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Monoclonal Antibodies

Avelumab Combinations for Triple Negative Breast Cancer (InCITe Trial)

Phase 2

Recruiting

Research Sponsored by Hope Rugo, MD

Eligibility Criteria Checklist

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

Must have

Clinical stage IV invasive breast cancer or unresectable locoregional recurrence of invasive breast cancer meeting specific criteria

Subjects >= 18 years of age

Must not have

Receipt of any organ transplantation including allogeneic stem-cell transplantation

History of acute or chronic pancreatitis, retinal vein occlusion, or requirement of anticoagulant therapy with oral vitamin K antagonists

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from treatment initiation until disease progression, an estimated average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying avelumab in combination with two other drugs to treat triple negative breast cancer.

Who is the study for?

This trial is for adults with stage IV or unresectable, recurrent triple negative breast cancer. Participants must be over 18, have an ECOG status of 0 or 1 (which means they are fully active or restricted in physically strenuous activity but ambulatory), and adequate organ function. They should not have had more than two chemotherapy treatments in the metastatic setting nor more than one prior checkpoint inhibitor therapy.

What is being tested?

The study tests avelumab combined with liposomal doxorubicin, with/without binimetinib, or paired with sacituzumab govitecan to see which works best for treating patients. Avelumab is an immunotherapy drug; sacituzumab govitecan targets tumor cells directly; liposomal doxorubicin is a chemo drug that may reduce side effects; binimetinib blocks enzymes needed for cell growth.

What are the potential side effects?

Potential side effects include immune system reactions due to avelumab, heart problems from liposomal doxorubicin, liver issues from binimetinib, and typical chemotherapy-related symptoms like nausea and fatigue. Sacituzumab govitecan can cause targeted cell death leading to reduced blood counts and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is at stage IV or has come back in the same area and cannot be surgically removed.

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I am 18 years old or older.

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I am willing to undergo a biopsy for the study.

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My cancer's PD-L1 status is known.

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I am fully active or have some restrictions but can still care for myself.

Exclusion Criteria

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

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I have received an organ or stem cell transplant.

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I have had pancreatitis, eye vein blockage, or take blood thinners.

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I do not have significant infections like HIV or hepatitis.

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I don't have lasting side effects from past treatments, severe allergies to monoclonal antibodies, or a history of severe allergic reactions.

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I do not have severe lung problems, uncontrolled heart or blood pressure issues.

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I have had more than one treatment with checkpoint inhibitors for my advanced cancer.

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I have had more than 2 chemotherapy treatments for my cancer after it spread.

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I have brain metastases but meet certain criteria for this trial.

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I have an autoimmune disease that might worsen with immune-stimulating treatments.

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I have a muscle disorder that causes high levels of creatine kinase.

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I have previously been treated with sacituzumab govitecan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from treatment initiation until disease progression, an estimated average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from treatment initiation until disease progression, an estimated average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment initiation until disease progression, an estimated average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Best Overall Response Rate (BORR)

Secondary study objectives

Change in Ability to Participate in Social Roles and Activities Over Treatment Duration Assessed by PROMIS

Change in Ability to Participate in Social Roles and Activities at 8 Weeks Assessed by PROMIS

Change in Quality of Life Over Treatment Duration Assessed by PROMIS Global Health Measure

+10 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: CLOSED TO ENROLLMENT: Arm III (utomilumab, avelumab)Experimental Treatment2 Interventions

Patients will receive a 15-day lead-in of utomilumab, followed by utomilumab IV over 60 minutes every 4 weeks and avelumab IV over 60 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: CLOSED TO ENROLLMENT: Arm II (anti-OX40 antibody PF-04518600, avelumab)Experimental Treatment2 Interventions

Patients will receive a 15-day lead-in of anti-OX40 antibody PF-04518600, followed by anti-OX40 antibody PF-04518600 IV over 60 minutes and avelumab IV over 60 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group III: CLOSED TO ENROLLMENT: Arm I (binimetinib, avelumab)Experimental Treatment2 Interventions

Patients will receive a 15-day lead-in of binimetinib, followed by binimetinib PO BID and avelumab IV over 60 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group IV: Arm C (avelumab, liposomal doxorubicin)Experimental Treatment2 Interventions

Patients will receive a 15-day lead-in of liposomal doxorubicin, followed by liposomal doxorubicin on Day 1 and 10mg/kg avelumab over 60 minutes on Day 1 and Day 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group V: Arm B (avelumab, sacituzumab govitecan)Experimental Treatment2 Interventions

Patients will receive a 15-day lead-in of sacituzumab govitecan given on day -15, followed by sacituzumab govitecan day 8 and day 15 of Cycle (C) 1; day 1,8, and 21 of C2; day 1, 15 and 21 of C3; day 8 and 15 of C4, and schedule continues with two weeks on, one week off for 21-day cycles. Patients also receive 10mg/kg avelumab over 60 minutes on day 1 and day 15 of each 28 day cycle. Cycles repeat in the absence of disease progression or unacceptable toxicity.

Group VI: Arm A (avelumab, binimetinib, liposomal doxorubicin)Experimental Treatment3 Interventions

Patients receive a 15 day lead-in of binimetinib orally (PO) twice daily (BID) in the absence of disease progression or unacceptable toxicity. Patients then receive binimetinib PO BID on days 1-28, avelumab intravenously (IV) over 60 minutes on days 1 and 15, and liposomal doxorubicin IV over 60 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Binimetinib

2018

Completed Phase 3

~1250

Utomilumab

2017

Completed Phase 2

~30