What side effects are associated with this type of intervention?

Atezolizumab, a PD-L1 inhibitor, is generally well tolerated but can cause treatment-related adverse events such as fatigue, pruritus, pyrexia, and decreased appetite. Grade 3 or higher adverse events are less common but can include more severe immune-related effects. ONC201, a TRAIL pathway activator, is still under investigation, but similar agents can cause gastrointestinal symptoms, fatigue, and potential liver toxicity. Combining these treatments may lead to overlapping toxicities, necessitating careful monitoring.

What prior FDA approvals exist?

Atezolizumab, a PD-L1 inhibitor, has received FDA approval for the treatment of various metastatic cancers, including non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC), often in combination with other agents like bevacizumab or chemotherapy. Pembrolizumab, another PD-1 inhibitor, is also approved for metastatic cancers such as NSCLC and RCC. These drugs enhance the immune system's ability to target cancer cells by inhibiting the PD-1/PD-L1 pathway. ONC201, a TRAIL pathway activator, is still under investigation and has not yet received FDA approval for metastatic cancer treatment.

What other types of research exist?

Promising alternatives to Atezolizumab + ONC201 for metastatic patients include: 1) Nivolumab (PD-1 Inhibitor) + Ipilimumab (CTLA-4 Inhibitor), which has shown efficacy in various cancers including melanoma and renal cell carcinoma. 2) Pembrolizumab (PD-1 Inhibitor) + Lenvatinib (VEGFR Inhibitor), which has demonstrated benefits in advanced cancers such as hepatocellular carcinoma. 3) Durvalumab (PD-L1 Inhibitor) + Tremelimumab (CTLA-4 Inhibitor), which is being explored in multiple cancer types and has shown promising results in clinical trials.

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Monoclonal Antibodies

ONC201 + Atezolizumab for Endometrial Cancer

Phase 1

Recruiting

Led By Victoria Bae-Jump, MD, PhD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

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 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, atezolizumab and ONC201, to treat women with advanced endometrial cancer who haven't responded to other treatments. Atezolizumab boosts the immune system to fight cancer, while ONC201 stops cancer cells from growing.

Who is the study for?

This trial is for adults over 18 with advanced or recurrent endometrial cancer, who have measurable disease and have had progression after chemotherapy. They must understand the study and consent to participate. Those with adequate organ function and a life expectancy of at least 3 months can join. People cannot join if they've had certain recent treatments, including ONC201, other clinical trials, chemotherapy, radiotherapy, immunostimulatory agents, systemic immunosuppressive medications or checkpoint blockade therapies.

What is being tested?

The trial tests the safety of combining Atezolizumab and ONC201 in treating obesity-related endometrial cancer based on body weight. This combination isn't FDA-approved yet for this use. The study includes both obese and non-obese subjects with metastatic/recurrent endometrial cancer to see how well these drugs work together.

What are the potential side effects?

Potential side effects may include immune-related reactions since Atezolizumab is an immune checkpoint inhibitor that can cause inflammation in various organs; fatigue; infusion reactions; digestive issues like nausea or diarrhea; skin rash; hormonal gland problems (like thyroid); liver enzymes increase.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recommended phase 2 dose (RP2D)

Secondary study objectives

Overall Response Rate (ORR)

Overall Survival (OS)

Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: ObeseExperimental Treatment2 Interventions

Subjects with BMI \> 30 kg/m2

Group II: Non-ObeseExperimental Treatment2 Interventions

Subjects with BMI ≤ 29.9 kg/m2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

ONC201

2017

Completed Phase 2

~60

Do I qualify?Apply below to find out

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

PD-L1 inhibitors, such as Atezolizumab, work by blocking the interaction between PD-L1 on tumor cells and PD-1 on T-cells, thereby enhancing the immune system's ability to recognize and destroy cancer cells. ONC201, a TRAIL pathway activator, induces apoptosis in cancer cells by activating the TRAIL (TNF-related apoptosis-inducing ligand) pathway, which triggers cell death in tumor cells. These mechanisms are crucial for metastasis patients because they target the cancer's ability to evade the immune system and promote cell death, potentially leading to better control of tumor spread and improved patient outcomes.