Metastatic Pancreatic CancerPhase 2NCT04212026
Irreversible Electroporation (IRE) Followed by Nivolumab in Patients With Metastatic Pancreatic Cancer.
A Phase 2 study testing Nivolumab in people with Metastatic Pancreatic Cancer, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
Trial summary
This proof of concept trial aims to assess whether the combination of IRE with Nivolumab is safe and effective to treat metastatic pancreatic cancer, based on the available preliminary evidence that IRE is able to cause a systemic anti-tumor immune response (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 28 Jun 2020to 12 Jul 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
- Written informed consent according to Swiss law and ICH GCP E6(R2) regulations before registration and prior to any trial specific procedures.
- Pathologically proven PDAC with liver metastases either by histology or cytology.
- Liver metastases fulfilling the following criteria:
- measurable per RECIST v 1.1 (Appendix 1), AND
- at least two metastases ≥ 1 cm AND
- percutaneously accessible for repeat biopsy, AND
Show all 20Show fewer
- one of the biopsied metastases can be treated with IRE.
- At least stable disease after the completion of 10-24 weeks of first line standard chemotherapy (either (m)FOLFIRINOX or Gemcitabine/Abraxane) as confirmed by tumor assessment within 21 days prior to registration OR at least stable disease after the completion of 10-24 weeks of second line standard chemotherapy (either (m)FOLFIRINOX or Gemcitabine/Abraxane) as confirmed by tumor assessment within 21 days prior to registration. The choice of chemotherapy regimen is based on the decision of the treating medical oncologist.
- Patients with a prior malignancy and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of that disease at registration. Note: Less than 2 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence.
- Patients must be willing to participate in the translational research part of the trial and to undergo a tumor biopsy of the primary tumor and of the two metastatic sites in the liver before trial treatment and after five cycles of nivolumab treatment.
- Patients must be willing to travel to the hospital where IRE and biopsy will be performed (Claraspital Basel).
- Age ≥ 18 years
- WHO performance status 0-1
- Life expectancy ≥4 months
- Adequate bone marrow function: neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 80 g/L
- Adequate hepatic function: total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease ≤ 3.0 x ULN), AST and ALT ≤ 3 x ULN.
- Adequate renal function: estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 (according to CKD-EPI formula).
- Adequate coagulation function: INR ≤ 1.5 x ULN (the ULN for INR is defined with the value 1.2 for all sites, in case no ULN is documented in the lab certificates/sheets). In case patient is under anti-vitamin K treatment, INR >1.5 x ULN is allowed; however, the patient has to be switched to LMWH treatment prior to any trial intervention.
- Women of childbearing potential must use effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and until 5 months after the last dose of nivolumab. A negative pregnancy test before inclusion into the trial is required for all women of childbearing potential (for nivolumab product information).
- Men agree not to donate sperm or to father a child during trial treatment and until 7 months after the last dose of nivolumab (for nivolumab product information).
Who cannot join
- Clinically significant ascites that is not controllable.
- Prior radiotherapy to any PDAC disease site.
- Prior treatment with any immune checkpoint inhibitor.
- Concomitant or recent (within 100 days of registration) treatment with any other experimental drug (enrollment in another clinical trial).
- Concomitant use of other anti-cancer drugs or radiotherapy.
- Severe or uncontrolled concurrent illness, such as cardiovascular disease (congestive heart failure NYHA III or IV; unstable angina pectoris, history of myocardial infarction within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension.
Show all 13Show fewer
- Known history of human immunodeficiency virus (HIV) or active chronic Hepatitis C or Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (i.v.) antimicrobial treatment.
- Known history of tuberculosis, known history of primary immunodeficiency, known history of allogeneic organ transplant, receipt of live attenuated vaccine within 30 days prior to registration.
- Concomitant or prior use of immunosuppressive medication within 30 days of registration, with the exceptions of intranasal and inhaled corticosteroids, or systemic corticosteroids which must not exceed 10 mg/day of prednisone (or a dose equivalent corticosteroid), and the premedication for chemotherapy
- Concomitant need for full anticoagulation treatment that cannot be stopped or bridged for the performance of the biopsy/IRE procedures Note: Aspirin or other acetylsalicylic acid containing drugs (up to 300 mg/day) are allowed
- Any concomitant drugs contraindicated for use with the trial treatment according to the approved product information
- Known hypersensitivity to nivolumab or to any component of nivolumab, to stainless steel or to contrast agents.
