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BC3402 + Tremelimumab + Durvalumab for Liver Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Must not be eligible for locoregional therapy for unresectable HCC. For participants who progressed after locoregional therapy for HCC, locoregional therapy (including TACE or TARE) must have been completed ≥28 days prior to the baseline scan for the current study

Confirmed HCC based on histopathological findings from tumor tissue

Must not have

Active infection including tuberculosis or human immunodeficiency virus

Radiotherapy treatment to more than 30% of the bone marrow within 28 days of the first dose of study drug(s)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from registration up to 2 years post end of treatment(eot) or study closure

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if a new product called BC3402 is safe and effective. BC3402 is still being studied and has not yet been approved by the FDA.

Who is the study for?

This trial is for individuals with hepatocellular carcinoma, a type of liver cancer. Participants should meet specific health criteria set by the study's guidelines but these are not detailed here.

What is being tested?

The trial is testing the safety and effectiveness of an experimental drug called BC3402 in combination with Tremelimumab and Durvalumab to treat liver cancer.

What are the potential side effects?

Possible side effects may include immune-related reactions, fatigue, nausea, and other symptoms common to cancer immunotherapies; however, exact side effects for BC3402 are not provided.

Eligibility Criteria

Inclusion Criteria

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

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I cannot have surgery for my liver cancer and it's been over 28 days since my last local treatment.

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My liver cancer diagnosis was confirmed through a tissue examination.

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I have not had any treatments for my advanced liver cancer that can't be removed by surgery.

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My liver cancer is at an intermediate or advanced stage.

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My liver function is good.

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

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My body weight is under 100kg.

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I am post-menopausal or not pregnant if pre-menopausal.

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I am being treated for Hepatitis B to control the virus.

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I have Hepatitis C confirmed by a positive test.

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I have a tumor that is larger than 10mm and can be measured by scans.

Exclusion Criteria

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

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I do not have an active infection like TB or HIV.

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I haven't had radiation on over 30% of my bone marrow in the last month.

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I am not currently on any cancer treatments like chemotherapy or hormonal therapy.

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I have received an organ from another person.

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

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I have needed fluid drained from my abdomen within the last 6 weeks.

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I have or had an autoimmune or inflammatory disorder.

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I have had cancer before, but it fits the exceptions.

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I have cancer that has spread to my brain or spinal cord.

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My liver cancer is a specific type (fibrolamellar, sarcomatoid, or mixed with bile duct cancer).

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I have previously received treatments targeting PD-1, PD-L1, or CTLA-4.

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I am not pregnant, breastfeeding, and willing to use birth control if of childbearing potential.

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I have not had major surgery in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from registration up to 2 years post end of treatment(eot) or study closure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from registration up to 2 years post end of treatment(eot) or study closure

This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration up to 2 years post end of treatment(eot) or study closure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall response rate(ORR) per RECIST v1.1

Secondary study objectives

Duration of objective response

Overall Survival(OS)

Progression free survival(PFS), per RECIST v1.1

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: BC3402 to tremelimumab plus durvalumabExperimental Treatment3 Interventions

The study consists of two parts: a safety lead-in study part (Phase Ib) to confirm the tolerable dose (RP2D) of BC3402 in combination with T+D followed by an efficacy study part (Phase II) to evaluate preliminary efficacy of the study regimen in a single arm, two stage Minimax design. Note that participants who are treated at the RP2D in the Phase Ib study part will automatically be part of the Phase II study part.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tremelimumab

2017

Completed Phase 2

~3070

Durvalumab

2017

Completed Phase 2

~3750