A Study of Intrapleural Administration of Bevacizumab and Camrelizumab for Malignant Pleural Effusion

NCT05330065 | Unknown Phase 1

• 1 other identifier: SHR-1210-MPE-001
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with a variety of malignancies can develop malignant pleural effusion (MPE). MPE can cause significant symptoms and result in a marked decrease in quality of life and a poor prognosis. MPE is primarily considered as an immune and vascular manifestation of pleural metastases. The combined use of anti-angiogenic therapy and immunotherapy may be a promising strategy for MPE. This is a Phase Ib/II clinical trial to evaluate the safety and tolerability of administering bevacizumab and camrelizumab into the intrapleural space of subjects with malignant pleural effusion through a pleurX catheter.

Conditions

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (2)

• Adverse Events (Safety)

  Incidence of safety events including: adverse events (AEs), Serious AEs, and dose limiting toxicities (DLTs) AEs:Percentage of participants with adverse events; SAEs:Percentage of participants with Serious AEs; Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity according to NCI CTCAE 4.0 criteria.

  up to 12 months

• ORR

  Complete remission (CR) was considered when the accumulated fluid had disappeared and was stable for at least four weeks; partial remission (PR) was considered when \>50% of the accumulated fluid had disappeared, symptoms had improved, and the remaining fluid had failed to increase for at least four weeks; The total efficiency ORR was calculated by taking the sum of CR+PR

  up to 12 months

Secondary Outcomes (2)

• Exploratory biomarkers

  up to 12 months

• Quality of life questionnaire EORTC QLQ 30

  up to12 months

Study Arms (1)

Bevacizumab and Camrelizumab for Malignant Pleural Effusion

EXPERIMENTAL

Drug: bevacizumab and camrelizumab

Interventions

bevacizumab and camrelizumab DRUG

Stage 1 was classical "3+3" dose escalation with pts assigned to one of the following 3 cohorts, Cohort A:Avastin 5mg/kg once every 2 weeks and camrelizumab 100mg once every 2 weeks;Cohort B:Avastin 7.5mg/kg once every 2 weeks and camrelizumab 100mg once every 2 weeks;Cohort C:Avastin 7.5mg/kg once every 2 weeks and camrelizumab 200mg once every 2 weeks.DLT was observed for 28 days.

Bevacizumab and Camrelizumab for Malignant Pleural Effusion

Eligibility Criteria

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

You may qualify if:

• Be ≥ 18 years of age on day of signing informed consent.
• Histologically or cytologically documented malignant pleural effusion
• Histologically confirmed cancer
• Malignant pleural effusion clinically judged as not responsive to conventional systemic therapy(ies) for primary malignancy
• Adequate liver and renal function as defined below:
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Life expectancy of \> 12 weeks
• Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
• Females of childbearing potential must have a negative serum pregnancy test at screening and be willing to have additional serum pregnancy tests during the study.
• Willing and able to comply with all study procedures

You may not qualify if:

• Receiving any investigational agent, or using an investigational device, currently or within 28 days or 5 half-lives of Day 1 of treatment on this study, whichever is longer.
• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.
• Has had a prior monoclonal antibody within 4 weeks prior to study Day 1, or who has not recovered to, ≤ Grade 1 toxicity at baselines from adverse events due to agents administered more than 4 weeks earlier.
• Has received prior intrapleural administration with an anti-programmed cell death receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
• Has received prior intrapleural administration with bevacizumab or Endostar.
• Any concurrent chemotherapy, intraperitoneal (IP), biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
• Major surgery within 28 days prior to day 1 of study treatment from which the patient has not completely recovered.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• Has a history of non-infectious pneumonitis that required steroids; currently active non-infectious pneumonitis; or evidence of interstitial lung disease.
• Has an active infection requiring systemic therapy or history of uncontrolled infection.
• Concurrent disease or condition which, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study participation or interpretation of individual patient results
• Breastfeeding at screening or planning to become pregnant (self or partner) at any time during study participation

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Bevacizumab; camrelizumab

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Feng Wang

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Wang

CONTACT

13938244776; zzuwangfeng@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: April 15, 2022
• Study Start: August 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2024
• Last Updated: April 15, 2022

Record last verified: 2022-04