- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04242173
Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC
A Single Arm Phase II Study of Cemiplimab-rwlc in Immunocompromised Patients With Unresectable Locally Recurrent and/or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85724
- University of Arizona Cancer Center
-
-
Florida
-
Tampa, Florida, United States, 33612
- Moffitt Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Positive serum pregnancy test (a false positive pregnancy test, if demonstrated by serial measurements and negative ultrasound, will not be exclusionary)
- Concurrent non-hematologic malignancy other than cutaneous SCC within 3 years of date of first planned dose of Cemiplimab-rwlc , except for tumors with negligible risk of metastasis or death, such as adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast, or low-risk early stage prostate adenocarcinoma (T1-T2a N0 M0 and Gleason score ≤6 and PSA ≤10 ng/mL) for which the management plan is active surveillance, or prostate adenocarcinoma with biochemical-only recurrence with documented PSA doubling time of > 12 months for which the management plan is active surveillance.
- Any acute or chronic psychiatric problems that, in the opinion of the investigator, make the patient ineligible for participation.
- Continued sexual activity in men or women of childbearing potential who are unwilling to practice highly effective contraception during the study and until 6 months after the last dose of study drug. Note: Highly effective contraceptive measures include stable use of oral contraceptives such as combined estrogen and progestogen and progestogen only hormonal contraception or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal ligation; vasectomy, and sexual abstinence.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cemiplimab-rwlc treatment
Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks
|
Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate
Time Frame: Up to 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: Up to 12 months
|
Progression Free Survival (PFS), defined as time from on study date to disease progression
|
Up to 12 months
|
Overall Survival
Time Frame: Up to 12 months
|
Overall Survival (OS), defined as time from on study date to death from any cause
|
Up to 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christine H Chung, MD, Moffitt Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-20114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cutaneous Squamous Cell Carcinoma of the Head and Neck
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 | Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 | Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck | Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck | Stage...United States
-
Arnaud Bewley, MDNational Cancer Institute (NCI); Genentech, Inc.TerminatedStage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 | Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck | Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and NeckUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingRecurrent Head and Neck Squamous Cell Carcinoma | Advanced Head and Neck Squamous Cell Carcinoma | Metastatic Head-and-neck Squamous-cell Carcinoma | Locally Advanced Head and Neck Squamous Cell Carcinoma | Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck | Stage IV Cutaneous...United States
-
Roswell Park Cancer InstituteCompletedStage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 | Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8United States
-
Peter MacCallum Cancer Centre, AustraliaSanofi; Regeneron Pharmaceuticals; Monash University; University of Adelaide; University...RecruitingNeoplasms | Cutaneous Squamous Cell Carcinoma of the Head and Neck | Non-melanoma Skin Cancer | Cutaneous Squamous Cell CarcinomaAustralia
-
Johns Hopkins UniversityCastle Biosciences IncorporatedRecruitingCutaneous Squamous Cell Carcinoma of the Head and NeckUnited States
-
Queensland HealthMerck Sharp & Dohme LLCRecruitingHead and Neck Cancer | Cutaneous Squamous Cell Carcinoma of the Head and NeckAustralia
-
Mayo ClinicRecruitingHead and Neck Carcinoma | Metastatic Malignant Neoplasm in the Lymph Nodes | Nasal Cavity Carcinoma | Oral Cavity Carcinoma | Paranasal Sinus Carcinoma | Salivary Gland Carcinoma | Cutaneous Squamous Cell Carcinoma of the Head and Neck | Hypopharyngeal Carcinoma | Laryngeal Carcinoma | Oropharyngeal Carcinoma and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHead and Neck Cancer | Cutaneous Squamous Cell Carcinoma of the Head and Neck | Healthy SubjectUnited States
-
Maastricht University Medical CenterRecruitingQuality of Life | Satisfaction, Patient | Squamous Cell Carcinoma of the Head and Neck | Squamous Cell Carcinoma of Head and Neck | Skin Cancer | Squamous Cell Carcinomas | Squamous Cell Carcinoma of the Skin | Cutaneous Squamous Cell Carcinoma of the Head and Neck | Cutaneous Squamous Cell Carcinoma | High-Risk CancerNetherlands
Clinical Trials on Cemiplimab-Rwlc
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 | Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 | Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck | Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck | Stage...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI)RecruitingRecurrent Skin Squamous Cell Carcinoma | Resectable Skin Squamous Cell Carcinoma | Stage I Skin Cancer | Stage II Skin Cancer | Stage III Skin CancerUnited States
-
University of MiamiRegeneron PharmaceuticalsWithdrawnHead and Neck Squamous Cell Carcinoma | HNSCC | Squamous Cell Carcinoma of the Larynx | Squamous Cell Carcinoma of the Oral Cavity | Squamous Cell Carcinoma of Hypopharynx
-
H. Lee Moffitt Cancer Center and Research InstituteRegeneron Pharmaceuticals; Sanofi-SynthelaboRecruitingMerkel Cell Carcinoma | Cutaneous Squamous Cell CarcinomaUnited States
-
Peter MacCallum Cancer Centre, AustraliaSanofi; Regeneron Pharmaceuticals; Monash University; University of Adelaide; University...RecruitingNeoplasms | Cutaneous Squamous Cell Carcinoma of the Head and Neck | Non-melanoma Skin Cancer | Cutaneous Squamous Cell CarcinomaAustralia
-
Emory UniversityNational Cancer Institute (NCI)RecruitingMetastatic Skin Squamous Cell Carcinoma | Recurrent Skin Squamous Cell CarcinomaUnited States
-
Alaunos TherapeuticsCompleted
-
M.D. Anderson Cancer CenterTerminatedAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
Marcelo BonomiRecruitingRecurrent Head and Neck Squamous Cell Carcinoma | Recurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Metastatic Head and Neck Squamous Cell Carcinoma | Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC... and other conditionsUnited States
-
Baptist Health South FloridaRegeneron PharmaceuticalsWithdrawnSquamous Cell Carcinoma | Cutaneous Squamous Cell Carcinoma | Advanced Squamous Cell CarcinomaUnited States