Clinical Trial: Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 2 Single-Arm, Open-Label Study of Nivolumab in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)

Brief Summary: This phase II trial studies how well nivolumab works in treating patients with peripheral T-cell lymphoma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess the clinical benefit of nivolumab in T-cell lymphomas, as measured by objective response rate (ORR) within 12 cycles according to the Lugano Classification Response Criteria (2014).

SECONDARY OBJECTIVES:

I. To assess safety and tolerability of the regimen in this patient population. II. To assess progression-free survival (PFS). III. To assess duration of response (DOR). IV. To assess overall survival (OS).

TERTIARY OBJECTIVES:

I. To evaluate T-cell/cytokine profile in the peripheral blood - peripheral blood specimens will be used to assess T-cell activation and cytokine up regulation as measures of treatment effect.

II. To evaluate intratumoral biomarkers- intratumoral cell populations and distribution, genetic variability, mutational burden and T-cell activation will be evaluated to identify potential biomarkers that correlate with response to therapy.

III. To assess the potential association between PD-L1/PD-1/PD-L2 expression on tumor and T-cells and/or PD-L1 soluble levels in plasma with clinical efficacy of PD-1 blockade.

OUTLINE:

Patients receive nivolumab intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive nivolumab IV over 60 minutes on day 1 of course 9. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or una
Sponsor: Mayo Clinic

Current Primary Outcome:

• Proportion of complete or partial responses assessed according to the revised Lugano Classification Response criteria [ Time Frame: Up to 390 days ]
  The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.
• Proportion of complete or partial responses assessed according to the revised Lugano Classification Response criteria [ Time Frame: Up to 390 days ]
  Confidence intervals for the true success proportion will be calculated.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Duration of Complete Response (DOR) [ Time Frame: Up to 390 days ]
  The distribution of duration of complete response will be estimated using the method of Kaplan-Meier.
• Incidence of adverse events [ Time Frame: Up to 390 days ]
  The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
• Incidence of adverse events [ Time Frame: Up to 390 days ]
  The relationship of the adverse event(s) to the study treatment will be taken into consideration.
• Overall Survival (OS) [ Time Frame: The time from registration to death due to any cause, assessed up to 2 years ]
  The distribution of survival time will be estimated using the method of Kaplan-Meier.
• Progression-Free Survival (PFS) [ Time Frame: The time from registration to relapse or death due to any cause, assessed up to 5 years ]
  The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. In addition, the progression-free survival rate will be reported.
• Progression-Free Survival (PFS) [ Time Frame: The time from registration to relapse or death due to any cause, assessed up to 5 years ]
  The progression-free survival rate will be reported.
• Response rates [ Time Frame: Up to 390 days ]
  Will be estimated using complete metabolic response divided by the total number of evaluable patients.
• Response rates [ Time Frame: Up to 390 days ]
  Will be estimated using partial metabolic response divided by the total number of evaluable patients.

Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: March 1, 2017
Date Started: March 31, 2017
Date Completion: March 2022
Last Updated: May 22, 2017
Last Verified: March 2017