Apatinib and Camrelizumab in Recurrent or Metastatic Nasopharyngeal Carcinoma With First-line Treatment Failure

Apatinib Combined With Camrelizumab in Recurrent or Metastatic Nasopharyngeal Carcinoma Who Failed at Least the First-line Treatment

Sponsors

Lead Sponsor: Sun Yat-sen University

Source Sun Yat-sen University
Brief Summary

This is a prospective phase II clinical trial to evaluate the efficacy and safety of apatinib and camrelizumab in recurrent or metastatic nasopharyngeal carcinoma who failed at least the first-line treatment.

Overall Status Recruiting
Start Date May 5, 2020
Completion Date May 5, 2022
Primary Completion Date January 1, 2022
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Objective response rate 1 year
Secondary Outcome
Measure Time Frame
The proportion of patients who achieved disease control 1 year
The proportion of patients who achieved clinical benefit 1 year
median progression-free survival 1 year
Duration of response 1 year
Adverse events 1 year
Enrollment 57
Condition
Intervention

Intervention Type: Drug

Intervention Name: Apatinib plus Camrelizumab

Description: Subjects receive Apatinib, 250mg, QD and Camrelizumab, 200mg, D1, Q3W. Treatment was continued until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or investigator decision.

Arm Group Label: Apatinib plus Camrelizumab arm

Eligibility

Criteria:

Inclusion Criteria: 1. Male or female; 18-70 years of age. 2. Subjects diagnosed with pathological confirmed metastatic nasopharyngeal carcinoma, or subjects with recurrent NPC that is unfit for local treatment 3. Underwent at least first-line treatment failure 4. ECOG performance status of 0 or 1. 5. Life expectancy more than 12 weeks. 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. Female subjects agree not to be pregnant or lactating from beginning of the study screening through at least 3 months after receiving the last dose of study treatment. Both men and women of reproductive potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy. 9. Able to understand and sign an informed consent form (ICF). Exclusion Criteria: 1. Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Subjects with the following conditions will not be excluded from this study: asthma that requires intermittent use of bronchodilators, hypothyroidism stable on hormone replacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptions may be made with medical monitor approval; 2. Known history of hypersensitivity to any components of the Camrelizumab formulation or other monoclonal antibodies ; 3. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses 10 mg/day prednisone or equivalent are prohibited within 4 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed; 4. Subjects who underwent anti-PD-1 /PD-L antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway) and anti-angiogenic drugs. 5. Abnormal coagulation function (INR>1.5×ULN, APTT>1.5×ULN) with bleeding tendency. 6. The laboratory test values within 7 days before enrollment do not meet the relevant standards. 7. Active central nervous system (CNS) metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease); 8. Diagnosed with other malignant tumors. 9. Uncontrolled clinically significant medical condition, including but not limited to the following: 1. Hypertension that cannot be reduced to the normal range after antihypertensive drug 2. congestive heart failure (New York Health Authority Class > 2), 3. unstable angina, 4. myocardial infarction within the past 12 months, 5. clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention; 10. Active bleeding, ulcer, intestinal perforation, major surgery in the previous month; Patients with tumors close to the internal carotid artery or other large vessels, thus at risk of massive bleeding 11. Active infection or an unexplained fever; 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled); 12. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease; active tuberculosis (TB), anti-TB treatment is ongoing or within 1 year prior to screening; Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation based on institutional guidelines and tests. Testing may include the following: HBV DNA, HCV RNA, hepatitis B surface antigen, or anti-Hepatitis B core antibody. 13. Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment. 14. Any other medical (eg, pulmonary, metabolic, congenital, endocrinal, or CNS disease), psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results;

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Contact

Last Name: Ming-Yuan Chen, MD, PhD

Phone: 86-20-8734-3361

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Sun Yat-sen University Cancer Center Ming-Yuan Chen, MD, PhD 86-20-8734-3361 [email protected] Ming-Yuan Chen, MD, PhD Principal Investigator
Location Countries

China

Verification Date

October 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Sun Yat-sen University

Investigator Full Name: Ming-Yuan Chen

Investigator Title: Chief physician, Proffessor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Apatinib plus Camrelizumab arm

Type: Experimental

Description: Subjects receive apatinib plus camrelizumab

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov