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Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies

Primary Purpose

Advanced Bladder Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Malignant Solid Neoplasm

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Atezolizumab
Avelumab
Durvalumab
Nivolumab
Pembrolizumab
Plinabulin
Radiation Therapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Bladder Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have one of seven histologically or cytologically confirmed malignant neoplasms (non-small cell lung cancer, small cell lung cancer, renal cell cancer, bladder cancer, Merkle cell cancer, microsatellite instability high (MSI-H) cancer (any histology), and melanoma) progressed on previous anti-PD-1/PD-L1 mAb treatment +/- chemotherapy or anti-CTLA4 requiring further treatment
  • At least one lesion is amenable to radiation
  • At least one additional non-contiguous lesion that has not been irradiated amenable to radiographic evaluation
  • Have measurable disease based on immune-related response criteria (immune-related Response Evaluation Criteria In Solid Tumors [RECIST])
  • Tissue must be newly obtained as a core needle biopsy (not fine-needle aspiration [FNA]) of the lesion being evaluated
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Subjects must be recovered from any prior major surgery. The major surgery must be performed at least 4 weeks prior to consent date
  • Platelets >= 100 x 10^9/L

    • Transfusions and growth factors are allowed
  • Hemoglobin >= 9 g/dL

    • Transfusions and growth factors are allowed
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

    • Transfusions and growth factors are allowed
  • White blood cell (WBC) >= 3 x 10^9/L

    • Transfusions and growth factors are allowed
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) (=< 1.5 x ULN if alkaline phosphatase is > 2.5 x ULN) (In the expansion cohort, subjects with known liver involvement may have ALT =< 5 x ULN)
  • Alkaline phosphatase < 4 x ULN
  • Total bilirubin =< 1 x ULN (In the expansion cohort, subjects with Gilbert's syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of =< 3 x ULN)
  • Albumin >= 3 g/dL
  • Renal function defined as a calculated or measured glomerular filtration rate (GFR) >= 30 mL/min and Cockcroft-Gault equation
  • The patient has recovered to grade =< 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies, with the exception of alopecia. The exceptions for such effects are allowed lab values of =< grade 2 specified elsewhere in these inclusion criteria
  • Subjects must give informed consent according to the rules and regulations of the individual participating sites
  • Negative urine pregnancy test in women of child bearing potential within 7 days of first dose of treatment and subjects of child-bearing potential must agree to use effective contraception during and for 5 months following the last dose of atezolizumab or nivolumab, and for 4 months after the last dose of pembrolizumab, and for 3 months after last dose of durvalumab and avelumab, and for 3 months after your last dose of plinabulin. A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant. This includes women on oral, injectable or mechanical contraception; women who are single and women whose male sexual partners have been vasectomized or whose male sexual partners have received or are utilizing mechanical contraceptive devices

Exclusion Criteria:

  • Evidence of complete or partial bowel obstruction
  • Subjects with primary central nervous system (CNS) tumor or CNS tumor involvement. However, subjects with metastatic CNS tumors may participate in this study if the patient is:

    • > 4 weeks from prior therapy completion
    • Clinically stable with respect to the CNS tumor at the time of study entry
    • Not receiving steroid therapy in treating CNS tumor or CNS tumor involvement
    • Not receiving anti-convulsive medications (that were started for brain metastases)
  • Need of total parenteral nutrition
  • Allergic to any of anti-PD-1/PD-L1 monoclonal antibody (mAb) intended to receive
  • Prior exposure to plinabulin
  • Pregnancy or lactation
  • Radiation (except planned or ongoing palliative radiation to bone outside of the region of measurable disease) =< 3 weeks prior to study drug administration date
  • Chemotherapy, or immunotherapy or any other systemic anticancer therapy =< 3 weeks prior to study drug administration date except anti-PD-1/PD-L1 mAb mono or combination therapy
  • Diagnosis or recurrence of invasive cancer other than the present cancer within 3 years (except basal or squamous cell carcinoma of the skin that has been definitively treated)
  • Major surgery within four weeks before consent date
  • Unstable cardiovascular function or active cardiac disease:

