What side effects are associated with this type of intervention?

Monoclonal antibody immunotherapy, such as pepinemab, used in treating solid tumors can lead to a range of side effects. Common adverse events include asthenia (weakness), rash, nausea, edema, and diarrhea. Severe and serious events, although less frequent, can also occur. These treatments aim to enhance the body's immune response against cancer cells but can also cause immune-related side effects, such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. It is crucial for patients to be monitored closely for these potential side effects during treatment.

What prior FDA approvals exist?

Several monoclonal antibody immunotherapies have received FDA approval for the treatment of solid tumors. Notable examples include Pembrolizumab (Keytruda), which is approved for various cancers such as melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma, and Nivolumab (Opdivo), approved for melanoma, renal cell carcinoma, and non-small cell lung cancer. These therapies work by targeting immune checkpoints like PD-1/PD-L1 to enhance the body's immune response against cancer cells. Similar to Pepinemab, these treatments aim to boost the immune system's ability to fight cancer.

What other types of research exist?

Promising novel alternatives to Pepinemab for solid tumors include: 1) Pembrolizumab (anti-PD-1 therapy), which has shown efficacy in various solid tumors including non-small cell lung cancer and melanoma. 2) Nivolumab combined with Ipilimumab (anti-PD-1 and anti-CTLA-4 therapy), which has demonstrated improved outcomes in melanoma and other cancers. 3) Atezolizumab (anti-PD-L1 therapy), which is effective in non-small cell lung cancer and urothelial carcinoma. 4) Cemiplimab (anti-PD-1 therapy), which has shown promise in non-small cell lung cancer. These therapies are supported by robust clinical trial data and are expected to be key options in 2024.

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Monoclonal Antibodies

Pepinemab for Solid Tumors in Young Patients

Phase 1 & 2

Waitlist Available

Led By Emily G Greengard

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Part B: Patients with recurrent or refractory osteosarcoma with histologic verification of malignancy at original diagnosis or relapse

Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life

Must not have

Patients receiving cyclosporine, tacrolimus, or other agents to prevent graft-versus-host disease post bone marrow transplant

Patients with an uncontrolled infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies pepinemab, an immunotherapy drug, in younger patients with hard-to-treat solid tumors. The drug helps the immune system attack cancer and prevents tumor growth.

Who is the study for?

This trial is for young patients with solid tumors that have returned or are not responding to treatment, excluding brain tumors. Eligible participants must have a confirmed diagnosis and either measurable or evaluable disease. They should be recovered from previous cancer treatments, meet specific blood count criteria, and not have had certain therapies within specified time frames before joining the trial.

What is being tested?

The study is testing pepinemab's safety and effectiveness in treating these cancers. Pepinemab is an immunotherapy drug designed to help the immune system fight cancer by stopping tumor cells from growing and spreading. The trial includes laboratory biomarker analysis and pharmacological studies to determine the best dose of pepinemab.

What are the potential side effects?

Possible side effects of pepinemab may include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions such as fever or chills during administration, fatigue, changes in liver function tests, allergic responses, and potential interference with growth in younger patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My osteosarcoma has come back or didn't respond to treatment, confirmed by tests.

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My condition has no cure or treatments that would extend life with good quality.

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I can do most activities myself, even if I use a wheelchair.

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My bilirubin levels are within the normal range for my age.

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I have a recurring or hard-to-treat tumor outside the brain, confirmed by tests.

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I do not have trouble breathing at rest or during exercise.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.

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I do not have any infections that aren't responding to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Area Under Curve (AUC)

Clearance

Disease Control Rate (Part A)

+6 more

Secondary study objectives

Immunogenicity of Pepinemab

T-lymphocyte Saturation

Total Soluble SEMA4D

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: Treatment (pepinemab)Experimental Treatment3 Interventions

Patients receive pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pepinemab

2021

Completed Phase 2

~80

0 / 8Eligibility criteria met

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

Monoclonal antibody immunotherapy, such as Pepinemab, works by targeting specific antigens on the surface of cancer cells, marking them for destruction by the immune system. These antibodies can block growth signals, recruit immune cells to attack the tumor, or deliver cytotoxic agents directly to cancer cells. This targeted approach is crucial for solid tumor patients as it offers a more precise treatment, potentially reducing damage to healthy tissues and improving overall treatment efficacy.

Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.