Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer

Titre officiel

A Multi-Institutional Phase 2 Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal

Sommaire:

Cet essai de phase II étudie le fonctionnement du nivolumab pour le traitement des patients ayant un carcinome squameux du canal postérieur qui n'a pas répondu au traitement précédent (réfractaire) et qui s'est étendu dans l'organisme (métastatique). Les anticorps monoclonaux, comme le nivolumab, peuvent inhiber la croissance de la tumeur de différentes façons en ciblant certaines cellules.

Description de l'essai

Primary Outcome:

  • Overall response rate: number of participants with response (Part A)
  • Progression-free survival (PFS) (Part B)
Secondary Outcome:
  • Number of participants with toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Part A)
  • Overall survival (Part A and B)
  • Progression-free Survival (Part A)
  • Overall response rates (Part B)
  • Incidence of grade 3/4/5 adverse events (Part B)
PRIMARY OBJECTIVES:
I. To evaluate overall response rate (ORR) with nivolumab in patients with previously treated metastatic squamous cell carcinoma (SCCA) of the anal canal. (Part A) II. To determine an improvement in progression-free survival (PFS) when nivolumab is combined with ipilimumab versus (vs.) nivolumab alone in patients with previously treated metastatic SCCA (Part B). SECONDARY OBJECTIVES:
I. To evaluate progression-free survival (PFS) of nivolumab in patients with previously treated metastatic SCCA of the anal canal. (Part A) II. To evaluate overall survival (OS) in patients with previously treated metastatic SCCA of the anal canal treated with nivolumab. (Part A) III. To evaluate the grade 3 and 4 toxicity rate in patients with previously treated metastatic SCCA of the anal canal when treated with nivolumab. (Part A) IV. To evaluate the overall response rate (ORR) of nivolumab plus or minus ipilimumab in patients with previously treated metastatic SCCA of the anal canal. (Part B) V. To evaluate overall survival (OS) in patients with previously treated metastatic SCCA of the anal canal treated with nivolumab plus or minus ipilimumab. (Part B) VI. To evaluate the grade 3 and 4 toxicity rate in patients with previously treated metastatic SCCA of the anal canal when treated with nivolumab plus or minus ipilimumab. (Part B) EXPLORATORY OBJECTIVES:
I. To evaluate ORR, PFS, and OS based on expression of programmed cell death 1 ligand 1 (PD-L1), programmed cell death 1 (PD-1), peritumoural cluster of differentiation (CD)8+ tumour infiltrating lymphocytes (TILs), peritumoural CD4+ TILs, and regulatory T cells as analyzed from tumour biopsies in previously treated patients with metastatic SCCA of the anal canal when treated with nivolumab. (Part A) II. To evaluate radiographic responses according to relative changes in proportions of anti-human papillomavirus (HPV) specific CD8+ and CD4+ TILs and regulatory T cells in patients with previously treated metastatic SCCA of the anal canal following treatment with nivolumab, analyzed from serial peripheral blood samples. (Part A) III. To evaluate ORR, PFS, and OS based on expression of PD-L1, PD-1, peritumoural CD8+ tumour infiltrating lymphocytes (TILs), peritumoural CD4+ TILs, and regulatory T cells as analyzed from tumour biopsies in previously treated patients with metastatic SCCA of the anal canal when treated with nivolumab plus or minus ipilimumab. (Part B) IV. To evaluate radiographic responses according to relative changes in proportions of anti-HPV specific CD8+ and CD4+ TILs and regulatory T cells in patients with previously treated metastatic SCCA of the anal canal following treatment with nivolumab plus or minus ipilimumab. (Part B) OUTLINE:

PART A: Patients receive nivolumab intravenously (IV) over 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. PART B: Patients are randomized to 1 of 2 arms. ARM I: Patients receive nivolumab IV over 30 minutes once every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive nivolumab as in Arm I. Patients also receive ipilimumab IV over 30 minutes once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 100 days and then every 3 months for 2 years.

Voir cet essai sur ClinicalTrials.gov

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