    • Symptomatic ischemia (chest pain of cardiac origin),or
    • Uncontrolled clinically significant conduction abnormalities (e.g. ventricular tachycardia on antiarrhythmics are excluded; 1st degree AV block or asymptomatic Left anterior fascicular block (LAFB)/ right bundle branch block (RBBB) will not be excluded),or
    • Congestive heart failure (CHF) of New York Heart Association (NYHA) class >= 3, or
    • Myocardial infarction (MI) within 3 months of consent date
  • Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to the first dose. Active infection with concurrent treatment is acceptable only if the patient is clinically stable
  • Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C
  • Significantly diseased (as determined by the PI or treating physician) or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea. Presence of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility
  • Treatment with an investigational anti-cancer study drug within 3 weeks prior to study drug administration date
  • Concurrent therapy with approved or investigational anticancer therapeutics
  • Medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Men whose partner is a woman of child-bearing potential, (i.e. biologically able to conceive), and who is not employing two forms of highly effective contraception. Highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for 5 months following the last dose of atezolizumab or nivolumab, for 4 months after the last dose of pembrolizumab, and for 3 months after last dose of durvalumab and avelumab, and for 3 months after your last dose of plinabulin. Women of child-bearing potential is defined as sexually mature women who are not surgically sterile or who have not been naturally postmenopausal for at least 12 consecutive months (e.g., who has had menses any time in the preceding 12 consecutive months)

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (radiation therapy, plinabulin, immunotherapy)

Arm B (radiation therapy, immunotherapy)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of adverse events (AEs)
AEs will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Objective tumor response rate (ORR) (complete response + partial response)
Radiologic evaluations will be performed at screening and every 9 weeks (± 1 week) for 27 weeks (during Q3W dosing) or every 8 weeks (± 1 week) for 24 weeks (during Q4W dosing), then every 12 weeks during treatment cycles in the Treatment Phase regardless of treatment cycles and follow up period. Categorization of response will be based on both immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) and modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.

Secondary Outcome Measures

Disease control rate (complete response, partial response + stable disease)
Assessed according to irRECIST criteria.
Progression-free survival
Will be analyzed using Kaplan-Meier method or Cox regression.
Overall survival
Will be analyzed using Kaplan-Meier method or Cox regression.

