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Monoclonal Antibodies

Immunomodulation Therapy + Radiation for Metastatic Breast Cancer

Phase 1

Recruiting

Led By Fumito Ito

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

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

Must have

Patient must have lesion that can be biopsied and is willing to undergo the procedure as part of the protocol

The unresectable disease to be irradiated and injected with medications must be located in breast, dermal, subcutaneous, or soft tissue, or lymph nodes with the longest axis of the tumor 2-7 centimeters, and should be considered safe for injection by the investigator

Must not have

Radiation induced sarcoma

Concurrent use of targeted therapy including CDK4/6, mTOR, PIK3CA, PARP, BRAF, MEK inhibitors or chemotherapy (endocrine therapy is allowed)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new immunotherapy treatment for breast cancer that has spread to other parts of the body. The treatment uses a combination of drugs and radiation therapy to kill tumor cells and stimulate the immune system.

Who is the study for?

This trial is for adults with certain advanced cancers (melanoma, SCC, Merkel cell carcinoma, sarcomas, HER2/neu(-) breast cancer) that can't be removed by surgery. Participants must have measurable disease and agree to receive injections of CDX-301, CDX-1140, poly-ICLC and radiation therapy. They should not have had recent heart issues or other invasive cancers in the last 3 years and must not be pregnant.

What is being tested?

The trial tests a combination of radio-immunotherapy treatments including CDX-301 to boost immune cells called dendritic cells; radiation therapy to kill tumor cells; CDX-1140 and Poly-ICLC to activate the immune system against cancer. It aims to see how well these work together in treating patients with unresectable metastatic solid tumors.

What are the potential side effects?

Possible side effects include reactions at injection sites, fatigue from radiation therapy, flu-like symptoms from Poly ICLC (fever/chills), potential activation of autoimmune diseases due to immune stimulation by CDX drugs.

Eligibility Criteria

Inclusion Criteria

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

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I am willing to have a biopsy of my lesion.

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My tumor is in the breast, skin, or lymph nodes, measures 2-7 cm, and can be safely injected.

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My cancer is advanced and cannot be surgically removed, with no cure available.

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My cancer has worsened despite previous treatments.

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I agree to receive injections of CDX-301, CDX-1140, and poly-ICLC.

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I agree to undergo radiation therapy on my tumor.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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My cancer was caused by previous radiation therapy.

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I am not currently on targeted cancer treatments except for hormone therapy.

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I have had immunotherapy directly into a tumor before.

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My heart condition severely limits my daily activities.

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I do not have recent brain metastases treated with radiation within the last 4 weeks.

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I have had a lung condition like pneumonitis but it didn't require treatment.

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I have not had a heart attack or severe heart issue in the last 3 months.

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I have had acute myeloid leukemia or FLT3 genetic changes.

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I have not received any live vaccines in the last 30 days.

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I have inflammatory breast cancer or uveal melanoma.

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I have been diagnosed with HIV.

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I have had a stroke, TIA, DVT, or PE in the past year.

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I am currently taking blood thinners at treatment doses.

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My breast cancer is HER2 positive.

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I haven't had targeted therapy, chemo, radiation, or immunotherapy in the last 3 weeks.

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My bilirubin levels are rising quickly without liver or bile duct issues.

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

Maximum tolerated dose or maximum administered dose

Secondary study objectives

Changes in Immune signatures in the tumor microenvironment

Changes in the levels of PD-L1 expression

Changes in the levels of infiltrating CD4+ and CD8+ T cells

+1 more

Other study objectives

Changes in the levels of peripheral blood (PB) biomarkers

Overall response rate (ORR)

Overall survival

+1 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: Cohort B (immunomodulators, radiation therapy)Experimental Treatment6 Interventions

Patients receive recombinant Flt3 ligand IT on days 1-5 and also receive pembrolizumab (IV), tocilizumab (SC) as well as undergo radiation therapy on day 8 or 9. Patients also receive agonistic anti-CD40 monoclonal antibody IT and IV over 90 minutes and Poly-ICLC IT on day 9 or 10. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Cohort A (immunomodulators, radiation therapy)Experimental Treatment4 Interventions

Patients receive recombinant Flt3 ligand IT on days 1-5 and undergo radiation therapy on day 8 or 9. Patients also receive agonistic anti-CD40 monoclonal antibody CDX-1140 IT and Poly-ICLC IT on day 9 or 10. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Tocilizumab

2012

Completed Phase 4

~1840