Niraparib And Sintilimab In Recurrent/Metastatic Nasopharyngeal Carcinoma

NCT05162872 | Unknown Phase 2

• 1 other identifier: 2021-FXY-039
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).

  up to 180 days.

Secondary Outcomes (4)

• DoR

  up to 180 days.

• DCR

  up to 180 days.

• PFS

  up to 180 days.

• OS

  up to 360 days.

Study Arms (2)

PD-(L)1 naive patients, ≥1L of platinum-based chemotherapy

EXPERIMENTAL

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.

Drug: Niraparib，Sintilimab

PD-(L)1 previously treated patients，≥1L of platinum-based chemotherapy

EXPERIMENTAL

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.

Drug: Niraparib，Sintilimab

Interventions

Niraparib，Sintilimab DRUG

Niraparib 200 mg QD D1-21 Sintilimab 200 mg IV q3W

PD-(L)1 naive patients, ≥1L of platinum-based chemotherapy; PD-(L)1 previously treated patients，≥1L of platinum-based chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. A written informed consent form should be signed prior to any study-related procedures 2. Male or female, aged from 18\~70 (inclusive) years 3. Histologically confirmed recurrent and/or metastatic nasopharyngeal carcinoma 4. At least 1 measurable lesion (RECIST 1.1 criteria) 5. Received ≥1L treatment (including but not limited to standard chemotherapy, targeted therapy, immunotherapy) ，with ≥1 platinum-based chemotherapy.
• \. ECOG score 0\~1 7. Expected survival time ≥ 3 months 8. Good organ function includes:
• Neutrophil count≥1.5×109/L,
• Platelet count≥100×109/L,
• Hemoglobin≥9 g/dL
• Serum creatinine≤1.5×upper limit of normal (ULN), creatinine clearance≥60 mL/min (Cockcroft-Gault formula)
• Total bilirubin≤1.5×ULN
• AST and ALT≤2.5×ULN; for patients with liver metastasis, AST and ALT≤5×ULN, the investigator should determine whether they are enrolled
• Normal coagulation function: INR and PT≤1.5×ULN 9. Negative pregnancy test at enrollment. Male or female subjects should commit to take adequate and effective contraceptive measures or abstain from sexual for the duration of study participation and within 3 months after the last dose of the study drug 10. Toxicity of any previous chemotherapy have recovered to ≤ CTCAE Grade 1 or baseline 11. Other anti-tumor treatments have been discontinued, including but not limited to chemotherapy, radiotherapy, and surgery 4 weeks before receiving the study drug

You may not qualify if:

• \. Known hypersensitivity to active or inactive ingredients of any drug in the study 2. Prior treatment with PARP inhibitors 3. Symptomatic and uncontrolled brain or leptomeningeal metastasis. No imaging scan is required to confirm no brain metastases 4. History of serious hypersensitivity reaction to any monoclonal antibody 5. Past or current diagnosis of MDS or AML 6. Major surgery within 4 weeks of starting the study or patient has not recovered from any effects of any major surgery 7. Patients with serious or uncontrolled diseases, including but not limited to:
• Uncontrollable nausea and vomiting, intestinal obstruction with symptoms that cannot be reduced, inability to swallow study drug, any gastrointestinal disorder that may interfere with drug absorption and metabolism
• Patients with respiratory syndrome due to pleural effusion or ascites (≥ CTCAE Grade 2 dyspnea)
• Active viral infections such as HIV, hepatitis B, hepatitis C, etc.
• Uncontrolled grand mal epilepsy, unstable spinal cord compression, superior vena cava syndrome, or other psychiatric disorders that affect the patient's signature of the informed consent form
• Immunodeficiency (other than splenectomy), or other condition that, in the opinion of the investigator, would expose the patient to high risk toxicity
• Active autoimmune disease or history of autoimmune disease that may recur and exert an effect on vital organ function or require treatment with immunosuppressive agents including systemic corticosteroids treatment period 8. Any systemic treatment requirement with corticosteroids (\> 10 mg/day prednisone) or other immunosuppressive drugs within 14 days after receiving the study drug; in the absence of active autoimmune diseases, inhaled or topical steroids application and adrenal replacement doses (≤ 10 mg/day prednisone) are allowed; topical, intraocular, intra-articular, nasal, and inhaled corticosteroids (with small systemic absorption) are allowed; physiological replacement doses of systemic corticosteroids (≤ 10 mg/day prednisone) are allowed; the short-term corticosteroid therapy for the prevention (e.g., contrast allergy) or treatment of non-autoimmune diseases (e.g., delayed hypersensitivity caused by contact allergens) is allowed 9. History of bleeding tendency and thrombosis:
• Any bleeding event at CTCAE Grade 2 within 3 months prior to screening or at CTCAE Grade 3 or higher within 6 months prior to screening
• With active bleeding or coagulation abnormalities, bleeding tendency, or receiving thrombolytic or anticoagulation therapy
• Anticoagulation therapy is needed with warfarin or heparin
• Chronic antiplatelet therapy (e.g., aspirin, clopidogrel) is needed
• Thrombotic or embolic event within the past 6 months, e.g., cerebrovascular accident (including transient ischemic attack), and pulmonary embolism 10. Serious cardiovascular history:
• NYHA (New York Heart Association) Class 3 and 4 congestive heart failure
• Unstable angina or newly diagnosed angina or myocardial infarction within 12 months before screening
• Arrhythmia requiring therapeutic intervention (patients taking β-blockers or digoxin can be included)

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Li zhang

Guangzhou, Guangdong, 510000, China

RECRUITING

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

Study Officials

• Li zhang, DOCTOR

  SUN YAT-SEN UNVERISITY CANCER CENTER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li zhang, Doctor

CONTACT

+8613902282893; zhangli@sysucc.org.cn

Wenfeng Fang, Doctor

CONTACT

+8615322302066; fangwf@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Oncology, Director of Medical Oncology Department of Sun Yat-Sen University Cancer Centre (SYSUCC), Deputy Director of Lung Cancer Research Centre of SYSU

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 17, 2021
• Study Start: August 5, 2021
• Primary Completion: June 30, 2023
• Study Completion: October 30, 2023
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)