Apatinib Plus SHR1210 in Advanced Mucosal Melanoma

NCT03986515 | Unknown Phase 2

• 1 other identifier: HenanCH immunotherapy003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

There is still no effective treatment for advanced mucosal melanoma at present. The efficacy of single-agent PD-1 inhibitors is less than 20%. It is urgent to explore regimens to improve the efficacy of PD-1 inhibitors in patients with advanced mucosal melanoma. This study is performed to explore the safety and efficacy of apatinib plus SHR-1210 in patients with advanced mucosa melanoma whose diseases progress after chemotherapy.

Conditions

Mucosal Melanoma; Advanced Cancer; Apatinib; SHR-1210

Outcome Measures

Primary Outcomes (1)

• objective response rate

  the proportion of patients with CR, PR, and SD in the group

  three months

Secondary Outcomes (2)

• progression-free survival

  six months

• overall survival

  eighteen months

Study Arms (1)

treatment group

EXPERIMENTAL

apatinib 250mg orally once a day until disease progression of occurrence of intolerable adverse events. SHR-1210 200mg every two weeks until disease progression of occurrence of intolerable adverse events. (the first dose of SHR-1210 is set on the 3-5 days after apatinib

Drug: apatinib plus SHR-1210

Interventions

apatinib plus SHR-1210 DRUG

apatinib 250mg qd, 3-5 days later SHR-1210 200mg q3w

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mucosal melanoma by pathology
• expected lifespan ≥ 3 months
• ECOG 0-2
• failure after one kind of chemotherapeutic regimen
• at least one measurable lesion by RECIST 1.1
• enough organ function
• blood pressure is normal; for patients with hypertension the blood pressure should be controlled in normal by antihypertensive drugs
• no other serious diseases conflicting with this regimen
• no history of other malignancies
• pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
• informed consent from the patient

You may not qualify if:

• Suffering from serious infectious diseases within 4 weeks before enrollment
• requiring intermittent use of bronchodilators or medical interventions
• usage of immunosuppressants before enrollment and the dose of immunosuppressant used ≥ 10mg / day oral prednisone for more than 2 weeks
• serious allergy
• serious mental diseases
• abnormal coagulation funtion,bleeding tendency or receiving thrombolytic or anticoagulant therapy
• abdominal fistula, gastrointestinal perforation, or abdominal abscess within 4 weeks prior to enrollment
• previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc.
• other situations evaluated by investigator unsuitable for this study

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Interventions

apatinib; camrelizumab

Study Officials

• Jing Ding, Master

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingdi Zhao, Dr.

CONTACT

+86-371-65587483; lingdizhao@126.com

Yonghao Yang, Master

CONTACT

+86-371-65587483; 215582454@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: June 4, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2022
• Last Updated: June 14, 2019

Record last verified: 2019-06

Locations

CN (1)