What side effects are associated with this type of intervention?

Immune checkpoint inhibitors, such as nivolumab, ipilimumab, pembrolizumab, and durvalumab, commonly cause immune-related adverse events (irAEs). These include skin reactions (rash, pruritus), gastrointestinal issues (diarrhea, colitis), endocrine disorders (thyroid dysfunction, adrenal insufficiency), and pulmonary issues (pneumonitis). Severe adverse events can include hepatitis, nephritis, and myocarditis, resulting from the immune system attacking normal tissues.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of various cancers. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are PD-1 inhibitors approved for multiple cancers, including melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma. Atezolizumab (Tecentriq) and avelumab (Bavencio) are PD-L1 inhibitors approved for urothelial carcinoma and Merkel cell carcinoma, respectively. Ipilimumab (Yervoy) is a CTLA-4 inhibitor approved for melanoma. These drugs work by blocking inhibitory checkpoint molecules, thereby enhancing the immune system's ability to fight cancer.

What other types of research exist?

Promising novel alternatives to Lorigerlimab for immune checkpoint inhibition include Pembrolizumab (Keytruda), Nivolumab (Opdivo), and Atezolizumab (Tecentriq). These agents have shown efficacy in various cancers and are being evaluated in ongoing clinical trials for new indications and combinations. Additionally, Relatlimab, targeting LAG-3, in combination with Nivolumab, is emerging as a novel option with promising results in recent studies.

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Anti-tumor antibiotic

Lorigerlimab + Docetaxel for Prostate Cancer

Phase 2

Recruiting

Research Sponsored by MacroGenics

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 every 3 weeks up to 2 years, followed by every 23 weeks for up to 2 more years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding lorigerlimab to standard treatments (docetaxel and prednisone) can slow down prostate cancer that has spread and is not responding to hormone therapy. Lorigerlimab helps the immune system fight cancer, while docetaxel kills cancer cells, and prednisone manages side effects. About 150 patients will participate, with some receiving the new combination and others receiving just the standard treatment.

Who is the study for?

This trial is for men with advanced prostate cancer that's resistant to hormone therapy and has spread. They should have tried at least one but no more than two previous treatments targeting the androgen receptor, like abiraterone or enzalutamide. If they have a BRCA mutation, they must have been treated with PARP inhibitors. Participants need to be in good physical condition with a decent life expectancy and acceptable lab results.

What is being tested?

The study is testing if adding Lorigerlimab to the standard treatment of Docetaxel and Prednisone can slow down cancer progression in metastatic castration-resistant prostate cancer patients. Patients will be randomly assigned (2:1) to either receive this combination or just Docetaxel and Prednisone.

What are the potential side effects?

Potential side effects include reactions related to immune system activation by Lorigerlimab such as inflammation, fatigue, digestive issues; plus those from chemotherapy like hair loss, nausea, low blood cell counts increasing infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 3 weeks up to 2 years, followed by every 23 weeks for up to 2 more years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 3 weeks up to 2 years, followed by every 23 weeks for up to 2 more years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 weeks up to 2 years, followed by every 23 weeks for up to 2 more 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

Median radiographic progression free survival (rPFS) determined by investigator review.

Secondary study objectives

Clearance (CL)

Description of types of adverse events (AEs) between treatment groups.

Duration of PSA response

+17 more

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: Standard of care docetaxel and prednisoneExperimental Treatment2 Interventions

Docetaxel 75 mg/m\^2 IV every 3 weeks and prednisone 5 mg orally twice daily.(up to 7 months)

Group II: Lorigerlimab + Docetaxel and PrednisoneExperimental Treatment3 Interventions

Lorigerlimab 6 mg/kg IV (up to 2 years) and docetaxel 75 mg/m\^2 IV every 3 weeks (up to 7 months) and prednisone 5 mg orally twice daily (up to 7 months).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

docetaxel

2015

Completed Phase 3

~7230

Prednisone

2014

Completed Phase 4

~2500

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

Immune checkpoint inhibitors, such as Lorigerlimab, work by targeting proteins like PD-1, PD-L1, and CTLA-4 that normally act to downregulate the immune system. By blocking these inhibitory checkpoints, these treatments enhance the immune system's ability to recognize and attack cancer cells. This mechanism is crucial for patients as it can lead to more effective cancer cell destruction, offering a promising option for those with cancers that are resistant to conventional therapies.

ATR Inhibition Induces CDK1-SPOP Signaling and Enhances Anti-PD-L1 Cytotoxicity in Prostate Cancer.Novel immune check point inhibiting antibodies in cancer therapy-Opportunities and challenges.The State of Immune Checkpoint Inhibition in Urothelial Carcinoma: Current Evidence and Future Areas of Exploration.