Off-label insurance coverage and care delays for people with advanced skin cancers
Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study
This study will see if adults with resectable advanced skin cancers face longer approval times, higher out-of-pocket costs, or different surgical outcomes when given off-label versus on-label neoadjuvant treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | NIVOLUMAB, IPILIMUMAB, PEMBROLIZUMAB, chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT07215988 on ClinicalTrials.gov |
What this trial studies
This is a non-interventional, observational study at a single academic cancer center that enrolls adults with resectable or potentially resectable advanced skin cancers receiving neoadjuvant therapy. Participants complete a survey and allow review of medical records to capture time to insurance approval, drug access timelines, payment methods, and patient costs. The study compares those receiving off-label neoadjuvant regimens with those receiving on-label therapies and documents resulting surgical timing and outcomes. Data are collected in real-world clinical practice without altering treatment decisions.
Who should consider this trial
Good fit: Adults (≥18) with resectable or potentially resectable locally advanced or high‑risk cutaneous cancers—such as Merkel cell carcinoma (clinical stage II–IV), mucosal melanoma (stage III–IV), locally advanced basal cell carcinoma, or other malignant skin neoplasms—who are planned to receive neoadjuvant therapy are ideal candidates.
Not a fit: Patients who are not receiving neoadjuvant therapy, are under 18, or whose disease is not amenable to surgery are unlikely to gain direct benefit from this study's findings.
Why it matters
Potential benefit: If successful, the study could identify delays and cost barriers to starting neoadjuvant therapy and inform changes that speed access and reduce patient financial burden.
How similar studies have performed: Previous research has documented that insurance preauthorization can delay cancer treatment broadly, but applying this specifically to off-label neoadjuvant use in skin cancers is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 Criteria:
* \* MERKEL CELL CARCINOMA
* Metastatic disease not amenable to complete resection
* Prior immunotherapy, chemotherapy, or radiation therapy for treatment of MCC
* 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
* 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
* 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
* 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 this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Claire F Verschraegen, MD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.