- Any other serious underlying medical (in particular coagulation deficiencies), psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
St. Claraspital
Basel, 4058
Lindenhofspital
Bern, Canton of Bern, 3012
UniversitätsSpital Zürich
Zurich, 8091
About this study
Official title: Irreversible Electroporation (IRE) Followed by Nivolumab in Patients With Metastatic Pancreatic Cancer: a Multicenter Single-arm Phase II Trial
This proof of concept trial aims to assess whether the combination of IRE with Nivolumab is safe and effective to treat metastatic pancreatic cancer, based on the available preliminary evidence that IRE is able to cause a systemic anti-tumor immune response (i.e. abscopal effect), which may enhance the effect of subsequent Nivolumab treatment. In addition, the trial aims to clarify the systemic effects of IRE over time and thereby to provide more insight in the mechanism of work of the technique.
Read the detailed description
The prognosis of patients newly diagnosed with pancreatic ductal adenocarcinoma (PDAC) is extremely poor with a 5-year overall survival rate of less than 5%. To improve this dismal outcome, new treatment approaches are urgently needed. So far, immune-checkpoint therapy was not successful in patients with PDAC. Given the poor response to conventional chemotherapy, there is an imperative need to make PDACs amenable to immune-checkpoint therapy. Irreversible electroporation (IRE) is a relatively novel and safe ablation technique that destroys tumors by using apoptosis-inducing electrical currents inducing local and systemic pro-inflammatory cytokine expression and enhances the presence of cytotoxic CD8+ T-cells, while the apoptotic cell material preserves neo-antigen properties detectable by dendritic cells. This effect might be further enhanced by immune-checkpoint therapy.
The rationale of our study is to convert immunologically cold PDACs into hot PDACs by triggering an enhanced local and systemic immune response. We hypothesize that among patients with metastatic PDAC, the IRE of one liver metastasis followed by the administration of an immune-checkpoint inhibitor leads to a measurable radiological response in a selected non-treated liver metastasis. Furthermore, we hypothesize that the immune response is both local in the form of tumor infiltrating lymphocytes (TILS) and an immunologically activated tumor microenvironment in the IRE-treated metastasis, as well as systemic as evidenced by an abscopal response in the IRE-untreated metastatic and primary site.
The objective of the trial is to examine whether for patients with metastatic PDAC the combination of IRE of one liver metastasis followed by the administration of five doses of nivolumab leads to a measurable radiological response in a selected non-treated liver metastasis.
To demonstrate that the trial treatment leads to a measurable immune response, multiple translational research projects will assess the effect of IRE and nivolumab on the development of the local and peripheral tumor immune response over time.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Nivolumab
- Keywords
- metastatic Pancreatic Cancer, Irreversible electroporation (IRE), nivolumab, Phase II trial
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
The patients start treatment with nivolumab on day 1 after IRE and will be given nivolumab at a flat dose of 240 mg every 2 weeks (q2wk) for 5 cycles until Week 8.
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Experimental | Nivolumab treatment will be given every 2 weeks at a standard flat dose of 240 mg for a total of 5 doses, and the IRE procedure will be performed using the standard setting to ablate tumors at the level of the liver that is well tolerated by the patients. Two weeks after the last dose of nivolumab ("Week 8"), radiological restaging will be performed (="Week 10"). Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective response rate (ORR) after the 5th dose of nivolumab of the reference liver metastasis that was not biopsied.
The objective response rate (ORR) according to RECIST v1.1 after the 5th dose of nivolumab of the reference liver metastasis that was not biopsied, assessed 2-4 weeks after the 5th dose of nivolumab, defined as proportion of patients achieving Complete Response (CR) or Partial Response (PR). The assessment will be based on re-staging the patients with a CT-scan 2-4 weeks after the 5th dose of nivolumab. Patients without tumor assessment 2-4 weeks after the 5th dose of nivolumab will be counted as non-responders.
Measured: At 2-4 weeks after the 5th dose of nivolumab
Secondary outcomes (8)
Objective Response Rate (ORR) after the 5th dose of nivolumab of the primary tumor site (pancreas).
The ORR according to RECIST v1.1 after the 5th dose of nivolumab of the primary tumor site (pancreas), assessed 2-4 weeks after the 5th dose of nivolumab, defined as percentage of patients achieving Complete Response (CR) or Partial Response (PR). Patients without tumor assessment 2-4 weeks after the 5th dose of nivolumab will be counted as non-responders.
Measured: At 2-4 weeks after the 5th dose of nivolumab
ORR after the 5th dose of nivolumab of the IRE-treated liver metastasis
The ORR according to RECIST v1.1 after the 5th dose of nivolumab of IRE-treated liver metastasis, assessed 2-4 weeks after the 5th dose of nivolumab, defined as percentage of patients achieving CR or PR. Patients without tumor assessment 2-4 weeks after the 5th dose of nivolumab will be counted as non-responders.
