Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-07206 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Merkel cell carcinoma | Patients complete a survey and have their medical records reviewed on study. |
| |
| Cohort 2: Mucosal melanoma | Patients complete a survey and have their medical records reviewed on study. |
| |
| Cohort 3: Basal cell carcinoma | Patients complete a survey and have their medical records reviewed on study. |
| |
| Cohort 4: Rare cutaneous cancers | Patients complete a survey and have their medical records reviewed on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
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).
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)
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)
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
Exclusion Criteria:
* 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.
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.
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.
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.
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Contact | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Claire F Verschraegen, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
Not provided
| Label | URL |
|---|---|
| The Jamesline | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
|