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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

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.Check my eligibility
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.See study design
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
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I have at least one cancer spot that hasn't been treated with radiation and can be seen on scans.
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I am 18 years old or older.
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My cancer progressed despite previous immunotherapy treatments.
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I am able to get out of my bed or chair and move around.
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I have a cancer lesion that can be treated with radiation.
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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:
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My female partner can have children and we are not using two effective birth control methods.
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I do not have unstable heart conditions or active heart disease.
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I have severe GI issues or can't control my vomiting or diarrhea.
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I need nutrition through an IV because I can't eat.
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I have had a blockage in my intestines.
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My cancer has spread to my brain.
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I have not had radiation therapy in the last 3 weeks.
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I have been treated with plinabulin before.
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I am allergic to certain cancer immunotherapy drugs.
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I have not had any other invasive cancer diagnosis or recurrence in the last 3 years.
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I am currently on a cancer treatment that is approved or in trial.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs)
Objective tumor response rate (ORR) (complete response + partial response)
Secondary outcome measures
Disease control rate (complete response, partial response + stable disease)
Overall survival
Progression-free survival

Side effects data

From 2018 Phase 2 trial • 55 Patients • NCT04345900
38%
Alopecia
31%
Leukopenia
23%
Neutropenia
15%
Nausea
15%
Tachycardia
15%
Sinus Tachycardia
8%
Anaemia
8%
Constipation
8%
Respiratory Tract Infection Viral
8%
Asthma
8%
White Blood Cell Count Decreased
8%
Cardiac Failure
8%
Blood Glucose Increased
8%
Abdominal Pain
8%
Dysgeusia
8%
Bone Pain
8%
Myocardial Ischaemia
8%
Myalgia
8%
Viral Infection
8%
Thrombocytopenia
8%
Pain in Extremity
8%
Non-Cardiac Chest Pain
8%
Dizziness
8%
Complex Regional Pain Syndrome
8%
Neuropathy Peripheral
8%
Atrial Fibrillation
8%
Respiratory Failure
8%
Retching
8%
Decreased Appetite
8%
Fatigue
8%
Myocardial Firbrosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1
Arm 2
Arm 3
Arm 4

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
Atezolizumab
2017
Completed Phase 3
~5860
Nivolumab
2014
Completed Phase 3
~4740
Radiation Therapy
2017
Completed Phase 3
~7250
Avelumab
2018
Completed Phase 2
~2450
Plinabulin
2017
Completed Phase 3
~280
Durvalumab
2017
Completed Phase 2
~3840
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,267 Total Patients Enrolled
Vivek SubbiahPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
362 Total Patients Enrolled
Siqing Fu, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
121 Total Patients Enrolled

Media Library

Atezolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04902040 — Phase 1 & 2
Cancer Research Study Groups: Arm B (radiation therapy, immunotherapy), Arm A (radiation therapy, plinabulin, immunotherapy)
Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04902040 — Phase 1 & 2
Atezolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04902040 — Phase 1 & 2
~2 spots leftby Jun 2025
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