Measured: At 2-4 weeks after the 5th dose of nivolumab
ORR based on best overall response
The ORR based on best overall response according to RECIST v1.1, assessed at any time between registration and disease progression by RECIST v1.1, death, or subsequent anticancer therapy, whichever occurs first, defined as percentage of patients achieving CR or PR.
Measured: From the date of registration until the date of progressive disease according to RECIST v1.1 or death, whichever occurs first, assessed up to 4 years after registration
Immune ORR (iORR) based on best overall immune response
The immune ORR (iORR) based on best overall immune response according to iRECIST, assessed at any time between registration and disease progression by iRECIST, death, or subsequent anticancer therapy, whichever occurs first, defined as percentage of patients achieving CR, PR, iCR or iPR.
Measured: From the date of registration until the date of progressive disease according to RECIST v1.1 or death, whichever occurs first, assessed up to 4 years after registration
Progression free survival (PFS)
Progression-free survival (PFS), defined as the time from registration until progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Measured: From the date of registration until the date of progressive disease according to RECIST v1.1 or death, whichever occurs first, assessed up to 4 years after registration
Immune PFS (iPFS)
Immune PFS (iPFS), defined as the time from registration until progression according to iRECIST (first iUPD without documented iSD, iPR or iCR thereafter) or death from any cause, whichever occurs first.
Patients without event at the time of analysis and patients starting a new anticancer therapy in the absence of an event will be censored at the date of the last tumor assessment showing non-progression (before the start of the new therapy, if any).
Measured: From the date of registration until the date of progressive disease according to RECIST v1.1 or death, whichever occurs first, assessed up to 4 years after registration
Overall survival (OS)
Overall survival (OS), defined as time form registration to death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known alive.
Measured: From the date of registration until the date of death, assessed up to 4 years after registration
Adverse events
Adverse events, assessed according to NCI CTCAE v5.0 and Clavien-Dindo Classification for procedural complications
Measured: From the date of registration to 100 days after last trial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start28 Jun 2020
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Why it stopped: difficult recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot, multicenter, single-arm phase II trial.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- St. Clara Research Ltd.
- Responsible party
- Sponsor
- Investigators
- Mathias Worni, MD, Study chair, Clarunis - St. Clara Hospital and University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212026
- Sponsor's protocol ID
- PDAC-IRE
- Status last verified
- Jul 2023
- First submitted
- 19 Dec 2019
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irreversible Electroporation (IRE) Followed by Nivolumab in Patients With Metastatic Pancreatic Cancer: a Multicenter Single-arm Phase II Trial
- ClinicalTrials.gov ID
- NCT04212026
- Acronym / sponsor ID
- PDAC-IRE
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- metastatic Pancreatic Cancer, Irreversible electroporation (IRE), nivolumab, Phase II trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult recruitement
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- St. Clara Research Ltd.
- Study start
- 28 Jun 2020 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 26 Dec 2019 (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.
This proof of concept trial aims to assess whether the combination of IRE with Nivolumab is safe and effective to treat metastatic pancreatic cancer, based on the available preliminary evidence that IRE is able to cause a systemic anti-tumor immune response (i.e. abscopal effect), which may enhance the effect of subsequent Nivolumab treatment. In addition, the trial aims to clarify the systemic effects of IRE over time and thereby to provide more insight in the mechanism of work of the technique.
Detailed description
The prognosis of patients newly diagnosed with pancreatic ductal adenocarcinoma (PDAC) is extremely poor with a 5-year overall survival rate of less than 5%. To improve this dismal outcome, new treatment approaches are urgently needed. So far, immune-checkpoint therapy was not successful in patients with PDAC. Given the poor response to conventional chemotherapy, there is an imperative need to make PDACs amenable to immune-checkpoint therapy. Irreversible electroporation (IRE) is a relatively novel and safe ablation technique that destroys tumors by using apoptosis-inducing electrical currents inducing local and systemic pro-inflammatory cytokine expression and enhances the presence of cytotoxic CD8+ T-cells, while the apoptotic cell material preserves neo-antigen properties detectable by dendritic cells. This effect might be further enhanced by immune-checkpoint therapy.
The rationale of our study is to convert immunologically cold PDACs into hot PDACs by triggering an enhanced local and systemic immune response. We hypothesize that among patients with metastatic PDAC, the IRE of one liver metastasis followed by the administration of an immune-checkpoint inhibitor leads to a measurable radiological response in a selected non-treated liver metastasis. Furthermore, we hypothesize that the immune response is both local in the form of tumor infiltrating lymphocytes (TILS) and an immunologically activated tumor microenvironment in the IRE-treated metastasis, as well as systemic as evidenced by an abscopal response in the IRE-untreated metastatic and primary site.
