Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Melanoma

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Pharmaceutical Solutions

All Drugs and Chemicals

Antineoplastic Agents

Cemiplimab

Antineoplastic Agents, Immunological

SAR444245 and cemiplimab administered every 3 weeks on Day 1 of each cycle (21 days per cycle) for up to 35 cycles.

Solution for infusion: intravenous infusion

THOR-707

Primary Objective:

-To determine the antitumor activity of SAR444245 in combination with cemiplimab.

Secondary Objectives:

* To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab
* To assess other indicators of antitumor activity
* To assess the concentrations of SAR444245 when given in combination with cemiplimab
* To assess the immunogenicity of SAR444245
* To assess active concentrations of cemiplimab when given in combination with SAR444245

The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 28 days, a treatment period \[max 35 cycles or until PD\], an end-of-treatment visit 30 days + 7 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or final cohort cut-off, whichever is earlier

A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)

A Phase 1/2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR- 707) Combined With Cemiplimab for the Treatment of Participants With Advanced Unresectable or Metastatic Skin Cancers

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Cohort A (melanoma): Objective response rate (ORR) defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) determined by investigator per response evaluation criteria in solid tumors (RECIST) 1.1.

Cohort B (CSCC): ORR defined as the proportion of participants who have a confirmed CR or PR determined by investigator per RECIST 1.1, or modified WHO criteria for medical photographs of external skin lesions, or composite criteria.

Incidence of Dose-limiting toxicities (DLTs) during DLT observation period

Incidence of treatment-emergent adverse event (TEAEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus gradings

Incidence of serious-adverse events (SAEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus gradings

Complete Response rate (CRR) defined as the proportion of participants who have a confirmed CR determined by the Investigator per RECIST 1.1 for melanoma participants and when applicable for CSCC participants (CR in localized unresectable CSCC is exploratory)

Time to CR defined as the time from the first administration of IMP to the first tumor assessment at which the overall response was CR that is subsequently confirmed and determined by Investigator per RECIST 1.1 for melanoma participants and when applicable for CSCC participants

Time to Response (TTR), defined as the time from first administration of IMP to the first tumor assessment at which the overall response was CR or PR that is subsequently confirmed and determined by Investigator per RECIST 1.1 or modified WHO Criteria or composite criteria whichever relevant

Duration of Response (DoR), defined as the time from first tumor assessment at which the overall response was CR or PR that is subsequently confirmed until documented progressive disease (PD) determined by Investigator per RECIST 1.1 or modified WHO Criteria for medical photographs or composite criteria when relevant, or death from any cause, whichever occurs first

Clinical Benefit Rate (CBR) including confirmed CR or PR at any time or stable disease (SD) of at least 6 months (determined by Investigator per RECIST 1.1 or modified WHO criteria for medical photographs or composite criteria whichever relevant).

Progression Free Survival (PFS), defined as the time from the date of first IMP administration to the date of the first documented disease progression determined by Investigator per RECIST 1.1, or modified WHO Criteria for medical photographs when relevant or death due to any cause, whichever occurs first.

Concentration observed just before treatment administration during repeated dosing (C trough)

The concentration observed just after the end of infusion

Sanofi

Neoplasms, Glandular and Epithelial

Neoplasms, Squamous Cell

Anti-Infective Agents

Capecitabine

Fluorouracil

Interferons

Peginterferon alfa-2b

Interferon-alpha

Peginterferon alfa-2a

Interferon alpha-2

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antiviral Agents

Participants will start the Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21).

Participants will receive 5-FU days 1-4 of each 21 day cycle.

Participants will receive the Interferon alpha-2b injection weekly every week. The three week period is referred to as one cycle.

After three cycles, new imaging studies will be performed that will measure how the disease is responding to treatment. Participants whose disease is stable or improved will undergo an additional 3 cycles of therapy and the imaging studies will be repeated. Again, participants whose disease is stable or improved will undergo a final 3 cycles of treatment (a total 27 weeks of treatment).

Drug administration will occur on an outpatient basis at the infusion center at Moffitt Cancer Center. Dose will be weight-based. Starting treatment doses of 3 mcg/kg will be given subcutaneously (SC) injection in the thigh, abdominal wall, or upper arm every week for a total of 27 weeks as tolerated.

Pegylated Interferon alpha-2b

Drug administration will be on an outpatient basis. Capecitabine will be administered at an initial dose of 800 mg/m\^2 by mouth twice daily on days 1-14 of a 21 day cycle with days 15-21 off. This cycle will be repeated every 21 days during the study for a maximum of 9 cycles as tolerated. Administration via feeding tube in patients unable to swallow is permitted.

If participants are not able to acquire oral capecitabine, then treating physicians will start participants on infusional 5-FU which can be delivered via standard of care. Participants will need to have a port placed for continuous infusion treatments. 5-FU pumps will be activated in the infusion center at Moffitt Cancer Center with a starting dose of 800 mg/m\^2 days 1-4, with pump removal on day 5 at the infusion center. 5-FU pumps will be attached every 21 days (1 cycle) for a maximum of 9 cycles.

5-FU

Christine Chung, M.D.

