Nasopharyngeal CarcinomaPhase 2NCT05162872
Niraparib And Sintilimab In Recurrent/Metastatic Nasopharyngeal Carcinoma
A Phase 2 study testing Niraparib，Sintilimab in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Niraparib，Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2021to 30 Oct 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 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.
- 6. 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)
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- 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
Who cannot join
- 1. 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
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- 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)
- ≥ CTCAE Grade 2 valvular heart disease
- Hypertension that cannot be controlled with medication (systolic pressure > 150 mmHg or diastolic pressure > 100 mmHg) 11. Patients with any previous or current disease, treatment, or laboratory abnormality that may interfere with the results of the study and the throughout participation of the patient, or in the opinion of the investigator, the patient is not appropriate for the study; patients should not receive platelet or red blood cell infusions 4 weeks before the start of treatment with study drug 12. Patients who are pregnant or lactating, or who intend to become pregnant during the study treatment period
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Li zhang
Guangzhou, Guangdong, 510000
Li zhang, zhangli@sysucc.org.cn
About this study
Official title: A Phase II Study of Combination of Niraparib And Sintilimab In Recurrent/Metastatic Nasopharyngeal Carcinoma
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
Read the detailed description
this is a phase II, open-label study, to see whether the combination of Niraparib and Sintilimab is effective and safe to treat recurrent/metastatic nasopharyngeal carcinoma.
we will enroll patients who are 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.
the study is designed to contain 2 cohorts: cohort A PD-(L)1 naive and cohort B PD-(L)1 previously treated patients, simon 2-steps design for each cohort, that is: for cohort A, first step will enroll 23 patients, if CR/PR patients ≥3， then go to the second step, continue to enroll 39 patients, otherwise this cohort ends. for cohort B, first step enroll 20 patients, if CR/PR patients ≥1，then continue to enroll 17 patients, otherwise the cohort ends.
Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage associated with nasopharyngeal carcinoma from occurring.
The FDA has not approved niraparib for nasopharyngeal carcinoma, but it has been approved for other uses.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Niraparib，Sintilimab
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niraparib，SintilimabDrug
Niraparib 200 mg QD D1-21 Sintilimab 200 mg IV q3W
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Niraparib，Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).
Measured: up to 180 days.
Secondary outcomes (4)
DoR
DoR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first.
Measured: up to 180 days.
DCR
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease(SD).
Measured: up to 180 days.
PFS
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Measured: up to 180 days.
OS
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Measured: up to 360 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start5 Aug 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, MD, Sun Yat-sen University
- Investigators
- Li zhang, DOCTOR, Principal investigator, SUN YAT-SEN UNVERISITY CANCER CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162872
- Sponsor's protocol ID
- 2021-FXY-039
- Status last verified
- Dec 2021
- First submitted
- 23 Nov 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Combination of Niraparib And Sintilimab In Recurrent/Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT05162872
- Acronym / sponsor ID
- 2021-FXY-039
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 17 Dec 2021 (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.
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
Detailed description
this is a phase II, open-label study, to see whether the combination of Niraparib and Sintilimab is effective and safe to treat recurrent/metastatic nasopharyngeal carcinoma.
we will enroll patients who are 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.
the study is designed to contain 2 cohorts: cohort A PD-(L)1 naive and cohort B PD-(L)1 previously treated patients, simon 2-steps design for each cohort, that is: for cohort A, first step will enroll 23 patients, if CR/PR patients ≥3， then go to the second step, continue to enroll 39 patients, otherwise this cohort ends. for cohort B, first step enroll 20 patients, if CR/PR patients ≥1，then continue to enroll 17 patients, otherwise the cohort ends.
Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage associated with nasopharyngeal carcinoma from occurring.
The FDA has not approved niraparib for nasopharyngeal carcinoma, but it has been approved for other uses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-(L)1 naive patients, ≥1L of platinum-based chemotherapy | Experimental | Drug: Niraparib，SintilimabHistologically 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. |
| PD-(L)1 previously treated patients，≥1L of platinum-based chemotherapy | Experimental | Drug: Niraparib，SintilimabHistologically 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. 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.
- 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)
Key exclusion criteria (17 listed)
- 1. 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
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 |
|---|---|---|
| Niraparib，SintilimabNiraparib 200 mg QD D1-21 Sintilimab 200 mg IV q3W | Drug | PD-(L)1 naive patients, ≥1L of platinum-based chemotherapy, PD-(L)1 previously treated patients，≥1L of platinum-based chemotherapy |
Primary outcome
Overall response rate (ORR)
Time frame: up to 180 days.
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).
4 secondary outcomes
DoR
Time frame: up to 180 days.
DCR
Time frame: up to 180 days.
PFS
Time frame: up to 180 days.
OS
Time frame: up to 360 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Li zhang, DOCTOR principal investigator
SUN YAT-SEN UNVERISITY CANCER CENTER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niraparib，Sintilimab in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
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 9 inclusion and 17 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 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Li zhang, Doctor (+8613902282893, zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: up to 180 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2021.