Recruiting

Neoadjuvant Treatment

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07215988

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

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

Study ID

NCT07215988

Start date

Feb 4, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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.

  • MUCOSAL MELANOMA
  • 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.

  • BASAL CELL CARCINOMA
  • 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.

  • RARE CUTANEOUS CANCERS
  • 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.

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Time spent obtaining approval and drugs [ Time Frame: Up to study completion, up to 17 weeks ]
  • Means of coverage [ Time Frame: Up to study completion, up to 17 weeks ]
  • Out of pocket expenses for patients [ Time Frame: Up to study completion, up to 17 weeks ]
  • Extent of surgical resection [ Time Frame: Up to study completion, up to 17 weeks ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Claire F. Verschraegen, MD

614-366-5068claire.verschraegen@osumc.edu

Principal Investigator:

Claire F. Verschraegen, MD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-06-25.