Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04862650
Other study ID # OSU-20258
Secondary ID NCI-2021-02081
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 30, 2021
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State University Comprehensive Cancer Center
Phone 800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma of the head and neck that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab , may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, like paclitaxel and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cemiplimab in combination with paclitaxel and carboplatin may work better in treating recurrent or metastatic squamous cell carcinoma of the head and neck.


Description:

PRIMARY OBJECTIVE: I. To assess the overall response rate (ORR) at 12 weeks of treatment with the treatment combination cemiplimab, paclitaxel, and carboplatin. SECONDARY OBJECTIVES: I. To assess toxicity/tolerance to the proposed treatment combination (a safety run-in phase of ten patients will be performed initially). II. To assess progression-free survival (PFS) and overall survival (OS) at one and two years. EXPLORATORY OBJECTIVES: I. Prospectively test the ability of our clinical nomogram to predict median OS in squamous cell carcinoma of the head and neck (SCCHN) patients planning to receive first-line cemiplimab in combination with low-dose weekly paclitaxel and carboplatin. II. To assess the PFS and OS of patients with combined positive score (CPS) <1%, >1%, and > 20%. III. Compare the predictive power of our nomogram to that of CPS in the prospective cohort, as well as evaluate the combined correlation of nomogram and CPS to median OS. IV. Perform comprehensive immune analysis including phenotypic analysis of immune cell subsets using high dimensional spectral flow cytometry. T cell functionality and ability to produce cytokines after ex vivo stimulation for all T cells and E6/E7-reactive T cells (P16+ subset patients) and TCR sequencing to determine if clonal T cell populations emerge from the tumor of responding patients in comparison with non-responders. OUTLINE: Patients receive cemiplimab intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 104 weeks, and paclitaxel IV over 60 minutes and carboplatin IV over 30 minutes once weekly (QW) for up to 24 weeks. Treatment continuous in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 14 days and then every 12 weeks.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Recurrent/metastatic (R/M) SCCHN of the oral cavity, oropharynx, larynx and hypopharynx - No prior systemic therapy for treatment of R/M disease - Patients with squamous cell carcinoma of an unknown primary are eligible provided their tumor tested positive for p-16 and they have previously received treatment for locoregional head and neck cancer - Must be at least four weeks since prior radiation and/or surgery - Must be at least four weeks from curative intent systemic therapy. Of note: patients who have received up to two courses of chemoradiotherapy (CRT) for locoregionally advanced disease are eligible. Induction chemotherapy will not be considered a separate line of therapy - At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 on screening computed tomography (CT) or magnetic resonance imaging (MRI) - 18 years of age and older - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - White blood cell (WBC) count > 2,500 cells/uL - Absolute neutrophil count (ANC) >1,500 cells/uL - Platelet count >= 100,000 cells/uL - Hemoglobin >= 9 g/dL - Creatinine =< 1.6 mg/dL - Total bilirubin =< 1.6 mg/dL - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase [AST]), serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x upper limit of normal (ULN) - Potassium >= lower limit of normal (LLN) - Willingness to use medically acceptable contraception throughout the study period and four months after the final administration of treatment - For female subjects with reproductive potential: a negative serum pregnancy test at baseline - Ability and willingness to provide written informed consent and to comply with the study visits and assessment schedule Exclusion Criteria: - Disease amenable to curative local therapy - Nasopharyngeal, salivary gland, lip, or sinonasal carcinoma - Disease that requires corticosteroids or other ongoing immunosuppressive treatment - Previous treatment with mAb-based immunotherapy - Previous treatment with PI3K inhibitors - Known brain metastases, unless stable for at least 21 days prior to registration - Known infection human immunodeficiency virus (HIV), hepatitis B or C - Clinically significant cardiac disease (e.g., congestive heart failure, unstable or uncontrolled angina, myocardial infarction) within the past six months - History of pneumonitis within the past five years - Recipient of live vaccines (including attenuated) within 30 days of planned study treatment - Female patients who are pregnant or breast-feeding - Any other condition or circumstance that could interfere with adherence to the study's procedures or requirements or otherwise compromise the study's objectives in the opinion of the Principal Investigator

Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Laryngeal Neoplasms
  • Lip Neoplasms
  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Mouth Neoplasms
  • Oropharyngeal Neoplasms
  • Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Recurrence
  • Recurrent 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
  • Squamous Cell Carcinoma of Head and Neck
  • Squamous Cell Carcinoma of Unknown Primary
  • Stage IV Hypopharyngeal Carcinoma AJCC v8
  • Stage IV Laryngeal Cancer AJCC v8
  • Stage IV Lip and Oral Cavity Cancer AJCC v8
  • Stage IVA Hypopharyngeal Carcinoma AJCC v8
  • Stage IVA Laryngeal Cancer AJCC v8
  • Stage IVA Lip and Oral Cavity Cancer AJCC v8
  • Stage IVB Hypopharyngeal Carcinoma AJCC v8
  • Stage IVB Laryngeal Cancer AJCC v8
  • Stage IVB Lip and Oral Cavity Cancer AJCC v8
  • Stage IVC Hypopharyngeal Carcinoma AJCC v8
  • Stage IVC Laryngeal Cancer AJCC v8
  • Stage IVC Lip and Oral Cavity Cancer AJCC v8

Intervention

Drug:
Carboplatin
Given IV
Biological:
Cemiplimab
Given IV
Drug:
Paclitaxel
Given IV

Locations

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Marcelo Bonomi

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Ability of our clinical nomogram to predict median OS in squamous cell carcinoma of the head and neck patients planning to receive first-line cemiplimab in combination with low-dose weekly paclitaxel and carboplatin Up to 24 weeks
Other PFS of patients with combined positive score (CPS) < 1%, > 1%, and > 20% Up to 2 years
Other OS of patients with CPS < 1%, > 1%, and > 20% Up to 2 years
Other Predictive power of our nomogram to that of CPS in the prospective cohort, as well as evaluate the combined correlation of nomogram and CPS to median OS Up to 24 weeks
Primary Overall response rate (ORR) ORR defined as the proportion of patients with a documented complete response (CR) + partial response (PR) at week 12 of treatment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. An ORR of 40% (percent) or higher will be consider a positive result. Simon two-stage optimal design will be used. 12 weeks
Secondary Progression-free survival (PFS) PFS will be calculated based on RECIST criteria. From the date of enrollment until documented disease progression, assessed up to 2 years
Secondary Overall survival (OS) From the date of patient enrollment into the trial until death, assessed up to 2 years
Secondary Incidence of adverse events Toxicity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Up to 24 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03468218 - Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer Phase 2
Recruiting NCT05945875 - Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer Phase 1
Completed NCT03229278 - Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma Phase 1
Recruiting NCT05980000 - Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma Phase 2
Active, not recruiting NCT01468896 - Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery Phase 1/Phase 2
Terminated NCT01602315 - A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 1/Phase 2
Recruiting NCT05726370 - Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC Phase 2
Terminated NCT03823131 - Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat Phase 2
Terminated NCT03522584 - Durvalumab, Tremelimumab and Hypofractionated Radiation Therapy in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 1/Phase 2
Completed NCT03032250 - Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer N/A
Withdrawn NCT04834349 - Re-irradiation With NBTXR3 in Combination With Pembrolizumab for the Treatment of Inoperable Locoregional Recurrent Head and Neck Squamous Cell Cancer Phase 2
Completed NCT04220775 - Bintrafusp Alfa and Stereotactic Body Radiation Therapy for the Treatment of Recurrent or Second Primary Head and Neck Squamous Cell Cancer Phase 1/Phase 2
Recruiting NCT06265285 - Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program Phase 2
Recruiting NCT05063552 - Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers Phase 2/Phase 3
Recruiting NCT04588038 - NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery Phase 1
Withdrawn NCT05359692 - INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 2
Active, not recruiting NCT04282109 - Study to Assess the Efficacy and Safety of Nivolumab in Combination With Paclitaxel in Subjects With Head and Neck Cancer Unable for Cisplatin-based Chemotherapy (NIVOTAX) Phase 2
Active, not recruiting NCT03521570 - Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer Phase 2
Recruiting NCT05156970 - Camrelizumab in Combination With Chemotherapy or Apatinib Mesylate as First-Line Treatment for R/M HNSCC Phase 2
Active, not recruiting NCT04576091 - Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer Phase 1

External Links