RECRUITING

Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma (OCSCC).

Conditions

Locally Recurrent Oral Cavity Squamous Cell Carcinoma local recurrence oral cavity cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent oral cavity squamous cell carcinoma.

Official Title

Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma (OCSCC).

Quick Facts

Study Start:2024-11-21

Study Completion:2027-05-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06448026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participants ≥18 years with histology-proven recurrent oral cavity squamous cell carcinoma. 2. Amenable to salvage surgery 3. Disease recurrence at least 3 months after completion of curative-intent therapy (including surgery, post operatory radiation, and/or chemotherapy) 4. Measurable disease per RECIST 1.1 5. Performance status ECOG of 0 or 1 6. Willing to undergo baseline (if archival tumor specimen is not available) and on-treatment biopsy for correlative studies 7. Laboratory measurements, blood counts: 1. Hemoglobin ≥ 9 g/dL. Red blood cell transfusions are permitted to meet the hemoglobin inclusion criteria 2. Absolute neutrophil count ≥ 1 x 109/mL 3. Platelets ≥ 80 x 109/mL 8. Laboratory measurements, renal function: 9. Laboratory measurements, hepatic function: 1. AST and ALT ≤ 3 x ULN 2. Total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN and primarily unconjugated if subject has a documented history of Gilbert's syndrome or genetic equivalent 10. Female participants with reproductive potential must practice two effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of study therapy. The two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom, copper intrauterine device, sponge, or spermicide. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents). 11. Male participants who are sexually active with women with reproductive potential must agree to use contraception for the duration of treatment and for at least 90 days after completion of study therapy.	1. Disease recurrence within 3 months after completion of definitive treatment (including surgery, post operatory, systemic therapy) 2. Distant metastatic disease (M1), visceral and/or distant nodal 3. Any prior treatment with an anti-PD1/PD-L1 agent 4. Participants with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug. 5. Participants with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date. 6. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. 7. Recipient of a solid organ transplant (other than corneal transplants) 8. Prior allogeneic stem cell transplantation, or autologous stem cell transplantation 9. History of previous malignancy other than malignancy treated with curative intent within less than 5 years. Participants with the following diagnoses represents an exception and may enroll if ≥ 1 year with no evidence of active disease before the first dose of the study drug: 1. Locally advanced non-melanoma skin cancers with no current evidence of disease 2. Melanoma in situ with no current evidence of disease 3. Localized cancer of the prostate with prostate-specific antigen of \<1 ng/mL 4. Treated or localized well-differentiated thyroid cancer 5. Treated cervical carcinoma in situ 6. Treated ductal/lobular carcinoma in situ of the breast 10. Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤ 10 days prior to administration of cemiplimab and cetuximab. Subjects with known hepatitis B, hepatitis C (HCV), or HIV infection could go on study if the viral load is undetectable at screening. 11. Disease or medical conditions that would substantially increase the risk-benefit ratio of participating in the study that include acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV 12. Female participants who are pregnant or breast-feeding 13. Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient

Inclusion Criteria

Exclusion Criteria

1. Participants ≥18 years with histology-proven recurrent oral cavity squamous cell carcinoma.
2. Amenable to salvage surgery
3. Disease recurrence at least 3 months after completion of curative-intent therapy (including surgery, post operatory radiation, and/or chemotherapy)
4. Measurable disease per RECIST 1.1
5. Performance status ECOG of 0 or 1
6. Willing to undergo baseline (if archival tumor specimen is not available) and on-treatment biopsy for correlative studies
7. Laboratory measurements, blood counts:
1. Hemoglobin ≥ 9 g/dL. Red blood cell transfusions are permitted to meet the hemoglobin inclusion criteria
2. Absolute neutrophil count ≥ 1 x 109/mL
3. Platelets ≥ 80 x 109/mL
8. Laboratory measurements, renal function:
9. Laboratory measurements, hepatic function:
1. AST and ALT ≤ 3 x ULN
2. Total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN and primarily unconjugated if subject has a documented history of Gilbert's syndrome or genetic equivalent
10. Female participants with reproductive potential must practice two effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of study therapy. The two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom, copper intrauterine device, sponge, or spermicide. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).
11. Male participants who are sexually active with women with reproductive potential must agree to use contraception for the duration of treatment and for at least 90 days after completion of study therapy.

1. Disease recurrence within 3 months after completion of definitive treatment (including surgery, post operatory, systemic therapy)
2. Distant metastatic disease (M1), visceral and/or distant nodal
3. Any prior treatment with an anti-PD1/PD-L1 agent
4. Participants with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
5. Participants with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
6. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
7. Recipient of a solid organ transplant (other than corneal transplants)
8. Prior allogeneic stem cell transplantation, or autologous stem cell transplantation
9. History of previous malignancy other than malignancy treated with curative intent within less than 5 years. Participants with the following diagnoses represents an exception and may enroll if ≥ 1 year with no evidence of active disease before the first dose of the study drug:
1. Locally advanced non-melanoma skin cancers with no current evidence of disease
2. Melanoma in situ with no current evidence of disease
3. Localized cancer of the prostate with prostate-specific antigen of \<1 ng/mL
4. Treated or localized well-differentiated thyroid cancer
5. Treated cervical carcinoma in situ
6. Treated ductal/lobular carcinoma in situ of the breast
10. Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤ 10 days prior to administration of cemiplimab and cetuximab. Subjects with known hepatitis B, hepatitis C (HCV), or HIV infection could go on study if the viral load is undetectable at screening.
11. Disease or medical conditions that would substantially increase the risk-benefit ratio of participating in the study that include acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV
12. Female participants who are pregnant or breast-feeding
13. Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient

Contacts and Locations

Study Contact

Luana Guimaraes De Sousa, MD

CONTACT

(832) 728-7849

lgsousa@mdanderson.org

Principal Investigator

Luana Guimaraes De Sousa, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Luana Guimaraes De Sousa, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-21

Study Completion Date2027-05-15

Study Record Updates

Study Start Date2024-11-21

Study Completion Date2027-05-15

Terms related to this study

Keywords Provided by Researchers

local recurrence
oral cavity cancer

Additional Relevant MeSH Terms

Locally Recurrent Oral Cavity Squamous Cell Carcinoma