Full Information

First Posted
May 5, 2021
Last Updated
August 22, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04902040
Brief Title
Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies
Official Title
An Open-label, Single-Center, Phase 1b/2 Study to Evaluate the Safety of Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Malignancies After Progression on PD-1 or PD-L1 Targeted Antibodies
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase Ib/II trial studies the side effects and best dose of plinabulin in combination with radiation therapy and immunotherapy in patients with select cancers that have spread to other places in the body (advanced) after progression on PD-1 or PD-L1 targeted antibodies. Plinabulin blocks tumor growth by targeting both new and existing blood vessels going to the tumor as well as killing tumor cells. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving plinabulin in combination with radiation therapy and immunotherapy may work better in treating advanced cancers.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the safety and tolerability of plinabulin when administered in combination with radiation/immunotherapy regimen in subjects with select advanced solid malignancies after progression on anti-PD-1/PD-L1 monoclonal antibody (mAb). II. To assess the objective tumor response rate (complete response + partial response). SECONDARY OBJECTIVES: I. To assess disease control rate (complete response, partial response + stable disease). II. To determine progression-free survival (PFS). III. To assess overall survival. EXPLORATORY OBJECTIVES: I. To analyze the gene mutation density within each sample. II. To assess T-cell receptor (TCR) sequencing in tumor tissue and peripheral blood, pre- and post- treatment. III. To perform imaging mass flow cytometry (CyTOF) and/or single cell ribonucleic acid sequencing (RNAseq) analysis on tumor tissue: Immune phenotyping, including dendritic cell (DC), T cells, tumor-associated macrophage (TAM)s, pre and post treatment. IV. To conduct phenotyping analysis of immune cells from peripheral blood using multicolor flow cytometry. V. To evaluate dendritic cell activation from whole blood upon the treatment. VI. To explore general predictive and response biomarker measurements from the collected biomarkers. OUTLINE: This is a phase Ib, dose-escalation study of plinabulin followed by a phase II study. Patients are randomized to 1 of 2 arms. ARM A: 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 intravenously (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. ARM B: 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. After completion of study treatment, patients are followed up every 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Bladder Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Melanoma, Advanced Merkel Cell Carcinoma, Advanced Renal Cell Carcinoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV Merkel Cell Carcinoma AJCC v8, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage III Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Pathologic Stage IV Merkel Cell Carcinoma AJCC v8, Stage III Bladder Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Bladder Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Bladder Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, Stage IVA Bladder Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Bladder Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (radiation therapy, plinabulin, immunotherapy)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B (radiation therapy, immunotherapy)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG7446, RO5541267, Tecentriq
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Avelumab
Other Intervention Name(s)
Bavencio, MSB-0010718C, MSB0010718C
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda, Lambrolizumab, MK-3475, SCH 900475
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Plinabulin
Other Intervention Name(s)
NPI-2358
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo radiation therapy
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Description
AEs will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time Frame
Up to 30 days after last dose of plinabulin
Title
Objective tumor response rate (ORR) (complete response + partial response)
Description
Radiologic evaluations will be performed at screening and every 9 weeks (± 1 week) for 27 weeks (during Q3W dosing) or every 8 weeks (± 1 week) for 24 weeks (during Q4W dosing), then every 12 weeks during treatment cycles in the Treatment Phase regardless of treatment cycles and follow up period. Categorization of response will be based on both immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) and modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Disease control rate (complete response, partial response + stable disease)
Description
Assessed according to irRECIST criteria.
Time Frame
Up to 4 years
Title
Progression-free survival
Description
Will be analyzed using Kaplan-Meier method or Cox regression.
Time Frame
From the first study dose date to the date of first documentation of confirmed disease progression or death (whichever occurs first), assessed up to 4 years
Title
Overall survival
Description
Will be analyzed using Kaplan-Meier method or Cox regression.
Time Frame
