A Phase II Clinical Study of Treprilimab in the Treatment of Recurrent Nasopharyngeal Carcinoma After Re-irradiation

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Sun Yat-sen University

Status and phase

Not yet enrolling
Phase 2

Conditions

Nasopharyngeal Carcinoma

Treatments

Drug: Treprilimab

Study type

Interventional

Funder types

Other

Identifiers

NCT04534855
B2020-154-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 v1.1.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Treprilimab treatment group
Experimental group
Description:
Treprilimab 240mg ivdrip Q3W until progression or unacceptable toxicity
Treatment:
Drug: Treprilimab

Trial contacts and locations

0

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Central trial contact

Fei Han, MD; Meiling Deng, MD

Data sourced from clinicaltrials.gov

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