Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC

NCT04242173 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: MCC-20114
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to determine how people with weakened immune systems and unresectable (cannot be removed by surgery) locally recurrent and/or metastatic cutaneous squamous cell carcinoma (CSCC) respond to study treatment with Cemiplimab. Cemiplimab is approved for sale in United States by the U.S. Food and Drug Administration (FDA).

Conditions

Cutaneous Squamous Cell Carcinoma; Cutaneous Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall Response Rate (ORR) as indicated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 analysis of radiologic scans. In some patients, response assessments include photos and radiologic scans and will be evaluated by composite efficacy criteria. Clinical lesions will only be considered measurable when they are superficial (eg, skin nodules and palpable lymph nodes) and ≥10 mm (≥1 cm) diameter as assessed using calipers (e.g., skin nodules). Patients who are deemed as not evaluable according to RECIST 1.1 or inevaluable by the composite efficacy criteria will be considered as not reaching ORR.

  Up to 12 months

Secondary Outcomes (2)

• Progression Free Survival

  Up to 12 months

• Overall Survival

  Up to 12 months

Study Arms (1)

Cemiplimab-rwlc treatment

EXPERIMENTAL

Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks

Drug: Cemiplimab-Rwlc

Interventions

Cemiplimab-Rwlc DRUG

Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days)

Also known as: Libtayo

Cemiplimab-rwlc treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of invasive Cutaneous Squamous Cell Carcinoma (CSCC)
• Immunocompromised patients with invasive CSCC. Immunocompromised patients are defined as: (a) History of HIV with CD4 counts \>/= 200 and no AIDS-defining illness (b) History of treated or active hematologic malignancies including lymphoma, Hodgkin's disease, chronic lymphocytic leukemia, chronic myeloid leukemia, multiple myeloma, and myeloproliferative neoplasm.
• At least 1 lesion that is measurable by study criteria by RECIST 1.1. Externally visible cutaneous Squamous Cell Cancer (SCC) target lesion(s) greater than \>10 mm, bi-dimensional measurements of the external lesion(s) with a color photograph may be used as target lesions.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Laboratory values as defined per protocol
• Ability to sign informed consent
• Ability and willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study-related procedures.
• CSCC not amenable to surgery or radiation therapy such as unresectable tumors determined by surgeons, surgical morbidity unacceptable by the patients, inability to deliver radiation safely determined by radiation oncologists, or radiation related toxicities unacceptable by the patients.
• Note: In lieu of individual consults performed during screening, it will suffice to document the contraindication of surgery and radiation therapy via a clinic note from the investigator indicating that an individualized benefit:risk assessment was performed by a multidisciplinary team (consisting of, at minimum, a radiation oncologist AND EITHER a medical oncologist with expertise in cutaneous malignancies OR a dermato-oncologist, OR a head and neck surgeon) within 60 days prior to enrollment in the proposed study, and the radiation therapy was deemed to be contraindicated. This is not required for patients with distant metastatic disease.

You may not qualify if:

• Prior known allergy to Cemiplimab-rwlc
• Prior exposure to PD-1 or PD-L1 inhibitors
• Prior exposure to idelalisib
• Immunocompromised patients due to solid organ transplant, allogenic bone marrow transplant, and/or autoimmune disease.
• Untreated brain metastasis(es) that may be considered active.
• Immunosuppresive corticosteroid doses (\>10 mg prednisone daily or equivalent for \>5 consecutive days) within 4 weeks prior to the first dose of Cemiplimab-rwlc.
• Known active infection requiring therapy, including acute infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). However, it is not required to test only to determine the eligibility for the trail. As an exception, known HIV infection is allowed.
• History of pneumonitis within the last 5 years.
• Grade \>/= 3 hypercalcemia at time of enrollment
• Patients on any systemic anticancer treatment (chemotherapy, targeted systemic therapy, photodynamic therapy), investigational or standard of care for CSCC within 28 days of the initial administration of Cemiplimab-rwlc are excluded.
• Patients on any systemic anticancer treatment (chemotherapy, targeted systemic therapy, photodynamic therapy), investigational or standard of care for non-hematologic malignancy within 28 days of the initial administration of Cemiplimab-rwlc or planned to occur during the study period are excluded.
• NOTE: (a) Patients receiving bisphosphonates or denosumab are not excluded. (b) Patients receiving maintenance or supportive therapies for their hematological malignancies are not excluded. (c) If the patients have been disease free for \>2 years, patients receiving adjuvant hormonal therapies for breast cancer, prostate cancer, or thyroid cancer are not excluded.
• Patients who cannot discontinue the concurrent use of other chemopreventive agents such as 5-FU, capecitabine, Efudex, imiquimod, acitretin are not allowed.
• Radiation therapy within 7 days of initial administration of Cemiplimab-rwlc or planned to occur during the study period.
• Breast feeding

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (2)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Results Point of Contact

• Title: Christine Chung
• Organization: Moffitt Cancer Center

Christine.Chung@moffitt.org

1-813-745-5061

Study Officials

• Christine H Chung, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: June 25, 2020
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: November 4, 2022
• Results First Posted: July 14, 2022

Record last verified: 2022-11

Locations

US (2)