NCT04749602

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

February 7, 2021

Last Update Submit

March 6, 2023

Conditions

Renal Cell Cancer MetastaticNon-small Cell Lung Cancer MetastaticPleural Effusion, Malignant

Keywords

NivolumabIntrapleural irrigationPleural carcinomatosis

Outcome Measures

Primary Outcomes (1)

  • 3-month recurrence-free survival

    Proportion of patients who will be without signs of radiographic recurrence after 3 months

    3 months

Secondary Outcomes (1)

  • Rate of any grade adverse events

    3 months

Study Arms (2)

Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma

EXPERIMENTAL

Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.

Drug: Nivolumab

Cohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer

EXPERIMENTAL

Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.

Drug: Nivolumab

Interventions

NivolumabDRUG

40 mg of the nivolumab will be used intrapleurally (once).

Also known as: Opdivo
Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinomaCohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Autoimmune disorders
  • Previous treatment for

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

I.M. Sechenov First Moscow State Medical University

Moscow, Russia

Location

Kidney Cancer Research Bureau

Moscow, Russia

Location

Medicine 24/7 clinic

Moscow, Russia

Location

Medscan

Moscow, Russia

Location

Yauza clinical hospital

Moscow, Russia

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Ilya Tsimafeyeu, M.D.

    Kidney Cancer Research Bureau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cohort 1 (renal cell carcinoma / lung cancer) Cohort 2 (lung cancer)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2021

First Posted

February 11, 2021

Study Start

August 10, 2020

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations

RU(5)