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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
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
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
~4750
Radiation Therapy
2017
Completed Phase 3
~7250
Avelumab
2018
Completed Phase 2
~2450
Plinabulin
2017
Completed Phase 3
~280
Durvalumab
2017
Completed Phase 2
~3870
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,309 Total Patients Enrolled
Vivek SubbiahPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
327 Total Patients Enrolled
Siqing Fu, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
121 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had an untreated infection in the week before starting treatment.I have at least one cancer spot that hasn't been treated with radiation and can be seen on scans.Your absolute neutrophil count is at least 1.5 billion per liter.Your albumin level in your blood is at least 3 grams per deciliter.My female partner can have children and we are not using two effective birth control methods.I do not have unstable heart conditions or active heart disease.I have severe GI issues or can't control my vomiting or diarrhea.I am 18 years old or older.I have mostly recovered from my last treatment, except for hair loss.You have a disease that can be measured using specific criteria related to the immune system's response.My cancer progressed despite previous immunotherapy treatments.I need nutrition through an IV because I can't eat.Your white blood cell count is higher than 3 billion per liter.I haven't had chemotherapy, immunotherapy, or other cancer treatments in the last 3 weeks, except for anti-PD-1/PD-L1.I am able to get out of my bed or chair and move around.I have had a blockage in my intestines.My cancer has spread to my brain.I have not had radiation therapy in the last 3 weeks.I have not had major surgery in the last four weeks.I have a cancer lesion that can be treated with radiation.I have been treated with plinabulin before.Your alkaline phosphatase levels are not more than 4 times the upper limit of normal.I have recovered from any major surgery I had at least 4 weeks ago.Your total bilirubin level should be no higher than the upper limit of normal. If you have Gilbert's syndrome, your total bilirubin level should be no higher than three times the upper limit of normal.My kidney function, measured by GFR, is at least 30 mL/min.I am allergic to certain cancer immunotherapy drugs.Your liver enzymes (AST and ALT) are not too high. If your alkaline phosphatase is very high, then the levels of AST and ALT should be even lower. If you are part of a specific group in the study, then your ALT levels can be a little higher.You have HIV, hepatitis B, or hepatitis C.Your hemoglobin level is at least 9 grams per deciliter.Your platelet count is at least 100 billion per liter.My sample for testing was recently taken with a needle biopsy.I have not had any other invasive cancer diagnosis or recurrence in the last 3 years.I am currently on a cancer treatment that is approved or in trial.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (radiation therapy, immunotherapy)
- Group 2: Arm A (radiation therapy, plinabulin, immunotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What health conditions is Plinabulin most commonly employed to address?
"Plinabulin is commonly prescribed to fight malignant neoplasms, however it has also been used for patients with microsatellite instability high and squamous cell carcinoma. Additionally, it may be beneficial in treating unresectable melanomas."
Answered by AI
What is unique about this research undertaking?
"Currently, there are 2384 Plinabulin trials happening in 79 different countries across 4231 cities. The very first trial conducted was sponsored by Hoffmann-La Roche and tested 720 patients during its Phase 2 approval stage back in 2008. Since then, 821 other studies have been launched."
Answered by AI
What is the aggregate amount of participants in this clinical investigation?
"Affirmative. According to the clinicaltrials.gov listing, this medical trial is actively enrolling members and was first posted on April 14th 2021. The experiment requires 12 individuals from one center in total."
Answered by AI
Are there any open enrollments for this trial presently?
"According to clinicaltrials.gov, this research is actively searching for participants as of now. This trial was first announced on April 14th 2021 and has been updated as recent as June 29th 2022."
Answered by AI
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