Plinabulin + Radiation/Immunotherapy for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cancer treatment that combines plinabulin with radiation and immunotherapy. It targets individuals with certain advanced cancers that have spread, even after previous treatments targeting PD-1 or PD-L1 proteins proved ineffective. The trial aims to determine the optimal dose and assess whether this combination can more effectively halt cancer growth. Individuals with advanced non-small cell lung cancer, small cell lung cancer, renal cell cancer, bladder cancer, Merkel cell cancer, MSI-H cancer, or melanoma that has not responded to other treatments may be suitable candidates. Participants should have at least one tumor that can be targeted with radiation and another that can be measured by imaging tests. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on certain cancer treatments or investigational drugs within 3 weeks before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that plinabulin is generally well-tolerated by cancer patients. In studies with over 700 participants, plinabulin proved to be safe, with serious side effects being uncommon. Only 4% of patients experienced treatment-related deaths, a rate similar to those who received a placebo. This suggests that plinabulin does not increase the risk of severe outcomes.
When combined with radiation and immunotherapy, plinabulin has also shown safety. One study revealed that 54% of patients had their disease controlled, meaning their condition either stabilized or improved. This study included patients who had already tried many other treatments, making these positive results encouraging.
The immunotherapies used in the trial, such as atezolizumab and pembrolizumab, have already received FDA approval for other uses, indicating they are generally safe. These treatments can cause side effects like tiredness or nausea, but serious side effects are less common.
Overall, the evidence suggests that the treatments in this trial are generally safe and well-tolerated. However, as with any treatment, there may be risks, and those interested should discuss these with their healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the potential of combining plinabulin with radiation and immunotherapy for cancer treatment. Plinabulin is unique because it acts as a novel agent that targets microtubules, disrupting the blood supply to tumors and enhancing the immune response. This is different from the standard of care that typically involves chemotherapy or immunotherapy alone. By combining plinabulin with radiation and checkpoint inhibitors like pembrolizumab or nivolumab, the treatment may boost the effectiveness of the immune system against cancer cells. This multi-pronged approach could lead to better outcomes and potentially fewer side effects by allowing for lower doses of traditional therapies.
What evidence suggests that this trial's treatments could be effective for advanced cancer?
In this trial, participants will receive different combinations of treatments. Research has shown that plinabulin, included in one treatment arm, can significantly improve survival rates in patients with non-small cell lung cancer when combined with standard treatments. It blocks the blood vessels that supply tumors and kills tumor cells. In the trial, plinabulin is combined with immunotherapy drugs like atezolizumab or pembrolizumab, which have increased survival rates in various cancers, including lung cancer. Another treatment arm involves immunotherapies such as nivolumab and durvalumab, which activate the body's immune system to find and destroy cancer cells. Radiation therapy, included in both arms of the trial, uses high-energy x-rays to shrink tumors. Together, these treatments aim to fight cancer more effectively by combining their strengths.678910
Who Is on the Research Team?
Siqing FU, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive plinabulin in combination with radiation therapy and immunotherapy. Radiation therapy is administered on days 1-3, 1-4, or 1-5 of cycle 1, with potential additional radiation in cycle 2. Plinabulin is given IV on specific days, and immunotherapy is administered according to the specific drug schedule. Cycles repeat every 21 or 28 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 12 months.
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Avelumab
- Durvalumab
- Nivolumab
- Pembrolizumab
- Plinabulin
- Radiation Therapy
Atezolizumab is already approved in United States, European Union for the following indications:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor