Metastatic Uveal MelanomaPhase 2PLUMENCT05282901
Efficacy and Safety of Pembrolizumab in Combination With Lenvatinib in Metastatic Uveal MElanoma Patients (PLUME)
A Phase 2 study testing Pembrolizumab 25 MG/1 ML Intravenous Solution in people with Metastatic Uveal Melanoma, run by Institut Curie at 1 site in France.
Trial summary
Because we suspect that the benefit of anti-PD-1 in metastatic UM patients could vary according to previous exposure to Tebentafusp (better efficacy of anti-PD-1 after Tebentafusp), the combination of pembrolizumab and lenvatinib will be assessed in two independent cohorts: cohort 1 with Tebentafusp-naive patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Uveal Melanoma
- What is being tested?
- Pembrolizumab 25 MG/1 ML Intravenous Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2022to 9 Jul 2026
- 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
- Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of metastatic uveal melanoma (UM).
- (i) Not having been treated with Tebentafusp for cohort 1 (Tebentafusp-naive patients) OR (ii) Having been previously treated with Tebentafusp for cohort 2.
- Life expectancy > 3 months.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG has to be performed at inclusion.
- Male participants must agree to use contraception
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Show all 14Show fewer
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the contraceptive guidance
- Measurable disease based on RECIST 1.1. lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Have provided a newly obtained (or archival if no systemic treatment since the sampling) core or excisional biopsy of a tumor lesion not previously irradiated.
- Patients with French Social Security in compliance with the French law relating to biomedical research
- All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to first administration of study drug.
- Have adequate organ function as defined in the protocol.
Who cannot join
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, and CD137) for metastatic UM.
- In contrast, prior therapy with Tebentafusp is permitted.
- Has recently received prior systemic anti-cancer therapy including investigational agents or biological agents [eg cytokines, antibodies or small molecules kinase inhibitors within 3 weeks or nitrosoureas/mitomycin C within 6 weeks] prior to allocation. Prior liver surgery or local treatment of metastases is allowed if there is an unequivocal progression.
- Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.
- Note: Do not administer for at least 2 weeks following major surgery and until adequate wound healing.
Show all 37Show fewer
- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. Only mRNA vaccines are authorized to prevent SARS-CoV-2 infection (COVID-19) during the trial.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ cancers
- Has known active CNS metastases and/or carcinomatous meningitis. Brain imaging is not required at inclusion if asymptomatic. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or lenvatinib and/or any of their excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug.
- Has a known history of Human Immunodeficiency Virus (HIV) infection. HIV testing is not required at allocation.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- Has a known history of active TB (Bacillus Tuberculosis).
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Has had an allogenic tissue/solid organ transplant.
- Concurrent or recent (less than 1 week prior inclusion) immunosuppressive medications (including corticosteroids exceeding 10 mg daily of prednisone equivalent, azathioprin); hydrocortisone at physiological doses is allowed;
- Uncontrolled blood pressure (Systolic BP>150 mmHg and/or diastolic BP >90 mmHg) in spite of an optimized regimen of antihypertensive medication.
- Electrolyte abnormalities that have not been corrected as assessed by the investigator.
- Significant cardiovascular impairment: history of congestive heart failure from New York Heart Association (NYHA) Class III or IV, unstable angina, myocardial infarction or stroke within 12 months of the first dose of study drug, or cardiac arrhythmia with hemodynamic instability. Note : medically controlled arrhythmia would be permitted.
- Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy.
- Subjects having > 1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is <1 g/24 hours.
- Subjects who have not recovered adequately from any toxicity from other anti-cancer treatment regimens and/or complications from major surgery prior to starting therapy.
- Has had major surgery within 3 weeks prior to first dose of study interventions. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.
- Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
- Has a LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).
- Prolongation of QTcF interval to >480 ms.
- Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
- Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Monocentric, Single Arm Trial Evaluating the Efficacy and Safety of Pembrolizumab in Combination With Lenvatinib in Metastatic Uveal MElanoma Patients
Because we suspect that the benefit of anti-PD-1 in metastatic UM patients could vary according to previous exposure to Tebentafusp (better efficacy of anti-PD-1 after Tebentafusp), the combination of pembrolizumab and lenvatinib will be assessed in two independent cohorts: cohort 1 with Tebentafusp-naive patients, and cohort 2 with patients previously treated by Tebentafusp.
The study is a monocentric, phase II trial with a single-arm of treatment in each cohort.
Liver MRI and chest-abdomen-pelvis CT will be performed every 9 weeks until progressive disease (PD), followed by a Follow-up visit within 28 days after last treatment intake. Survival status will be registered after patient discontinuation.
Read the detailed description
After a screening phase of up to 28 days, each participant will receive assigned study intervention of pembrolizumab (maximum of 35 cycles) plus lenvatinib until reaching a discontinuation criterion including disease progression.
Because we suspect that the benefit of anti-PD-1 in metastatic UM patients could vary according to previous exposure to Tebentafusp (better efficacy of anti-PD-1 after Tebentafusp), the combination of pembrolizumab and lenvatinib will be assessed in two independent cohorts: cohort 1 with Tebentafusp-naive patients, and cohort 2 with patients previously treated by Tebentafusp.
The study is a monocentric, phase II trial with a single-arm of treatment in each cohort.
Liver MRI and chest-abdomen-pelvis CT will be performed every 9 weeks until progressive disease (PD), followed by a Follow-up visit within 28 days after last treatment intake. Survival status will be registered after patient discontinuation.
Participants who discontinue for reasons other than radiographic PD will have post-treatment follow-up imaging for disease status until (i) PD is documented radiographically per RECIST 1.1, or (ii) a non-study anticancer treatment is initiated, or (iii) consent is withdrawn, or (iv) the participant becomes lost to follow-up.
Lenvatinib will not be stopped for complete response (CR); participants should remain on lenvatinib until the discontinuation criterion are met.
All participants will be followed for OS until death, withdrawal of consent, loss to follow-up, or the end of the study. The survival status of all the participants will be collected at the date of the Last Visit of the Last Patient.
Exploratory research on biomarkers of response or resistance will also be conducted.
- Conditions
- Metastatic Uveal Melanoma
- Being tested
- Pembrolizumab 25 MG/1 ML Intravenous Solution
- Keywords
- Metastatic, Uveal, Melanoma, Immune, Response
- Medical subject headings
- Uveal Melanoma, Neoplasm Metastasis, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab 25 MG/1 ML Intravenous SolutionDrug
Also called Lenvatinib
Taken together, we hypothesize that combining pembrolizumab with lenvatinib in metastatic UM may target essential cellular oncogenic pathways while normalizing tumor vascularization, thus allowing an increased infiltration of the tumor by immune cells and an improved immune response.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Uveal MElanoma patients | Experimental | Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of metastatic uveal melanoma (UM) Receives: Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) according to RECIST 1.1 criteria
PFS will be estimated as a crude rate at 27 weeks (+/- 2 weeks, i.e. 14 days) after the start of treatment. Will be considered progression events: objective clinical progression, radiological progression according to RECIST 1.1 criteria and death from any cause.
Measured: After 9 cycles (i.e. 27 weeks +/- 2 weeks)
Secondary outcomes (4)
Progression-free survival (PFS)
PFS is defined as the time from the date of treatment start until the date of first objective clinical or radiological disease progression (RECIST 1.1) or death. Patients alive and without progression at the date of last contact will be censored at this date.
Measured: From date of first study treaments intakes until the date of first documented progression assessed up to 30 months
Objective response rate (ORR)
Objective response rate using the RECIST criteria version 1.1 is defined as a Confirmed complete response (CR) or partial response (PR) at nine cycles, 27 weeks (+/- 2 weeks, i.e. 14 days)
Measured: After 9 cycles (i.e. 27 weeks +/- 2 weeks)
Progression-free survival (PFS) using the iRECIST criteria
27-weeks PFS using the iRECIST criteria, based on investigator assessment
Measured: After 9 cycles (i.e. 27 weeks +/- 2 weeks)
Overall Survival (OS)
OS is defined as the time from the date of treatment start until the date of death due to any cause. Patients alive at the date of last contact will be censored at this date.
Measured: From date of first study treatments intake until the date of death from any cause, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start7 Jul 2022
- Primary completion28 Apr 2025
- Study completion9 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Uveal MelanomaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric, phase II trial with a single-arm of treatment in two independent cohorts with Tebentafusp-naive patients, and with patients previously treated by Tebentafusp
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Manuel Rodrigues, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282901
- Sponsor's protocol ID
- IC 2020-06
- Acronym
- PLUME
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2022
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Monocentric, Single Arm Trial Evaluating the Efficacy and Safety of Pembrolizumab in Combination With Lenvatinib in Metastatic Uveal MElanoma Patients
- ClinicalTrials.gov ID
- NCT05282901
- Acronym / sponsor ID
- PLUME / IC 2020-06
- Conditions
- Metastatic Uveal Melanoma
- Keywords
- Metastatic, Uveal, Melanoma, Immune, Response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 16 Mar 2022 (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.
Because we suspect that the benefit of anti-PD-1 in metastatic UM patients could vary according to previous exposure to Tebentafusp (better efficacy of anti-PD-1 after Tebentafusp), the combination of pembrolizumab and lenvatinib will be assessed in two independent cohorts: cohort 1 with Tebentafusp-naive patients, and cohort 2 with patients previously treated by Tebentafusp.
The study is a monocentric, phase II trial with a single-arm of treatment in each cohort.
Liver MRI and chest-abdomen-pelvis CT will be performed every 9 weeks until progressive disease (PD), followed by a Follow-up visit within 28 days after last treatment intake. Survival status will be registered after patient discontinuation.
Detailed description
After a screening phase of up to 28 days, each participant will receive assigned study intervention of pembrolizumab (maximum of 35 cycles) plus lenvatinib until reaching a discontinuation criterion including disease progression.
