Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies
NCT04902040 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2026-04-30
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.
Conditions
- 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
Interventions
- BIOLOGICAL
-
Given IV
- DRUG
-
Avelumab
Given IV
- BIOLOGICAL
-
Given IV
- BIOLOGICAL
-
Given IV
- BIOLOGICAL
-
Given IV
- DRUG
-
Plinabulin
Given IV
- RADIATION
-
Radiation Therapy
Undergo radiation therapy
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Siqing Fu, MD, PHD · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-14
- Primary Completion
- 2025-02-27
- Completion
- 2025-02-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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