Advanced Solid TumoursPhase 1/2MOVIENCT03518606
Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours
A Phase 1/2 study testing Durvalumab + Tremelimumab + metronomic Vinorelbine in people with Advanced Solid Tumours and Breast Cancer, run by UNICANCER at 9 sites in France.
Trial summary
This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumours, Breast Cancer, Head and Neck Cancer
- What is being tested?
- Durvalumab + Tremelimumab + metronomic Vinorelbine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 9 sitesFrance
- Study dates
- 20 Jun 2018to 19 Dec 2024
- Phase
- Phase 1/2
- 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
- Patient must have signed a written informed consent form prior to any study specific procedures.
- Histologically confirmed locally advanced or metastatic solid tumours, resistant to conventional therapies, and candidate to experimental therapy by local clinical board, from the following primary tumours:
- Head and neck squamous cell carcinomas,
- Breast cancer,
- Prostate cancer,
- Cervical cancer,
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- Miscellaneous primary tumours (except melanoma, non-small cell lung cancer [NSCLC], and renal cell cancer) with a high mutational load, as defined by a molecular clinical board after next-generation sequencing (comprehensive cancer gene panel or whole genome/exome sequencing) analysis.
- Patients aged ≥18 years at registration.
- Life expectancy ≥3 months.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Body weight >30 kg.
- Normal haematological function (ANC ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L; haemoglobin ≥9.0 g/dL).
- Normal hepatic function: total bilirubin ≤1.5 upper limit of normal (ULN) (unless documented Gilbert's syndrome); asparate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤2.5 ULN (≤5 ULN in the presence of liver metastases).
- Normal cardiac function: left ventricular ejection fraction (LVEF) ≥50% (any assessment method).
- Measured Creatinine clearance (Cockcroft and Gault) ≥40 mL/min OR creatinine ≤1.5 times ULN.
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients (urine within 72 hours, or serum pregnancy test within 14 days prior to enrolment).
- Patient willing and able to comply with the protocol for the duration of the study including: treatment and scheduled visits during the treatment phase, and visits during follow up.
- Patient is willing to comply with a baseline tumour biopsy (unless an archived biopsy of a secondary or a primary site of the current disease-collected within 3 months prior enrolment is available for research ; bone metastasis are accepted only when predominant extra-bone tissue is available), and with a series of blood samples throughout the study.
- Patient must be affiliated to a social health insurance.
Who cannot join
- Other concurrent malignancies, except adequately treated cone-biopsied in situ carcinoma of the cervix, or basal cell or squamous cell carcinoma of the skin. Patients who have had potentially curative therapy for a prior malignancy are eligible provided there has been no evidence of disease for ≥5 years and the risk of recurrence is considered low.
- Active brain metastases, spinal cord compression, or leptomeningeal disease. Patients whose brain metastases have been treated may participate if the brain metastases are stable by imagery (defined as 2 brain images, both obtained after treatment of the brain metastases and at least four weeks apart, and showing no evidence of intracranial progression). In addition, any neurologic symptoms caused by the brain metastases or their treatment must be resolved or stable, without steroidal treatment or with a dose of steroid ≤10 mg/day of prednisone or its equivalent and an anticonvulsants, for at least 14 days prior to the start of treatment.
- Previous treatment with an anti-PD1/PD-L1 including durvalumab or an anti-CTLA-4 therapy including tremelimumab or vinorelbine.
- Patients with known allergy or severe hypersensitivity to any of the study treatments or any of the study treatment excipients.
- History of active primary immunodeficiency.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
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- Patients with vitiligo or alopecia.
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement therapy.
- Any chronic skin condition that does not require systemic therapy.
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
- Patients with celiac disease controlled by diet alone.
- History of allogeneic organ transplantation.
- History or evidence of active, non-infectious pneumonitis.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive hepatitis B virus (HBV) surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody (anti-HBc) and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Uncontrolled intercurrent illness, including but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, clinically significant cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events, or compromise the ability of the patient to give written informed consent
- Patients who have received a live vaccine within 30 days of the planned start of the study treatment(s).
- Prior anticancer therapy, within the last 3 weeks. It includes radiotherapy (concurrent palliative radiotherapy is allowed), endocrine therapy, immunotherapy, chemotherapy (2 weeks for weekly schedule, 6 weeks for nitrosoureas and mitomycin C), or other investigational agents.
- Major surgery within 28 days prior to the first dose of study treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach or proximal small bowel that could affect absorption of oral vinorelbine
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Coordinator.
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Coordinator.
- Patients enrolled in another clinical study with an investigational product within 30 days of inclusion.
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Female patients who are pregnant or breastfeeding. Male or female patients of reproductive potential who are not willing to employ highly effective methods of contraception from screening to 180 days after receipt of the final dose of durvalumab and tremelimumab in combination or 90 days after the last dose of durvalumab monotherapy or vinorelbine.
- Persons deprived of their liberty or under protective custody or guardianship.
- Patients with any psychological, family, sociological or geographical problem potentially hampering compliance with the study protocol and follow-up schedule.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Institut de Cancérologie de l'Ouest - Site Paul Papin
Angers
Centre François Baclesse
Caen
Centre Georges-François Leclerc
Dijon, 21079
Institut Paoli-Calmettes
Marseille, 13273
Centre Antoine Lacassagne
Nice
Institut Curie
Paris
Centre Eugène Marquis
Rennes, 35042
Institut de Cancérologie de l'Ouest - Site René Gauducheau
Saint-Herblain
Gustave Roussy
Villejuif
About this study
Official title: A Phase I/II Basket Trial Evaluating a Combination of Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumour
This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours.
Read the detailed description
Methodology:
The study divided in two parts:
- Phase I part: dose escalation study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy,
- Phase II part: activity study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy.
Indication:
Patient eligible to the study are patients with histologically confirmed locally advanced or metastatic solid tumours, resistant to conventional therapies, and candidate to experimental therapy by local clinical board, from the following primary tumours: head and neck, prostate, cervix, and breast cancers, as well as miscellaneous malignancies with high mutational load.
- Conditions
- Advanced Solid Tumours, Breast Cancer, Head and Neck Cancer, Cervix Cancer, Prostate Cancer
- Being tested
- Durvalumab + Tremelimumab + metronomic Vinorelbine
- Keywords
- Advanced solid tumours, Durvalumab, Tremelimumab, Metronomic vinorelbine, High mutational load malignancies, Immunotherapy, Early phase, Combination study
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Uterine Cervical Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durvalumab + Tremelimumab + metronomic VinorelbineDrug
Patient will be treated by metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer cohort | Experimental | Patients presenting advanced refractory breast cancer Receives: Drug: Durvalumab + Tremelimumab + metronomic Vinorelbine |
| Head and neck cohort | Experimental | Patients presenting advanced refractory head and neck cancer Receives: Drug: Durvalumab + Tremelimumab + metronomic Vinorelbine |
| Cervix cohort | Experimental | Patients presenting advanced refractory cervix cancer Receives: Drug: Durvalumab + Tremelimumab + metronomic Vinorelbine |
| Prostate cohort | Experimental | Patients presenting advanced refractory prostate cancer Receives: Drug: Durvalumab + Tremelimumab + metronomic Vinorelbine |
| Miscellaneous cohort | Experimental | Patients presenting advanced refractory solid tumour with high mutational load Receives: Drug: Durvalumab + Tremelimumab + metronomic Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) and the phase II recommended dose (RP2D)
Phase I
Measured: 9 months
CBR-24week
Phase II
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start20 Jun 2018
- Primary completion1 Apr 2022
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumoursStudies of the same condition, open and under way.
- More trials run by UNICANCERThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study divided in two parts: * Phase I part: dose escalation study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy, * Phase II part: activity study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy.
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, AstraZeneca, Pierre Fabre Laboratories
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518606
- Sponsor's protocol ID
- UC-0101/1709
- Other IDs
- 2017-001857-14, 2017
- Acronym
- MOVIE
- Status last verified
- Jan 2024
- First submitted
- 23 Apr 2018
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De La Motte Rouge T, Frenel JS, Cropet C, Borcoman E, Hervieu A, Emile G, Augereau P, Charafe E, Legrand F, Dasse E, Goncalves A. Tremelimumab plus durvalumab combined to metronomic oral vinorelbine: Results from the breast cancer cohort of the phase II MOVIE study. Breast. 2025 Oct;83:104549. doi: 10.1016/j.breast.2025.104549. Epub 2025 Aug 5.
PubMed 40795480
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Basket Trial Evaluating a Combination of Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumour
- ClinicalTrials.gov ID
- NCT03518606
- Acronym / sponsor ID
- MOVIE / UC-0101/1709
- Conditions
- Advanced Solid Tumours, Breast Cancer, Head and Neck Cancer, Cervix Cancer, Prostate Cancer
- Keywords
- Advanced solid tumours, Durvalumab, Tremelimumab, Metronomic vinorelbine, High mutational load malignancies, Immunotherapy, Early phase, Combination study
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, AstraZeneca, Pierre Fabre Laboratories
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 8 May 2018 (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 is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours.
