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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from treatment initiation until disease progression, an estimated average of 1 year
Awards & highlights
InCITe Trial 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.Check my eligibility
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.See study design
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.
InCITe Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
InCITe Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best Overall Response Rate (BORR)
Secondary outcome measures
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 moreInCITe 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
~1100
Utomilumab
2018
Completed Phase 2
~30
Liposomal Doxorubicin
2013
Completed Phase 2
~570
Avelumab
2018
Completed Phase 2
~2450
Find a Location
Who is running the clinical trial?
Translational Breast Cancer Research ConsortiumOTHER
22 Previous Clinical Trials
2,207 Total Patients Enrolled
13 Trials studying Breast Cancer
1,575 Patients Enrolled for Breast Cancer
Hoosier Cancer Research NetworkOTHER
68 Previous Clinical Trials
3,605 Total Patients Enrolled
8 Trials studying Breast Cancer
853 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,835 Total Patients Enrolled
111 Trials studying Breast Cancer
36,404 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received any vaccines within 28 days before starting the study drugs, except for inactivated ones.My breast cancer is at stage IV or has come back in the same area and cannot be surgically removed.I have received an organ or stem cell transplant.I have had pancreatitis, eye vein blockage, or take blood thinners.I do not have significant infections like HIV or hepatitis.My heart, liver, kidneys, and blood are all functioning well.My thyroid condition is treated and under control.I use corticosteroids or immunosuppressants only under certain conditions.I don't have lasting side effects from past treatments, severe allergies to monoclonal antibodies, or a history of severe allergic reactions.I am 18 years old or older.I agree to use two forms of birth control if I can have children.I do not have severe lung problems, uncontrolled heart or blood pressure issues.I have had more than one treatment with checkpoint inhibitors for my advanced cancer.I have had more than 2 chemotherapy treatments for my cancer after it spread.I am willing to undergo a biopsy for the study.I haven't had cancer other than breast cancer in the last 5 years.My cancer's PD-L1 status is known.I have brain metastases but meet certain criteria for this trial.I have stopped my cancer treatment for a specific time before joining.I have an autoimmune disease that might worsen with immune-stimulating treatments.I have a muscle disorder that causes high levels of creatine kinase.I am fully active or have some restrictions but can still care for myself.I have previously been treated with sacituzumab govitecan.
Research Study Groups:
This trial has the following groups:- Group 1: CLOSED TO ENROLLMENT: Arm II (anti-OX40 antibody PF-04518600, avelumab)
- Group 2: Arm B (avelumab, sacituzumab govitecan)
- Group 3: Arm A (avelumab, binimetinib, liposomal doxorubicin)
- Group 4: Arm C (avelumab, liposomal doxorubicin)
- Group 5: CLOSED TO ENROLLMENT: Arm III (utomilumab, avelumab)
- Group 6: CLOSED TO ENROLLMENT: Arm I (binimetinib, avelumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this particular experiment the inaugural iteration of its type?
"Since 1997, Alfacell has spearheaded research on Binimetinib. After the first study's completion in that same year involving 300 participants, this drug was granted Phase 3 approval. Currently there are 562 active trials for Binimetinib occuring 69 countries and 2472 cities worldwide."
Answered by AI
How many medical centers are actively conducting this investigation?
"Seven medical centres are recruiting participants for this trial, including University of California San Francisco in San Francisco, Mayo Clinic Rochester and the University of Alabama Birmingham. Additionally there are 4 other sites enrolling patients as well."
Answered by AI
Is there any availability for participants in this medical trial?
"According to the clinicaltrials.gov website, this study is currently enrolling participants and has been modified as recently as June 2nd 2022 from its original post date of July 8th 2019."
Answered by AI
Could you outline the potential perils of Binimetinib administration?
"The safety of Binimetinib is rated as a 2 on our team's assessment scale, indicative of its Phase 2 trial status and the absence of efficacy data."
Answered by AI
What other experiments have been conducted to explore Binimetinib's therapeutic potential?
"Currently, 562 medical studies are in progress that investigate Binimetinib. 137 of those active research projects have reached the Phase 3 stage. While most clinical trials for this drug take place in Cambridge, England, there is additionally a global network of 31696 locations conducting tests and gathering data on its effects."
Answered by AI
What is the size of the participant group for this clinical investigation?
"Affirmative. According to the information hosted on clinicaltrials.gov, this medical trial is presently recruiting participants and has been since July 8th 2019 with a most recent update made June 2nd 2022. 150 individuals are being accepted from 7 different facilities."
Answered by AI
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