A Phase II Single-Arm Clinical Trial Assessing Comprehensive Ablative Radiation Therapy With Avelumab in Unresectable and Metastatic Merkel Cell Carcinoma (CARTA)
Trial tests radiation and immunotherapy for advanced Merkel cell carcinoma
Plain English Summary
Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma is a Phase 2 clinical trial sponsored by Memorial Sloan Kettering Cancer Center studying Merkel Cell Carcinoma. This trial tests a combination of radiation therapy and a drug called avelumab. It is for patients with Merkel cell carcinoma that has spread and cannot be removed by surgery. Participation involves receiving radiation therapy and avelumab infusions. Alternative treatments may include other immunotherapies or chemotherapy. The trial aims to enroll 18 participants.
Official Summary
This study will test the use of comprehensive ablative radiation therapy (CART), with the immunotherapy drug avelumab, in people with Merkel cell carcinoma (MCC) that has progressed after treatment and cannot be removed with surgery. The study researchers want to find out if CART works well when combined with avelumab.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with stage III or IV Merkel cell carcinoma that has spread and cannot be surgically removed. Must have previously received a specific type of immunotherapy (aPD1) and their cancer has progressed. Must be 18 years or older and in good general health, with adequate blood counts and organ function. Cannot have received other types of chemotherapy for this cancer, have certain autoimmune diseases, or have active infections. This trial is studying Merkel Cell Carcinoma, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how long patients live without their cancer getting worse after 12 weeks of treatment. The specific primary outcome measures are: progression free survival (at 12 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses a need for new treatment options for advanced Merkel cell carcinoma that has not responded to initial immunotherapy. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Merkel Cell Carcinoma, where improved treatment options are needed.
Investor Insight
This trial explores a novel combination therapy for a rare but aggressive cancer, potentially offering a new treatment pathway if successful. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this combination therapy is right for you, especially if you've had prior immunotherapy. You will receive radiation therapy and avelumab infusions every two weeks. Regular blood tests and check-ups will be needed to monitor your health and the cancer's response. The trial is being conducted at 7 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 18 participants
Interventions
- DRUG: Avelumab — Avelumab 800 mg given intravenously over 60 minutes (+20 minutes / -10 minutes) every 2 weeks (+/- 3 days)
- RADIATION: Comprehensive Ablative Radiation Therapy — Comprehensive ablative radiation therapy 24 Gy in 3 fractions every 2-3 days
Primary Outcomes
- progression free survival (at 12 weeks)
Secondary Outcomes
- overall response rate (up to 12 weeks)
Full Eligibility Criteria
Inclusion Criteria: * Biopsy proven Merkel cell carcinoma which is unresectable or metastatic, stage III or IV * Prior first-line treatment with aPD1 monotherapy (defined as at least one dose of pembrolizumab, avelumab, nivolumab, etc.) with evidence of progression of disease ≥10 weeks after starting therapy, in the absence of significant clinical deterioration * Patients with clinical deterioration during aPD1 monotherapy are eligible ≥6 weeks after starting aPD1 therapy * Criteria for clinical deterioration to be determined and agreed upon by treating physician and Principal Investigator * All detectable sites of MCC are amenable to comprehensive ablative radiation therapy in opinion of treating radiation oncologist and principal investigator * ≥18 years of age * Performance status ≤2 on the Eastern Cooperative Oncology Group Performance Scale * Able to provide valid written informed consent * Normal organ and marrow function * Hematologic: Neutrophil count ≥1500/mm\^3, platelet count ≥100,000/mm\^3, hemoglobin ≥9 g/dL * Hepatic: Total bilirubin ≤ 1.5 times the upper limit of normal, unless Gilbert's syndrome; aspartate transaminase and alanine transaminase ≤ 2.5 times the upper limit of normal (in the absence of hepatobiliary metastases); ≤ 3.0 times the upper limit of normal (in the presence of hepatobiliary metastases) * Renal: Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula. Exclusion Criteria: * Prior systemic therapy for MCC other than first-line aPD1 monotherapy (ie, chemotherapy) * Pregnancy or breastfeeding * Adverse events due to prior cancer therapy which are grade 3 or higher and have not resolved °Patients with prior grade 3 or higher immune related adverse events are not eligible, even if they have resolved * Prior severe hypersensitivity reaction (CTCAE version 5.0 grade ≥3) to avelumab * Prior radiotherapy which precludes the ability to safely deliver comprehensive