Skip to main content
Clinical Trials/NCT04534855
NCT04534855Not yet recruitingPhase 2

A Phase II Single Arm Clinical Study of Treprilimab in the Treatment of Local Recurrent/Residual Nasopharyngeal Carcinoma After Re-irradiation

Sun Yat-sen University0 sites40 target enrollmentStarted: September 1, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
40
Primary Endpoint
objective response rate

Study Overview

Brief Summary

To establish the antitumor activity and safety of the anti-programmed death 1 receptor monoclonal antibody, Treprilimab, in patients with local recurrent/residual nasopharyngeal carcinoma after re-irradiation.Patients with local recurrent/residual NPC after re-irradiation were treated with Treprilimab until disease progression or unacceptable toxicity. The primary end point was objective response rate (ORR) and secondary end points included survival and toxicity.The sample size of this study was estimated on the assumption that response rates (RRs) to Treprilimab should be around 25%,based on a report that was available at the time this study was planned.Furthermore, the RR to noncytotoxic, experimental agents such as pazopanib and cetuximab in similarly pretreated patient cohorts was approximately 5% to 10%. This study's design was based on the modified Simon two-stage optimal design (α=0.05,β=0.2,n1=2/22,n2=7/40). If two responses were observed during the first stage, enrollment was continued until a total of 40 patients was reached.

Detailed Description

To establish the antitumor activity and safety of the anti-programmed death 1 receptor monoclonal antibody, Treprilimab, in patients with local recurrent/residual nasopharyngeal carcinoma after re-irradiation.Patients with local recurrent/residual NPC after re-irradiation were treated with Treprilimab until disease progression or unacceptable toxicity. The primary end point was objective response rate (ORR) and secondary end points included survival and toxicity.The sample size of this study was estimated on the assumption that response rates (RRs) to Treprilimab should be around 25%,based on a report that was available at the time this study was planned.Furthermore, the RR to noncytotoxic, experimental agents such as pazopanib and cetuximab in similarly pretreated patient cohorts was approximately 5% to 10%. This study's design was based on the modified Simon two-stage optimal design (α=0.05,β=0.2,n1=2/22,n2=7/40). If two responses were observed during the first stage, enrollment was continued until a total of 40 patients was reached. The target lesions had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST). Radiologic assessments were performed every 8 weeks for 6 months and then every 12 weeks thereafter. Eligible patients were treated with Treprilimab at a dosage of 240mg intravenously every 3 weeks until they experienced disease progression or unacceptable toxicity. The primary end point of this study was objective response by the RECIST criteria , and the secondary end points were overall survival (OS), progression-free survival (PFS), duration of response and toxicity.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ages from 18 years to 65 years.
  • Histologically confirmed local recurrent/residual Nasopharyngeal carcinoma with previous re-irradiation.
  • measurable disease at baseline on the basis of RECIST v1.
  • Eastern Cooperative Oncology Group performance status of 0 or
  • adequate organ function.
  • anticipate survival≥3 months.

Exclusion Criteria

  • a diagnosis of immuno deficiency or systemic corticosteroid therapy within 14 days of study start.
  • prior anticancer monoclonal antibody therapy within 4 weeks of study start.
  • any anticancer therapy within 4 weeks preceding the study start.
  • therapy with any other immune checkpoint inhibitor.
  • active autoimmune disease, interstitial lung disease, known additional malignancy that was progressing or that required active treatment.
  • not received platinum based chemotherapy previously.
  • confirmed systemic metastasis
  • HBV positive and Child-Pugh B or C cirrhosis
  • HCV positive and Child-Pugh B or C cirrhosis

Arms & Interventions

Treprilimab treatment group

Experimental

Treprilimab 240mg ivdrip Q3W until progression or unacceptable toxicity

Intervention: Treprilimab (Drug)

Outcomes

Primary Outcomes

objective response rate

Time Frame: Response was assessed by magnetic resonance imaging every 8 weeks for the first 6 months and every 12 weeks thereafter.

the proportion of patients with confirmed complete response or partial response (PR) per RECIST v1.1

Secondary Outcomes

  • OS(time from enrollment to death from any cause)
  • Number of participants with treatment-related adverse events(through the study and for 30 days after treatment discontinuation (90 days for serious AEs).)
  • PFS(time from enrollment to the first documented progression of disease or death from any cause))

Investigators

Sponsor
Sun Yat-sen University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fei Han

Deputy Director of radiotherapy Department

Sun Yat-sen University

Similar Trials