Nasopharyngeal CarcinomaPhase 2NCT04534855
A Phase II Clinical Study of Treprilimab in the Treatment of Recurrent Nasopharyngeal Carcinoma After Re-irradiation
A Phase 2 study testing Treprilimab in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Treprilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- confirmed systemic metastasis
- HBV positive and Child-Pugh B or C cirrhosis
- HCV positive and Child-Pugh B or C cirrhosis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II Single Arm Clinical Study of Treprilimab in the Treatment of Local Recurrent/Residual Nasopharyngeal Carcinoma After Re-irradiation
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.
Read the 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.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Treprilimab
- Keywords
- Treprilimab,recurrent/residual NPC
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreprilimabDrug
Treprilimab 240mg Q3W until progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Treprilimab treatment group | Experimental | Treprilimab 240mg ivdrip Q3W until progression or unacceptable toxicity Receives: Drug: Treprilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
the proportion of patients with confirmed complete response or partial response (PR) per RECIST v1.1
Measured: Response was assessed by magnetic resonance imaging every 8 weeks for the first 6 months and every 12 weeks thereafter.
Secondary outcomes (3)
PFS
progression free survival
Measured: time from enrollment to the first documented progression of disease or death from any cause)
OS
overall survival
Measured: time from enrollment to death from any cause
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: through the study and for 30 days after treatment discontinuation (90 days for serious AEs).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Han, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534855
- Sponsor's protocol ID
- B2020-154-01
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 29584545Hsu 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.
PubMed 28837405Chan 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.
PubMed 15809453Zhou 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.
PubMed 28881642
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single Arm Clinical Study of Treprilimab in the Treatment of Local Recurrent/Residual Nasopharyngeal Carcinoma After Re-irradiation
- ClinicalTrials.gov ID
- NCT04534855
- Acronym / sponsor ID
- B2020-154-01
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Treprilimab,recurrent/residual NPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treprilimab treatment group | Experimental | Drug: TreprilimabTreprilimab 240mg ivdrip Q3W until progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreprilimabTreprilimab 240mg Q3W until progression or unacceptable toxicity | Drug | Treprilimab treatment group |
Primary outcome
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
3 secondary outcomes
PFS
Time frame: time from enrollment to the first documented progression of disease or death from any cause)
OS
Time frame: time from enrollment to death from any cause
Number of participants with treatment-related adverse events
Time frame: through the study and for 30 days after treatment discontinuation (90 days for serious AEs).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Background: PubMed 29584545Ma 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.
- Background: PubMed 28837405Hsu 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.
- Background: PubMed 15809453Chan 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.
- Background: PubMed 28881642Zhou 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treprilimab in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Han, MD (+8613822113698, hanfei@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534855, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.