Clinical Stage II Cutaneous Merkel Cell Carcinoma AJCC v8NCT07215988
Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study
An observational study of Clinical Stage II Cutaneous Merkel Cell Carcinoma AJCC v8 and Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study evaluates the time spent on obtaining insurance approval and drugs, means of insurance coverage, out-of-pocket costs for patients, and the surgical outcomes after neoadjuvant treatment is completed in skin cancer patients receiving "off label" and "on label" neoadjuvant treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- What is being tested?
- Non-Interventional Study
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with Merkel cell carcinoma, mucosal melanoma, basal cell carcinoma, and miscellaneous rare cutaneous cancers will be recruited from The James Comprehensive Cancer Center during the course of usual care.
Who may be able to join
- * 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
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- 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)
Who cannot join
- * 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Claire F. Verschraegen, MD, 614-366-5068, claire.verschraegen@osumc.edu
Claire F. Verschraegen, MD
About this study
This study evaluates the time spent on obtaining insurance approval and drugs, means of insurance coverage, out-of-pocket costs for patients, and the surgical outcomes after neoadjuvant treatment is completed in skin cancer patients receiving "off label" and "on label" neoadjuvant treatment. "Neoadjuvant therapy" means cancer treatment given before surgery. However, in many instances, neoadjuvant therapy is used as an "off-label" approach for several types of skin cancers. "Off-label" means that the FDA has not yet approved its use for that type of cancer. Therefore, insurance approval of these "off-label" treatments could be delayed compared to label use, and "off-label" treatments may require several weeks of pre-authorization. There is evidence that the delayed start of cancer treatment can lead to poorer outcomes.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess in real-life clinical practice, the timing, cost, and surgical outcomes of patients who have resectable various skin cancers that are locally advanced or have a high risk of recurrence.
OUTLINE: This is an observational study.
Patients complete a survey and have their medical records reviewed on study.
- 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
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Merkel cell carcinoma | Patients complete a survey and have their medical records reviewed on study. Receives: Other: Non-Interventional Study | |
| Cohort 2: Mucosal melanoma | Patients complete a survey and have their medical records reviewed on study. Receives: Other: Non-Interventional Study | |
| Cohort 3: Basal cell carcinoma | Patients complete a survey and have their medical records reviewed on study. Receives: Other: Non-Interventional Study | |
| Cohort 4: Rare cutaneous cancers | Patients complete a survey and have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent obtaining approval and drugs
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.
Measured: Up to study completion, up to 17 weeks
Means of coverage
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.
Measured: Up to study completion, up to 17 weeks
Out of pocket expenses for patients
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.
Measured: Up to study completion, up to 17 weeks
Extent of surgical resection
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.
Measured: Up to study completion, up to 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start4 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage II Cutaneous Merkel Cell Carcinoma AJCC v8Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Verschraegen, Ohio State University Comprehensive Cancer Center
- Investigators
- Claire F Verschraegen, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215988
- Sponsor's protocol ID
- OSU-23272
- Other IDs
- NCI-2025-07206
- Status last verified
- Jun 2026
- First submitted
- 9 Oct 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study
- ClinicalTrials.gov ID
- NCT07215988
- Acronym / sponsor ID
- OSU-23272
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the time spent on obtaining insurance approval and drugs, means of insurance coverage, out-of-pocket costs for patients, and the surgical outcomes after neoadjuvant treatment is completed in skin cancer patients receiving "off label" and "on label" neoadjuvant treatment. "Neoadjuvant therapy" means cancer treatment given before surgery. However, in many instances, neoadjuvant therapy is used as an "off-label" approach for several types of skin cancers. "Off-label" means that the FDA has not yet approved its use for that type of cancer. Therefore, insurance approval of these "off-label" treatments could be delayed compared to label use, and "off-label" treatments may require several weeks of pre-authorization. There is evidence that the delayed start of cancer treatment can lead to poorer outcomes.
Detailed description
PRIMARY OBJECTIVE:
- To assess in real-life clinical practice, the timing, cost, and surgical outcomes of patients who have resectable various skin cancers that are locally advanced or have a high risk of recurrence.
OUTLINE: This is an observational study.
Patients complete a survey and have their medical records reviewed on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Merkel cell carcinoma | – | Other: Non-Interventional StudyPatients complete a survey and have their medical records reviewed on study. |
| Cohort 2: Mucosal melanoma | – | Other: Non-Interventional StudyPatients complete a survey and have their medical records reviewed on study. |
| Cohort 3: Basal cell carcinoma | – | Other: Non-Interventional StudyPatients complete a survey and have their medical records reviewed on study. |
| Cohort 4: Rare cutaneous cancers | – | Other: Non-Interventional StudyPatients complete a survey and have their medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Merkel cell carcinoma, mucosal melanoma, basal cell carcinoma, and miscellaneous rare cutaneous cancers will be recruited from The James Comprehensive Cancer Center during the course of usual care.
Key inclusion criteria (34 listed)
- * MERKEL CELL CARCINOMA
Key exclusion criteria (20 listed)
- * MERKEL CELL CARCINOMA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Cohort 1: Merkel cell carcinoma, Cohort 2: Mucosal melanoma, Cohort 3: Basal cell carcinoma, Cohort 4: Rare cutaneous cancers |
Primary outcome
Time spent obtaining approval and drugs
Time frame: Up 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 coverage
Time frame: Up 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 patients
Time frame: Up 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 resection
Time frame: Up 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Claire F Verschraegen, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Stage II Cutaneous Merkel Cell Carcinoma AJCC v8 and Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent obtaining approval and drugs (time frame: Up to study completion, up to 17 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.