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

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04242173
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 3
• Locations: 2
• Arm: 1
• Actual Duration (Months): 23
• Patients Per Site: 1.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Squamous Cell Carcinoma; Cutaneous Squamous Cell Carcinoma of the Head and Neck	Drug: Cemiplimab-Rwlc	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Arm Phase II Study of Cemiplimab-rwlc in Immunocompromised Patients With Unresectable Locally Recurrent and/or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)
• Actual Study Start Date: Jun 25, 2020
• Actual Primary Completion Date: May 26, 2022
• Actual Study Completion Date: May 26, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cemiplimab-rwlc treatment Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks	Drug: Cemiplimab-Rwlc; Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days); Other Names: Libtayo

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate [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.

Secondary Outcome Measures

1. Progression Free Survival [Up to 12 months]

   Progression Free Survival (PFS), defined as time from on study date to disease progression

2. Overall Survival [Up to 12 months]

   Overall Survival (OS), defined as time from on study date to death from any cause

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona Cancer Center	Tucson	Arizona	United States	85724
2	Moffitt Cancer Center	Tampa	Florida	United States	33612

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Christine H Chung, MD, Moffitt Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 29, 2020
• Informed Consent Form - Jul 23, 2020

More Information

Additional Information:

• Moffitt Cancer Center Clinical Trials website

Publications

None provided.

• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• ClinicalTrials.gov Identifier: NCT04242173
• Other Study ID Numbers: MCC-20114
• First Posted: Jan 27, 2020
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Cemiplimab

Study Results

Participant Flow

Arm/Group Title	Cemiplimab-rwlc Treatment
Arm/Group Description	Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks Cemiplimab-Rwlc: Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days)
Period Title: Overall Study
STARTED	3
COMPLETED	3
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Cemiplimab-rwlc Treatment
Arm/Group Description	Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks Cemiplimab-Rwlc: Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days)
Overall Participants	3
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 33.3%
>=65 years	2 66.7%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	3 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	3 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 33.3%
White	2 66.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	3 100%

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Data was not collected due to low number of patients accrued to study

Arm/Group Title	Cemiplimab-rwlc Treatment
Arm/Group Description	Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks Cemiplimab-Rwlc: Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days)
Measure Participants	0

2. Secondary Outcome

Title	Progression Free Survival
Description	Progression Free Survival (PFS), defined as time from on study date to disease progression
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Data was not collected due to low number of patients accrued to study

Arm/Group Title	Cemiplimab-rwlc Treatment
Arm/Group Description	Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks Cemiplimab-Rwlc: Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days)
Measure Participants	0

3. Secondary Outcome

Title	Overall Survival
Description	Overall Survival (OS), defined as time from on study date to death from any cause
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Data was not collected due to low number of patients accrued to study

Arm/Group Title	Cemiplimab-rwlc Treatment
Arm/Group Description	Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks Cemiplimab-Rwlc: Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days)
Measure Participants	0

Adverse Events

Time Frame	Adverse events were collected from start of treatment to 30 days after end of treatment, approximately 7 months
Arm/Group Title	Cemiplimab-rwlc Treatment
Arm/Group Description	Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks Cemiplimab-Rwlc: Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days)
All Cause Mortality
	Cemiplimab-rwlc Treatment
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Serious Adverse Events
	Cemiplimab-rwlc Treatment
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	Cemiplimab-rwlc Treatment
	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)
Blood and lymphatic system disorders
Leukocytosis	1/3 (33.3%)	1
Metabolism and nutrition disorders
Hyperkalemia	1/3 (33.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.