Detailed description
Methodology:
The study divided in two parts:
- Phase I part: dose escalation study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy,
- Phase II part: activity study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy.
Indication:
Patient eligible to the study are patients with histologically confirmed locally advanced or metastatic solid tumours, resistant to conventional therapies, and candidate to experimental therapy by local clinical board, from the following primary tumours: head and neck, prostate, cervix, and breast cancers, as well as miscellaneous malignancies with high mutational load.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study divided in two parts: * Phase I part: dose escalation study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy, * Phase II part: activity study of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy.
| Arm | Type | Receives |
|---|---|---|
| Breast cancer cohort | Experimental | Drug: Durvalumab + Tremelimumab + metronomic VinorelbinePatients presenting advanced refractory breast cancer |
| Head and neck cohort | Experimental | Drug: Durvalumab + Tremelimumab + metronomic VinorelbinePatients presenting advanced refractory head and neck cancer |
| Cervix cohort | Experimental | Drug: Durvalumab + Tremelimumab + metronomic VinorelbinePatients presenting advanced refractory cervix cancer |
| Prostate cohort | Experimental | Drug: Durvalumab + Tremelimumab + metronomic VinorelbinePatients presenting advanced refractory prostate cancer |
| Miscellaneous cohort | Experimental | Drug: Durvalumab + Tremelimumab + metronomic VinorelbinePatients presenting advanced refractory solid tumour with high mutational load |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient must have signed a written informed consent form prior to any study specific procedures.
- Histologically confirmed locally advanced or metastatic solid tumours, resistant to conventional therapies, and candidate to experimental therapy by local clinical board, from the following primary tumours:
- Patients aged ≥18 years at registration.
- Life expectancy ≥3 months.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Key exclusion criteria (31 listed)
- Other concurrent malignancies, except adequately treated cone-biopsied in situ carcinoma of the cervix, or basal cell or squamous cell carcinoma of the skin. Patients who have had potentially curative therapy for a prior malignancy are eligible provided there has been no evidence of disease for ≥5 years and the risk of recurrence is considered low.
- Active brain metastases, spinal cord compression, or leptomeningeal disease. Patients whose brain metastases have been treated may participate if the brain metastases are stable by imagery (defined as 2 brain images, both obtained after treatment of the brain metastases and at least four weeks apart, and showing no evidence of intracranial progression). In addition, any neurologic symptoms caused by the brain metastases or their treatment must be resolved or stable, without steroidal treatment or with a dose of steroid ≤10 mg/day of prednisone or its equivalent and an anticonvulsants, for at least 14 days prior to the start of treatment.
- Previous treatment with an anti-PD1/PD-L1 including durvalumab or an anti-CTLA-4 therapy including tremelimumab or vinorelbine.
- Patients with known allergy or severe hypersensitivity to any of the study treatments or any of the study treatment excipients.
- History of active primary immunodeficiency.
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 |
|---|---|---|
| Durvalumab + Tremelimumab + metronomic VinorelbinePatient will be treated by metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy | Drug | Breast cancer cohort, Cervix cohort, Head and neck cohort, Miscellaneous cohort, Prostate cohort |
Primary outcome
Maximum Tolerated Dose (MTD) and the phase II recommended dose (RP2D)
Time frame: 9 months
Phase I
CBR-24week
Time frame: 24 months
Phase II
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 15 Jan 2025.
- Derived from this study: PubMed 40795480De La Motte Rouge T, Frenel JS, Cropet C, Borcoman E, Hervieu A, Emile G, Augereau P, Charafe E, Legrand F, Dasse E, Goncalves A. Tremelimumab plus durvalumab combined to metronomic oral vinorelbine: Results from the breast cancer cohort of the phase II MOVIE study. Breast. 2025 Oct;83:104549. doi: 10.1016/j.breast.2025.104549. Epub 2025 Aug 5.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Durvalumab + Tremelimumab + metronomic Vinorelbine in people with Advanced Solid Tumours and Breast Cancer, run by UNICANCER at 9 sites 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 20 inclusion and 31 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 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum Tolerated Dose (MTD) and the phase II recommended dose (RP2D) (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03518606, which also lists 1 linked publication.
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 15 Jan 2025.