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Studying Insurance Coverage for Off-Label Skin Cancer Treatments

This study looks at how long it takes to get insurance approval and medications, what kind of insurance coverage patients receive, and their out-of-pocket costs for certain skin cancers. It focuses on patients with Merkel Cell Carcinoma (stages II, III, or IV) or locally advanced basal cell carcinoma and other malignant skin tumors. The study is interested in treatments given before surgery, called "neoadjuvant therapy." Sometimes, these treatments are used "off-label," meaning they aren't yet FDA-approved for that specific cancer type. This can lead to delays in insurance approval. By observing patients' experiences, researchers hope to understand the timing, costs, and surgical outcomes for both "off-label" and "on-label" neoadjuvant treatments.

Study design
This is an observational study involving about 70 participants. It does not involve new treatments but rather observes real-life clinical practice.
What's involved
You would complete a survey, and researchers would review your medical records. The study duration for each participant is up to 17 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, such as time spent obtaining approval and drugs, means of coverage, and out-of-pocket expenses, are measured up to study completion, which is up to 17 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07215988

Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study

Recruiting
Not specifiedAges 18+Observational
Ohio State University Comprehensive Cancer Center
~70 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time spent obtaining approval and drugs
Measured over Up to study completion, up to 17 weeks
+3 more outcomes measured

Conditions

Clinical Stage II Cutaneous Merkel Cell Carcinoma AJCC v8
Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8
Locally Advanced Basal Cell Carcinoma
Locally Advanced Malignant Skin Neoplasm
Locally Advanced Merkel Cell Carcinoma
Locally Advanced Mucosal Melanoma
Locally Advanced Squamous Cell Carcinoma

Explore related trials

Basal Cell CarcinomaMerkel Cell CarcinomaMucosal MelanomaSquamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Claire F Verschraegen, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\* MERKEL CELL CARCINOMA
Signed informed consent
Pathology report confirming Merkel at the time of screening
Stage II, III or IV resectable (criteria based on Merkel Cell carcinoma TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy
≥ 18 years of age
Genomics of the cancer attempted
Description of planned surgical resection by surgeon
Planned treatment with immunotherapy. Possible Beacon plan entitled OP NIVOLUMAB IPILIMUMAB NEUROENDOCRINE (PRL 8149)
2 cycles will be given prior to surgery (=12 weeks).
MUCOSAL MELANOMA
Signed informed consent
Pathology report confirming mucosal melanoma at the time of screening
Stage III or IV resectable (TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy
≥ 18 years of age
Genomics of the cancer attempted
Description of planned surgical resection by surgeon
SOC (standard of care) treatment planned with immunotherapy Possible Beacon plan entitled OP NIVOLUMAB IPILIMUMAB -\> NIVOLUMAB Q4 WEEK MAINTENANCE MELANOMA 4 cycles will be given prior to surgery (=12 weeks)
BASAL CELL CARCINOMA
Signed informed consent
Pathology report confirming basal cell carcinoma with subtype at the time of screening
Resectable tumor of any stage, or unresectable tumor that could be amenable to surgery if there is a good response.
≥ 18 years of age
Genomics of the cancer attempted
Description of planned surgical resection by surgeon
SOC treatment planned with possible Beacon plan entitled OP SONIDEGIB BASAL CELL CARCINOMA 3 months will be given prior to surgery (= 12 weeks) (Vismodegib may be substituted if current national shortage of sonidegib persists)
RARE CUTANEOUS CANCERS
Signed informed consent
Pathology report confirming squamous cell carcinoma at the time of screening
Stage II, III, or IV resectable or (TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy
≥ 18 years of age
Genomics of the cancer attempted
Description of planned surgical resection by surgeon
Planned SOC treatment with possible Beacon plan entitled OP WEEKLY CARBOPLATIN PACLITAXEL + PEMBROLIZUMAB Q3 WEEKS HEAD AND NECK
4 cycles will be given prior to surgery (= 12 weeks)

Exclusion

\* MERKEL CELL CARCINOMA
Metastatic disease not amenable to complete resection
Prior immunotherapy, chemotherapy, or radiation therapy for treatment of MCC within the past year
Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy
Is pregnant or breast feeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.
MUCOSAL MELANOMA
Metastatic disease not amenable to complete resection
Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this mucosal melanoma within the past year
Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.
BASAL CELL CARCINOMA
Metastatic disease not amenable to complete resection
Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this basal cell carcinoma within the past year
Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.
RARE CUTANEOUS CANCERS
Metastatic disease not amenable to complete resection
Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this mucosal melanoma within the past year
Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.

What this trial measures

  • Time spent obtaining approval and drugsUp to study completion, up to 17 weeks

    Start and end times for obtaining approval for drugs will be based on date the initial request is submitted by the provider and the date the drugs are obtained. Confidence intervals will provide precision for estimating the mean time spent on obtaining approval and drugs and out-of-pocket expenses for patients.

  • Means of coverageUp to study completion, up to 17 weeks

    Descriptive statistics will summarize the conditions of off label coverage among patients, with mean, median, interquartile range, min, and max for continuous variables and frequencies / percentages for categorical variables.

  • Out of pocket expenses for patientsUp to study completion, up to 17 weeks

    Descriptive statistics will summarize the conditions of off label coverage among patients, with mean, median, interquartile range, min, and max for continuous variables and frequencies / percentages for categorical variables.

  • Extent of surgical resectionUp to study completion, up to 17 weeks

    Planned vs empirical extent of surgical resection will be calculated and compared within each cohort, with Clopper-Pearson exact binomial 95% confidence intervals for the percent of patients receiving lesser extent of surgery.