Because we suspect that the benefit of anti-PD-1 in metastatic UM patients could vary according to previous exposure to Tebentafusp (better efficacy of anti-PD-1 after Tebentafusp), the combination of pembrolizumab and lenvatinib will be assessed in two independent cohorts: cohort 1 with Tebentafusp-naive patients, and cohort 2 with patients previously treated by Tebentafusp.
The study is a monocentric, phase II trial with a single-arm of treatment in each cohort.
Liver MRI and chest-abdomen-pelvis CT will be performed every 9 weeks until progressive disease (PD), followed by a Follow-up visit within 28 days after last treatment intake. Survival status will be registered after patient discontinuation.
Participants who discontinue for reasons other than radiographic PD will have post-treatment follow-up imaging for disease status until (i) PD is documented radiographically per RECIST 1.1, or (ii) a non-study anticancer treatment is initiated, or (iii) consent is withdrawn, or (iv) the participant becomes lost to follow-up.
Lenvatinib will not be stopped for complete response (CR); participants should remain on lenvatinib until the discontinuation criterion are met.
All participants will be followed for OS until death, withdrawal of consent, loss to follow-up, or the end of the study. The survival status of all the participants will be collected at the date of the Last Visit of the Last Patient.
Exploratory research on biomarkers of response or resistance will also be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric, phase II trial with a single-arm of treatment in two independent cohorts with Tebentafusp-naive patients, and with patients previously treated by Tebentafusp
| Arm | Type | Receives |
|---|---|---|
| Metastatic Uveal MElanoma patients | Experimental | Drug: Pembrolizumab 25 MG/1 ML Intravenous SolutionMale/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of metastatic uveal melanoma (UM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of metastatic uveal melanoma (UM).
- (i) Not having been treated with Tebentafusp for cohort 1 (Tebentafusp-naive patients) OR (ii) Having been previously treated with Tebentafusp for cohort 2.
- Life expectancy > 3 months.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG has to be performed at inclusion.
- Male participants must agree to use contraception
Key exclusion criteria (37 listed)
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, and CD137) for metastatic UM.
- In contrast, prior therapy with Tebentafusp is permitted.
- Has recently received prior systemic anti-cancer therapy including investigational agents or biological agents [eg cytokines, antibodies or small molecules kinase inhibitors within 3 weeks or nitrosoureas/mitomycin C within 6 weeks] prior to allocation. Prior liver surgery or local treatment of metastases is allowed if there is an unequivocal progression.
- Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.
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 |
|---|---|---|
| Pembrolizumab 25 MG/1 ML Intravenous SolutionAlso: LenvatinibTaken together, we hypothesize that combining pembrolizumab with lenvatinib in metastatic UM may target essential cellular oncogenic pathways while normalizing tumor vascularization, thus allowing an increased infiltration of the tumor by immune cells and an improved immune response. | Drug | Metastatic Uveal MElanoma patients |
Primary outcome
Progression-free survival (PFS) according to RECIST 1.1 criteria
Time frame: After 9 cycles (i.e. 27 weeks +/- 2 weeks)
PFS will be estimated as a crude rate at 27 weeks (+/- 2 weeks, i.e. 14 days) after the start of treatment. Will be considered progression events: objective clinical progression, radiological progression according to RECIST 1.1 criteria and death from any cause.
4 secondary outcomes
Progression-free survival (PFS)
Time frame: From date of first study treaments intakes until the date of first documented progression assessed up to 30 months
Objective response rate (ORR)
Time frame: After 9 cycles (i.e. 27 weeks +/- 2 weeks)
Progression-free survival (PFS) using the iRECIST criteria
Time frame: After 9 cycles (i.e. 27 weeks +/- 2 weeks)
Overall Survival (OS)
Time frame: From date of first study treatments intake until the date of death from any cause, assessed up to 100 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 28 Jul 2026.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Related trials for Metastatic Uveal Melanoma
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Recruiting
Immune Response to Percutaneous Hepatic Perfusion With Melphalan for Ocular Melanoma Metastatic to the Liver
Uveal Melanoma
Active, not recruitingPhase 2
Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma
Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size
Not yet recruitingPhase 1/2
Safety and Efficacy Study in Adults With Advanced Solid Tumors Receiving REGN13089-M404-M2980, an Antibody-drug Conjugate That Targets MET Protein on Tumors
Advanced Solid Tumors
Active, not recruitingPhase 1/2
Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma
Melanoma Metastatic, Melanoma of Skin
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.
Manuel Rodrigues, MD principal investigator
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab 25 MG/1 ML Intravenous Solution in people with Metastatic Uveal Melanoma, run by Institut Curie at 1 site in France.
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 14 inclusion and 37 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 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Progression-free survival (PFS) according to RECIST 1.1 criteria (time frame: After 9 cycles (i.e. 27 weeks +/- 2 weeks)). 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 28 Jul 2026.