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CDK4/6 Inhibitor Plus Camrelizumab for PD-1 Inhibitor Refractory R/M NPC

Primary Purpose

Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Dalpiciclib Isetionate Tablets, Camrelizumab
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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. Exclusion Criteria: 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). 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.

Sites / Locations

  • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dalpiciclib plus Camrelizumab

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Duration of response (DoR)
Defined as the time from first documentation of objective response to radiological disease progression
Disease control rate (DCR)
Disease control rate is the rate of patients achieving complete response, partial response or stable disease
Incidence of adverse events
NCI-CTCAE 5.0 standard is adopted.

Full Information

First Posted
February 2, 2023
Last Updated
February 2, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05724355
Brief Title
CDK4/6 Inhibitor Plus Camrelizumab for PD-1 Inhibitor Refractory R/M NPC
Official Title
Dalpiciclib Combined With Camrelizumab for PD-1 Inhibitor Refractory R/M NPC
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dalpiciclib plus Camrelizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dalpiciclib Isetionate Tablets, Camrelizumab
Intervention Description
Dalpiciclib, D1-21, po, 150mg, qd, Q4W. Camrelizumab, iv, 200mg, D1, Q3W.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Objective response rate is the rate of patients achieving complete response or partial response for a certain period of time after intervention.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Median progression-free survival (PFS)
Description
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.
Time Frame
1 year
Title
Median overall survival (OS)
Description
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.
Time Frame
3 years
Title
Duration of response (DoR)
Description
Defined as the time from first documentation of objective response to radiological disease progression
Time Frame
1 year
Title
Disease control rate (DCR)
Description
Disease control rate is the rate of patients achieving complete response, partial response or stable disease
Time Frame
1 year
Title
Incidence of adverse events
Description
NCI-CTCAE 5.0 standard is adopted.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Yuan Chen, MD, PhD
Phone
86-20-8734-3361
Email
chmingy@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Rui You, PhD
Phone
86-13580439820
Email
yourui@sysucc.org.cn
Facility Information:
Facility Name
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Yuan Chen, MD,PhD
Phone
86-20-8734-2422
Email
chmingy@mail.sysu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

CDK4/6 Inhibitor Plus Camrelizumab for PD-1 Inhibitor Refractory R/M NPC

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