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

NCT04534855 | Unknown Phase 2

• 1 other identifier: B2020-154-01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Treprilimab,recurrent/residual NPC

Outcome Measures

Primary Outcomes (1)

• objective response rate

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

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

Secondary Outcomes (3)

• PFS

  time from enrollment to the first documented progression of disease or death from any cause)

• 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).

Study Arms (1)

Treprilimab treatment group

EXPERIMENTAL

Treprilimab 240mg ivdrip Q3W until progression or unacceptable toxicity

Drug: Treprilimab

Interventions

Treprilimab DRUG

Treprilimab 240mg Q3W until progression or unacceptable toxicity

Treprilimab treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Related Publications (4)

• Ma BBY, Lim WT, Goh BC, Hui EP, Lo KW, Pettinger A, Foster NR, Riess JW, Agulnik M, Chang AYC, Chopra A, Kish JA, Chung CH, Adkins DR, Cullen KJ, Gitlitz BJ, Lim DW, To KF, Chan KCA, Lo YMD, King AD, Erlichman C, Yin J, Costello BA, Chan ATC. Antitumor Activity of Nivolumab in Recurrent and Metastatic Nasopharyngeal Carcinoma: An International, Multicenter Study of the Mayo Clinic Phase 2 Consortium (NCI-9742). J Clin Oncol. 2018 May 10;36(14):1412-1418. doi: 10.1200/JCO.2017.77.0388. Epub 2018 Mar 27.

  PMID: 29584545 BACKGROUND

• Hsu C, Lee SH, Ejadi S, Even C, Cohen RB, Le Tourneau C, Mehnert JM, Algazi A, van Brummelen EMJ, Saraf S, Thanigaimani P, Cheng JD, Hansen AR. Safety and Antitumor Activity of Pembrolizumab in Patients With Programmed Death-Ligand 1-Positive Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Study. J Clin Oncol. 2017 Dec 20;35(36):4050-4056. doi: 10.1200/JCO.2017.73.3675. Epub 2017 Aug 24.

  PMID: 28837405 BACKGROUND

• Chan AT, Hsu MM, Goh BC, Hui EP, Liu TW, Millward MJ, Hong RL, Whang-Peng J, Ma BB, To KF, Mueser M, Amellal N, Lin X, Chang AY. Multicenter, phase II study of cetuximab in combination with carboplatin in patients with recurrent or metastatic nasopharyngeal carcinoma. J Clin Oncol. 2005 May 20;23(15):3568-76. doi: 10.1200/JCO.2005.02.147. Epub 2005 Apr 4.

  PMID: 15809453 BACKGROUND

• Zhou Y, Miao J, Wu H, Tang H, Kuang J, Zhou X, Peng Y, Hu D, Shi D, Deng W, Cao X, Zhao C, Xie C. PD-1 and PD-L1 expression in 132 recurrent nasopharyngeal carcinoma: the correlation with anemia and outcomes. Oncotarget. 2017 Apr 19;8(31):51210-51223. doi: 10.18632/oncotarget.17214. eCollection 2017 Aug 1.

  PMID: 28881642 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Fei Han, MD

CONTACT

+8613822113698; hanfei@sysucc.org.cn

Meiling Deng, MD

CONTACT

+8613711479924; dengml@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of radiotherapy Department

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 1, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2025
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE