Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observationa… (NCT07215988) | Clinical Trial Compass
RecruitingNot Applicable
Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study
United States70 participantsStarted 2026-02-04
Plain-language 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. "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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time spent obtaining approval and drugs
Timeframe: Up to study completion, up to 17 weeks
2
Means of coverage
Timeframe: Up to study completion, up to 17 weeks
3
Out of pocket expenses for patients
Timeframe: Up to study completion, up to 17 weeks
4
Extent of surgical resection
Timeframe: Up to study completion, up to 17 weeks
Trial details
NCT IDNCT07215988
SponsorOhio State University Comprehensive Cancer Center
Sponsor typeOTHER
Study typeOBSERVATIONAL
Primary completion2027-12-31
Contact for this trial
The Ohio State University Comprehensive Cancer Center