A Phase II Single-Arm Clinical Trial Assessing Comprehensive Ablative Radiation Therapy With Avelumab in Unresectable and Metastatic Merkel Cell Carcinoma (CARTA)

STATUS

Recruiting
End date

Mar 18, 2024
participants needed

18
sponsor

Memorial Sloan Kettering Cancer Center

Updated on 18 October 2022

See if I qualify

platelet count

neutrophil count

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.

Details

Condition	Merkel Cell Carcinoma
Treatment	Avelumab, Comprehensive Ablative Radiation Therapy
Clinical Study Identifier	NCT04792073
Sponsor	Memorial Sloan Kettering Cancer Center
Last Modified on	18 October 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
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 progression in only one of several responding metastases will not be eligible
	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: Lymphocyte count ≥800/mm^3, neutrophil count ≥1500/mm^3, platelet count ≥75,000/mm^3, leukocyte count ≥3000/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 radiotherapy which precludes the ability to safely deliver comprehensive ablative radiation therapy in the opinion of the treating radiation oncologist and principal investigator
	Prior severe hypersensitivity reaction (CTCAE version 5.0 grade ≥3) to avelumab
	determination
	°Institutional guidelines for reirradiation will be used when making this
	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
	Iatrogenic immunosuppression with daily systemic corticosteroid equivalent of >10 mg of prednisone
	°Inactivated vaccines are permissible
	Active autoimmune disease that may cause clinical deterioration during immunotherapy
	Inflammatory bowel disease or immune colitis
	°Including, but not limited to
	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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

platelet count

neutrophil count

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

A Phase II Single-Arm Clinical Trial Assessing Comprehensive Ablative Radiation Therapy With Avelumab in Unresectable and Metastatic Merkel Cell Carcinoma (CARTA)