Studying insurance approval and costs for skin cancer patients given pre-surgery treatment
Observes insurance approval, costs and surgery results in adults with skin cancers receiving neoadjuvant treatment.
Key facts
- Who runs it
- Ohio State University Comprehensive Cancer Center
- Where
- Columbus, United StatesSee the site
- Trial code
- Registry title
- Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study
- Status
- Recruiting
- People taking part
- 70 people, planned
- Started
- 4 Feb 2026
- Expected to end
- 31 Dec 2027
- Type of study
- Observational, 4 groups
- Treatments tested
- Non-Interventional Study
- Record updated
- 25 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with certain skin cancers (Merkel cell carcinoma, mucosal melanoma, basal cell carcinoma, or squamous cell carcinoma) who are planned to get treatment before surgery. It studies insurance approval time and costs.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Merkel cell carcinoma: stage II, III or IV, removable by surgery, or possible to operate on if the tumor responds to treatment first. Mucosal melanoma: stage III or IV, same rule. Basal cell carcinoma: any stage, same rule. Squamous cell carcinoma: stage II, III or IV, same rule.
- Earlier treatment
- No immunotherapy, chemotherapy or radiation for this cancer within the past year. Treatment before surgery must be planned (immunotherapy, sonidegib, or carboplatin, paclitaxel and pembrolizumab, depending on cancer type).
- Biomarker or test result
- Genetic testing of the cancer must have been tried.
Main reasons for not taking part
- Cancer has spread and cannot be fully removed by surgery
- Immunotherapy, chemotherapy or radiation for this cancer within the past year
- Medical condition that the doctor judges would rule out immunotherapy
- Pregnant, breastfeeding, or planning to conceive or father children during the study
- Planning to have children until 120 days after the last dose of standard treatment
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- * 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)
Who cannot take part
- * 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
Where in United States
- Ohio State University Comprehensive Cancer CenterColumbus, United StatesContact: Claire F. Verschraegen, MDTaking people
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Cohort 1: Merkel cell carcinoma
Patients complete a survey and have their medical records reviewed on study.
Treatment: Non-Interventional Study
- Cohort 2: Mucosal melanoma
Patients complete a survey and have their medical records reviewed on study.
Treatment: Non-Interventional Study
- Cohort 3: Basal cell carcinoma
Patients complete a survey and have their medical records reviewed on study.
Treatment: Non-Interventional Study
- Cohort 4: Rare cutaneous cancers
Patients complete a survey and have their medical records reviewed on study.
Treatment: Non-Interventional Study
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study
- Plain-language title
- Studying insurance approval and costs for skin cancer patients given pre-surgery treatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 25 June 2026