Nasopharyngeal CarcinomaPhase 2NCT05724355
CDK4/6 Inhibitor Plus Camrelizumab for PD-1 Inhibitor Refractory R/M NPC
A Phase 2 study testing Dalpiciclib Isetionate Tablets, Camrelizumab in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
Because most patients with R/M NPC have received long-term maintenance of immunotherapy at the time of initial treatment and the first-line treatment, there are a large number of PD-1 inhibitor refractory patients. How to deal with the ICIs resistance is an urgent problem in clinical practice. 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?
- Dalpiciclib Isetionate Tablets, Camrelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to Oct 2024
- 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
- Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC.
- ECOG performance status of 0 or 1.
- Progression after previous treatment with platinum-based dual-drug chemotherapy.
- Progression after previous treatment with PD-1 inhibitors.
- Experieced at least 1 line systemic therapy.
- Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1.
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- Adequate organ function assessed by laboratory parameters during the screening period.
- Life expectancy more than 12 weeks.
- Able to understand and sign an informed consent form (ICF).
- Able to swallow the pill.
Who cannot join
- Recurrent lesions suitable for radical treatment (radiotherapy or surgery).
- Previous treatment over 3 lines.
- Prior use of CDK4/6 inhibitors.
- Patients with other malignancies.
- Patients with known or suspected autoimmune diseases including dementia and seizures.
- Multiple factors affecting the absorption of oral medications (e.g., dysphagia, chronic diarrhea, and bowel obstruction).
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- An excessive dose of glucocorticoids given within 4 weeks before enrollment.
- Complications requiring long-term use of immunosuppressive drugs or systemic or local use of immunosuppressive-dose corticosteroids.
- Patients with active pulmonary tuberculosis (TB) receiving anti-TB treatment or who have received anti-TB treatment within 1 year prior to screening.
- HIV positive; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/ml); chronic hepatitis C with blood screening positive (HCV antibody positive).
- Any anti-infective vaccines such as influenza vaccine, varicella vaccine, etc., within 4 weeks before enrollment.
- Women of childbearing age with a positive pregnancy test and lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ming-Yuan Chen, MD,PhD, 86-20-8734-2422, chmingy@mail.sysu.edu.cn
About this study
Official title: Dalpiciclib Combined With Camrelizumab for PD-1 Inhibitor Refractory R/M NPC
Because most patients with R/M NPC have received long-term maintenance of immunotherapy at the time of initial treatment and the first-line treatment, there are a large number of PD-1 inhibitor refractory patients. How to deal with the ICIs resistance is an urgent problem in clinical practice.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Dalpiciclib Isetionate Tablets, Camrelizumab
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalpiciclib Isetionate Tablets, CamrelizumabDrug
Dalpiciclib, D1-21, po, 150mg, qd, Q4W. Camrelizumab, iv, 200mg, D1, Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Dalpiciclib plus Camrelizumab | Experimental | Not described Receives: Drug: Dalpiciclib Isetionate Tablets, Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate is the rate of patients achieving complete response or partial response for a certain period of time after intervention.
Measured: 1 year
Secondary outcomes (5)
Median progression-free survival (PFS)
Progression-free survival is defined as the time to the date of death of any cause or the first progress at any site, censored on the last date of tumor evaluation if no progress has happened.
Measured: 1 year
Median overall survival (OS)
Overall survival is defined as the time to the date of death of any cause, censored on the last date of known survival if no death has happened.
Measured: 3 years
Duration of response (DoR)
Defined as the time from first documentation of objective response to radiological disease progression
Measured: 1 year
Disease control rate (DCR)
Disease control rate is the rate of patients achieving complete response, partial response or stable disease
Measured: 1 year
Incidence of adverse events
NCI-CTCAE 5.0 standard is adopted.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Sep 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2024 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Yuan Chen, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724355
- Sponsor's protocol ID
- SYSUCC-CMY-2022-CDK46
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dalpiciclib Combined With Camrelizumab for PD-1 Inhibitor Refractory R/M NPC
- ClinicalTrials.gov ID
- NCT05724355
- Acronym / sponsor ID
- SYSUCC-CMY-2022-CDK46
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 13 Feb 2023 (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.
Because most patients with R/M NPC have received long-term maintenance of immunotherapy at the time of initial treatment and the first-line treatment, there are a large number of PD-1 inhibitor refractory patients. How to deal with the ICIs resistance is an urgent problem in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dalpiciclib plus Camrelizumab | Experimental | Drug: Dalpiciclib Isetionate Tablets, Camrelizumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC.
- ECOG performance status of 0 or 1.
- Progression after previous treatment with platinum-based dual-drug chemotherapy.
- Progression after previous treatment with PD-1 inhibitors.
- Experieced at least 1 line systemic therapy.
Key exclusion criteria (12 listed)
- Recurrent lesions suitable for radical treatment (radiotherapy or surgery).
- Previous treatment over 3 lines.
- Prior use of CDK4/6 inhibitors.
- Patients with other malignancies.
- Patients with known or suspected autoimmune diseases including dementia and seizures.
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 |
|---|---|---|
| Dalpiciclib Isetionate Tablets, CamrelizumabDalpiciclib, D1-21, po, 150mg, qd, Q4W. Camrelizumab, iv, 200mg, D1, Q3W. | Drug | Dalpiciclib plus Camrelizumab |
Primary outcome
Objective response rate (ORR)
Time frame: 1 year
Objective response rate is the rate of patients achieving complete response or partial response for a certain period of time after intervention.
5 secondary outcomes
Median progression-free survival (PFS)
Time frame: 1 year
Median overall survival (OS)
Time frame: 3 years
Duration of response (DoR)
Time frame: 1 year
Disease control rate (DCR)
Time frame: 1 year
Incidence of adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
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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.
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 Dalpiciclib Isetionate Tablets, Camrelizumab 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 10 inclusion and 12 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 13 Feb 2023. 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 Ming-Yuan Chen, MD, PhD (86-20-8734-3361, chmingy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 1 year). 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 13 Feb 2023.