Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04749602
  4. Details
NCT04749602 Clinical Trial

Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.

Non-small Cell Lung Cancer Metastatic Clinical Trial

Official title:
A Phase II Trial of Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04749602
Other study ID # KCRB-Hadassah-01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 10, 2020
Est. completion date March 1, 2023

Study information
Verified date March 2023
Source Kidney Cancer Research Bureau
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with advanced cancers who have pleural effusion, especially those requiring pleural evacuation, experienced poorer survival when treated with immunotherapy. The pleura also acts as a natural barrier that can limit the penetration of immune checkpoint inhibitors. In this multicenter phase 2 study, the preliminary efficacy and toxicity of intrapleural instillation of the nivolumab in patients with immune-sensitive metastatic cancers will be accessed.

Description:

Patients ≥18 years old who have large volume of pleural effusion, required evacuation, and received systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor) for metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC) will be eligible. Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date March 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients =18 years old - Large volume of pleural effusion (1 liter and more), required evacuation - Systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor) - Metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC) Exclusion Criteria: - Autoimmune disorders - Previous treatment for

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nivolumab
40 mg of the nivolumab will be used intrapleurally (once).

Locations
Country Name City State
Russian Federation I.M. Sechenov First Moscow State Medical University Moscow
Russian Federation Kidney Cancer Research Bureau Moscow
Russian Federation Medicine 24/7 clinic Moscow
Russian Federation Medscan Moscow
Russian Federation Yauza clinical hospital Moscow

Sponsors (1)
Lead Sponsor Collaborator
Kidney Cancer Research Bureau

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary 3-month recurrence-free survival Proportion of patients who will be without signs of radiographic recurrence after 3 months 3 months
Secondary Rate of any grade adverse events Percentage of patients who will experience any grade adverse events (according to CTCAE criteria ver. 5.0) associated with intrapleural nivolumab use 3 months
See also
  Status Clinical Trial Phase
Completed NCT01523340 - A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response
Recruiting NCT03956641 - Evolution of the Physical Condition in Treated Cancer Patients N/A
Active, not recruiting NCT02035683 - PET/CT Scan as a Tool to Rationalize the Treatment of of Advanced NSCLC Patients Undergoing First Chemotherapy N/A
Completed NCT01848613 - Study of Patient Preference for Oral or Intravenous Vinorelbine in the Treatment of Advanced NSCLC Phase 4
Suspended NCT01320501 - Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer Phase 4
Terminated NCT01471964 - Study to Assess Safety and Tolerability of MLN8237, In Combination With Erlotinib to Treat Non-Small Cell Lung Cancer Phase 1/Phase 2
Recruiting NCT06127940 - K-SAB Trial - Sotorasib Followed by SBRT to 1-3 Lesions in Advanced NSCLC With KRASG12C Mutation Phase 1
Terminated NCT04069936 - Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC Phase 2
Terminated NCT03445000 - ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer Phase 2
Terminated NCT03386929 - Survival Prolongation by Rationale Innovative Genomics Phase 1/Phase 2
Recruiting NCT02922764 - A Study of RGX-104 in Patients With Advanced Lung & Endometrial Cancer Phase 1
Terminated NCT01574300 - Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network
Active, not recruiting NCT04646824 - Almonertinib With Chemotherapy in mEGFR NSCLC Phase 2
Completed NCT01966003 - Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer Phase 3
Recruiting NCT03656094 - Chemotherapy With Pembrolizumab Continuation After Progression to PD-1/L1 Inhibitors Phase 2
Terminated NCT01348126 - Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer Phase 2/Phase 3
Active, not recruiting NCT03469960 - Double Immune Checkpoint Inhibitors in PD-L1-positive Stage IV Non-small Lung CancEr Phase 3
Recruiting NCT05919264 - FOG-001 in Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT04793815 - Lung Cancer Cryo-Activation as a Novel Approach to Augment Immunotherapy Efficacy (CRYOVATE) N/A
Terminated NCT01380795 - Feasibility of the Research for Mutation of K-ras and EGFR in CTCs From Metastatic Non Small Cells Bronchial Carcinomas Early Phase 1