ablative radiation therapy in the opinion of the treating radiation oncologist and principal investigator °Institutional guidelines for reirradiation will be used when making this determination * Known central nervous system metastases * Known clinically significant cardiovascular disease, defined as: * Stroke or myocardial infarction within 6 months of first dose of avelumab * Symptomatic congestive heart failure (New York Heart Association Class 2 or higher) * Serious arrhythmia requiring anti-arrhythmic agents * Known Human Immunodeficiency Virus infection * Known Hepatitis B or C infection requiring ongoing treatment * Vaccination within 4 weeks of first dose of avelumab °Inactivated vaccines are permissible * Iatrogenic immunosuppression with daily systemic corticosteroid equivalent of \>10 mg of prednisone * Active autoimmune disease that may cause clinical deterioration during immunotherapy °Including, but not limited to: * Inflammatory bowel disease or immune colitis * Immune mediated pneumonitis or pulmonary fibrosis * History of solid organ or hematopoietic transplant * Active infection requiring systemic therapy * Active suicidal ideation or behavior * Comorbid or diagnostic abnormalities which would interfere with interpretation of study results * Known hematopoietic cancer or dysfunction (i.e., leukemia, lymphoma) * Known non-MCC solid tumor with known metastasis or estimated risk of metastasis \>20% within 3 months
Trial Locations
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, United States
- Memorial Sloan Kettering Commack (All Protocol Activities), Commack, New York, United States
- Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States
- Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale, New York, United States
Frequently Asked Questions
What is clinical trial NCT04792073?
NCT04792073 is a Phase 2 INTERVENTIONAL study titled "Study of Avelumab and/or Radiation Therapy in People With Advanced Merkel Cell Carcinoma." It is currently active, not recruiting and is sponsored by Memorial Sloan Kettering Cancer Center. The trial targets enrollment of 18 participants.
What conditions does NCT04792073 study?
This trial investigates treatments for Merkel Cell Carcinoma. The primary condition under study is Merkel Cell Carcinoma.
What treatments are being tested in NCT04792073?
The interventions being studied include: Avelumab (DRUG), Comprehensive Ablative Radiation Therapy (RADIATION). Avelumab 800 mg given intravenously over 60 minutes (+20 minutes / -10 minutes) every 2 weeks (+/- 3 days)
What does Phase 2 mean for NCT04792073?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT04792073?
This trial is currently "Active, Not Recruiting." It started on 2021-03-08. The estimated completion date is 2027-03.
Who is sponsoring NCT04792073?
NCT04792073 is sponsored by Memorial Sloan Kettering Cancer Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04792073?
The trial aims to enroll 18 participants. The trial status is active, not recruiting.
How is NCT04792073 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT04792073?
The primary outcome measures are: progression free survival (at 12 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04792073 being conducted?
This trial is being conducted at 7 sites, including Basking Ridge, New Jersey; Middletown, New Jersey; Montvale, New Jersey; Commack, New York and 3 more sites (United States).
Where can I find official information about NCT04792073?
The official record for NCT04792073 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04792073. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04792073 testing in simple terms?
This trial tests a combination of radiation therapy and a drug called avelumab. It is for patients with Merkel cell carcinoma that has spread and cannot be removed by surgery.
Why is this trial significant?
This trial addresses a need for new treatment options for advanced Merkel cell carcinoma that has not responded to initial immunotherapy.
What are the potential risks of participating in NCT04792073?
Common side effects of radiation can include skin irritation and fatigue. Avelumab can cause immune-related side effects affecting various organs, such as lungs, liver, or skin. Some patients may experience fatigue, nausea, or diarrhea. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04792073?
Ask your doctor if this combination therapy is right for you, especially if you've had prior immunotherapy. You will receive radiation therapy and avelumab infusions every two weeks. Regular blood tests and check-ups will be needed to monitor your health and the cancer's response. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04792073 signal from an investment perspective?
This trial explores a novel combination therapy for a rare but aggressive cancer, potentially offering a new treatment pathway if successful. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participation involves receiving radiation therapy and avelumab infusions. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.