Study on Plinabulin with Radiation and Immunotherapy for Advanced Cancers After PD-1 or PD-L1 Treatment

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04902040

Provider View

This clinical trial is testing a new treatment combining plinabulin with radiation and immunotherapy for patients with certain advanced cancers that have spread and did not respond to previous PD-1 or PD-L1 antibody treatments.

Patient Parameters

Program Overview

The study aims to find the safest and most effective dose of plinabulin when used with radiation and immunotherapy in patients with advanced cancers that have progressed after PD-1 or PD-L1 treatments. Plinabulin works by targeting blood vessels that feed tumors and killing tumor cells. Immunotherapy helps the immune system fight cancer, and radiation uses high-energy rays to shrink tumors. This combination may improve treatment outcomes for advanced cancers.

Description

The study has two main parts: Phase Ib to find the best dose of plinabulin, and Phase II to test its effectiveness. Patients are divided into two groups:

  • Group A: Receives radiation therapy and plinabulin, along with one of several immunotherapy drugs (avelumab, atezolizumab, durvalumab, nivolumab, or pembrolizumab). Treatment cycles repeat every 21 or 28 days unless the cancer worsens or side effects become too severe.

  • Group B: Receives radiation therapy and one of the same immunotherapy drugs without plinabulin. Treatment cycles also repeat every 21 or 28 days.

After finishing the study treatment, patients will have follow-up visits every 12 months to monitor their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Have one of the following cancers: non-small cell lung cancer, small cell lung cancer, kidney cancer, bladder cancer, Merkel cell cancer, microsatellite instability high (MSI-H) cancer, or melanoma.
  • Cancer must have progressed after previous PD-1/PD-L1 antibody treatment, with or without chemotherapy.
  • At least one tumor that can be treated with radiation.
  • At least one other tumor that can be evaluated with scans.
  • Must be 18 years or older.
  • In good overall health with an ECOG performance status of 0-2.
  • Recovered from any major surgery at least 4 weeks before joining the study.
  • Meet specific blood test requirements for platelets, hemoglobin, white blood cells, liver and kidney function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment.

Exclusion Criteria

  • Have a complete or partial bowel obstruction.
  • Have a primary brain tumor or untreated brain metastases.
  • Need total parenteral nutrition.
  • Allergic to any of the immunotherapy drugs used in the study.
  • Have had plinabulin before.
  • Pregnant or breastfeeding.
  • Have had recent radiation, chemotherapy, or other cancer treatments within 3 weeks before starting the study.
  • Have another invasive cancer diagnosed within the last 3 years.
  • Have unstable heart conditions or recent heart attack.
  • Have uncontrolled infections or are positive for HIV, hepatitis B, or hepatitis C.
  • Have significant gastrointestinal issues or uncontrolled vomiting or diarrhea.
  • Are taking other investigational cancer drugs or treatments.
  • Have medical, psychological, or social conditions that could interfere with the study.
  • Men whose partners are women of childbearing potential must use effective contraception during and after treatment.

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