From the start date of the treatment period until date of death from any cause, assessed up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have one of seven histologically or cytologically confirmed malignant neoplasms (non-small cell lung cancer, small cell lung cancer, renal cell cancer, bladder cancer, Merkle cell cancer, microsatellite instability high (MSI-H) cancer (any histology), and melanoma) progressed on previous anti-PD-1/PD-L1 mAb treatment +/- chemotherapy or anti-CTLA4 requiring further treatment At least one lesion is amenable to radiation At least one additional non-contiguous lesion that has not been irradiated amenable to radiographic evaluation Have measurable disease based on immune-related response criteria (immune-related Response Evaluation Criteria In Solid Tumors [RECIST]) Tissue must be newly obtained as a core needle biopsy (not fine-needle aspiration [FNA]) of the lesion being evaluated Age >= 18 years Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Subjects must be recovered from any prior major surgery. The major surgery must be performed at least 4 weeks prior to consent date Platelets >= 100 x 10^9/L Transfusions and growth factors are allowed Hemoglobin >= 9 g/dL Transfusions and growth factors are allowed Absolute neutrophil count (ANC) >= 1.5 x 10^9/L Transfusions and growth factors are allowed White blood cell (WBC) >= 3 x 10^9/L Transfusions and growth factors are allowed Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) (=< 1.5 x ULN if alkaline phosphatase is > 2.5 x ULN) (In the expansion cohort, subjects with known liver involvement may have ALT =< 5 x ULN) Alkaline phosphatase < 4 x ULN Total bilirubin =< 1 x ULN (In the expansion cohort, subjects with Gilbert's syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of =< 3 x ULN) Albumin >= 3 g/dL Renal function defined as a calculated or measured glomerular filtration rate (GFR) >= 30 mL/min and Cockcroft-Gault equation The patient has recovered to grade =< 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies, with the exception of alopecia. The exceptions for such effects are allowed lab values of =< grade 2 specified elsewhere in these inclusion criteria Subjects must give informed consent according to the rules and regulations of the individual participating sites Negative urine pregnancy test in women of child bearing potential within 7 days of first dose of treatment and subjects of child-bearing potential must agree to use effective contraception during and for 5 months following the last dose of atezolizumab or nivolumab, and for 4 months after the last dose of pembrolizumab, and for 3 months after last dose of durvalumab and avelumab, and for 3 months after your last dose of plinabulin. A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant. This includes women on oral, injectable or mechanical contraception; women who are single and women whose male sexual partners have been vasectomized or whose male sexual partners have received or are utilizing mechanical contraceptive devices Exclusion Criteria: Evidence of complete or partial bowel obstruction Subjects with primary central nervous system (CNS) tumor or CNS tumor involvement. However, subjects with metastatic CNS tumors may participate in this study if the patient is: > 4 weeks from prior therapy completion Clinically stable with respect to the CNS tumor at the time of study entry Not receiving steroid therapy in treating CNS tumor or CNS tumor involvement Not receiving anti-convulsive medications (that were started for brain metastases) Need of total parenteral nutrition Allergic to any of anti-PD-1/PD-L1 monoclonal antibody (mAb) intended to receive Prior exposure to plinabulin Pregnancy or lactation Radiation (except planned or ongoing palliative radiation to bone outside of the region of measurable disease) =< 3 weeks prior to study drug administration date Chemotherapy, or immunotherapy or any other systemic anticancer therapy =< 3 weeks prior to study drug administration date except anti-PD-1/PD-L1 mAb mono or combination therapy Diagnosis or recurrence of invasive cancer other than the present cancer within 3 years (except basal or squamous cell carcinoma of the skin that has been definitively treated) Major surgery within four weeks before consent date Unstable cardiovascular function or active cardiac disease: Symptomatic ischemia (chest pain of cardiac origin),or Uncontrolled clinically significant conduction abnormalities (e.g. ventricular tachycardia on antiarrhythmics are excluded; 1st degree AV block or asymptomatic Left anterior fascicular block (LAFB)/ right bundle branch block (RBBB) will not be excluded),or Congestive heart failure (CHF) of New York Heart Association (NYHA) class >= 3, or Myocardial infarction (MI) within 3 months of consent date Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to the first dose. Active infection with concurrent treatment is acceptable only if the patient is clinically stable Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C Significantly diseased (as determined by the PI or treating physician) or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea. Presence of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility Treatment with an investigational anti-cancer study drug within 3 weeks prior to study drug administration date Concurrent therapy with approved or investigational anticancer therapeutics Medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results Men whose partner is a woman of child-bearing potential, (i.e. biologically able to conceive), and who is not employing two forms of highly effective contraception. Highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for 5 months following the last dose of atezolizumab or nivolumab, for 4 months after the last dose of pembrolizumab, and for 3 months after last dose of durvalumab and avelumab, and for 3 months after your last dose of plinabulin. Women of child-bearing potential is defined as sexually mature women who are not surgically sterile or who have not been naturally postmenopausal for at least 12 consecutive months (e.g., who has had menses any time in the preceding 12 consecutive months)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siqing Fu, MD, PHD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siqing Fu, MD,PHD
Phone
713-563-1930
Email
CCTTNewPtTeam@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Siqing Fu, MD,PHD

12. IPD Sharing Statement

Learn more about this trial

Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies

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