) combined with Tremelimumab (CTLA-4 Inhibition), which has shown trends towards improved overall survival in patients with high tumor mutational burden. 2) Nivolumab (PD-1 Inhibition) combined with Ipilimumab (CTLA-4 Inhibition), which has demonstrated higher response rates in patients with high tissue tumor mutational burden. 3) Pembrolizumab (PD-1 Inhibition) combined with chemotherapy, which has shown clinical benefits in various solid tumors. These alternatives offer different mechanisms of action and have shown promising results in clinical trials.

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Monoclonal Antibodies

RO7296682 + Atezolizumab for Advanced Cancer

Phase 1

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

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 new drug combination to help patients with advanced cancers that haven't responded to other treatments. The drugs aim to boost the immune system's ability to fight cancer.

Who is the study for?

This trial is for adults with advanced solid tumors that have worsened after standard treatment or who can't tolerate it. They must be relatively healthy, able to perform daily activities (ECOG 0-1), and provide a tumor tissue sample. Participants need stable blood clotting if on anticoagulants and agree to use effective birth control. Exclusions include brain cancer, recent major surgery, active infections like Hepatitis B/C or HIV, pregnancy, certain allergies, recent radiotherapy outside of palliative care, dementia preventing consent.

What is being tested?

The study tests the combination of RO7296682 with Atezolizumab in patients with advanced solid tumors. It aims to assess how safe and tolerable this mix is while also checking its initial effectiveness against the tumors.

What are the potential side effects?

While specific side effects are not listed here, common ones related to drugs like RO7296682 and Atezolizumab may include immune-related reactions affecting organs, infusion reactions similar to allergic responses during drug administration, fatigue from treatment burden on the body's resources.

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

3Treatment groups

Experimental Treatment

Group I: Part III (Exploratory)Experimental Treatment2 Interventions

Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I and if clinical activity is seen in this trial or in the single agent study (WP41188). Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab at the dosing regimen established in Part I.

Group II: Part IIExperimental Treatment2 Interventions

Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I. Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab.

Group III: Part IExperimental Treatment2 Interventions

Dose-Escalation: Mixed solid tumors participants will receive ascending doses of RO7296682 with a fixed dose of Atezolizumab, every three weeks (Q3W) until either the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) is defined.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RO7296682

2021

Completed Phase 1

~50

Atezolizumab

2016

Completed Phase 3

~5860

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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, such as Atezolizumab, which targets the PD-L1 protein. These inhibitors work by blocking the interaction between PD-L1 on tumor cells and PD-1 on T cells, thereby preventing the 'off' signal that allows cancer cells to evade the immune system. This reactivates T cells to recognize and attack tumor cells. This mechanism is crucial for solid tumor patients as it enhances the body's natural immune response to fight cancer, potentially leading to better outcomes and prolonged survival. Other treatments may include targeted therapies that focus on specific genetic mutations within the tumor, but immune checkpoint inhibitors like Atezolizumab are particularly significant due to their ability to harness the immune system in combating cancer.

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