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Monoclonal Antibodies

Pemigatinib + Atezolizumab + Bevacizumab for Bile Duct Cancer

Phase 2

Waitlist Available

Led By Sunyoung Lee, MD,PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Has FGFR2 fusion or rearrangement in tumor tissue. Presence of the FGFR2 fusion and rearrangement should be determined by CLIA-validated genomic testing of a tumor tissue specimen (DNA-based or RNA-based).

Has adequate hematologic and end-organ function, defined by specific laboratory test results.

Must not have

Had previous treatment with selective FGFR inhibitors including erdafitinib, infigratinib, or futibatinib.

Has a history of specific hemoptysis within a defined timeframe.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing whether a combination of pemigatinib, atezolizumab, and bevacizumab can help treat cholangiocarcinoma."

Who is the study for?

This trial is for adults with advanced cholangiocarcinoma, a type of bile duct cancer that has an FGFR2 fusion. Participants should not have had prior treatment with similar drugs and must be in good physical condition to handle the treatments.

What is being tested?

The study tests if pemigatinib combined with atezolizumab and bevacizumab can manage advanced cholangiocarcinoma better than current standard treatments. It's a Phase II trial, which means it's checking the effectiveness and safety of this drug combo.

What are the potential side effects?

Possible side effects include immune-related reactions due to atezolizumab, high blood pressure from bevacizumab, and abnormal blood tests or eye issues from pemigatinib. Each patient may experience different side effects.

Eligibility Criteria

Inclusion Criteria

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

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My tumor has an FGFR2 fusion or rearrangement.

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My blood and organ functions meet the required levels.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

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My cancer is a type that started in the bile ducts and cannot be removed with surgery.

Exclusion Criteria

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

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I have been treated with FGFR inhibitors like erdafitinib.

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I have had coughing up blood in the past within a specific timeframe.

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I have a bleeding disorder.

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I have pain from my cancer that isn't managed well.

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I haven't had chemotherapy, immunotherapy, or other cancer treatments in the last 3 weeks.

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I have a history of or currently have extensive tissue calcification.

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I have a current eye condition affecting my cornea or retina.

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I have had blood clots in the past within a specific time.

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I have high blood pressure that is not well-managed.

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I have high calcium levels in my blood that are causing symptoms.

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I have a history of brain or spinal cord disease.

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I have had certain stomach or intestine problems recently.

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I need frequent procedures to remove fluid from my chest, heart area, or abdomen.

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I have a history of lung problems.

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I have active tuberculosis.

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I have had cancer other than bile duct cancer in the past.

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I have had a severe gastrointestinal bleed in the last 3 months.

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I have had leptomeningeal disease.

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I have been treated with drugs that target blood vessel growth in cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an 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

Safety and adverse events (AEs)

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: Part 2Experimental Treatment3 Interventions

Participants in Part 2, you will receive pemigatinib at the recommended dose that was found in Part 1.

Group II: Part 1Experimental Treatment3 Interventions

Participants enrolled in Part 1, the dose of pemigatinib the participant receive will depend on when the participant join this study. Up to 2 dose levels of pemigatinib will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the highest dose level of pemigatinib. A second group will receive a lower dose of pemigatinib than the group before it, if intolerable side effects are seen.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Pemigatinib

2022

Completed Phase 2

~300