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

NCT07215988 | Recruiting

• 2 other identifiers: OSU-23272NCI-2025-07206
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Up to study completion, up to 17 weeks

Study Arms (4)

Cohort 1: Merkel cell carcinoma

Patients complete a survey and have their medical records reviewed on study.

Other: Non-Interventional Study

Cohort 2: Mucosal melanoma

Patients complete a survey and have their medical records reviewed on study.

Other: Non-Interventional Study

Cohort 3: Basal cell carcinoma

Patients complete a survey and have their medical records reviewed on study.

Other: Non-Interventional Study

Cohort 4: Rare cutaneous cancers

Patients complete a survey and have their medical records reviewed on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study

Cohort 1: Merkel cell carcinoma; Cohort 2: Mucosal melanoma; Cohort 3: Basal cell carcinoma; Cohort 4: Rare cutaneous cancers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \* 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)
• 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

You may not qualify if:

• \* 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

Study Officials

• Claire F Verschraegen, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 14, 2025
• Study Start: February 4, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)