The purpose of this study is to find out if the combination of two established anti-cancer therapies are beneficial in patients with squamous cell carcinoma of the skin. Specifically, investigators want to determine if the combination of 5-FU/Capecitabine (oral pills) and Interferon alpha-2b (injection) can help people with advanced cases of squamous cell carcinoma of the skin. For participants that are not approved for oral capecitabine, treating physicians will use continuous infusion 5-FU. Both 5-FU/Capecitabine and Interferon alpha-2b have been used separately to treat squamous cell carcinoma of the skin and are FDA approved in other cancer types.

Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma

A Phase 2 Study of Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma

ORR: Stable Disease (SD); Partial Response (PR); Complete Response (CR). Response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR: disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

PFS: Alive without RECIST progression. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

OS: The time from registration to death or date of last contact. Participants with overall survival at 1 year. Kaplan-Meier estimator will be utilized.

Number of participants with treatment emergent SAEs, overall and per Event Description.

H. Lee Moffitt Cancer Center and Research Institute

Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.

After 3 cycles, new imaging studies will be performed to measure how the disease is responding to treatment. Participants whose disease is stable or improved will undergo an additional 3 cycles of therapy and the imaging studies will be repeated. Again, participants whose disease is stable or improved will undergo a final 3 cycles of treatment (a total 27 weeks of treatment).

Capecitabine or 5-FU With Pegylated Interferon Alpha-2b

Age, Continuous

Sex: Female, Male

White Non-Hispanic

Black or African American

Asian

Hispanic or Latino

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

Dr. Christine Chung

Stable Disease

Complete Response

Partial Response

Objective Response Rate (ORR)

Progression Free Survival (PFS)

Expired in less than a year

Alive at the end of the year

Had not completed survival follow-up at closeout

All participants who received study treatment.

Overall Survival (OS)

Any Related SAE

Dehydration

INR Increased

Occurence of Treatment Related Serious Adverse Events (SAEs)

Overall Study

Carcinoma, Basal Cell

Neoplasms, Basal Cell

Patients referred for Mohs surgery for non-melanoma skin cancer will have a preoperative consultation in advance of the day of the procedure.

Patients referred for Mohs surgery for non-melanoma skin cancer will have a preoperative consultation on the day same day as the procedure.

Preoperative consultation occurs on the same day as Mohs surgery

Same-day preoperative consultation

Faramarz Samie, MD, PhD

The purpose of this study is to determine whether separate- versus same-day preoperative consultation affects time to treatment (start to finish), utilization rate of Mohs, rate of case cancellations, cost, and patient satisfaction. The investigators hypothesize that patients with same-day preoperative consultation will have a shorter time between cancer diagnosis and removal but, only when coordination of care is needed, longer time between removal and consultation with other specialists, as compared to patients with separate-day consultation. The investigators anticipate that patients with same-day preoperative consultation will have a decrease in travel cost as compared to patients with separate-day consultation. The investigators expect that there will be no difference in various satisfaction matters between groups, with the exception of potentially greater convenience reported by patients in the same-day preoperative consultation group. Finally, the investigators hypothesize that there will be no difference between groups in regards to rates of surgery cancellation.

Procedure: Prospective trial which randomly assigns patients to either separate- or same-day preoperative consultation for Mohs surgery. A phone consultation will take place, which will assist in determining whether the patient is appropriate for enrollment into the study. If so, the patient will be randomized to either separate-day or same-day preoperative consultation.

Materials: Patient survey

Methods of data collection: The patient-specific data obtained from the medical record will include: Patient age, number of previous skin cancers, preoperative size, history of cutaneous surgery, employment status, and distance between home address and dermatology facility. Outcome measures that will be obtained from the medical record will include: Time between cancer diagnosis, removal and defect repair, rate of proceeding with Mohs as opposed to other treatment options, and rate of cancelling surgery (due to site discrepancy, anticoagulation issues). A survey will be used to assess patient satisfaction.

Same-day Versus Separate-day Preoperative Consultation for Mohs Surgery

Assess the total amount of time elapsed between skin cancer diagnosis and defect repair

Assess the amount of time between cancer diagnosis and consultation with non-dermatologic specialties

Assess the amount of time elapsed between cancer removal and defect repair

Administer a survey to assess patient's perception of convenience, level of comfort with the procedure, and self-evaluation of knowledge regarding the diagnosis and treatment

Assess the percentage of patients who actually proceed with undergoing Mohs surgery in each arm

Assess the number of cases that are cancelled due to site discrepancy, anticoagulation or other medical issues in each arm

Assess the total distance traveled by each patient coming and going to Mohs appointment(s)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)	NCT04913220	Malignant Melan... Squamous Cell C...	THOR-707 Cemiplimab	18 Years -	Sanofi
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma	NCT02218164	Squamous Cell C... Carcinoma, Squa...	Pegylated Inter... Capecitabine 5-FU	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma	NCT02218164	Squamous Cell C... Carcinoma, Squa...	Pegylated Inter... Capecitabine 5-FU	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Same-day Versus Separate-day Preoperative Consultation for Mohs Surgery	NCT02321982	Non-melanoma Sk... Squamous Cell C... Basal Cell Carc...	Same-day preope...	18 Years -	Dartmouth-Hitchcock Medical Center

Spots Global Cancer Trial Database for squamous cell carcinoma of skin