The objective of the trial is to examine whether for patients with metastatic PDAC the combination of IRE of one liver metastasis followed by the administration of five doses of nivolumab leads to a measurable radiological response in a selected non-treated liver metastasis.
To demonstrate that the trial treatment leads to a measurable immune response, multiple translational research projects will assess the effect of IRE and nivolumab on the development of the local and peripheral tumor immune response over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot, multicenter, single-arm phase II trial.
| Arm | Type | Receives |
|---|---|---|
| Nivolumab | Experimental | Drug: NivolumabNivolumab treatment will be given every 2 weeks at a standard flat dose of 240 mg for a total of 5 doses, and the IRE procedure will be performed using the standard setting to ablate tumors at the level of the liver that is well tolerated by the patients. Two weeks after the last dose of nivolumab ("Week 8"), radiological restaging will be performed (="Week 10"). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Written informed consent according to Swiss law and ICH GCP E6(R2) regulations before registration and prior to any trial specific procedures.
- Pathologically proven PDAC with liver metastases either by histology or cytology.
- Liver metastases fulfilling the following criteria:
- At least stable disease after the completion of 10-24 weeks of first line standard chemotherapy (either (m)FOLFIRINOX or Gemcitabine/Abraxane) as confirmed by tumor assessment within 21 days prior to registration OR at least stable disease after the completion of 10-24 weeks of second line standard chemotherapy (either (m)FOLFIRINOX or Gemcitabine/Abraxane) as confirmed by tumor assessment within 21 days prior to registration. The choice of chemotherapy regimen is based on the decision of the treating medical oncologist.
- Patients with a prior malignancy and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of that disease at registration. Note: Less than 2 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence.
Key exclusion criteria (13 listed)
- Clinically significant ascites that is not controllable.
- Prior radiotherapy to any PDAC disease site.
- Prior treatment with any immune checkpoint inhibitor.
- Concomitant or recent (within 100 days of registration) treatment with any other experimental drug (enrollment in another clinical trial).
- Concomitant use of other anti-cancer drugs or radiotherapy.
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 |
|---|---|---|
| NivolumabThe patients start treatment with nivolumab on day 1 after IRE and will be given nivolumab at a flat dose of 240 mg every 2 weeks (q2wk) for 5 cycles until Week 8. | Drug | Nivolumab |
Primary outcome
The objective response rate (ORR) after the 5th dose of nivolumab of the reference liver metastasis that was not biopsied.
Time frame: At 2-4 weeks after the 5th dose of nivolumab
The objective response rate (ORR) according to RECIST v1.1 after the 5th dose of nivolumab of the reference liver metastasis that was not biopsied, assessed 2-4 weeks after the 5th dose of nivolumab, defined as proportion of patients achieving Complete Response (CR) or Partial Response (PR). The assessment will be based on re-staging the patients with a CT-scan 2-4 weeks after the 5th dose of nivolumab. Patients without tumor assessment 2-4 weeks after the 5th dose of nivolumab will be counted as non-responders.
8 secondary outcomes
Objective Response Rate (ORR) after the 5th dose of nivolumab of the primary tumor site (pancreas).
Time frame: At 2-4 weeks after the 5th dose of nivolumab
ORR after the 5th dose of nivolumab of the IRE-treated liver metastasis
Time frame: At 2-4 weeks after the 5th dose of nivolumab
ORR based on best overall response
Time frame: From the date of registration until the date of progressive disease according to RECIST v1.1 or death, whichever occurs first, assessed up to 4 years after registration
Immune ORR (iORR) based on best overall immune response
Time frame: From the date of registration until the date of progressive disease according to RECIST v1.1 or death, whichever occurs first, assessed up to 4 years after registration
Progression free survival (PFS)
Time frame: From the date of registration until the date of progressive disease according to RECIST v1.1 or death, whichever occurs first, assessed up to 4 years after registration
Immune PFS (iPFS)
Time frame: From the date of registration until the date of progressive disease according to RECIST v1.1 or death, whichever occurs first, assessed up to 4 years after registration
Overall survival (OS)
Time frame: From the date of registration until the date of death, assessed up to 4 years after registration
Adverse events
Time frame: From the date of registration to 100 days after last trial treatment
Results and safety
The study was stopped early (reason given: difficult recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
Related trials for Metastatic Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
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.
Mathias Worni, MD study chair
Clarunis - St. Clara Hospital and University Hospital Basel
3 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 Metastatic Pancreatic Cancer, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
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 20 inclusion and 13 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: stopped early, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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 was stopped early (reason given: difficult recruitement). Results are not available in the source record.
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?
The objective response rate (ORR) after the 5th dose of nivolumab of the reference liver metastasis that was not biopsied. (time frame: At 2-4 weeks after the 5th dose of nivolumab). 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 18 Jul 2023.