Clinical Trials /

Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC)

NCT04831450

Description:

The purpose of this study is to evaluate the experimental immunotherapy agent cemiplimab-rwlc when given after completion of chemotherapy and radiation treatment and determine if it will improve progression free survival and cure rates in patients with PD-L1 positive locally advanced head and neck cancer.

Related Conditions:
  • Hypopharyngeal Squamous Cell Carcinoma
  • Laryngeal Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Official Title: Phase II Trial of Maintenance Cemiplimab-rwlc After Concurrent Chemoradiotherapy (CRT) in Intermediate and High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC)

Clinical Trial IDs

  • ORG STUDY ID: 20200543
  • NCT ID: NCT04831450

Conditions

  • Head and Neck Squamous Cell Carcinoma
  • HNSCC
  • Squamous Cell Carcinoma of the Larynx
  • Squamous Cell Carcinoma of the Oral Cavity
  • Squamous Cell Carcinoma of Hypopharynx

Interventions

DrugSynonymsArms
Cemiplimab-RwlcREGN2810Cemiplimab After CRT in HNSCC

Purpose

The purpose of this study is to evaluate the experimental immunotherapy agent cemiplimab-rwlc when given after completion of chemotherapy and radiation treatment and determine if it will improve progression free survival and cure rates in patients with PD-L1 positive locally advanced head and neck cancer.

Trial Arms

NameTypeDescriptionInterventions
Cemiplimab After CRT in HNSCCExperimentalParticipants will receive Cemiplimab for 6 consecutive months (a total of 8 cycles) 14-42 days after completion of standard of care CRT.
  • Cemiplimab-Rwlc

Eligibility Criteria

        Inclusion Criteria:

          1. Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx,
             hypopharynx or larynx

          2. Intermediate or high-risk disease defined by the following:

               1. Squamous Cell Carcinoma of the oral cavity, larynx or hypopharynx American Joint
                  Committee on Cancer (AJCC) 8th Stage III-IVB

               2. p16-Negative oropharynx SCC, AJCC 8th Stage III-IVB

               3. p16--positive oropharyngeal SCC, AJCC 8th stage II-III

          3. Tumor must have documented Programmed Death (PD) Ligand (L) -1 Combined Positive Score
             (CPS) PD-L1 CPS ≥ 1 by immunohistochemistry (IHC).

          4. Prior therapy for advanced stage HNSCC with definitive Standard of Care (SoC) CRT
             Intensity Modulated Radiation Therapy (IMRT (66-70 Gy) with concurrent Cisplatin with
             curative intent. Patients must have received a total cumulative dose of cisplatin of ≥
             200 mg/m2 or equivalent carboplatin plus taxanes combination per investigator criteria
             during concurrent treatment.

          5. No clinical or radiographic evidence of progressive disease at the time of enrollment.

          6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.

          7. Adequate bone marrow function, including:

               1. Absolute Neutrophil Count (ANC) ≥ 1,000/µL or ≥ 1.0 x 10^9/L.

               2. Platelets ≥ 75,000/µL or ≥ 100 x 10^9/L.

               3. Hemoglobin ≥ 8 g/dL (may have been transfused).

          8. Adequate renal function, as determined by an estimated creatinine clearance ≥ 30
             mL/min as calculated using the Cockcroft- Gault.

          9. Adequate liver function, including:

               1. Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN)

               2. Aspartate and alanine aminotransferase (AST and ALT) < 2.5 x ULN.

         10. Pregnancy test (for patients of childbearing potential) negative at screening.

         11. Male patients able to father children and female patients of childbearing potential
             and at risk for pregnancy must agree to use two methods of contraception (at least one
             of which is considered to be highly effective throughout the study and for at least 3
             months after the last dose of cemiplimab-rwlc.

         12. Evidence of a signed and dated informed consent document indicating that the patient
             (or a legally acceptable representative, as allowed by local guideline/practice) has
             been informed of all pertinent aspects of the study.

        Exclusion Criteria:

          1. Prior immunotherapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
             anti-Cytotoxic T lymphocyte Associated (CTLA)-4 antibody (including ipilimumab), or
             any other antibody or drug specifically targeting T cell co-stimulation or immune
             checkpoint pathways.

          2. Major surgery ≤ 4 weeks prior to enrollment.

          3. Prior malignancy (other than the current Head and Neck cancer or in situ disease)
             requiring tumor-directed therapy within the last 2 years prior to enrollment, or
             concurrent malignancy associated with clinical instability. Exceptions for disease
             within the 2 years are superficial esophageal cancer (TIS or T1a) fully resected by
             endoscopy, prostate cancer (Gleason score ≤6) either curatively treated or deemed to
             not require treatment, ductal in situ carcinoma of the breast that has completed
             curative treatment, adequately treated basal cell or squamous cell skin cancer.

          4. Active autoimmune disease that might deteriorate when receiving an immunostimulatory
             agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid
             disease not requiring immunosuppressive treatment are eligible.

          5. Active infection requiring systemic therapy.

          6. Use of immunosuppressive medication at time of enrollment, except the following:

               -  Intranasal, inhaled, topical steroids, or local steroid injections (eg,
                  intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤10
                  mg/day of prednisone or equivalent

               -  Steroids as premedication for hypersensitivity reactions (eg, CT scan
                  premedication).

          7. Prior organ transplantation including allogenic stem-cell transplantation.

          8. Diagnosis of prior immunodeficiency or known human immunodeficiency virus (HIV) or
             acquired immunodeficiency syndrome (AIDS) related illness.

          9. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive
             HBV surface antigen or HCV RNA [ribonucleic acid] if anti-HCV antibody screening test
             positive).

         10. Pregnant female patients, breastfeeding female patients, and male patients able to
             father children and female patients of childbearing potential who are unwilling or
             unable to use 2 methods of contraception (at least one of which is considered to be
             highly effective) for at least 3 months after the last dose of cemiplimab-rwlc.

         11. Patients with impaired decision-making capacity.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-Free Survival (PFS)
Time Frame:Up to 2 years
Safety Issue:
Description:Progression-Free Survival (PFS) is defined as the elapsed time from the date of starting maintenance treatment until disease progression or death (whichever occurs first). Patients who have not had an event will be censored at the date of last disease assessment documenting the patient was free of progression. Progression will be assessed using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.

Secondary Outcome Measures

Measure:PFS Rate
Time Frame:Up to 1 year
Safety Issue:
Description:PFS is defined as the elapsed time from the date of starting maintenance treatment until disease progression or death (whichever occurs first). Patients who have not had an event will be censored at the date of last disease assessment documenting the patient was free of progression. Progression will be assessed using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
Measure:Overall Survival (OS)
Time Frame:Up to 2 years
Safety Issue:
Description:Overall survival (OS) will be defined as the elapsed time from the date of starting maintenance treatment (Cycle 1 Day 1) until death. Alive patients will be censored at the date of last known to be alive.
Measure:Incidence of Treatment-Related Toxicity and Adverse Events
Time Frame:Up to 9 months
Safety Issue:
Description:Safety of the intervention will be reported as the incidence of treatment-related toxicity, including serious adverse events (SAEs) and adverse events (AEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University of Miami

Last Updated

June 9, 2021