Renal Cell Cancer MetastaticPhase 2NCT04749602
Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.
A Phase 2 study testing Nivolumab in people with Renal Cell Cancer Metastatic and Non-small Cell Lung Cancer Metastatic, run by Kidney Cancer Research Bureau at 5 sites in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Cancer Metastatic, Non-small Cell Lung Cancer Metastatic, Pleural Effusion, Malignant
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 5 sitesRussia
- Study dates
- 10 Aug 2020to 1 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Autoimmune disorders
- Previous treatment for
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Russia5 sites
I.M. Sechenov First Moscow State Medical University
Moscow
Kidney Cancer Research Bureau
Moscow
Medicine 24/7 clinic
Moscow
Medscan
Moscow
Yauza clinical hospital
Moscow
About this study
Official title: A Phase II Trial of Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.
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.
Read the detailed 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.
- Conditions
- Renal Cell Cancer Metastatic, Non-small Cell Lung Cancer Metastatic, Pleural Effusion, Malignant
- Being tested
- Nivolumab
- Keywords
- Nivolumab, Intrapleural irrigation, Pleural carcinomatosis
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
40 mg of the nivolumab will be used intrapleurally (once).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma | Experimental | Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed. Receives: 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. Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month recurrence-free survival
Proportion of patients who will be without signs of radiographic recurrence after 3 months
Measured: 3 months
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start10 Aug 2020
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cohort 1 (renal cell carcinoma / lung cancer) Cohort 2 (lung cancer)
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kidney Cancer Research Bureau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilya Tsimafeyeu, M.D., Principal investigator, Kidney Cancer Research Bureau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749602
- Sponsor's protocol ID
- KCRB-Hadassah-01
- Status last verified
- Mar 2023
- First submitted
- 7 Feb 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.
- ClinicalTrials.gov ID
- NCT04749602
- Acronym / sponsor ID
- KCRB-Hadassah-01
- Conditions
- Renal Cell Cancer Metastatic, Non-small Cell Lung Cancer Metastatic, Pleural Effusion, Malignant
- Keywords
- Nivolumab, Intrapleural irrigation, Pleural carcinomatosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kidney Cancer Research BureauUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cohort 1 (renal cell carcinoma / lung cancer) Cohort 2 (lung cancer)
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma | Experimental | Drug: NivolumabDrainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed. |
| Cohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer | Experimental | Drug: NivolumabDrainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Autoimmune disorders
- Previous treatment for
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: Opdivo40 mg of the nivolumab will be used intrapleurally (once). | Drug | Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma, Cohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer |
Primary outcome
3-month recurrence-free survival
Time frame: 3 months
Proportion of patients who will be without signs of radiographic recurrence after 3 months
1 secondary outcome
Rate of any grade adverse events
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilya Tsimafeyeu, M.D. principal investigator
Kidney Cancer Research Bureau
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab in people with Renal Cell Cancer Metastatic and Non-small Cell Lung Cancer Metastatic, run by Kidney Cancer Research Bureau at 5 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month recurrence-free survival (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.