Immunotherapy + Radiation for Cancer

Not currently recruiting at 305 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

Why 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?

JJ

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

Your blood urea nitrogen level should be less than or equal to 30 mg/dl.
Your diastolic blood pressure is less than or equal to 90 mm Hg.
I am not pregnant or nursing and, if capable of becoming pregnant, I have a recent negative pregnancy test.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-ups every 6 months for up to 5 years.

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • Stereotactic Body Radiation Therapy
Trial Overview The trial is testing whether adding Stereotactic Body Radiation Therapy to Pembrolizumab, an immunotherapy drug, improves outcomes in patients with MCC. Participants will either receive just Pembrolizumab or both treatments together to see which works better.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (pembrolizumab, SBRT)Experimental Treatment2 Interventions
Group II: Group I (pembrolizumab)Active Control1 Intervention

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

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Approved in United States as KEYTRUDA for:
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Approved in European Union as KEYTRUDA for:
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Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
A 74-year-old woman with lung adenocarcinoma developed fatal immune thrombocytopenia after receiving pembrolizumab following radiotherapy, highlighting a potential risk of severe immune-related adverse events (irAEs) when combining these treatments.
Flow cytometry analysis showed increased PD-1 and Ki-67 expression in T cells post-radiotherapy, suggesting that radiotherapy may enhance immune activation and contribute to the development of irAEs in patients undergoing anti-PD-1 therapy.
Pembrolizumab-related Immune Thrombocytopenia in a Patient with Lung Adenocarcinoma Treated by Radiotherapy: Potential Immune-related Adverse Event Elicited by Radiation Therapy.Tamanoi, D., Saruwatari, K., Imamura, K., et al.[2022]

Citations

Five-Year Outcomes With Pembrolizumab Versus ...With 5-year OS rates of up to 22%, these data support the continued use of pembrolizumab monotherapy as a standard-of-care treatment for previously untreated PD ...
Five-Year Data for Merck's KEYTRUDA® (pembrolizumab ...Five-year overall survival rate of 19.4% and 18.4% for KEYTRUDA plus chemotherapy in KEYNOTE-189 and KEYNOTE-407, respectively.
3.keytrudahcp.comkeytrudahcp.com/efficacy/
Efficacy Data for KEYTRUDA® (pembrolizumab)The most common adverse reactions (≥20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%). In KEYNOTE⁠-⁠671, adverse reactions ...
Five-Year Outcomes With Pembrolizumab Versus ...With 5-year OS rates of up to 22%, these data support the continued use of pembrolizumab monotherapy as a standard-of-care treatment for ...
Pembrolizumab improves outcomes in high-risk bladder ...In preliminary data on overall survival, at three years, about 61% of patients in the pembrolizumab group were still alive, compared with about ...
Safety profile of pembrolizumab monotherapy based on an ...Pembrolizumab has a manageable safety profile as described in its label, which was primarily based on 2799 patients who participated in clinical trials for ...
Ten-Year Data for Merck's KEYTRUDA® (pembrolizumab ...At 10 years, more than one-third (34.0%) of patients with advanced melanoma were alive after treatment with KEYTRUDA, compared to 23.6% of patients treated ...
NCT01295827 | Study of Pembrolizumab (MK-3475) in ...The study will investigate the safety, tolerability, and efficacy of pembrolizumab (2 mg/kg and 10 mg/kg) in participants with advanced or metastatic MEL.
Safety of pembrolizumab as adjuvant therapy in a pooled ...In the current analysis, 78.6 % of patients in the pembrolizumab group experienced at least 1 treatment-related AE and 16.3 % experienced at least 1 grade ≥ 3 ...
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