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Peptide Vaccine + Durvalumab + Tremelimumab for Biliary Tract Cancer

Phase 1

Waitlist Available

Led By Marina Baretti, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Age ≥18 years

Must have evidence of radiological disease and accept to have a tumor biopsy of an accessible lesion at baseline and on treatment

Must not have

Has an active known or suspected autoimmune disease or which has required systemic therapy in the last 5 years

Requires the use of home oxygen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and immune response of a personalized mutant peptide vaccine called mBTCvax, along with other medications, in patients with advanced stage bile duct cancer after they have received initial

Who is the study for?

This trial is for patients with advanced biliary tract or pancreatic cancer who have completed initial treatment. It's not suitable for those with certain medical conditions that could interfere with the study, or if they've had previous treatments that might affect the results.

What is being tested?

The trial tests a personalized peptide vaccine (mBTCvax) combined with two immune-boosting drugs, Durvalumab and Tremelimumab, to see how safe it is and how well it triggers an immune response against cancer after first-line therapy.

What are the potential side effects?

Potential side effects may include typical reactions to vaccines such as soreness at injection site, fever, fatigue; and immune-related effects from Durvalumab and Tremelimumab like skin rash, diarrhea, liver inflammation.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I agree to have a biopsy of my cancer before and during treatment.

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I have enough stored tumor tissue for advanced genetic testing.

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My body weight is over 30 kg.

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My organ and bone marrow functions meet the required levels.

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My biliary tract cancer was treated with gemcitabine, cisplatin, and anti-PD(L)1 therapy.

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My cancer has a specific mutation targeted by the vaccine.

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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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I have an autoimmune disease that needed treatment in the last 5 years.

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I need to use oxygen at home.

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I have had another cancer or blood disorder in the last 5 years needing treatment.

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I or my partner can become pregnant and we are not planning to use birth control.

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I have had a cancer-related blockage in my intestines.

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I have not had severe side effects from previous immunotherapy.

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I have had cancer spread to the lining of my brain and spinal cord.

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I have brain metastases.

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I have a history of lung inflammation that needed steroids.

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I have a known history of HIV/AIDS.

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I have both hepatitis B and C or hepatitis B and delta.

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I do not have any uncontrolled illnesses that could interfere with the study.

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I have been diagnosed with an immune system disorder.

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I have not had any organ or tissue transplants, including bone marrow.

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Any side effects from previous immunotherapy have gone away or returned to normal before screening.

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I have been treated with anti-PD-1 or anti-PD-L1 therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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 percentage change in interferon-producing mutant-specific cluster of differentiation 8 (CD8) and cluster of differentiation 4 (CD4) T cells.

Number of participants experiencing grade 3 or above drug-related toxicities

Secondary study objectives

Overall Survival (OS)

Progression Free Survival (PFS)

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: Arm A - mBTCvax, Durvalumab and TremelimumabExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

Tremelimumab

2017

Completed Phase 2

~3070

0 / 24Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

570 Previous Clinical Trials

33,205 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,403 Previous Clinical Trials

289,124,984 Total Patients Enrolled

Private Philanthropic FundsUNKNOWN

3 Previous Clinical Trials

122 Total Patients Enrolled

~17 spots leftby Jan 2029

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