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

Not yet recruiting

• 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

• Registration Number: NCT07215988
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Detailed Description

PRIMARY OBJECTIVE:

I. 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 Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-09
• Study First Submitted QC: 2025-10-09
• Last Update Submitted: 2025-10-09
• Study First Posted: 2025-10-14
• Last Update Posted: 2025-10-14
• Study Start: 2026-01-25
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time spent obtaining approval and drugs	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	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	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	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.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States