Immunotherapy + Radiation for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of pembrolizumab, with or without targeted radiation, in treating advanced Merkel cell cancer that has metastasized. Pembrolizumab is an immunotherapy drug that helps the immune system attack cancer cells, while the radiation precisely targets tumors to minimize damage to healthy tissue. The study seeks participants with advanced Merkel cell cancer who have not received immunotherapy for this condition and whose cancer has spread beyond the original site. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it does mention that patients with controlled brain metastases must be off steroids for at least 2 weeks before enrolling. 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 pembrolizumab is generally safe, with a well-established safety record. In a study of 2,799 patients, the side effects of pembrolizumab were manageable. Most participants experienced at least one treatment-related side effect, but serious side effects were less common, affecting about 16.3% of patients.
The safety of pembrolizumab combined with stereotactic body radiation therapy (SBRT) has also been studied. In a study of 73 patients who received both treatments, the safety was deemed acceptable, with side effects similar to those expected from each treatment individually.
Overall, pembrolizumab, whether used alone or with SBRT, has a manageable safety profile based on these studies. However, like any treatment, risks and side effects can occur. It is important to discuss expectations with the trial team.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining pembrolizumab with SBRT because it offers a potentially powerful one-two punch against cancer. Pembrolizumab is an immunotherapy that helps the body's immune system recognize and attack cancer cells, a mechanism that's different from traditional chemotherapy. When paired with SBRT, a precise form of radiation therapy, there's hope that the treatment can not only target tumors more effectively but also reduce side effects compared to conventional methods. This combination could potentially enhance the immune response and improve outcomes for patients compared to standard treatments alone.
What evidence suggests that this trial's treatments could be effective for advanced Merkel cell cancer?
Research has shown that pembrolizumab effectively treats advanced cancers, such as Merkel cell cancer. Studies have found that about 22% of patients using pembrolizumab alone survive for five years, supporting its use as a standard treatment for some cancer types. In this trial, one group of participants will receive pembrolizumab alone, while another group will receive a combination of pembrolizumab and stereotactic body radiation therapy (SBRT). Real-world data suggest that combining SBRT with pembrolizumab helps control the disease and might increase survival rates. This combination is believed to strengthen the body's immune response against tumors.36789
Who Is on the Research Team?
Jason J Luke
Principal Investigator
Alliance for Clinical Trials in Oncology
Are You a Good Fit for This Trial?
This trial is for adults with advanced Merkel Cell Carcinoma (MCC) who are in fairly good health, as shown by their ECOG status and normal organ function tests. They must have at least two cancerous deposits suitable for the study treatments and cannot be pregnant or nursing. People with HIV can join if they meet certain health criteria.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab intravenously every 21 days for up to 2 years. Group II also undergoes stereotactic body radiation therapy (SBRT) for 3 doses during cycle 1.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-ups every 6 months for up to 5 years.
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Stereotactic Body Radiation Therapy
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor