← Back to Search

PD-L1 Inhibitor

Plinabulin + Radiation/Immunotherapy for Cancer

Phase 1 & 2

Recruiting

Led By Vivek Subbiah

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

At least one additional non-contiguous lesion that has not been irradiated amenable to radiographic evaluation

Age >= 18 years

Must not have

Men whose partner is a woman of child-bearing potential and who is not employing two forms of highly effective contraception

Unstable cardiovascular function or active cardiac disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of plinabulin when given with radiation therapy and immunotherapy to patients with advanced cancer that has progressed after treatment with PD-1 or PD-L1 targeted antibodies.

Who is the study for?

This trial is for adults with certain advanced cancers that have worsened after treatment with PD-1 or PD-L1 inhibitors. Participants must be in fair health (ECOG 0-2), have at least one tumor suitable for radiation, and adequate organ function. Pregnant women, those with recent major surgery, uncontrolled infections, or heart disease are excluded.

What is being tested?

The study is testing the combination of plinabulin (a drug that targets blood vessels to tumors) with radiation therapy and immunotherapy drugs like Pembrolizumab. The goal is to find the best dose of plinabulin and see if this combo can better treat advanced cancers than current methods.

What are the potential side effects?

Possible side effects include reactions related to immune system changes such as inflammation in organs, fatigue, digestive issues from radiation therapy, blood cell count changes due to plinabulin, and typical risks associated with immunotherapies.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have at least one cancer spot that hasn't been treated with radiation and can be seen on scans.

Select...

I am 18 years old or older.

Select...

My cancer progressed despite previous immunotherapy treatments.

Select...

I am able to get out of my bed or chair and move around.

Select...

I have a cancer lesion that can be treated with radiation.

Select...

My kidney function, measured by GFR, is at least 30 mL/min.

Exclusion Criteria

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

Select...

My female partner can have children and we are not using two effective birth control methods.

Select...

I do not have unstable heart conditions or active heart disease.

Select...

I have severe GI issues or can't control my vomiting or diarrhea.

Select...

I need nutrition through an IV because I can't eat.

Select...

I have had a blockage in my intestines.

Select...

My cancer has spread to my brain.

Select...

I have not had radiation therapy in the last 3 weeks.

Select...

I have been treated with plinabulin before.

Select...

I am allergic to certain cancer immunotherapy drugs.

Select...

I have not had any other invasive cancer diagnosis or recurrence in the last 3 years.

Select...

I am currently on a cancer treatment that is approved or in trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

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

Incidence of adverse events (AEs)

Objective tumor response rate (ORR) (complete response + partial response)

Secondary study objectives

Disease control rate (complete response, partial response + stable disease)

Overall survival

Progression-free survival

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

Active Control

Group I: Arm A (radiation therapy, plinabulin, immunotherapy)Experimental Treatment7 Interventions

Patients undergo radiation therapy on days 1-3, 1-4, or 1-5 of cycle 1. Patients may undergo additional radiation in cycle 2 at the discretion of treating physician. Patients receive plinabulin IV over 30-60 minutes on days 1 and 4 of cycle 1, days 1 and 4 of cycle 2 (if receiving radiation therapy in cycle 2), and day 1 and or 15 (any day receiving immunotherapy) of subsequent cycles. Patients also receive immunotherapy consisting of either: avelumab IV over 1 hour on days 1 and 15; atezolizumab over 30-60 minutes on day 1; durvalumab IV over 1 hour on days 1 and 15; nivolumab IV over 30-60 min on days 1 and 15; or pembrolizumab IV over 30 min on day 1. Cycles repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (radiation therapy, immunotherapy)Active Control6 Interventions

Patients undergo radiation therapy on days 1-3, 1-4, or 1-5 of cycle 1. Patients may undergo additional radiation in cycle 2 at the discretion of treating physician. Patients also receive immunotherapy consisting of either: avelumab IV over 1 hour on days 1 and 15; atezolizumab over 30-60 minutes on day 1; durvalumab IV over 1 hour on days 1 and 15; nivolumab IV over 30-60 min on days 1 and 15; or pembrolizumab IV over 30 min on day 1. Cycles repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

Radiation Therapy

2017

Completed Phase 3

~7250