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

NCT ID: NCT05724355

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-10-31

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dalpiciclib plus Camrelizumab

Group Type: EXPERIMENTAL

Dalpiciclib Isetionate Tablets, Camrelizumab

Intervention Type: DRUG

Dalpiciclib, D1-21, po, 150mg, qd, Q4W. Camrelizumab, iv, 200mg, D1, Q3W.

Interventions

Dalpiciclib Isetionate Tablets, Camrelizumab

Dalpiciclib, D1-21, po, 150mg, qd, Q4W. Camrelizumab, iv, 200mg, D1, Q3W.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC.

2. ECOG performance status of 0 or 1.

3. Progression after previous treatment with platinum-based dual-drug chemotherapy.

4. Progression after previous treatment with PD-1 inhibitors.

5. Experieced at least 1 line systemic therapy.

6. Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1.

7. Adequate organ function assessed by laboratory parameters during the screening period.

8. Life expectancy more than 12 weeks.

9. Able to understand and sign an informed consent form (ICF).

10. Able to swallow the pill.

Exclusion Criteria

1. Recurrent lesions suitable for radical treatment (radiotherapy or surgery).

2. Previous treatment over 3 lines.

3. Prior use of CDK4/6 inhibitors.

4. Patients with other malignancies.

5. Patients with known or suspected autoimmune diseases including dementia and seizures.

6. Multiple factors affecting the absorption of oral medications (e.g., dysphagia, chronic diarrhea, and bowel obstruction).

7. An excessive dose of glucocorticoids given within 4 weeks before enrollment.

8. Complications requiring long-term use of immunosuppressive drugs or systemic or local use of immunosuppressive-dose corticosteroids.

9. Patients with active pulmonary tuberculosis (TB) receiving anti-TB treatment or who have received anti-TB treatment within 1 year prior to screening.

10. 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).

11. Any anti-infective vaccines such as influenza vaccine, varicella vaccine, etc., within 4 weeks before enrollment.

12. Women of childbearing age with a positive pregnancy test and lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming-Yuan Chen

Chief physician, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming-Yuan Chen, MD, PhD

Role: CONTACT

chmingy@mail.sysu.edu.cn

86-20-8734-3361

Rui You, PhD

Role: CONTACT

yourui@sysucc.org.cn

86-13580439820

Facility Contacts

Ming-Yuan Chen, MD,PhD

Role: primary

chmingy@mail.sysu.edu.cn

86-20-8734-2422

Other Identifiers

SYSUCC-CMY-2022-CDK46

Identifier Type: -

Identifier Source: org_study_id