Niraparib And Sintilimab In Recurrent/Metastatic Nasopharyngeal Carcinoma

Sponsor
Sun Yat-sen University
Study ID
NCT05162872
Phase
PHASE2
Status
Unknown

Conditions

  • Nasopharyngeal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

this study is aimed to evaluate the efficacy and safety of the combination of Niraparib and Sintilimab in the treatment of recurrent/metastatic nasopharyngeal carcinoma

Key Dates

Start date
Aug 5, 2021
Status verified
Dec 2021
Primary completion
Jun 30, 2023
Completion
Oct 30, 2023

Study Design

Enrollment
99 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PD-(L)1 naive patients, ≥1L of platinum-based chemotherapy
    Histologically confirmed recurrent or metastatic nasopharyngeal carcinoma (including recurrence and metastasis after radiotherapy, or a condition not suitable for surgery and radiotherapy judged by investigator) ≥ 1L of platinum-based chemotherapy at least 1 measurable lesion (RECIST 1.1) ECOG 0-1, PD-(L)1 naive patients, Niraparib 200 mg QD D1-21,Sintilimab 200 mg IV q3W, first step enroll N1=23 participants, if CR+PR≥3,then go to the second step, continue to enroll N2=39 participants, if CR+PR\<3，then do not go to the second step.
  • Experimental: PD-(L)1 previously treated patients，≥1L of platinum-based chemotherapy
    Histologically confirmed recurrent or metastatic nasopharyngeal carcinoma (including recurrence and metastasis after radiotherapy, or a condition not suitable for surgery and radiotherapy judged by investigator) ≥ 1L of platinum-based chemotherapy at least 1 measurable lesion (RECIST 1.1) ECOG 0-1, PD-(L)1 previously treated patients, Niraparib 200 mg QD D1-21,Sintilimab 200 mg IV q3W, first step enroll N1=20 participants, if CR+PR≥1,then go to the second step, continue to enroll N2=17 participants, if CR+PR\<1，then do not go to the second step.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: up to 180 days. ]

Central Contacts

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