Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568172
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Testing the Addition of an Immunotherapy Drug Cemiplimab REGN2810 Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Phase III Trial of Perioperative Immunotherapy With Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage IIIIV Cutaneous Squamous Cell Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial compares the effect of adding cemiplimab to standard therapy surgery with or without radiation versus standard therapy alone in treating patients with stage IIIIV squamous cell skin cancer that is able to be removed by surgery resectable and that may have come back after a period of improvement recurrent The usual treatment for patients with resectable squamous cell skin cancer is the removal of the cancerous tissue surgery with or without radiation which uses high energy x-rays particles or radioactive seeds to kill cancer cells and shrink tumors Immunotherapy with monoclonal antibodies such as cemiplimab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Cemiplimab has been approved for the treatment of skin cancer that has spread or that cannot be removed by surgery but it has not been approved for the treatment of skin cancer than can be removed by surgery Adding cemiplimab to the usual treatment of surgery with or without radiation may be more effective in treating patients with stage IIIIV resectable squamous cell skin cancer than the usual treatment alone
Detailed Description:
PRIMARY OBJECTIVE
I To determine if neoadjuvant immunotherapy combined with response-adapted oncologic surgery improves site-reported event-free survival EFS compared to standard-of-care surgery in resectable stage IIIIV cutaneous squamous cell carcinoma CSCC
SECONDARY OBJECTIVES
I To compare disease-free survival DFS between arms II To compare overall survival OS between arms III To compare adverse events Common Terminology Criteria for Adverse Events CTCAE version v50 between arms
IV To assess pathologic complete response in arm 2
PATIENT-REPORTED OUTCOMES
I Compare changes in patient reported quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 EORTC QLQ-C30 at 1 6 and 12 months after surgery between treatment arms Primary objective II To compare patient reported symptoms functioning and quality of life as measured by the Cutaneous Squamous Cell Carcinoma NeoAdjuvant Adjuvant and Perioperative 32 question scale CSCC NAAP-32 Patient Reported Outcomes Measurement Information System PROMIS-Short Form SF-Anxiety PROMIS-SF-Fatigue and EuroQol-5D EQ-5D between arms at 1 6 and 12 months after surgery
III Develop a scoring algorithm and validate the CSCC-NAAP-32 for use in this patient population
EXPLORATORY OBJECTIVES
I To compare disease-specific survival DSS between arms II To correlate pathologic response with DFS in arm 2 III To compare patterns of failure between arms IV To compare pathologic measurements of lymph node yield between arms V To compare primary tumor specimen dimensions and volume between arms VI To compare utilization of adjuvant radiation between arms
OUTLINE Patients are randomized to 1 of 2 arms
ARM 1 Patients undergo surgery per standard of care within 6 weeks of randomization Starting within 84 days of surgery patients may undergo image-guided radiation therapy IGRT with intensity modulated radiation therapy IMRT for 5 fractions per week for 6 weeks as clinically indicated Patients also undergo computed tomography CT magnetic resonance imaging MRI andor positron emission tomography PETCT on study and CT andor MRI during follow up Patients may also undergo optional collection of tissue whole blood and plasma on study
ARM 2 Patients receive cemiplimab intravenously IV over 30 minutes on day 1 of each cycle Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity Patients then undergo response-adaptive surgery 21 days after last dose of cemiplimab Starting within 84 days of surgery patients may undergo IGRT with IMRT for 5 fractions per week for 6 weeks as clinically indicated Starting within 6 weeks of completion of surgery or radiation therapy if indicated patients without pathologic complete response pCR receive cemiplimab IV over 30 minutes on day 1 of each cycle Cycles repeat every 42 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo CT MRI andor PETCT on study and CT andor MRI during follow up Patients may also undergo optional collection of tissue whole blood and plasma on study
After completion of study treatment patients are followed up at 6 and 12 months post-surgery then every 3 months for 2 years every 6 months in year 3 and then annually thereafter
I To determine if neoadjuvant immunotherapy combined with response-adapted oncologic surgery improves site-reported event-free survival EFS compared to standard-of-care surgery in resectable stage IIIIV cutaneous squamous cell carcinoma CSCC
SECONDARY OBJECTIVES
I To compare disease-free survival DFS between arms II To compare overall survival OS between arms III To compare adverse events Common Terminology Criteria for Adverse Events CTCAE version v50 between arms
IV To assess pathologic complete response in arm 2
PATIENT-REPORTED OUTCOMES
I Compare changes in patient reported quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 EORTC QLQ-C30 at 1 6 and 12 months after surgery between treatment arms Primary objective II To compare patient reported symptoms functioning and quality of life as measured by the Cutaneous Squamous Cell Carcinoma NeoAdjuvant Adjuvant and Perioperative 32 question scale CSCC NAAP-32 Patient Reported Outcomes Measurement Information System PROMIS-Short Form SF-Anxiety PROMIS-SF-Fatigue and EuroQol-5D EQ-5D between arms at 1 6 and 12 months after surgery
III Develop a scoring algorithm and validate the CSCC-NAAP-32 for use in this patient population
EXPLORATORY OBJECTIVES
I To compare disease-specific survival DSS between arms II To correlate pathologic response with DFS in arm 2 III To compare patterns of failure between arms IV To compare pathologic measurements of lymph node yield between arms V To compare primary tumor specimen dimensions and volume between arms VI To compare utilization of adjuvant radiation between arms
OUTLINE Patients are randomized to 1 of 2 arms
ARM 1 Patients undergo surgery per standard of care within 6 weeks of randomization Starting within 84 days of surgery patients may undergo image-guided radiation therapy IGRT with intensity modulated radiation therapy IMRT for 5 fractions per week for 6 weeks as clinically indicated Patients also undergo computed tomography CT magnetic resonance imaging MRI andor positron emission tomography PETCT on study and CT andor MRI during follow up Patients may also undergo optional collection of tissue whole blood and plasma on study
ARM 2 Patients receive cemiplimab intravenously IV over 30 minutes on day 1 of each cycle Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity Patients then undergo response-adaptive surgery 21 days after last dose of cemiplimab Starting within 84 days of surgery patients may undergo IGRT with IMRT for 5 fractions per week for 6 weeks as clinically indicated Starting within 6 weeks of completion of surgery or radiation therapy if indicated patients without pathologic complete response pCR receive cemiplimab IV over 30 minutes on day 1 of each cycle Cycles repeat every 42 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo CT MRI andor PETCT on study and CT andor MRI during follow up Patients may also undergo optional collection of tissue whole blood and plasma on study
After completion of study treatment patients are followed up at 6 and 12 months post-surgery then every 3 months for 2 years every 6 months in year 3 and then annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None