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Arm A - mBTCvax, Durvalumab and Tremelimumab for Pancreatic 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 a histologically- or cytologically, proven biliary tract cancer (BTC) previously treated with gemcitabine/cisplatin/anti-PD(L)1 therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Summary

The purpose of this study is to evaluate the safety and the immune response of personalized mutant peptide vaccine with poly-ICLC adjuvant (mBTCvax) in combination with durvalumab and tremelimumab following front-line treatment in patients with advanced stage BTC.

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

Timeline

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)

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
Tremelimumab
2017
Completed Phase 2
~3130
Durvalumab
2017
Completed Phase 2
~3840

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
565 Previous Clinical Trials
33,354 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,331 Previous Clinical Trials
288,640,060 Total Patients Enrolled
Private Philanthropic FundsUNKNOWN
2 Previous Clinical Trials
70 Total Patients Enrolled
~17 spots leftby Sep 2028
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