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

STATUS

Recruiting
participants needed

27
sponsor

H. Lee Moffitt Cancer Center and Research Institute

Send

Updated on 19 February 2024

See if I qualify

cancer

metastasis

squamous cell carcinoma

lymphoma

hodgkin's disease

multiple myeloma

carcinoma

acquired immunodeficiency syndrome (aids)

cemiplimab

metastatic cutaneous squamous cell carcinoma

squamous cell carcinoma of the skin

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).

Details

Condition	Cutaneous Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma of the Head and Neck
Age	18years - 100years
Treatment	Cemiplimab-Rwlc
Clinical Study Identifier	NCT04242173
Sponsor	H. Lee Moffitt Cancer Center and Research Institute
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

cancer

metastasis

squamous cell carcinoma

acquired immunodeficiency syndrome (aids)

cemiplimab

metastatic cutaneous squamous cell carcinoma

squamous cell carcinoma of the skin

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

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