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

NCT ID: NCT07215988

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-25

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1: Merkel cell carcinoma

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

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Cohort 2: Mucosal melanoma

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

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Cohort 3: Basal cell carcinoma

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

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Cohort 4: Rare cutaneous cancers

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

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Other Intervention Names

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Non-Interventional Observational Study Noninterventional (Observational) Study

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Claire Verschraegen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claire F Verschraegen, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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The Ohio State University Comprehensive Cancer Center

Role: CONTACT

Phone: 800-293-5066

Email: [email protected]

Facility Contacts

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Claire F. Verschraegen, MD

Role: primary

Related Links

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http://cancer.osu.edu

The Jamesline

Other Identifiers

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OSU-23272

Identifier Type: -

Identifier Source: org_study_id

NCI-2025-07206

Identifier Type: REGISTRY

Identifier Source: secondary_id