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Monoclonal Antibodies

SELINEXOR in Combination w/Bevacizumab and Atezolizumab in Newly Diagnosed Advanced Hepatocellular Carcinoma

Phase 1

Waitlist Available

Led By Rutika Mehta, MD, MPH

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if adding Selinexor to the standard treatment of bevacizumab and atezolizumab can help people with advanced liver cancer.

Eligible Conditions

Liver Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months 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 Tolerated Dose

Secondary study objectives

Overall Survival

Progression Free Survival

Rate of Objective Response (per RECIST)

+1 more

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: Dose Level 2 - 80 mg Selinexor with Bevacizumab and AtezolizumabExperimental Treatment3 Interventions

80 mg Selinexor (oral tablet) will be administered once a week continuously. Bevacizumab and atezolizumab will be administered intravenously once every 3 weeks. Each cycle length will be 21 days. On the days when Selinexor and bevacizumab/atezolizumab are given the same day, Selinexor will be administered prior to the intravenous infusions of bevacizumab and atezolizumab.

Group II: Dose Level 1 - 60 mg Selinexor with Bevacizumab and AtezolizumabExperimental Treatment3 Interventions

60 mg Selinexor (oral tablet) will be administered once a week continuously. Bevacizumab and atezolizumab will be administered intravenously once every 3 weeks. Each cycle length will be 21 days. On the days when Selinexor and bevacizumab/atezolizumab are given the same day, Selinexor will be administered prior to the intravenous infusions of bevacizumab and atezolizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Bevacizumab

2013

Completed Phase 4

~5540