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

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.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: Dalpiciclib Isetionate Tablets, Camrelizumab

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rui You, PhD; Phone Number: 86-13580439820; Email: yourui@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dalpiciclib plus Camrelizumab	Drug: Dalpiciclib Isetionate Tablets, Camrelizumab; Dalpiciclib, D1-21, po, 150mg, qd, Q4W. Camrelizumab, iv, 200mg, D1, Q3W.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 years
Duration of response (DoR)	Defined as the time from first documentation of objective response to radiological disease progression	1 year
Disease control rate (DCR)	Disease control rate is the rate of patients achieving complete response, partial response or stable disease	1 year
Incidence of adverse events	NCI-CTCAE 5.0 standard is adopted.	1 year

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2022
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): October 1, 2024

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (ACTUAL): February 13, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma
• Other Study ID Numbers: SYSUCC-CMY-2022-CDK46

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No