Brief Title
A Phase II Clinical Study of Treprilimab in the Treatment of Recurrent Nasopharyngeal Carcinoma After Re-irradiation
Official Title
A Phase II Single Arm Clinical Study of Treprilimab in the Treatment of Local Recurrent/Residual Nasopharyngeal Carcinoma After Re-irradiation
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
objective response rate
Secondary Outcome
PFS
Condition
Nasopharyngeal Carcinoma
Intervention
Treprilimab
Study Arms / Comparison Groups
Treprilimab treatment group
Description: Treprilimab 240mg ivdrip Q3W until progression or unacceptable toxicity
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
September 1, 2020
Completion Date
September 1, 2025
Primary Completion Date
September 1, 2022
Eligibility Criteria
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
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
, +8613822113698, [email protected]
Administrative Informations
NCT ID
NCT04534855
Organization ID
B2020-154-01
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
, ,
Verification Date
August 2020